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Generic name:chlorpromazine Brand name:Thorazine Preparations: PO 10-25mg 2=4 times daily; may increase every 3-4 days (usual

dose is 200ng/day; up to 1g/day) CLASSIFI-CATION: Antipsychotics ACTION: Block dopamine receptors in the brain; also alter dopamine release and turnover. Prevention of seizures INDICATION / USES: Acute and chronic psychoses, particularly when accompanied by increased psychomotor activity. Nausea and vomiting. Also used in the treatment of intractable hiccups. COMMON ADVERSE EFFECTS: CNS: neuroleptic malignant syndrome, sedation, extrapyramidal reactions, tardive dyskinesia CV: hypotension (increased with IM, IV) EENT: blurred vision, dry eyes, lens opacities GI: constipation, dry mouth, anorexia, hepatitis, ileus GU: urinary retention Hematologic: agranulocytosis, leukopenia Skin: photosensitivity, pigment changes, rashes CONTRA-INDICATIONS: Hypersensitivity. Cross-sensitivity may exist among phenothiazines. Should not be used in narrow-angle glaucoma. Should not be used in patients who have CNS depression. NURSING CONSIDERATIONS: Assess mental status prior to and periodically during therapy.

Monitor BP and pulse prior to and frequently during the period of dosage adjustment. May cause QT interval changes on ECG. Observe patient carefully when administering medication, to ensure that medication is actually taken and not hoarded. Monitor I&O ratios and daily eight. Assess patient for signs and symptoms of dehydration. Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control. Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CPK. Advise patient to take medication as directed. Take missed doses as soon as remembered, witih remaining doses evenly spaced through out the day. May require several weeks to obtain desired effects. Do not increase dose or discontinue medication without consulting health care professional. Abrupt withdrawal may cause dizziness, nausea, vomiting, GI upset, trembling, or uncontrolled movements of mouth, tongue or jaw.

Stelazine (trifluoperazine) Generic name: Trifluoperazine Available strengths: 1 mg, 2 mg, 5 mg, 10 mg tablets; 10 mg/mL oral concentrate Available in generic: Yes Drug class: First-generation (conventional) antipsychotic General Information Stelazine (trifluoperazine) belongs to a class of antipsychotics known as the firstgeneration antipsychotics, sometimes referred to as conventional or typical antipsychotics. The first-generation antipsychotics represent an older class of antipsychotics that have been the standard for treating psychotic disorders for many decades. When compared with a newer class of second-generation antipsychotics, these earlier antipsychotics are referred to as typical or conventional because they lack the wider spectrum of therapeutic activity. The first-generation antipsychotics are also more likely to induce side effects that cause movement disorders, such as extrapyramidal symptoms (EPS) and tardive dyskinesia (TD), than the newer antipsychotics. Stelazine is a high-potency antipsychotic, relative to low-potency first-generation antipsychotics

such as Thorazine (chlorpromazine) and Mellaril (thioridazine). Stelazine is moderately sedating and less likely to lower blood pressure. Like other high-potency antipsychotics such as Haldol (haloperidol) and Prolixin (fluphenazine), Stelazine frequently induces EPS. Common Side Effects Patients taking Stelazine may experience sedation and drowsiness accompanied by fatigue. Sedation may be useful early on in therapy to lessen agitation and help the patient sleep, but as acute symptoms improve, this side effect may become bothersome, interfering with daily activities. Over time, most patients develop tolerance to the side effects of the medication. Daytime sedation may be minimized by taking a larger proportion of the divided dosage at bedtime and a small dose in the morning. Stelazine may induce side effects known as extrapyramidal symptoms. Adverse Reactions and Precautions Stelazine may cause drowsiness and sedation and impair physical coordination and mental alertness. Patients should avoid potentially dangerous activities, such as driving a car or operating machinery, until they are sure that these side effects will not affect their ability to perform these tasks. Stelazine may enhance ultraviolet light absorption in the skina reaction known as photosensitivity and predispose the person to sunburn. Patients should avoid prolonged exposure to sunlight, use sunscreen, and wear protective clothing until tolerance is developed to the medication. Nursing Considerations Do not discontinue your medication without consulting your physician. If you miss a dose, take it as soon as possible. If it is close to your next scheduled dose, skip the missed dose and continue on your regular dosing schedule, but do not take double doses. Stelazine may be taken with or without food. Stelazine may cause sedation and drowsiness, especially during initiation of therapy, and impair your alertness. Use caution when driving or performing tasks that require alertness. Stelazine may enhance ultraviolet light absorption and increase the risk of sunburn. Use a sunscreen and avoid excessive exposure to sunlight. Store the medication in its originally labeled, light-resistant container, away from heat and moisture. Heat and moisture may precipitate breakdown of your medication.

Keep your medication out of reach of children.

