Drug Reference

amiodarone hydrochlorid (a mee o' da rone)Cordarone, Pacerone
Pregnancy Category D
Drug classes
Antiarrhythmic Adrenergic blocker (not used as sympatholytic drug)

Therapeutic actions
Type III antiarrhythmic: Acts directly on cardiac cell membrane; prolongs repolarization and refractory period; increases ventricular fibrillation threshold; acts on peripheral smooth muscle to decrease peripheral resistance
Indications
Only for treatment of the following documented life-threatening recurrent ventricular arrhythmias that do not respond to other antiarrhythmics or when alternative agents are not tolerated: Recurrent ventricular fibrillation, recurrent hemodynamically unstable ventricular tachycardia. Serious and even fatal toxicity has been reported with this drug; use alternative agents first; very closely monitor patient receiving this drug Unlabeled uses: Treatment of refractory sustained or paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia; treatment of symptomatic atrial flutter Contraindicated with hypersensitivity to amiodarone, sinus node dysfunction, heart block, severe bradycardia, hypokalemia, lactation. Use cautiously with thyroid dysfunction, pregnancy.
Contraindications and cautions
Available forms
Tablets200, 400 mg; injection50 mg/mL

Dosages
Careful patient assessment and evaluation with continual monitoring of cardiac response are necessary for titrating the dosage. Therapy should begin in the hospital with continual monitoring and emergency equipment on standby. The following is a guide to usual dosage.
ADULTS Oral
Loading dose: 8001,600 mg/day PO in divided doses, for 13 wk; reduce dose to 600800 mg/day in divided doses for 1 mo; if rhythm is stable, reduce dose to 400 mg/day in one to two divided doses for maintenance dose. Adjust to the lowest possible dose to limit side effects.
IV
1,000 mg IV over 24 hr150 mg loading dose over 10 min, followed by 360 mg over 6 hr at rate of 1 mg/min. For maintenance infusion, 540 mg at 0.5 mg/min over 18 hr. May be continued up to 96 hr or until rhythm is stable. Switch to oral form as soon as possible.
Pharmacokinetics
Route Oral IV Onset 23 days Immediate Peak 37 hr 20 min Duration 68 hr Infusion
Metabolism: Hepatic; T1/2: 10 days, then 4055 days Distribution: Crosses placenta; enters breast milk Excretion: Bile, feces
IV facts
Preparation: Do not use PVC container if infusion is to exceed 2 hr; use glass or polyolefin instead. Dilute 150 mg in 100 mL D5W for rapid loading dose (1.5 mg/mL). Dilute 900 mg in 500 mL D5W for slow infusions (1.8 mg/mL). Store at room temperature and use within 24 hr. Infusion: Infuse loading dose over 10 min. Immediately follow with slow infusion of 1 mg/min or 33.3 mL/hr. Maintenance infusion of 0.5 mg/min or 16.6 mL/hr can be continued up to 96 hr. Use of an infusion pump is advised. Incompatibilities: Do not mix with aminophylline, cefazolin, meclocillin, heparin, sodium bicarbonate; do not mix in solution with other drugs.
Adverse effects
CNS: Malaise, fatigue, dizziness, tremors, ataxia, paresthesias, lack of coordination CV: Cardiac arrhythmias, CHF, cardiac arrest, hypotension EENT: Corneal microdeposits (photophobia, dry eyes, halos, blurred vision); ophthalmic abnormalities including permanent blindness Endocrine: Hypothyroidism or hyperthyroidism GI: Nausea, vomiting, anorexia, constipation, abnormal LFTs, liver toxicity Respiratory: Pulmonary toxicitypneumonitis, infiltrates (shortness of breath, cough, rales, wheezes) Other: Photosensitivity, angioedema
Interactions
Drug-drug Increased digitalis toxicity with digoxin Increased quinidine toxicity with quinidine Increased procainamide toxicity with procainamide Increased flecainide toxicity with amiodarone Increased phenytoin toxicity with phenytoin, ethotoin Increased bleeding tendencies with warfarin Potential sinus arrest and heart block with beta blockers, calcium channel blockers Drug-lab test Increased T3 levels, increased serum reverse T3 levels
Nursing considerations CLINICAL ALERT!
Name confusion has occurred with amrinone (name has now been changed to inamrinone, but confusion may still occur); use caution.
Assessment
History: Hypersensitivity to amiodarone, sinus node dysfunction, heart block, severe bradycardia, hypokalemia, lactation, thyroid dysfunction, pregnancy Physical: Skin color, lesions; reflexes, gait, eye examination; P, BP, auscultation, continuous ECG monitoring; R, adventitious sounds, baseline chest x-ray; liver evaluation; LFTs, serum electrolytes, T4, and T3
Interventions
Monitor cardiac rhythm continuously. Monitor for an extended period when dosage adjustments are made. WARNING: Monitor for safe and effective serum levels (0.52.5 mcg/mL). WARNING: Doses of digoxin, quinidine, procainamide, phenytoin, and warfarin may need to be reduced one-third to one-half when amiodarone is started. Give drug with meals to decrease GI problems. Arrange for ophthalmologic examinations; reevaluate at any sign of optic neuropathy. Arrange for periodic chest x-ray to evaluate pulmonary status (every 36 mo). Arrange for regular periodic blood tests for liver enzymes, thyroid hormone levels
Atracurium Besylate Injection, USP (For IV Injection

Atracurium Besylate Injection, USP 50 mg per 5 mL (10 mg per mL) 5 mL Single-Dose Vial For IV Injection
CLINICAL PHARMACOLOGY
Atracurium besylate is a nondepolarizing skeletal muscle relaxant. Nondepolarizing agents antagonize the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end-plate. This antagonism is inhibited, and neuromuscular block reversed, by acetylcholinesterase inhibitors such as neostigmine, edrophonium, and pyridostigmine.
WARNINGS
ATRACURIUM SHOULD BE USED ONLY BY THOSE SKILLED IN AIRWAY MANAGEMENT AND RESPIRATORY SUPPORT. EQUIPMENT AND PERSONNEL MUST BE IMMEDIATELY AVAILABLE FOR ENDOTRACHEAL INTUBATION AND SUPPORT OF VENTILATION, INCLUDING ADMINISTRATION OF POSITIVE PRESSURE OXYGEN. ADEQUACY OF RESPIRATION MUST BE ASSURED THROUGH ASSISTED OR CONTROLLED VENTILATION. ANTICHOLINESTERASE REVERSAL AGENTS SHOULD BE IMMEDIATELY AVAILABLE. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED95), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection. An atracurium besylate dose of 0.4 to 0.5 mg/kg (1.7 to
2.2 times the ED95), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection.
Diltiazem Hydrochloride for Injection

For Continuous Intravenous Infusion Not For BolusADD-Vantage Vials Mechanisms of Action Diltiazem inhibits the influx of calcium (Ca2+) ions during membrane depolarization of cardiac and vascular smooth muscle. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Diltiazem exhibits frequency (use) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates. Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry circuit in AV nodal reentrant tachycardias and reciprocating tachycardias, e.g., Wolff-Parkinson-White syndrome (WPW). Diltiazem prolongs the sinus cycle length. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Diltiazem has no significant electrophysiologic effects on tissues in the heart that are fast sodium channel dependent, e.g., His-Purkinje tissue, atrial and ventricular muscle, and extranodal accessory pathways. Like other calcium channel antagonists, because of its effect on vascular smooth muscle, diltiazem decreases total peripheral resistance resulting in a decrease in both systolic and diastolic blood pressure. 1. Atrial Fibrillation or Atrial Flutter. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff- Parkinson-White (WPW) syndrome or short PR syndrome. 2. Paroxysmal Supraventricular Tachycardia. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. The use of diltiazem hydrochloride should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.
Contraindications
Diltiazem hydrochloride injection is contraindicated in: 1. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. 2. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. 3. Patients with severe hypotension or cardiogenic shock. 4. Patients who have demonstrated hypersensitivity to the drug. 5. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). 6. Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome.
Adverse Reactions
The following adverse reaction rates are based on the use of diltiazem hydrochloride in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or openlabel conditions. Worldwide experience in over 1,300 patients was similar. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Hypotension was the most commonly reported adverse event during clinical trials. Asymptomatic hypotension occurred in 4.3% of patients. Symptomatic hypotension occurred in 3.2% of patients. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Other events reported in at least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) - 3.9%, vasodilation (flushing) - 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) - 1%. In addition, the following events were reported infrequently (less than 1%): Cardiovascular: Asystole, atrial flutter, AV block first degree, AV block second degree, bradycardia, chest pain, congestive heart failure, sinus pause, sinus node dysfunction, syncope, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia. Dermatologic: Pruritus, sweating. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting. Nervous System: Dizziness, paresthesia. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia. Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria.
Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor. Other: Allergic reactions, angioedema (including facial or periorbital edema), CPK elevation, epistaxis, eye irritation, gingival hyperplasia, hemolytic anemia, hyperglycemia, impotence, increased bleeding time, leukopenia, muscle cramps, myopathy, nasal congestion, nocturia, osteoarticular pain, polyuria, retinopathy, sexual difficulties, thrombocytopenia, tinnitus. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient.
Overdosage
Overdosage experience is limited. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. The following measures may be considered: Bradycardia: Administer atropine (0.6 to 1 mg). If there is no response to vagal blockade administer isoproterenol cautiously. High-degree AV Block: Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. Hypotension: Vasopressors (e.g., dopamine or levarterenol bitartrate). The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes, and repeated every 10-20 minutes as necessary. Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. Infusions of calcium for 24 hours or more may be required. Patients should be monitored for signs of hypercalcemia. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. The intravenous LD50s in mice and rats were 60 and 38 mg/kg, respectively. The toxic dose in man is not known.
Diltiazem Injection Dosage and Administration

NOTE: This drug product is not for direct bolus injection. Text referring to direct bolus injection is provided for information purposes only.
Direct Intravenous Single Injections (Bolus) The initial dose of Diltiazem Hydrochloride Injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Subsequent intravenous bolus doses should be individualized for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Experience with this dose is limited. Continuous Intravenous Infusion For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. Some patients may maintain response to an initial rate of 5 mg/h. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required. The infusion may be maintained for up to 24 hours. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. Dilution: To prepare Diltiazem Hydrochloride for Injection for continuous intravenous infusion, assemble the ADD-Vantage vial as directed for use with either 0.9% Sodium Chloride or Dextrose (5%) injection. Mix thoroughly. Keep diluted Diltiazem Hydrochloride for Injection at controlled room temperature (15 to 30C) (59 to 86F) [See USP.] or refrigerated (2 to 8C) (36 to 46F) until use. Use within 24 hours. Administration Dose* Infusion Rate 10 10 mL/h mg/h 15 15 mL/h mg/h
Diluent Volume 100 mL
Quantity of Diltiazem Hydrochloride Final to Add Concentration 100 mg 1 mg/mL (1 ADD-Vantage Vial)
*5 mg/h may be appropriate for some patients. INSTRUCTIONS FOR USE To Use Vial in ADD-Vantage Flexible Diluent Container To Open: Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.
Fig. 1
Fig. 2
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the tie membrane, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
Fig. 3 To Reconstitute the Drug:
Fig. 4
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time.
Fig. 5 Preparation for Administration: (Use Aseptic Technique)
Fig. 6
1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible containers in series connections.
Dobutamine 250 mg Injection, USP 20 mL Single Dose Vial
Precautions
1. During the administration of Dobutamine, as with any adrenergic agent, ECG and blood pressure should be continuously monitored. In addition, pulmonary wedge pressure and cardiac output should be monitored whenever possible to aid in the safe and effective infusion of Dobutamine. 2. Hypovolemia should be corrected with suitable volume expanders before treatment with Dobutamine is instituted. 3. No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis. Usage Following Acute Myocardial Infarction Clinical experience with Dobutamine following myocardial infarction has been insufficient to establish the safety of the drug for this use. There is concern that any agent that increases contractile force and heart rate may increase the size of an infarction by intensifying ischemia, but it is not known whether Dobutamine does so. Laboratory Tests Dobutamine, like other 2-agonists, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels. Accordingly, consideration should be given to monitoring serum potassium. Drug Interactions Animal studies indicate that Dobutamine may be ineffective if the patient has recently received a -blocking drug. In such a case, the peripheral vascular resistance may increase. Preliminary studies indicate that the concomitant use of Dobutamine and nitroprusside results in a higher cardiac output and, usually, a lower pulmonary wedge pressure than when either drug is used alone. There was no evidence of drug interactions in clinical studies in which Dobutamine was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen
Adverse Reactions
Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related. Hypotension Precipitous decreases in blood pressure have occasionally been described in association with Dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate. Reactions at Sites of Intravenous Infusion Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported. Miscellaneous Uncommon Effects The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported. Administration of Dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Overdosage
Overdoses of Dobutamine have been reported rarely. The following is provided to serve as a guide if such an overdose is encountered. Signs and Symptoms Toxicity from Dobutamine is usually due to excessive cardiac -receptor stimulation. The duration of action of Dobutamine is generally short (T1/2= 2 minutes) because it is rapidly metabolized by catechol-0-methyltranferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of Dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. The initial actions to be taken in a Dobutamine overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy. Protect the patients airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patients vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be
decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patients airway when employing gastric emptying or charcoal. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of Dobutamine.
Dosage and Administration

Note Do not add Dobutamine to 5% Sodium Bicarbonate Injection or to any other strongly alkaline solution. Because of potential physical incompatibilities, it is recommended that Dobutamine not be mixed with other drugs in the same solution. Dobutamine should not be used in conjunction with other agents or diluents containing both sodium bisulfite and ethanol. Preparation and Stability At the time of administration, Dobutamine must be further diluted in an IV container to at least a 50 mL solution using one of the following intravenous solutions as a diluent: 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 10% Dextrose Injection, Isolyte M with 5% Dextrose Injection, Lactated Ringers Injection, 5% Dextrose in Lactated Ringers Injection, Normosol-M in D5-W, 20% Osmitrol in Water for Injection, 0.9% Sodium Chloride Injection, or Sodium Lactate Injection. Intravenous solutions should be used within 24 hours. Recommended Dosage Infusion of Dobutamine should be started at a low rate (0.5 to 1 mcg/kg/min) and titrated at intervals of a few minutes, guided by the patients response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate and (whenever possible) measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure. In reported trials, the optimal infusion rates have varied from patient to patient, usually 2 to 20 mcg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. Rates of infusion (mL/h) for Dobutamine concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL necessary to attain various delivery rates of Dobutamine (mcg/kg/ min) for patients of different weights are given in Table 1. Table 1 Dobutamine Injection USP Infusion Rate (mL/h) for 500 mcg/mL concentration
Dopamine Hydrochloride
Pronunciation: (DOE-pa-meen HYE-droe-KLOR-ide) Class: Vasopressor
Trade Names
Dopamine Hydrochloride - Injection 40 mg/mL - Injection 80mg/mL - Injection 160 mg/mL Dopamine Hydrochloride in Dextrose 5% - Injection 200 mg per 250 mL (0.8 mg/mL) - Injection 400 mg per 500 mL (0.8 mg/mL) - Injection 400 mg per 250 mL (1.6 mg/mL) - Injection 800 mg per 500 mL (1.6 mg/mL) - Injection 800 mg per 250 mL (3.2 mg/mL)
Pharmacology
Stimulates beta-1 receptors in the heart, causing more complete and forceful contractions (inotropy). Also acts on alpha receptors (dose dependent) and has dopaminergic effects.
Pharmacokinetics
Distribution
Widely distributed; does not cross the blood-brain barrier to a significant extent.
Metabolism
Metabolized in the liver, kidney, and plasma by MAO and catechol-O-methyltransferase to inactive compounds. Approximately 25% of dose is taken up in the adrenergic nerve terminals where it is hydrolyzed to norepinephrine.
Elimination
Half-life approximately 2 min. Approximately 80% excreted in the urine within 24 h as metabolites; a very small amount excreted unchanged.
Onset
Within 5 min.
Duration
Less than 10 min.
Indications and Usage

Correction of hemodynamic imbalances present in shock syndrome after MI, trauma, endotoxic septicemia, open heart surgery, and renal failure or chronic cardiac decompensation (eg, CHF).
Unlabeled Uses
Calcium channel blocker or beta-blocker overdose; drug-induced hypovolemic shock; treatment of RDS in infants; COPD; CHF.
Contraindications
Pheochromocytoma; uncorrected tachyarrhythmias; ventricular fibrillation; allergy to corn/corn products (dextrose solutions).

Adults and Children IV Initial dose of 2 to 5mcg/kg/min with incremental changes of 5 to 10 mcg/kg/min gradually until adequate response is noted. Most patients are maintained at less than 20 mcg/kg/min. If dosage exceeds 50mcg/kg/min, assess renal function frequently.
General Advice

Administer by IV infusion only, preferably into a large vein. Metering device is essential for controlling rate of flow. Administration into an umbilical artery catheter is not recommended. Dopamine is potent drug. Dilute before use if not prediluted. Do not use if solution is discolored. Chemically incompatible with alkaline solutions, including sodium bicarbonate or other alkaline IV solutions (dopamine is inactivated). Do not mix dopamine in the same container with alteplase because particulate matter has been observed. Do not add dopamine to amphotericin B solutions because amphotericin B is physically unstable in dopamine-containing solutions. When appropriate, increase blood volume with whole blood or plasma. If a marked decrease in pulse pressure and disproportionate increase in diastolic BP are observed, the rate of infusion should be decreased and the patient monitored for further evidence of predominant vasoconstrictive activity, unless such an effect is desired. If an increased number of ectopic beats are observed, the dose should be reduced if possible. Chemically incompatible with alkaline solutions (drug is inactivated). Avoid contact with oxidizing agents or iron salts.
Storage/Stability
Store at 68 to 77F. Avoid excessive heat. Protect from freezing. Dilute just prior to administration. Solution is stable for 24 h after dilution.
Drug Interactions
Alpha-blockers May antagonize peripheral vasoconstriction caused by high-dose dopamine. Beta-blockers (eg, metoprolol, propranolol) May antagonize the cardiac effects of dopamine. Cyclopropane, halogenated hydrocarbons May sensitize the myocardium to the action of dopamine. Use with extreme caution. Diuretics May produce an additive or potentiating effect on urine flow.
Furazolidone, methyldopa, reserpine Hypertension may result. Guanethidine Antihypertensive effects of guanethidine may be negated. Haloperidol, phenothiazines (eg, chlorpromazine) May suppress the dopaminergic renal and mesenteric vasodilation produced with low-dose dopamine infusion. MAOIs May greatly increase pressor response from dopamine. Oxytocic agents, vasoconstrictors (eg, ergonovine), vasopressors Severe hypertension may occur. Phenytoin Severe hypotension and bradycardia may result after coadministration with dopamine. Tricyclic antidepressants May decrease pressor response from dopamine.
Laboratory Test Interactions

Infusion of dopamine suppresses pituitary secretion of TSH, growth hormone, and prolactin.
Adverse Reactions
Cardiovascular
Anginal pain, bradycardia, cardiac conduction abnormalities, ectopic beats, hypertension, hypotension, palpitation, tachycardia, vasoconstriction, ventricular arrhythmia, widened QRS complex.
CNS
Anxiety, headache.
GI
Nausea, vomiting.
Miscellaneous
Azotemia, dyspnea, gangrene of the extremities, peripheral cyanosis, piloerection.
Precautions
Warnings
Antidote for peripheral ischemia To prevent sloughing and necrosis, infiltrate the area as soon as possible with 10 to 15 mL of
sodium chloride 0.9% injection containing phentolamine 5 to 10 mg (0.1 to 0.2 mg/kg; max, 10 mg/dose for children).
Monitor
Monitor vital signs and ECG closely throughout therapy. Monitor I&O regularly; note decreases in urine output. Monitor CVP or pulmonary wedge pressure if possible during infusion. Note significant changes in vital signs, ECG changes, deterioration of peripheral pulses, and/or cold, mottled extremities. Closely monitor urine flow, cardiac output, and BP during dopamine infusion. Acidosis, hypercapnia, hypoxia, and hypovolemia must be identified and corrected prior to or concurrent with dopamine administration. Closely monitor patients with a history of occlusive vascular disease (eg, atherosclerosis, arterial embolism, Raynaud disease, cold injury, diabetic endarteritis, Buerger disease) for any change in color or skin temperature of the extremities. Monitoring CVP or left ventricular filling pressure may be useful in detecting and treating
Epinephrine
Pronunciation: (ep-i-NEF-rin) Class: Sympathomimetic, Vasopressor used in shock
Trade Names
Adrenalin Chloride - Solution, intranasal 1:1,000 (1 mg/mL) as hydrochloride - Injection, solution 1:1,000 (1 mg/mL) as hydrochloride Epinephrine - Injection, solution 1:10,000 (0.1 mg/mL) as hydrochloride - Injection, solution 1:1,000 (1 mg/mL) as hydrochloride - Injection, solution 1:1,000 (0.3 mg per 0.3 mL) single-dose prefilled syringe - Aerosol, inhalation 0.22 mg/spray EpiPen - Injection, solution 1:1,000 (0.3 mg per 0.3 mL) EpiPen Jr. - Injection, solution 1:2,000 (0.15 mg per 0.3 mL) Primatene Mist - Aerosol, inhalation 0.22 mg of epinephrine per spray S2 - Solution, inhalation 1.125% (2.25% racepinephrine hydrochloride) Twinject - Injection, solution 1:1,000 (0.15 mg per 0.15 mL) - Injection, solution 1:1,000 (0.3 mg per 0.3 mL)
Pharmacology
Stimulates alpha and beta receptors (alpha receptors at high doses; beta- 1 and beta- 2 receptors at moderate doses) within the sympathetic nervous system. Relaxes smooth muscle of bronchi and iris, and is an antagonist of histamine.
Pharmacokinetics
Metabolism
Inactivated by enzymatic transformation to metabephrine or normetanephrine; these are subsequently conjugated and excreted in the urine.
Elimination
Mostly excreted in urine as inactive metabolites; remainder is excreted as unchanged drug or is conjugated.
Onset
5 to 10 min (subcutaneous), 1 to 5 min (inhalation).
Duration
4 to 6h (subcutaneous), 1 to 4 h (IM), 1 to 3 h (inhalation).

Epinephrine 1:1,000 injection Relief of respiratory distress due to bronchospasm; to provide rapid relief of hypersensitivity reactions to drugs and other allergens (eg, anaphylactic reactions to drugs, animal serums, insect stings); to prolong the action of local and regional anesthetics; restore cardiac rhythm in cardiac arrest due to various causes; treatment of mucosal congestion of hay fever, rhinitis, and acute sinusitis; relieve bronchial asthmatic paroxysms; symptomatic relief of serum sickness, urticaria, angioneurotic edema; for relaxation of uterine musculature and to inhibit uterine contractions; epinephrine injection can be used as a hemostatic agent; in syncope due to complete heart block or carotid sinus hypersensitivity; for resuscitation in cardiac arrest following anesthetic accidents; used in open-angle glaucoma. Epinephrine 1:1,000 (auto-injector) and 1:2,000 (auto-injector), Prefilled syringe Emergency treatment of allergic reactions (type I) including anaphylaxis to insect stings (eg, bees, fire ants, hornets, yellow jackets, wasps) and biting insects (eg, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (eg, radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The auto-injectors and prefilled syringes are intended for immediate self-administration in patients who are at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Autoinjectors and prefilled syringes are for immediate use and are not a substitute for immediate medical attention. Epinephrine 1:10,000 injection Treatment and prophylaxis of cardiac arrest in the absence of ventricular fibrillation and attacks of transitory atrioventricular heart block with syncopal seizures; to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity; for resuscitation in cardiac arrest following anesthetic accidents; in cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of pacemaker fail; seldom
used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock. Nasal solution Nasal decongestant. Oral inhalation Temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma; temporary relief of bronchial asthma; easing breathing for asthma patients by reducing spasms of bronchial muscles.
Unlabeled Uses
Endoscopic injection for the management of acute lower GI bleeding; overdosage of betablockers, calcium channel blockers, and tricyclic antidepressants (and other sodium channel blockers); symptomatic bradycardia or hypotension that did not respond to atropine and transcutaneous pacing.
Contraindications
Note: There are no absolute contraindications to use in a life-threatening situation. Narrow-angle glaucoma; shock (nonanaphylactic); during general anesthesia with halogenated hydrocarbons or cyclopropane; individuals with organic brain damage; local anesthesia of certain areas (eg, fingers, toes); use during labor; use in cardiac dilation and coronary insufficiency; situations in which vasopressor drugs may be contraindicated (eg, diabetes, hypertension and other CV disorders, obstetrics when maternal BP is in excess of 130/80, in thyrotoxicosis); hypersensitivity to sympathomimetic amines.