Generic name: haloperidol Brand name: Haldol Preparations: Tablets: 0.5mg, 1mg, 2mg, 5mg, 10mg CLASSIFICATION: Antipsychotics ACTION: Alters the effects of dopamine in the CNS Also has anticholinergic and alpha-adrenergic blocking activity. Diminished signs and symptoms of psychoses INDICATION / USES: Organic Psychoses acute psychotic symptoms Relieve hallucinations, delusions, disorganized thinking severe anxiety seizures

COMMON ADVERSE EFFECTS: CNS: extrapyramidal symptom such as muscle rigidity or spasm, shuffling gait, posture leaning forward, drooling, masklike facial appearance, dysphagia, akathisia, tardive dyskinesia, headache, seizures. CV: tachycardia, arrhythmias, hypertension, orthostatic hypertension. EENT: blurred vision, glaucoma GI: dry mouth, anorexia, nausea, vomiting, constipation, diarrhea, weight gain. GU: urinary frequency, urine retention, impotence, enuresis, amenorrhea, gynecomastia Hematologic: anemia, leucopenia, agranulocytosis

Skin: rash, dermatitis, phtosensitivity CONTRA-INDICATIONS: seizure disorder glaucoma elderly clients

NURSING CONSIDERATIONS: Assess mental status prior to and periodically during therapy. Monitor BP and pulse prior to and frequently during the period of dosage adjustment. May cause QT interval changes on ECG. Observe patient carefully when administering medication, to ensure that medication is actually taken and not hoarded. Monitor I&O ratios and daily eight. Assess patient for signs and symptoms of dehydration. Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control. Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CPK. Advise patient to take medication as directed. Take missed doses as soon as remembered, witih remaining doses evenly spaced through out the day. May require several weeks to obtain desired effects. Do not increase dose or discontinue medication without consulting health care professional. Abrupt withdrawal may cause dizziness, nausea, vomiting, GI upset, trembling, or uncontrolled movements of mouth, tongue or jaw.

Generic Name: Thioridazine; Thioridazine hydrochloride Product Name: Melleril Indication of Melleril: Melleril is used to treat psychotic disorders unresponsive to at least 2 other antipsychotics. Action of Melleril:

Antagonise D2 receptors resulting in anti-psychotic effects, including relief from symptoms such as hallucinations, delusions or abnormal behaviour/thought. Dose advice of Melleril: Adult: 50-600mg daily in 3 divided doses. Maximum 800mg daily for up to 4 weeks. Schedule of Melleril: S4 Common side effects of Melleril: Anticholinergic effects: dry mouth, blurred vision, constipation, tachycardia, urinary hesitancy, increased intraocular pressure, nausea, sexual adverse effects. Orthostatic hypotension Sedation Extrapyramidal effects (Parkinsonism, Akathisia, Dystonias, Tardive Dyskinesia) Hyperprolactinaemia (may result in galactorrhoea, gynaecomastia, amenorrhoea or infertility) Uncommon side effects of Melleril: Allergic reactions Pigmentary changes of skin or eyes Corneal and lens opacities Hypothermia Hyperthermia SIADH Diseases treated by Melleril: Tardive Dyskinesia Treatments associated with Melleril: Conventional Antipsychotics (Conventional Antipsychotics)

GENERIC NAME: Diazepam BRAND NAME: Valium CLASSIFICATION: Antianxiety agents, anticonvulsants, sedative/hyptonics, skeletal muscle relaxants (centrally acting) DOSAGE: 10 mg IM MECHANISM OF ACTION: - Depress the CNS, probably by potentiating GABA, an inhibitory neurotransmitter. - Produces skeletal muscle relaxation by inhibiting spinal polysynaptic afferent pathways. - Has anticonvul-sant properties due to enhanced presynaptic inhibi-tion.Therapeutic effects: (1) Relief of Anxiety (2) Sedation (3) Amnesia (4) Skeletal muscle relaxant (5) Decreased seizure activity INDICATION: -Adjunct in the management of: 1) Anxiety 2) Preoperative sedation 3) Conscious sedation - Provides light anesthesia and anterograde amnesia - Treatment of status epilepticus/ uncontrolled seizures - Skeletal muscle relaxant

- Management of the symptoms of alcohol withdrawal CONTRAINDICATIONS: - Hypersensitivity - Cross-sensitivity with other benzodiazepines may occurs - Comatose patients - Pre-existing CNS depression - Uncontrolled severe painUse cautiously in: 1) Hepatic dysfunction 2) Severe renal impairment 3) History of suicide attempt or drug dependence SIDE EFFECTS/ ADVERSE EFFECTS: - CNS: 1) dizziness 2) drowsiness 3) lethargy 4) hangover 5) headache 6) depression - EENT: 1) blurred vision - RESP: 1) respiratory depression - CV: 1) hypotension - GI: 1) constipation 2) diarrhea