Allergic Emergencies/Anaphylaxis Adults and Children IM/Subcutaneous EpiPen , Twinject , prefilled syringe: Patients weighing 30 kg (66 lb) or more 0.3 mg. EpiPen Jr , Twinject : Patients weighing 15 to 30 kg (33 to 66 lb) - 0.15 mg. Adults IM/Subcutaneous 1:1,000 (1 mg/mL) solution: 0.2 to 1 mg (mL), repeated every 10 to 15 min as needed. IV 1:10,000 (0.1 mg/mL) solution: 0.1 to 0.25 mg (1 to 2.5 mL), administered slowly over 5 min. Repeat every 5 to 15 min as needed. Children Subcutaneous 1:1,000 (1 mg/mL) solution: 0.01 mg/kg (or 0.3 mg/m 2 ) (max 0.5 mg/dose). May be repeated every 15 min for 2 doses, then every 4 h as needed. IV 1:10,000 (0.1 mg/mL): 0.3 mg (3 mL) administered slowly. Repeat every 15 min for 3 or 4 doses as needed. Asthma Adults and Children 4 Yr of Age and Older Oral inhalation Primatene Mist : Start with 1 inhalation, then wait 1 min. If not relieved, use once more. Do not use again for at least 3 h (OTC). S2 : Add 0.5 mL (contents of 1 vial) of solution to nebulizer. Use 1 to 3 inhalations not more often than every 3 h (OTC). Adults IM/Subcutaneous 1:1,000 (1 mg/mL) solution: 0.2 to 1 mg (mL). Start with a small dose and increase if required. IV 1:10,000 (0.1 mg/mL) 0.1 to 0.25 mg (1 to 2.5 mL) injected slowly.
Children Subcutaneous 1:1,000 (1 mg/mL) 0.01 mg/kg (or 0.3 mg/m 2 ) (max 0.5 mg/dose) every 4 h as needed. Cardiac Arrest Adults IV 1:10,000 (0.1 mg/mL) solution: 0.1 to 1 mg (1 to 10 mL), repeated every 5 min, if necessary. Alternatively, in intubated patients, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dose as for IV injection. Intracardiac 1:10,000 (0.1 mg/mL) solution: 0.3 to 0.5 mg (3 to 5 mL). This route should only be used if there is insufficient time to establish an IV route and should only be administered by personnel well trained in this technique. Children IV 1:10,000 (0.1 mg/mL): 0.005 to 0.01 mg/kg. Intraspinal Adults Intraspinal 1:1,000 (1 mg/mL) injection solution (preservative free, sulfite free) 0.2 to 0.4 mg added to anesthetic spinal fluid mixture. Epinephrine 1:100,000 (0.01 mg/mL) to 1:20,000 (0.05 mg/mL) is the usual concentration employed with local anesthetics. Nasal Congestion Adults and Children 6 yr of age and older Topical Apply as drops, spray, or with sterile swab as needed. Ophthalmologic Use for Producing Conjunctival Decongestion, to Control Hemorrhage, to Produce Mydriasis, to Reduce Intraocular Pressure Ophthalmic Use concentrations of 1:10,000 to 1:1,000.
General Advice
Multiple concentrations and dosage forms are available. Ensure the proper concentration and doseform are being used. Injection Incompatibilities: Epinephrine is destroyed by alkalines and oxidizing agents (eg, bromine, chlorine, chromates, iodine, nitrates, oxygen, permanganates, salts of easily reducible metals [eg, iron]). Subcutaneous is the preferred route of administration. For medical emergencies, the IV route is usually used. If given IM, avoid injection into the buttocks. Subcutaneous injection results in slower absorption. Inspect visually for particulate matter and discoloration whenever solution and container permit. Cardiac resuscitation: In adults, the effect of IV epinephrine (1:10,000) may only last a few minutes; therefore, the IV dose may be followed by 0.3 mg of 1:1,000 (1 mg/mL) subcutaneously. Note: Intracardiac injection is no longer recommended in Advanced Cardiac Life Support (ACLS) guidelines. Auto-injector, Prefilled syringe Only inject into the anterolateral aspect of the thigh, through clothing if necessary. Auto-injector: Do not inject IV. Only inject into the anterolateral aspect of the thigh. Do not inject into the buttock; this may not provide effective treatment for anaphylaxis. According to ACLS guidelines, IM injection is the preferred route of administration for patients with anaphylaxis with signs of systemic reaction. Solution
Do not use an epinephrine solution if it is pinkish or darker than slightly yellow or if it contain a precipitate.
Storage/Stability
Adrenalin nasal solution Store at 59 to 77F. Protect from light. Protect from freezing. Epinephrine injection, auto-injectors, and prefilled syringes Store at 59 to 86F. Protect from light. Protect from freezing. Discard vial and contents 30 days after initial use. Primatene Mist Store at 68 to 77F. S2 Store at 36 to 68F. Protect from light. Avoid excessive heat.
Drug Interactions
Alpha-adrenergic blocking agents (eg, phentolamine), ergot derivative (eg, ergotamine), nitrites, phenothiazines (eg, chlorpromazine) May counteract the epinephrine pressor effects. Antihistamines (eg, chlorpheniramine, diphenhydramine), COMT inhibitors (eg, entacapone, tolcapone), levothyroxine, linezolid, MAOIs (eg, phenelzine), tricyclic antidepressants (amitriptyline) Epinephrine effects may be potentiated. Beta-adrenergic blockers (eg, propranolol) Beta-adrenergic effects of epinephrine may be blocked, resulting in hypertension. Diuretics May decrease vascular response to epinephrine. Drugs that sensitize the heart to arrhythmias (eg, antiarrhythmics, digitalis, diuretics, quinidine) Epinephrine may precipitate or aggravate angina pectoris or produce ventricular arrhythmias. Furazolidone, methyldopa, rauwolfia alkaloids (eg, alseroxylon, rauwolfia) Risk of hypertension may be increased. General anesthetics (eg, cyclopropane, halothane) Coadministration is contraindicated; may induce cardiac arrhythmias. Guanethidine Neuronal blockade may be antagonized by epinephrine, resulting in decreased antihypertensive effect and requiring subsequent dosage adjustments. Oxytocic drugs Severe persistent hypertension may occur; rupture of a cerebral blood vessel may occur during the postpartum period.
Sympathomimetic agents (eg, isoproterenol) Possible additive effects and increased toxicity (eg, serious cardiac arrhythmias); administer alternatively when the preceding effect of the other drug has subsided, not concurrently.

None well documented.
Adverse Reactions
Cardiovascular
Angina; cardiac arrhythmias including fatal ventricular fibrillation; excessive and/or rapid rise in BP; palpitations.
CNS
Anxiety; apprehension; cerebral hemorrhage; dizziness; fear; headache; hemiplegia; restlessness; subarachnoid hemorrhage; tremor; weakness.
Dermatologic
Sweating.
GI
Nausea; vomiting.
Local
Necrosis.
Respiratory
Respiratory difficulty.
Miscellaneous
Pallor.
Precautions
Monitor
Monitor patient's respiratory status during each treatment with inhalation solution and aerosol. If bronchospasm worsens during a treatment, discontinue the treatment.
Pregnancy
Category C .
Lactation
Excreted in breast milk.
Children
Administer drug with caution. Syncope has occurred in asthmatic children.
Labor and Delivery

Do not use when maternal BP exceeds 130/80 mm Hg; may delay second stage or induce uterine atony.
Renal Function
Parenterally administered epinephrine initially may produce constriction of renal blood vessels and decease urine blood flow.
Special Risk Patients

Use with caution in elderly patients; in patients with CV disease, diabetes, hypertension or hyperthyroidism, and psychoneurotic individuals; in patients with long-standing bronchial asthma and emphysema who have developed degenerative heart disease; in patients with ventricular fibrillation; in patients with prefibrillatory rhythm; and in pregnancy.
Sulfite Sensitivity
Some products contain sulfites; in serious allergic, emergency, or life-threatening situations, use with caution in sulfite-sensitive individuals.
CV effects
Inadvertently induced high arterial BP may result in angina pectoris or aortic rupture; potentially serious cardiac arrhythmias may occur in patients not suffering from heart disease and patients with organic heart disease or who are receiving drugs that sensitize the myocardium; a paradoxical but transient lowering of BP, bradycardia, and apnea may occur immediately after injection.
Cerebrovascular hemorrhage
May result from overdosage or inadvertent IV injection.
Extravasation
Tissue necrosis may develop if extravasation occurs.
Hypovolemia
Epinephrine use is not a replacement for blood, plasma, fluids, and electrolytes, which should be restored promptly when loss has occurred.
Pulmonary edema
May cause fatalities because of peripheral constriction or cardiac stimulation.
Overdosage
Symptoms
Cerebrovascular hemorrhage from extremely elevated arterial pressure, dyspnea, elevated BP, extreme pallor and coldness of the skin, fatal cardiac arrhythmia, headache, kidney failure, metabolic acidosis, pulmonary edema, precordial distress, premature ventricular contractions followed by multifocal ventricular tachycardia and occasionally by AV block, transient bradycardia, vomiting.
Patient Information

Injection Advise patient, family, or caregiver that medication (other than that delivered by autoinjector or prefilled syringe) will be prepared and administered by a health care provider in a medical setting. Advise patient using the auto-injector or prefilled syringe ( Adamis Laboratories ) to go immediately to the nearest emergency room for further treatment of anaphylaxis. Ensure patient using auto-injector understands how to store, prepare the auto-injector or prefilled syringe, administer the injection, and dispose of used equipment. Ensure patient using auto-injector or prefilled syringe understands how and when to use oral medications for allergic reactions (eg, antihistamines, corticosteroids) if prescribed or recommended by health care provider. Inhalation Solution and Aerosol If using solution for inhalation, ensure patient or caregiver can prepare, use, and clean the nebulizer without difficulty. If using the aerosol, ensure patient understands how to store and use the inhaler properly. Instruct patient not to mix with other nebulizer medications unless advised by health care provider. Instruct patient not to exceed prescribed dose or frequency of use. Advise patient to contact health care provider if this medication no longer seems to control asthma symptoms or if increasing doses of the medicine are needed. This may indicate worsening asthma. Advise patient using more than 1 inhaled medication to use this medication first if needed. Inhaled corticosteroids or other inhaled controller medications should be taken last. Advise patient that i f breathing symptoms worsen during or immediately after using this medication to stop using it and inform health care provider immediately. Caution patient not to use solution if it is pinkish or darker than slightly yellow, or if it contains a precipitate. Caution patient not to puncture canister, dispose of used aerosol canister in incinerator, or store canister near open flame or heat above 120F. Topical Solution Ensure patient or caregiver understands how and when to apply topical solution as drops, spray, or directly on mucosal surface with sterile swab, as directed. Advise patient or caregiver not to increase the frequency of use if symptoms of congestion do not improve or worsen but to notify health care provider.
Atenolol
Pronunciation: (a-TEN-oh-lol) Class: Beta-adrenergic blocking agent
Trade Names
Atenolol - Tablets 25 mg - Tablets 50 mg - Tablets 100 mg Tenormin - Tablets 25 mg - Tablets 50 mg - Tablets 100 mg APO-Atenol (Canada) CO Atenolol (Canada) Gen-Atenolol (Canada) Novo-Atenol (Canada) PMS-Atenolol (Canada) RAN-Atenolol (Canada) ratio-Atenolol (Canada) Sandoz Atenolol (Canada)
Pharmacology
Blocks beta receptors, primarily affecting heart (slows rate), vascular system (decreases BP), and, to lesser extent, lungs (reduces function).
Pharmacokinetics
Absorption
Rapid and consistent but incomplete; approximately 50% is absorbed from the GI tract. T max is 2 to 4 h.
Distribution
6% to 16% bound to plasma proteins.
Metabolism
Little or no metabolism by the liver.
Elimination
Approximately 50% is excreted unchanged in the feces. Approximately 50% is excreted in the urine within 24 h. Half-life is approximately 6 to 7 h.
Onset
1 h (oral).
Peak
2 to 4 h (oral).
Duration
24 h (oral). Duration of action is dose related.
Special Populations
Renal Function Impairment Elimination is closely related to glomerular filtration rate. Significant accumulation occurs when CrCl falls below 35 mL/min per 1.73 m 2 . Elderly Total Cl is about 50% lower than in younger subjects. Half-life is markedly longer in elderly patients.

Treatment of hypertension (used alone or in combination with other drugs), angina pectoris resulting from coronary atherosclerosis, acute MI.
Unlabeled Uses
Migraine prophylaxis, supraventricular arrhythmias or tachycardias, esophageal varices rebleeding, anxiety.
Contraindications
Hypersensitivity to beta-blockers; sinus bradycardia; greater than first-degree heart block; overt cardiac failure; cardiogenic shock.

Acute MI Adults PO 100 mg/day for 6 to 9 days or until hospital discharge. Angina Pectoris PO May require up to 200 mg/day. Hypertension Adults PO 50 to 100 mg/day. Elderly PO Initial dosage is 25 mg daily. Renal Function Impairment PO Adjust dose in severe renal impairment. CrCl 15 to 35 mL/min per 1.73 m 2 Max dose 50 mg daily. CrCl less than 15 mL/min per 1.73 m 2 Max dose 25 mg daily.
Hemodialysis Give 25 to 50 mg after each dialysis session; marked falls in blood pressure can occur.
General Advice

May be used alone or with other antihypertensive agents. In angina, withdraw atenolol gradually; observe patient for exacerbation of angina, MI, and arrhythmias. Advise patients to limit physical activity.
Storage/Stability
Store at 68 to 77F in a tightly closed container in a cool location.
Drug Interactions
Aluminum salts, ampicillin, calcium salts Plasma levels and pharmacologic effects may be decreased. Clonidine May add to or reverse antihypertensive effects; potentially life-threatening situations may occur, especially on withdrawal. Diltiazem Pharmacologic effects of atenolol may be increased; symptomatic bradycardia may occur. Nifedipine, verapamil Effects of both drugs may be increased. NSAIDs Some agents may impair antihypertensive effect. Prazosin May increase orthostatic hypotension. Quinidine Pharmacologic effects of atenolol may be increased.

Adverse Reactions
Cardiovascular
Cold extremities (12%); postural hypotension (4%); bradycardia (3%); Raynaud phenomenon, sick sinus syndrome (postmarketing).
CNS
Tiredness (26%); dizziness (13%); depression (12%); fatigue (6%); dreaming, lethargy, lightheadedness (3%); drowsiness, vertigo (2%); hallucinations, headaches, psychoses (postmarketing).
Dermatologic
Lupus syndrome, psoriasiform rash or exacerbation of psoriasis, purpura, reversible alopecia (postmarketing).
GI
Diarrhea, nausea (3%); dry mouth (postmarketing).
Genitourinary
Impotence, Peyronie disease (postmarketing).
Respiratory
Dyspnea (6%); wheezing (3%).
Miscellaneous
Leg pain (3%); antinuclear antibodies, thrombocytopenia, visual disturbances (postmarketing).
Precautions
Warnings
Abrupt withdrawal In patients with angina pectoris or coronary artery disease (CAD), atenolol may cause exacerbation of angina and occurrence of MI and ventricular arrhythmias. Monitor patients closely. Because CAD is common and may be unrecognized, it may be prudent not to discontinue beta-blocker therapy abruptly in patients treated only for hypertension.
Monitor
Closely monitor patients suspected of developing thyrotoxicosis from whom atenolol is to be withdrawn. Upon discontinuation, observe patients for exacerbation of angina, MI, and arrhythmias, and advise patients to limit physical activity.
Pregnancy
Category D .
Lactation
Children
Safety not established.
Elderly
Dosage reduction may be necessary.
Renal Function
Reduce dose.
Hepatic Function
Reduce dose.
Anaphylaxis
Deaths have occurred; aggressive therapy may be required.
CHF
Administer cautiously in patients with CHF controlled by digitalis and diuretics.
Diabetes mellitus
May mask symptoms of hypoglycemia (eg, BP changes, tachycardia).
Nonallergic bronchospastic diseases (eg, chronic bronchitis, emphysema)

In general, do not give beta-blockers to patients with bronchospastic diseases.
Peripheral vascular disease

May precipitate or aggravate symptoms of arterial insufficiency.
Thyrotoxicosis
May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm.
Overdosage
Symptoms
Bradycardia, bronchospasm, CHF, hypoglycemia, hypotension, lethargy, respiratory depression, sinus pause, wheezing.
Patient Information
Explain that full effectiveness of drug may not occur for up to 1 to 2 wk after initiation of therapy, and that dosage will be tapered slowly before stopping. Warn that sudden discontinuation can cause chest pain or heart attack.
Teach patient how to take pulse and instruct patient to check before taking drug. Warn patient not to take drug if pulse is less than 60 bpm, and to call health care provider. When medication is being used for treatment of hypertension, teach patient how to take daily BP. Advise patient that medication may cause increased sensitivity to cold. Inform patients with diabetes to monitor blood glucose level carefully. It may be necessary to alter insulin dose while taking drug. Instruct patient to report the following symptoms to health care provider: altered mood; depression; difficulty breathing; irregular heart beat; swelling of feet, legs, and hands. Caution patient to avoid sudden position changes to prevent orthostatic hypotension. Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.
Streptokinase
Pronunciation: (STREP-toe-KIN-ace) Class: Thrombolytic enzyme Trade Names: Streptase - Powder for Injection 250,000 units - Powder for Injection 750,000 units - Powder for Injection 1,500,000 units
Pharmacology
Converts plasminogen to the enzyme plasmin, which aids in dissolution of blood clots.
Pharmacokinetics
Metabolism
No metabolites identified.
Elimination
Streptokinase is cleared by the liver. The t is approximately 23 min (for activator complex).

Acute MI, lysis of intracoronary thrombi, improvement of ventricular function, and reduction of mortality associated with acute MI (IV or intracoronary route); reduction of infarct size and CHF associated with acute MI (IV); lysis of objectively diagnosed (eg, angiography) pulmonary emboli (involving obstruction of blood flow to a lobe or multiple segments, with or without unstable hemodynamics); lysis of objectively diagnosed (eg, ascending venography), acute, extensive thrombi of the deep veins (eg, those involving the popliteal vessels); lysis of acute arterial thrombi and emboli; alternative to surgical revision for clearing totally or partially occluded arteriovenous cannulae when acceptable flow cannot be achieved.
Contraindications
Active internal bleeding; recent cerebrovascular accident (within 2 mo); intracranial or intraspinal surgery; intracranial neoplasm; severe uncontrolled hypertension.

Acute Evolving Transmural MI Adults IV infusion Administer as soon as possible after symptom onset (greatest benefit when administered within 4 h, but benefit has been reported up to 24 h). Infuse a total dose of 1,500,000 units within 60 min. Intracoronary infusion Administer 20,000 units by bolus followed by 2000 units/min for 60 min (total dose, 140,000 units). Pulmonary Embolism, Deep Vein Thrombosis (DVT), Arterial Thrombosis, or Embolism Adults IV infusion Administer as soon as possible after onset of thrombolic event, preferably within 7 days. A loading dose of 250,000 units infused into a peripheral vein over 30 minutes has been found appropriate in over 90% of patients. If thrombin time or any parameter of lysis after 4 h of therapy is not significantly different from the normal control level, discontinue streptokinase because excessive resistance is present. Dose and duration of therapy (following the loading dose of 250,000 units/30 min): pulmonary embolism 100,000 units/h for 24 h (72 h if concurrent DVT is suspected); DVT 100,000 units/h for 72 h; arterial thrombosis or embolism 100,000 units/h for 24 to 72 h. Arteriovenous Cannulae Occlusion Slowly instill 250,000 in 2 mL of solution into each occluded limb of the cannula. Clamp off cannula limb(s) for 2 h. Closely observe patient for adverse effects. After treatment, aspirate contents of infused cannula limb(s) and flush with saline before reconnecting cannula.
Storage/Stability
Store unopened vials at controlled room temperature (59 to 86F). Use reconstituted solution immediately or within 8 h if stored at 36 to 46F. Discard any unused solution.
Drug Interactions
Anticoagulants, agents that alter platelet function (eg, aspirin, other NSAIDs, dipyridamole), other thrombolytic agents, agents that alter coagulation May increase the risk of bleeding.
Incompatibility
Do not add other medication to the streptokinase container.

Will cause marked decreases in plasminogen and fibrinogen levels and increases in thrombin time, activated partial thromboplastin time, and prothrombin time, which usually normalize within 12 to 24 h.
Adverse Reactions
Cardiovascular
Hypotension (sometimes severe).
Hematologic
Bleeding (major and minor).
Respiratory
Respiratory depression.
Miscellaneous
Allergic reactions (eg, fever and shivering, urticaria, itching, flushing, nausea, headache, musculoskeletal pain); anaphylactic and anaphylactoid reactions (ranging from minor breathing difficulty to bronchospasm, periorbital swelling or angioneurotic edema); transient elevations of serum transaminases; back pain.
Precautions
Pregnancy
Category C .
Children
Safety and efficacy not established.

Use with caution in patients with recent (within 10 days) major surgery, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels; recent (within 10 days) serious GI bleeding, recent (within 10 days) trauma including cardiopulmonary resuscitation, hypertension (systolic BP greater than 180 mm Hg or diastolic BP greater than 110 mm Hg), high likelihood of left heart thrombus (eg, mitral stenosis with atrial fibrillation), subacute bacterial endocarditis, hemostatic defects including those secondary to severe hepatic or renal disease, cerebrovascular disease, diabetic hemorrhagic retinopathy, septic thrombophlebitis, occluded AV cannula at seriously infected site, or any condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of location; use with caution in patients who are pregnant or older than 75 yr of age.
Arrhythmia
Rapid lysis of coronary thrombi has been shown to cause reperfusion arterial or ventricular dysrhythmias, requiring immediate treatment.
Bleeding
Major and minor bleeding may occur. Severe, sometimes fatal, internal bleeding involving GI, hepatic, GU, or intracerebral sites has occurred.
Cholesterol embolism
Serious and fatal cholesterol embolism may occur.
Repeat administration
Because of increased likelihood of resistance caused by antistreptokinase antibodies, streptokinase may not be effective if administered within 5 days to 12 mo of prior streptokinase or anistreplase administration, or streptococcal infections (eg, streptococcal pharyngitis).
Patient Information

Advise patient, family, or caregiver that medication will be prepared and administered by a health care professional in a medical setting. Instruct patient, family member, or caregiver to report any signs of bleeding or allergic reaction immediately.
Pentazocine Lactate
Pronunciation: (pen-TAZ-oh-seen lak-tate) Class: Opioid agonist-antagonist analgesic
Trade Names
Talwin - Injection 30 mg/mL
Pharmacology
Produces analgesia by an agonistic effect at the kappa opioid receptor. Weakly antagonizes effects of opiates at mu opioid receptor.
Pharmacokinetics
Distribution
Moderate protein binding. Passes into fetal circulation.
Metabolism
Hepatic.
Elimination
Excreted primarily by the kidney. Half-life is 2 to 3 h.
Onset
IM/subcutaneous is 15 to 20 min; IV is 2 to 3 min.
Special Populations
Renal Function Impairment No data available. Hepatic Function Impairment No data available.
Elderly Longer mean elimination half-life, lower mean total plasma Cl, and a larger mean AUC. Children No data available.

Management of moderate to severe pain; preoperative or preanesthetic medication; supplement to surgical anesthesia.
Contraindications
Standard considerations.

Labor Adults IM 30 mg as single dose; alternatively, when contractions are regular, IV 20mg for 2 to 3 doses given every 2 to 3 h. Moderate to Severe Pain/Surgical Anesthesia/Preoperative or Preanesthetic Medication Adults IM / subcutaneous / IV 30 mg every 3 to 4 h (max, 360 mg/day). Doses greater than 30 mg IV or 60 mg subcutaneous/IM are not recommended. Premedication for sedation Children 1 yr of age and older IM 0.5 mg/kg single dose.
General Advice

For IM administration, inject deep into well-developed tissue. For IV administration, inject undiluted by slow bolus. Do not exceed a 30 mg dose. Administer subcutaneously only when necessary; severe tissue damage is possible at injection sites. Do not mix in the same syringe with barbiturates; precipitation will occur. Constantly rotate injection sites.
Storage/Stability
Store at 59 to 86F.
Drug Interactions
Alcohol Causes additive CNS depression. Use with caution. Barbiturate anesthetics and any other CNS depressants (eg, antidepressants, benzodiazepines) Causes increased CNS and respiratory depression.
Adverse Reactions
Cardiovascular
Circulatory depression, hypertension, shock, tachycardia.
CNS
Confusion, depression, disorientation, disturbed dreams, dizziness, euphoria, excitement, faintness, hallucinations, headache, insomnia, irritability, light-headedness, muscle tremor, paresthesia, sedation, syncope, tremor, weakness.
Dermatologic
Dermatitis, including pruritus; diaphoresis; flushed skin, including plethora.
EENT
Diplopia, miosis, nystagmus, tinnitus, visual blurring and focusing difficultly.
GI
Constipation, cramps, diarrhea, dry mouth, nausea, taste alteration, vomiting.
Hematologic
Eosinophilia, granulocytopenia.
Local
Cutaneous depression, nodules, severe sclerosis, soft tissue induration, sting on injection, and ulceration at injection sites.
Respiratory
Dyspnea, respiratory depression, transient apnea in newborns whose mothers received parenteral pentazocine during labor.
Miscellaneous
Allergic reactions (eg, edema of the face, toxic epidermal necrolysis), alterations in rate or strength of uterine contractions during labor, chills, urinary retention.
Precautions
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established in children younger than 1 yr of age.
Elderly
May be more sensitive to the analgesic effects. Use low doses and observe these patients closely for confusion and oversedation.
Labor and Delivery

Use drug with caution in women delivering premature infants.

Use with caution in patients with acute MI accompanied by asthma, cyanosis, decreased respiratory reserve, head injury, hypertension or left ventricular failure, increased intracranial pressure, obstructive pulmonary condition, respiratory depression, or seizure.
Sulfite Sensitivity
Drug may cause allergic-type reactions (eg, anaphylaxis, hives, itching, wheezing) in susceptible persons.
Abuse/Dependence/Withdrawal
Abuse potential exists. Abrupt discontinuation after long-term use may cause withdrawal symptoms. Do not substitute other opiates in pentazocine withdrawal syndrome. Pentazocine may induce withdrawal symptoms in narcotic-dependent patients.
Acute CNS manifestations

Confusion, disorientation, hallucinations, and seizures.
Biliary surgery
May elevate biliary tract pressure.
Renal or hepatic function impairment

Duration of action may be prolonged; dosage reduction may be required.
Tissue damage
Severe sclerosis of skin, subcutaneous tissues, and underlying muscle have occurred at injection sites.
Overdosage
Symptoms
Hypertension, respiratory depression, tachycardia.
Patient Information

Caution patient not to stop taking drug abruptly without consulting health care provider. Advise patient to avoid sudden position changes to prevent orthostatic hypotension. Instruct patient to avoid intake of alcoholic beverages or other CNS depressants. Advise patient that drug may cause dizziness and to use caution while driving or performing other tasks requiring mental alertness.

Theophylline
Pronunciation: (thee-OF-i-lin) Class: Xanthine derivative
Trade Names
Elixophyllin - Elixir, oral 80 mg per 15 mL (26.7 mg per 5 mL) Theo-24 - Capsules, timed-release (24 h) 100 mg - Capsules, timed-release (24 h) 200 mg - Capsules, timed-release (24 h) 300 mg - Capsules, timed-release (24 h) 400 mg Theophylline - Solution, oral 80 mg per 15 mL Theophylline - Tablets, ER 100 mg - Tablets, ER 200 mg - Tablets, ER 300 mg - Tablets, ER 450 mg Apo-Theo LA (Canada)
Pharmacology
Relaxes bronchial smooth muscle and stimulates central respiratory drive.
Pharmacokinetics
Absorption
Theophylline is rapidly and completely absorbed after oral administration. Theophylline C max is 10 mcg/mL (range, 5 to 15 mcg/mL) and T max is 1 to 2 h. Food and antacids do no cause any clinically significant changes. The therapeutic range is 10 to 20 mcg/mL.
Distribution
Theophylline is approximately 40% protein bound (primarily to albumin). Unbound theophylline distributes throughout body water, but distributes poorly into body fat. Vd is approximately 0.45 L/kg (range, 0.3 to 0.7 L/kg) based on ideal body weight. Theophylline freely passes across the placenta, into breast milk, and into CSF.
Metabolism
Theophylline does not undergo any measurable first-pass elimination. In adults and children older than 1 y of age, about 90% of the dose is metabolized in the liver. Caffeine and 3-methylxanthine are the only theophylline metabolites with pharmacologic activity.
Elimination
Excretion is via the kidneys. In neonates, approximately 50% of a theophylline dose is excreted unchanged in the urine. Beyond 0 to 3 mo, 10% of a theophylline dose is excreted unchanged in the urine.
Special Populations
Renal Function Impairment
No dosage adjustment is required for adults or children older than 3 mo of age with renal function impairment. In neonates with reduced renal function, dose reduction and frequent monitoring of serum concentrations is required. Hepatic Function Impairment Cl is decreased at least 50% in patients with hepatic impairment. Select dose with care and frequently monitor theophylline levels Elderly Cl is decreased by an average of 30% in healthy adults older than 60 y of age compared with younger adults.
General Advice

Medication should be taken at approximately the same time each day and should not exceed the prescribed dose. Theophylline ER tablets may be given on a once-daily schedule to adult nonsmokers with appropriate total body Cl and to other patients with low dosage requirements. Once-daily administration should be considered only after gradual titration to therapeutic levels with 12-h dosing. Once-daily dosing should be based on twice the 12-h dose and should be initiated at the end of the last 12-h interval. It is essential that theophylline plasma levels be monitored before and after transfer to once-daily dosing. Theo-24 ER capsules should be taken in the morning at approximately the same time. Theo-24 should not be taken with food by patients requiring a relatively high dose of theophylline (ie, a dose equal to or more than 900 mg or 13 mg/kg, whichever is less).
Storage/Stability
Elixophyllin Store at 59 to 86F. Protect from light. Theo-24 ER capsules Store below 77F. Theophylline ER tablets and oral solution Store at 68 to 77F.
Drug Interactions
Acyclovir, alcohol, allopurinol, calcium channel blockers (ie, diltiazem, verapamil), cimetidine, corticosteroids (eg, hydrocortisone, prednisone), disulfiram, estrogencontaining hormonal contraceptives, fluvoxamine, influenza virus vaccine, interferon, macrolide antibiotics (azithromycin), methotrexate, mexiletine, nonselective beta-blockers (eg, propranolol), pentoxifylline, propafenone, quinolone antibiotics (ie, ciprofloxacin, norfloxacin), tacrine, thiabendazole, thyroid hormones (eg, levothyroxine), ticlopidine, zileuton Theophylline levels may be increased. Aminoglutethimide, barbiturates (eg, pentobarbital, phenobarbital, primidone, secobarbital), hydantoins (eg, phenytoin), isoproterenol IV, ketoconazole, moricizine, rifampin, smoking (ie, marijuana and tobacco), St. John's wort, sulfinpyrazone, sympathomimetics (eg, albuterol, isoproterenol, terbutaline) Theophylline levels may be decreased. Benzodiazepines, propofol Theophylline may antagonize sedative effects.
Beta-agonists CV adverse reactions may be additive. However, may be used together for additive beneficial effects. Carbamazepine, isoniazid, loop diuretics May increase or decrease theophylline levels. Ephedrine, tetracycline Increased risk of theophylline toxicity. Erythromycin Elevated theophylline levels, increasing the risk of toxicity, while erythromycin levels may be reduced. Halothane Coadministration has caused catecholamine-induced arrhythmias. Ketamine Coadministration may result in seizures. Lithium Theophylline may reduce lithium levels. Nondepolarizing muscle relaxants Theophylline may antagonize neuromuscular blockade.
Incompatibility
Do not mix following solutions with theophylline in IV fluids: ascorbic acid, chlorpromazine, corticotropin, dimenhydrinate, epinephrine hydrochloride, erythromycin gluceptate, hydralazine, hydroxyzine hydrochloride, insulin, levorphanol tartrate, meperidine, methadone, methicillin sodium, morphine sulfate, norepinephrine bitartrate, oxytetracycline, papaverine, penicillin G potassium, phenobarbital sodium, phenytoin sodium, procaine, prochlorperazine maleate, promazine, promethazine, tetracycline, vancomycin, vitamin B complex with C.

Adverse Reactions
Cardiovascular
Atrial flutter and tachycardia, cardiac arrhythmias.
CNS
Headache, insomnia, irritability, restlessness, seizures.
GI
Diarrhea, nausea, vomiting.
Genitourinary
Transient diuresis.
Musculoskeletal
Fine skeletal muscle tremors.
Miscellaneous
Death.
Precautions
Monitor
Frequently monitor theophylline levels in elderly patients and smokers, as well as in patients with hepatic or renal impairment. Determine appropriate theophylline concentrations before making a dose increase as follows: determine whether the plasma concentration is subtherapeutic in a patient who continues to be symptomatic; whenever signs or symptoms of theophylline toxicity are present; and whenever there is a new illness, worsening of an existing concurrent illness, or a change in the treatment regimen.

Use with caution in patients with active peptic ulcer disease, cardiac arrhythmias, or seizure disorders.
Overdosage
Symptoms
General Acute MI; death caused by cardiorespiratory arrest and/or hypoxic encephalopathy; increased serum calcium, creatine kinase, myoglobin, and leukocyte count; decreased serum phosphate and magnesium; urinary retention in men with obstructive uropathy. Many manifestations of acute and chronic overdosage are similar. Acute overdosage Abdominal pain, acid/base disturbance, atrial fibrillation or flutter, death, disorientation, hyperglycemia, hypokalemia, hypotension/shock, nervousness, rhabdomyolysis, seizures, sinus tachycardia, supraventricular tachycardia, tremors, ventricular arrhythmias, ventricular premature beats, vomiting. Chronic overdosage Abdominal pain, acid/base disturbance, atrial fibrillation or flutter, atrial tachycardia, death, diarrhea, disorientation, hematemesis, hyperglycemia, hypokalemia, hypotension/shock, nervousness, seizures, sinus tachycardia, supraventricular tachycardia, tremors, ventricular arrhythmias, ventricular premature beats, vomiting.
Patient Information
Emphasize importance of follow-up with health care provider to monitor drug levels. Explain to patient that the medication is used to prevent asthma attacks and to use it continuously. Explain that some sustained-release forms should be taken on empty stomach, and not to crush or chew sustained-release forms. Explain that low-protein, high-carbohydrate diets may increase theophylline levels, while high-protein, low-carbohydrate diets and charcoal-broiled foods may decrease theophylline levels. Instruct patient to avoid food products containing caffeine. Instruct patient not to take extra doses of theophylline for acute asthma attack. Instruct patients to contact health care provider if they experience insomnia, nausea, new illness accompanied by fever, persistent headache, rapid heart rate, or vomiting. Instruct patients that if a dose is missed, to take the next dose at the usually scheduled time and not to attempt to make up for the missed dose. Instruct patients not to alter the dose, timing of the dose, or frequency of administration without contacting health care provider. Advise patients not to start or stop smoking without contacting health care provider. If patients change their smoking habits or stop smoking, dosage adjustment may be necessary.
Sodium Bicarbonate
Pronunciation: (SO-dee-uhm by-CAR-boe-nate) Class: Urinary alkalinizer, System alkalinizer, Electrolyte, Antacid
Trade Names
Bell/ans - Tablets 520 mg Neut - Neutralizing additive solution 4% (0.48 mEq/mL) Sodium Bicarbonate - Injection 4.2% (0.5mEq/mL) - Injection 5% (0.6 mEq/mL) - Injection 7.5% (0.9 mEq/mL) - Injection 8.4% (1 mEq/mL) - Neutralizing additive solution 4.2% (0.5mEq/mL) - Powder 120 g - Tablets 325 mg - Tablets 650 mg
Pharmacology
Increases plasma bicarbonate; buffers excess hydrogen ion concentrations; raises blood pH; reverses metabolic acidosis.
Treatment of metabolic acidosis; promotion of gastric, systemic, and urinary alkalinization; replacement therapy in severe diarrhea; used to reduce incidence of chemical phlebitis (used as neutralizing additive solution).
Contraindications
Loss of chloride from vomiting or continuous GI suction when patient is receiving diuretics known to produce hypochloremic alkalosis; metabolic and respiratory alkalosis; hypocalcemia in which alkalosis may produce tetany, hypertension, convulsions, or CHF; when administration of sodium could be clinically detrimental.

Adults and Children older than 2yr of age IV Administration performed in concentrations ranging from 1.5% (isotonic) to 8.4% depending on clinical condition and requirements of patient. Subcutaneous After dilution to isotonicity (1.5%). The dose depends on the clinical condition and requirements of the patient (including age and weight). PO 325mg to 2 g 1 to 4 times daily (patients younger than 60yr of age, max dose 16 g/day; patients older than 60 yr of age max dose 8 g/day). Infants up to 2 yr of age IV 4.2% solution at rate up to 8 mEq/kg/day.
Drug Interactions
Amphetamine, dextroamphetamine, ephedrine, flecainide, mecamylamine, methamphetamine, pseudoephedrine, quinidine Sodium bicarbonate can decrease elimination of these drugs, thus increasing their therapeutic effects. Chlorpropamide, lithium, methotrexate, salicylates, tetracyclines Sodium bicarbonate can increase elimination of these drugs, thus decreasing their therapeutic effect. Ketoconazole PO sodium bicarbonate may decrease the dissolution of ketoconazole in the GI tract, reducing the effectiveness.
Incompatibility
Do not mix with IV solutions containing catecholamines, such as dobutamine, dopamine, and norepinephrine.

Adverse Reactions
Cardiovascular
Exacerbation of CHF.
GI
Rebound hyperacidity; milk-alkali syndrome.
Lab Tests
Hypernatremia; alkalosis.
Miscellaneous
Extravasation with cellulitis, tissue necrosis, ulceration, and sloughing; local pain; venous irritation; tetany; edema.
Precautions
Pregnancy
Category C .
Lactation
Undetermined.
Children
Newborns and children younger than 2 yr Administration of at least 10mL/min of hypertonic sodium bicarbonate may produce hypernatremia, decreased CSF pressure, and possible intracranial hemorrhage.

Use drug with caution in edematous sodium-retaining states, CHF, liver cirrhosis, toxemia of pregnancy, or renal impairment.
Sodium content
May be significant, especially in patients with hypertension or CHF or in patients on low-sodium diets.
Overdosage
Symptoms
Alkalosis, hyperirritability, tetany, nausea, vomiting.
Patient Information
Instruct patient not to take medication with milk because renali calculi can develop.
Explain need to avoid OTC medications containing sodium bicarbonate, such as AlkaSeltzer . Excessive use of sodium bicarbonate can result in increase acid secretion or systemic alkalosis. Instruct patient not to use max dose of antacids for more than 2 wk except under supervision of health care provider. Advise patient not to take sodium bicarbonate on routine or long-term basis. Tell patient to notify health care provider if symptoms of gastric distress continue. Caution patient to report these symptoms to health care provider immediately: nausea, vomiting, anorexia.
Diazepam
Pronunciation: (DIE-aze-uh-pam) Class: Benzodiazepine, Centrally acting muscle relaxant
Trade Names
Diastat - Gel, rectal 2.5 mg (pediatric) - Gel, rectal 10 mg - Gel, rectal 15 mg (adult) - Gel, rectal 20 mg (adult) Diazepam - Solution, oral 1 mg/mL - Injection 5 mg/mL Diazepam Intensol - Solution (intensol) 5 mg/mL Valium - Tablets 2 mg - Tablets 5 mg - Tablets 10mg Apo-Diazepam (Canada) Diazemuls (Canada) Valium Roche Oral (Canada)
Pharmacology
Potentiates action of GABA, inhibitory neurotransmitter, resulting in increased neural inhibition and CNS depression, especially in limbic system and reticular formation.
Pharmacokinetics
Absorption
IM Slow and erratic absorption unless administered in the deltoid muscle; C max is lower than oral or IV administration.
Rectal T max is 1.5 h. Bioavailability is 90%. Oral T max is 0.5 to 2 h.
Distribution
95% to 98% protein bound. Highly lipophilic. Crosses the placenta and is excreted in breast milk.
Metabolism
Metabolized in the liver (involving CYP2C19 and CYP3A4) to desmethyldiazepam (active) and 2 minor active metabolites.
Elimination
The t is 20 to 80 h.
Onset
Rapid.
Special Populations
Hepatic Function Impairment The t is prolonged and Cl decreased in those with alcoholic cirrhosis. Elderly The t is increased and Cl is decreased. Children The t is longer in neonates and children younger than 2 yr of age; t is shorter in children 2 to 16 yr of age.

Management of anxiety disorders; relief of acute alcohol withdrawal symptoms; relief of preoperative apprehension and anxiety and reduction of memory recall; treatment of muscle spasms, convulsive disorders (used adjunctively), and status epilepticus.
Unlabeled Uses
Treatment of irritable bowel syndrome; relief of panic attack.
Contraindications
Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; use in children younger than 6mo of age; lactation.

Individualize dosage; increase cautiously.
Adults and Children Usual recommended dose IM/IV 2 to 20 mg, depending on indication and severity. In acute conditions injection may be repeated within 1 h, but every 3 to 4 h is usually satisfactory. Dosage and route vary with indication and age. Children 6 mo of age and older Usual daily dose PO 1 to 2.5 mg 3 or 4 times daily initially; increase gradually as needed and tolerated. Acute Alcohol Withdrawal Adults PO 10 mg 3 to 4 times daily first 24h, then 5 mg 3 to 4 times daily as needed. IM/IV 10mg initially, then 5 to 10 mg in 3 to 4h if needed. Anticonvulsant Adjunct Adults PO 2 to 10 mg 2 to 4 times daily. Elderly or Debilitated Patients PO Initial dose 2 to 2.5 mg once to twice daily; increase gradually. Anxiety Adults PO 2 to 10 mg 2 to 4 times daily. IM/IV 2to 10mg; repeat in 3 to 4 h if needed. Cardioversion (Anxiety and Tension) Adults IM/IV 5 to 15 mg 5 to 10 min before procedure. Endoscopic Procedures IM/IV 10 to 20 mg IV or 5 to 10 mg IM approximately 30 min prior to procedure. Preoperative (Anxiety and Tension) Adults IM 10 mg before surgery. Sedation/Muscle Relaxation Adults IM/IV 2 to 10 mg/dose every 3 to 4h as needed. Children 6 mo of age and older PO 0.12 to 0.8mg/kg/day in divided doses. IM/IV 0.04 to 0.2mg/kg/dose every 2 to 4h (max, 0.6 mg/kg in 8-h period). Skeletal Muscle Spasm Adults PO 2 to 10 mg 3 to 4 times daily. IM/IV 5to 10mg initially, then 5 to 10 mg in 3 to 4h if needed. Larger doses may be necessary in tetanus. Status Epilepticus and Severe Recurrent Convulsive Disorders Adults IM/IV (IV preferred) 5 to 10mg initially; then 5 to 10 mg at 10 to 15 min intervals (max total dose, 30mg). If needed, repeat in 2 to 4 h. Children 5 yr of age and older
IM/IV 1 mg every 2to 5min (max total dose, 10 mg). If needed, repeat in 2 to 4 h. Infants and Children 1 mo to 5 yr of age IM/IV 0.2 to 0.5 mg slowly every 2 to 5 min (max total dose, 5mg). Tetanus Children 5 yr of age and older IM/IV 5 to 10mg; repeat every 3 to 4 h as needed. Infants and Children 1 mo to 5 yr of age IM/IV 1 to 2mg slowly; repeat every 3 to 4 h as needed. Rectal Gel Children 2 to 5 yr of age Rectal 0.5 mg/kg. Children 6 to 11 yr of age Rectal 0.3 mg/kg. Adults and Children 12 yr of age and older Rectal 0.2 mg/kg. A second dose, when required, may be given 4 to 12 h after the first dose.
General Advice

Oral Solution Use calibrated dropper to measure prescribed dose of concentrated oral solution. Add prescribed dose to a liquid (eg, juice, water, soda) or semisolid food (eg, applesauce, pudding); stir for a few seconds then immediately administer entire amount of mixture. Do not prepare and store doses for future use. Injection For IM or IV administration only. Do not administer if particulate matter, cloudiness, or discoloration is noted. For IM administration, inject deeply into muscle. To reduce risk of IV injection-site reactions (eg, venous thrombosis, phlebitis, local irritation) administer IV injection slowly (no more than 5 mg/min) directly into large vein. Do not administer using small veins (eg, dorsum of hand, wrist). To reduce risk of apnea and hypersomnolence in children, administer prescribed IV dose over 3 min.
Storage/Stability
Store tablets, oral solution, and injection at controlled room temperature (59 to 86F). Protect from light. Protect tablets from moisture.
Drug Interactions
Azole antifungal agents (eg, itraconazole, ketoconazole), diltiazem, fluvoxamine, isoniazid, macrolide antibiotics (eg, erythromycin), nefazodone, non-nucleoside reverse transcriptase inhibitors (eg, delavirdine, efavirenz), protease inhibitors (eg, indinavir) May increase diazepam plasma concentrations. Cimetidine, oral contraceptives, disulfiram
May increase effects of diazepam with excessive sedation and impaired psychomotor function. Digoxin May increase serum digoxin concentrations. Omeprazole May increase diazepam levels and enhance effects. Rifamycins May decrease diazepam plasma concentrations. Theophyllines May antagonize sedative effects of diazepam.
Incompatibility
Diazepam interacts with plastic containers and IV tubing, significantly decreasing availability of drug delivered. Do not mix or dilute with other solutions or drugs in a syringe or infusion container.

Adverse Reactions
Cardiovascular
CV collapse; bradycardia; tachycardia; hypertension; palpitations; edema; hypotension; phlebitis or thrombosis at IV sites.
CNS
Drowsiness; confusion; ataxia; dizziness; lethargy; fatigue; apathy; memory impairment; disorientation; anterograde amnesia; restlessness; headache; slurred speech; loss of voice; stupor; coma; euphoria; irritability; vivid dreams; psychomotor retardation; paradoxical reactions (eg, anger, hostility, mania, insomnia, muscle spasms); depression; dysarthria; hypoactivity; tremor; vertigo.
Dermatologic
Urticaria; skin rash.
EENT
Visual or auditory disturbances; depressed hearing; blurred vision; diplopia; nystagmus.
GI
Constipation; diarrhea; dry mouth; coated tongue; nausea; anorexia; vomiting.
Genitourinary
Incontinence; changes in libido; urinary retention.
Hematologic
Blood dyscrasias including agranulocytosis, anemia, thrombocytopenia, leukopenia, neutropenia.
Hepatic
Hepatic dysfunction including hepatitis and jaundice; abnormal LFTs.
Miscellaneous
Dependency/withdrawal symptoms.
Precautions
Monitor
Ensure that CBC with differential and liver enzymes are evaluated periodically in patient on prolonged therapy.
Pregnancy
Category D . Avoid drug especially during first trimester because of possible increased risk of congenital malformations.
Lactation
Children
Oral form not recommended in patients younger than 6 mo of age; parenteral form not recommended in infants younger than 30days of age.
Elderly
Initial dose should be small and gradually increased. Give with extreme care to elderly patients with limited pulmonary reserve.
Renal Function
Observe caution to avoid accumulation of drug.
Hepatic Function
Observe caution to avoid accumulation of drug.
Dependency
Prolonged use can lead to dependency. Withdrawal syndrome has occurred within 4 to 6 wk of treatment, especially if abruptly discontinued. For discontinuation after long-term treatment, use caution and taper dosage.
Parenteral administration
Reserved primarily for acute states.
Psychiatric disorders
Not intended for use in patients with primary depressive disorder, psychosis, or disorders in which anxiety is not prominent.
Seizures
Tonic status epilepticus has been precipitated in patients treated with IV for petit mal or variant status.
Suicide
Use drug with caution in patients with suicidal tendencies; do not allow access to large quantities of drug.
Overdosage
Symptoms
Hypotension, respiratory or cardiac arrest, drowsiness, confusion, somnolence, impaired coordination, diminished reflexes, lethargy, ataxia, hypotonia, hypnosis, coma, death.
Patient Information

Advise patient or caregiver to read the patient information leaflet before starting therapy and with each refill. Advise patient that medication is usually started at a low dose and then gradually increased until maximum benefit is obtained. Caution patient that medication may be habit forming, to take as prescribed, and not to stop taking or change the dose unless advised by health care provider. Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs. Advise patient or caregiver using concentrated oral solution to measure prescribed dose using calibrated dropper and then add solution to a liquid (eg, juice, water, soda) or semisolid food (eg, applesauce, pudding); stir for a few seconds then immediately take (give) the entire mixture. Caution patient or caregiver not to prepare mixtures ahead of time and store. Advise patient that if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take 2 doses at the same time. Advise patient if medication needs to be discontinued, it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal. Instruct patient to avoid alcoholic beverages and other depressants while taking this medication. Advise patient with anxiety to take medication as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress reduction, counseling). Instruct patient to contact health care provider if symptoms (eg, anxiety, panic attacks, seizures) do not appear to be getting better, are getting worse, or if bothersome adverse reactions (eg, drowsiness, memory impairment) occur.
Advise patient that drug may cause drowsiness or impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined. Encourage patient with seizure disorder to carry identification (eg, card, bracelet) indicating condition and medication being used to treat. Injection Advise patient or caregiver that medication will be prepared by a health care provider and administered in a health care setting under close observation, when oral therapy is not feasible. Caution patient who receives parenteral therapy as an outpatient (eg, outpatient surgery) to use caution while ambulating, avoid ingestion of alcohol or other sedatives, and avoid driving or other hazardous activities for 24 to 48 h.
Atropine
Pronunciation: (AT-troe-peen) Class: Belladonna alkaloid, Cycloplegic mydriatic
Trade Names
AtroPen - Injection 0.5 mg - Injection 1 mg - Injection 2 mg Atropine Sulfate - Ophthalmic solution 1% - Injection 0.05 mg/mL - Injection 0.1 mg/mL - Injection 0.4 mg/mL - Injection 0.8 mg/mL - Injection 1 mg/mL Atropine Sulfate Ophthalmic - Ointment 1% Sal-Tropine - Tablets 0.4 mg Atropine (Canada) Atropine Injection (Canada) Atropine Ointment (Canada) Minims Atropine (Canada)
Pharmacology
Inhibits action of acetylcholine or other cholinergic stimuli at postganglionic cholinergic receptors, including smooth muscles, secretory glands, and CNS sites.
Pharmacokinetics
Absorption
Rapidly absorbed after oral administration.
Distribution
Readily crosses blood-brain barrier.
Elimination
The t is 3 h (IV). 94% of dose is eliminated through urine in 24 h.

Administration prior to anesthesia to reduce or prevent secretions of respiratory tract; to control rhinorrhea; treatment of parkinsonism; restoration of cardiac rate and arterial pressure in some situations; treatment of peptic ulcers; management of hypersecretion, irritation, or inflammation of stomach, intestines, or pancreas; treatment of diarrhea; relief of infant colic; management of spasms of bile tract; treatment of hypertonicity of small intestine and uterus; management of hypermotility of colon; prevention of spasm of pylorus, biliary tree, ureters, and bronchi; treatment of frequent urination and bed-wetting; therapy for certain bradycardias and heart blocks; treatment of closed head injury with acetylcholine release; reduction of laughing and crying associated with brain lesions; treatment of alcohol withdrawal symptoms; relief of motion sickness. Antidote for CV collapse in certain overdoses or poisonings (eg, organophosphorous nerve agents having cholinesterase activity, organophosphorous or carbamate insecticides, muscarinic symptoms of insecticide or nerve agent poisonings). Short-term treatment and prevention of bronchospasm associated with chronic bronchial asthma, bronchitis, and COPD. Ophthalmic Production of cycloplegia and mydriasis.
Contraindications
In the face of life-threatening poisonings by organophosphorous nerve agents and insecticides, there are no absolute contraindications for atropine use. Hypersensitivity to anticholinergics; narrow-angle glaucoma; primary glaucoma or tendency toward glaucoma (ophthalmic); adhesions between iris and lens; prostatic hypertrophy; obstructive uropathy; myocardial ischemia; unstable cardiac status caused by hemorrhage; tachycardia; myasthenia gravis; pyloric or intestinal obstruction; asthma; hyperthyroidism; renal disease; hepatic disease; toxic megacolon; intestinal atony or paralytic ileus.

Adults 0.4 to 0.6 mg every 4 to 6 h. Children PO Use lowest effective dose. The following doses may be exceeded in certain cases: 7 to 16 lb: 0.1 mg; 17 to 24 lb: 0.15 mg; 24 to 40 lb: 0.2 mg; 40 to 65 lb: 0.3 mg; 65 to 90 lb: 0.4 mg; over 90 lb: 0.4 mg. Surgery Adults Subcutaneous/IM/IV 0.4 to 0.6 mg every 4 to 6h. Children
Subcutaneous/IM/IV 0.01 mg/kg to max of 0.4 mg every 4 to 6 h. Infants less than 5kg Subcutaneous/IM/IV 0.04mg/kg. Infants over 5kg Subcutaneous/IM/IV 0.03 mg/kg. Bradyarrhythmias Adults Subcutaneous/IM/IV 0.4 to 2 mg every 1 to 2 h as needed. Children Subcutaneous/IV/IM 0.01 to 0.03 mg/kg, every 1 to 2 h as needed. Antidote (Insecticide Poisoning) Adults Parenteral At least 2 to 3 mg, repeated until signs of poisoning subside or signs of intoxication appear. Children 0.02 to 0.05 mg/kg/dose every 10 to 20 min until signs of atropic effect are observed, then every 1 to 4 h for at least 24 h. AtroPen It is recommended that 3 AtroPen auto-injectors be available for use in each person at risk of nerve agent or organophosphate insecticide poisoning: 1 for mild symptoms plus 2 for severe symptoms as described in package insert. Adults and Children weighing over 90 lb (41 kg) (generally older than 10 yr of age) IM 2 mg. Children weighing 40 to 90 lb (18 to 41 kg) (generally 4 to 10 yr of age) IM 1 mg. Children weighing 15 to 40 lb (7 to 18 kg) (generally 6 mo to 4 yr of age) IM 0.5 mg. Children weighing less than 15 lb (7 kg) (generally younger than 6 mo of age) IM 0.25 mg. Ophthalmic Uveitis Adults 1 to 2 drops 0.5% to 1% solution up to 4 times daily or ointment once or twice daily. Children 1 to 2 drops 0.5% solution 3 times daily. Refraction Adults 1 to 2 drops of 1% solution 1 h before refraction examination. Children 1 to 2 drops 0.5% solution twice daily 1 to 3 days before refraction examination.
General Advice

Multiple concentrations are available for use. Carefully check concentration before administering medication to ensure that proper strength is being used. Inspect injection solution before administration. Do not administer if solution is discolored, cloudy, or if particulate matter noted. Use auto-injector as soon as symptoms of organophosphorous or carbamate poisoning (eg, tearing, excessive oral secretions, wheezing, muscle fasciculations) appear. Use additional auto-injectors as needed, but no more than 3 units unless under supervision of trained medical personnel, until atropinization (eg, flushing, mydriasis, tachycardia, dry mouth) is achieved. Administer as IM injection into patient's mid-lateral thigh.
Storage/Stability
Tablets Store at temperature below 86F. Ophthalmic Store at room temperature (less than 86F). Protect from heat. Injection Store vials, prefilled syringes, and auto-injector at controlled room temperature (68 to 77F). Protect from light and freezing.
Drug Interactions
Haloperidol Worsened schizophrenic symptoms; decreased serum haloperidol concentrations. Other anticholinergic agents Additive anticholinergic effects. Phenothiazines Decreased antipsychotic effects and increased anticholinergic effects may occur.

Adverse Reactions
Cardiovascular
Altered ST-T waves; systole; atrial arrhythmia; atrial ectopic beats; atrial fibrillation; bigeminal beats; bradycardia; cardiac dilation; cardiac syncope; decreased BP; flattening of T wave; increased BP; intermittent nodal rhythm (no P wave); labile BP; left ventricular failure; MI; nodal extrasystole; palpitations; prolongation of sinus node recovery time; prolonged P wave; prolonged QT interval; retrograde conduction; R on T phenomenon; shortened PR segment; shortened RT duration; supraventricular extrasystole; tachycardia (sinus, supraventricular, junctional); transient AV dissociation; trigeminal beats; ventricular arrhythmia; ventricular extrasystole; ventricular fibrillation; ventricular flutter; ventricular premature contractions; weak or impalpable pulses; widening and flattening of QRS complex.
CNS
Abnormal movements; agitation; amnesia; anxiety; ataxia; Babinski reflex/Chaddock reflex; behavioral changes; coma; confusion; delirium; depression; difficulty concentrating; diminished tendon reflex; dizziness; dysarthria; dysmetria; fatigue; hallucinations; headache; hyperreflexia; hypertonia; insomnia; lethargy; locomotor difficulties; loss of libido; mania; mental disorder; muscle clonus; muscle twitching; opisthotonos; paranoia; restlessness; seizures; sensation of intoxication; somnolence; stupor; tremor; vertigo; weakness; withdrawal behavior.
Dermatologic
Cold skin; cyanosed skin; dermatitis; dry mucous membranes; dry warm skin; erythematous rash; flushing; macular rash; maculopapular rash; oral lesions; popular rash; petechiae rash; salivation; scarlatiniform rash; sweating/moist skin.
EENT
Acute angle-closure glaucoma; blepharitis; blindness; blurred vision; conjunctivitis; cyclophoria; cycloplegia; decreased accommodation; decreased contrast sensitivity; decreased visual acuity; dry conjunctiva; dry eyes; eyelid crusting; heterophoria; irritated eyes; keratoconjunctivitis; mydriasis; photophobia; pupils poorly reactive to light; sicca; strabismus; tearing. Ophthalmic solution/ointment Eczematoid dermatitis; follicular conjunctivitis; vascular congestion, edema, and exudates.
GI
Abdominal distention; abdominal pain; constipation; decreased bowel sounds; decreased food absorption; delayed gastric emptying; distended abdomen; dry mouth; dysphagia; nausea; paralytic ileus; vomiting.
Genitourinary
Bed wetting; difficulty in micturition; distended urinary bladder; impotency; urinary hesitancy or retention; urinary urgency.
Hypersensitivity
Anaphylaxis.
Lab Tests
Alpha waves (EEG) blocked upon opening eyes; elevated BUN; elevated erythrocytes; elevated hemoglobin; hyperglycemia; hypoglycemia; hypokalemia; hyponatremia; increase in photic stimulation on EEG; leukocytosis; low hemoglobin; runs of alpha waves on EEG; signs of drowsiness on EEG.
Local
Injection-site reaction.
Metabolic-Nutritional
Dehydration; failure to feed.
Respiratory
Breathing difficulty; inspiratory stridor; labored respirations; laryngospasm; pulmonary edema; respiratory failure; shallow respiration; slow respiration; subcostal recession; syncope; tachypnea.
Miscellaneous
Chest pain; excessive thirst; feeling hot; heat intolerance; hyperpyrexia; tongue chewing.
Precautions
Monitor
Baseline signs and symptoms Identify baseline signs and symptoms, and monitor patients response to therapy according to indications for use: increased heart rate when used for bradycardia; decreased secretions for preanesthesia; decreased GI motility or decreased abdominal pain in GI disorders; pupil dilation in eye disorders; decreased tremor, rigidity and drooling in Parkinson disease. Notify health care provider if signs or symptoms do not improve or worsen. Eyelid inflammation Monitor patient's response to therapy. Notify health care provider if eye or eyelid inflammation is noted or if symptoms do not improve or worsen (ophthalmic). Poisoning Ensure that patient with moderate to severe poisoning is closely monitored for at least 48 h after emergency treatment has been provided (auto-injector). Respiratory status Monitor patients respiratory status. Be prepared to provide artificial respiration if severe breathing difficulty is noted (auto-injector).
Pregnancy
Category C .
Lactation
Excreted in breast milk. If possible, do not use.
Children
Use cautiously in infants.

Use with caution in the elderly, in patients with Down syndrome, brain damage, spastic paralysis, disorders of heart rhythm (eg, atrial flutter), severe narrow-angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal failure, or a recent MI.
Anticholinergic psychosis
Has occurred in sensitive patients.
Diarrhea
May be an early symptom of incomplete intestinal obstruction.
Gastric ulcer
May delay gastric emptying time and complicate therapy.
Glaucoma
Determine IOP and depth of angle of anterior chamber before and during ophthalmic use to avoid glaucoma attacks.
Heat prostration
May occur at high ambient temperature.
Overdosage
Symptoms
Dry mouth, thirst, vomiting, nausea, abdominal distention, CNS stimulation, delirium, drowsiness, restlessness, stupor, fever, seizures, hallucinations, convulsions, coma, circulatory failure, tachycardia, weak pulse, hypertension, hypotension, respiratory depression, palpitations, urinary urgency, blurred vision, dilated pupils, photophobia, rash, dry and hot skin.
Patient Information

Oral Advise patient using atropine for GI problems to take prescribed dose 30 to 60 min before meals and at bedtime. Advise patient using atropine for other conditions to take as prescribed without regard to meals, but to take with food if stomach upset occurs. Advise patient that dose and/or frequency of use may be changed periodically to achieve max benefit. Caution patient not to change the dose or stop taking unless advised by health care provider. Advise patient to notify health care provider if symptoms do not improve, appear to worsen, or if bothersome side effects occur. Instruct patient to stop taking the drug and notify health care provider immediately if any of the following occur: rash, flushing, eye pain, inability to urinate, confusion, disorientation, hallucinations, change in behavior. Advise patient to avoid strenuous activity during periods of high temperature or humidity. Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs. Inform patient that medication may cause pupils to dilate, resulting in intolerance to bright lights or sunlight. Advise patient to wear dark glasses to make bright lights or sunlight tolerable. Advise patient that drug may cause drowsiness, dizziness, or blurred vision, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined. Ophthalmic Remind patient or caregiver that solution and ointment are for use in the eye only.
Teach patient or caregiver proper technique for instilling ophthalmic solution or ointment: wash hands; do not allow tip of dropper bottle or tube to touch eye, eyelid, fingers or any other surface. Tilt head back, look up; pull lower eyelid down to form pocket; place prescribed number of drops or amount of ointment in the pocket; look downward before closing eye; compress lacrimal sac for 2 to 3 min after instillation complete. Caution patient not to rub eye(s). Advise patient or caregiver that if more than 1 topical ophthalmic drug is being used, instill eye drops first, wait at least 5 min, and then instill ointment last. Caution patient that blurred vision may occur and not to drive or engage in hazardous activities while pupil(s) are dilated. Advise patient or caregiver to contact health care provider if eye drops or ointment cause intolerable stinging, if eye or eyelid inflammation is noted, or if eye symptoms do not improve or worsen. Injection Advise patient that medication, with exception of auto-injector, will be prepared and administered by a health care provider in a medical setting. Review the patient information leaflet and instruction guide with potential user of autoinjector. Ensure that potential user of the auto-injector understands the indications for and use of the auto-injector, including symptoms of poisoning and preparation and use of the auto-injector. Emphasize to potential user of auto-injector that medical attention must be sought immediately after use of the auto-injector. Caution potential user of auto-injector that the primary protection against exposure to chemical nerve agents and insecticide poisonings is the wearing of protective garments, including masks designed specifically for protection.

Aminophylline
( Theophylline Ethylenediamine ) Pronunciation: (AM-i-NOF-i-lin) Class: Xanthine derivative
Trade Names
Aminophylline - Injection 250 mg (equiv. to theophylline 197 mg) per 10 mL Aminophylline - Tablets 100 mg - Tablets 200 mg Phyllocontin (Canada) Phyllocontin-350 (Canada)
Pharmacology
Relaxes bronchial smooth muscle and pulmonary blood vessels; stimulates central respiratory drive; increases diaphragmatic contractility.
Pharmacokinetics
Absorption
(Note: Information for the pharmacokinetics/dynamics section was taken from theophylline because aminophylline is a mixture of theophylline and base.) Rapidly and completely absorbed in solution or immediate-release. C max is 10 mcg/mL (5 to 15 mcg/mL). T max is 1 to 2 h. Food and antacid does not cause any clinically important changes; therapeutic range is 10 to 20 mcg/mL.
Distribution
40% protein bound (primarily albumin). Unbound theophylline distributes throughout the body water, but distributes poorly into body fat. Vd is 0.45 L/kg (0.3 to 0.7 L/kg) based on ideal body weight. Freely passes across the placenta into breast milk and into CSF.
Metabolism
Does not undergo any measurable first-pass elimination. About 90% of dose is metabolized in the liver in adults and children older than 1 yr of age. Caffeine and 3methylxanthine are the only theophylline metabolites with pharmacological activity.
Elimination
In neonates, about 50% of theophylline dose is excreted unchanged in the urine (ie, excretion is by the kidneys). 10% of theophylline dose is excreted unchanged in the urine in infants 0 to 3 mo of age.
Special Populations
Renal Function Impairment No dosage adjustment required in adults and children older than 3mo of age. In neonates with reduced renal function, dose reduction and frequent monitoring of serum concentrations are required. Hepatic Function Impairment Theophylline Cl is decreased 50% or more in patients with hepatic insufficiency. Dose reduction is required. Elderly Cl is decreased by an average of 30% in healthy patients older than 60 yr of age compared with younger adults. Children Cl is very low in neonates and reaches max values by 1 yr of age, remains relatively constant until about 9 yr of age, and then slowly decreases by approximately 50% to adult values at about 16 yr of age. Gender Pharmacokinetic differences between men and women are small and not expected to be clinically important. Race Pharmacokinetics have not been studied. Concurrent illness Theophylline Cl is decreased in patients with acute pulmonary edema, CHF, cor pulmonale, fever, hypothyroidism, liver disease (eg, acute hepatitis, cirrhosis), reduced renal function in infants younger than 3 mo of age, sepsis with multiorgan failure, and shock. Smoking Theophylline Cl is increased by smoking (ie, marijuana or tobacco), approximately 50% in young adult smokers and 80% in elderly tobacco smokers. Cessation of smoking for 1 wk causes a reduction in theophylline Cl by 40%. Special risk patients Pharmacokinetics vary widely among similar patients and cannot be predicted by age, sex, body weight, or other demographic parameters. However, a prolonged half-life may occur in patients with CHF, liver dysfunction, alcoholism, and respiratory infection patients.

Oral Treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases (eg, chronic bronchitis, emphysema). Parenteral Adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung disease (eg, chronic bronchitis, emphysema).
Contraindications
Hypersensitivity to theophyllines or any component of the product, including ethylenediamine.
Aminophylline is approximately 79% anhydrous theophylline by weight. The steady-state theophylline peak plasma concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and Cl in individual patients. The dose required to achieve a theophylline peak plasma concentration in the 10 to 20 mcg/mL range varies 4fold among similar patients in the absence of factors known to alter theophylline Cl. For a given population, there is no single dose that will provide both safe and effective concentrations for all patients. The dose of theophylline must be individualized on the basis of plasma theophylline concentration measurement in order to achieve a dose that provides max potential benefit with minimal risk of adverse reactions. The dose should be calculated based on ideal body weight.
General Advice

IV infusion Do not mix aminophylline injection in a syringe with other drugs. Add aminophylline separately to the IV solution. When an IV solution containing aminophylline is given piggyback, the IV system already in place should be turned off while aminophylline is infused if there is a potential problem with admixture compatibility. Because of the alkalinity of aminophylline-containing solutions, drugs that are alkali labile (eg, epinephrine, isoproterenol, norepinephrine, penicillin G potassium) should be avoided in admixture.
Storage/Stability
Store injection at 59 to 86F. Protect from light. Store tablets at 68 to 77F. Protect from light and moisture.
Drug Interactions
Acyclovir, alcohol, allopurinol, calcium channel blockers (ie, diltiazem, verapamil), cimetidine, corticosteroids (eg, hydrocortisone, prednisone), disulfiram, estrogencontaining hormonal contraceptives, fluvoxamine, influenza virus vaccine, interferon, macrolide antibiotics (azithromycin), methotrexate, mexiletine, nonselective beta-blockers (eg, propranolol), pentoxifylline, propafenone, quinolone antibiotics (ie, ciprofloxacin, norfloxacin), tacrine, thiabendazole, thyroid hormones (eg, levothyroxine), ticlopidine, zileuton Theophylline levels may be increased. Aminoglutethimide, barbiturates (eg, pentobarbital, phenobarbital, primidone, secobarbital), hydantoins (eg, phenytoin), isoproterenol IV, ketoconazole, moricizine, rifampin, smoking (ie, marijuana or tobacco), St. John's wort, sulfinpyrazone, sympathomimetics (eg, albuterol, isoproterenol, terbutaline) Theophylline levels may be decreased. Benzodiazepines, propofol Aminophylline may antagonize sedative effects. Beta-agonists Effects of both drugs may be antagonized. Carbamazepine, isoniazid, loop diuretics May increase or decrease aminophylline levels.
Ephedrine, tetracycline Increased risk of theophylline toxicity. Erythromycin Elevated theophylline levels, increasing the risk of toxicity, while erythromycin levels may be reduced. Food Low-protein, high-carbohydrate diet may increase aminophylline levels. Charcoal-broiled foods or high-protein, low-carbohydrate diet may decrease aminophylline levels. Halothane May cause catecholamine-induced arrhythmias. Ketamine May result in seizures. Lithium Aminophylline may reduce lithium levels. Nondepolarizing muscle relaxants May antagonize neuromuscular blockade.

Adverse Reactions
See also, signs and symptoms of overdosage.
Cardiovascular
Atrial flutter and tachycardia.
CNS
Headache; insomnia; irritability; restlessness; seizures.
Dermatologic
Contact dermatitis; exfoliative dermatitis.
GI
Diarrhea; nausea; vomiting.
Genitourinary
Transient diuresis.
Musculoskeletal
Fine skeletal muscle tremors.
Precautions
Monitor
Frequently monitor theophylline levels in elderly patients and smokers, as well as in patients with hepatic or renal impairment. Determine appropriate theophylline concentrations before making a dose increase as follows: determine whether the plasma level is subtherapeutic in a patient who continues to be symptomatic; whenever signs or symptoms of theophylline toxicity are present; and whenever there is a new illness, worsening of an existing concurrent illness, or a change in the treatment regimen.
Pregnancy
Category C .
Lactation
Children
Safe and effective for the approved indications in children.
Elderly
Elderly patients are at increased risk of experiencing serious theophylline adverse reactions and toxicity compared with younger patients because of pharmacodynamic and pharmacokinetic changes associated with aging.

Use with caution in patients with active peptic ulcer disease, cardiac arrhythmias, or seizure disorders.
Overdosage
Symptoms
General Acute MI; death due to cardiorespiratory arrest and/or hypoxic encephalopathy; increased serum calcium, creatine kinase, myoglobin and leukocyte count; decreased serum phosphate and magnesium; urinary retention in men with obstructive uropathy. Many manifestations of acute and chronic overdosage are similar. Acute overdosage Abdominal pain, acid/base disturbance, atrial fibrillation or flutter, death, disorientation, hyperglycemia, hypokalemia, hypotension/shock, nervousness, rhabdomyolysis, seizures, sinus tachycardia, supraventricular tachycardia, tremors, ventricular arrhythmias, ventricular premature beats, vomiting. Chronic overdosage
Abdominal pain, acid/base disturbance, atrial fibrillation or flutter, atrial tachycardia, death, diarrhea, disorientation, hematemesis, hyperglycemia, hypokalemia, hypotension/shock, nervousness, seizures, sinus tachycardia, supraventricular tachycardia, tremors, ventricular arrhythmias, ventricular premature beats, vomiting.
Patient Information

Advise patient not to smoke. If patient changes smoking habits or stops smoking, dosage adjustment may be necessary. For patients taking theophylline, emphasize that serum theophylline levels should be tested every 6 to 12 mo. Advise elderly patients to take safety precautions (eg, rise slowly, use handrails, request assistance in ambulation) if dizziness occurs. Instruct patient to avoid foods or beverages containing caffeine and to limit intake of charcoal-broiled foods. Instruct patients to contact health care provider if they experience insomnia, nausea, new illness accompanied by fever, persistent headache, rapid heart rate, or vomiting. Instruct patients that if a dose is missed, the patient should take the next dose at the usual scheduled time and not to attempt to make up for the missed dose. Instruct patients not to alter the dose, timing of the dose, or frequency of administration without contacting health care provider.

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