3) nausea 4) vomiting - DERM: 1) rashes - LOCAL: 1) pain (IM) 2) phlebitis (IV) 3) venous thrombosis - MISC: 1) physical & psychological depen-dence 2)tolerance

NURSING IMPLICATIONS/RESPONSIBILITIES: - Monitor BP, PR,RR prior to periodically throughout therapy and frequently during IV therapy. - Assess IV site frequently during administration, diazepam may cause phlebitis and venous thrombosis. - Prolonged high-dose therapy may lead to psychological or physical dependence. Restrict amount of drug available to patient. Observe depressed patients closely for suicidal tendencies. - Observe and record intensity, duration and location of seizure activity. The initial dose of diazepam offers seizure control for 15-20 min after administration. - IM injections are painful and erratically absorbed. If IM route is used, inject deeply into deltoid muscle for maximum absorption. - Caution patient to avoid taking alcohol or other CNS depressants concurrently with this medication. - Effectiveness of therapy can be demonstrated by decrease anxiety level; control of seizures; decreased tremulousness.

Generic Name and Formulations:

Chlordiazepoxide HCl 5mg, 10mg, 25mg; caps. Indications for LIBRIUM: Anxiety. Adult Dose for LIBRIUM: Mild to moderate: 510mg 34 times daily. Severe: 2025mg 34 times daily. Elderly or debilitated: 5mg 24 times daily. Children's Dose for LIBRIUM: <6yrs: not recommended. 6yrs: 5mg 24 times daily. May increase to 10mg 23 times daily. Pharmacological Class: Benzodiazepine. Warnings/Precautions: Drug or alcohol abuse. Suicidal tendencies. Depression. Renal or hepatic disease. Therapy for >4 months. Porphyria. Psychosis. Epilepsy. Change dose gradually. Monitor blood counts and liver function. Elderly. Debilitated. Pregnancy, nursing mothers: not recommended. Interactions: Potentiates CNS depression with alcohol, other CNS depressants. Variable effects with anticoagulants. Avoid other psychotropics. Adverse Reactions: Drowsiness, CNS depression, ataxia, confusion, paradoxical excitement, memory impairment, blood dyscrasias, jaundice, rash, edema, extrapyramidal effects, abuse potential.

EQUANIL Tablets EQUANIL L.A. Tablets COMPOSITION: Each EQUANIL tablet contains meprobamate 400 mg. Each EQUANIL L.A. tablet contains meprobamate 400 mg as a slow release tablet.

Chemically, meprobamate is 2,2-di-(carbamoyl-oxymethyl)-pentane EQUANIL L.A. tablets contain TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION: Category A, 2.6 Tranquillizers

PHARMACOLOGICAL ACTION: EQUANIL (meprobamate) is a carbamate derivative which has been shown to have effects at multiple sites in the central nervous system including the thalamus and limbic system.

Pharmacokinetics: Meprobamate is well absorbed from the gastrointestinal tract. The drug is widely distributed in the body; there is little binding to plasma protein. Meprobamate undergoes extensive metabolism in the liver with 10 to 20% of the drug eliminated unchanged via the kidneys; the remainder is excreted as hydroxymeprobamate and as the glucoronide. Meprobamate can induce some hepatic microsomal enzymes, but is not clear whether the drug induces the enzymes responsible for its own metabolism.

INDICATIONS: For the relief of anxiety and tension; as an adjunct in the treatment of various disease states in which anxiety and tension are manifested. The effectiveness of EQUANIL and EQUANIL L.A. in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient. CONTRA-INDICATIONS: Acute intermittent porphyria and allergic or idiosyncratic reactions to meprobamate or related compounds, such as carisoprodol, mebutamate or carbromal. WARNINGS:

Addiction potential: Physical dependence, psychological dependence, and abuse have occurred. Chronic intoxication from prolonged ingestion of, usually, greater than recommended doses is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs. DOSAGE AND DIRECTIONS FOR USE: EQUANIL tablets: Usual adult dose is 1 200-1 600 mg/day in divided doses. Doses greater than 2 400 mg/day are not recommended. The usual dose of children ages 6-12 years is 100-200 mg two to three times daily. Not recommended for children under 6 years.

EQUANIL L.A. tablets: Usual adult dose is 1 tablet twice daily. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: SIDE-EFFECTS: Central nervous system: Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement, fast EEG activity.

Gastrointestinal: Nausea, vomiting, diarrhoea. Cardiovascular: Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope, hypotensive crises. Other: Exacerbation of porphyric symptoms.

Nursing consideration: The least effective dose should be administered, particularly to elderly and/or debilitated patients in order to preclude oversedation. Meprobamate is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in the administration to patients with

compromised liver or kidney function. Meprobamate occasionally may precipitate seizures in epileptic patients. The drug should be prescribed cautiously and in small quantities to patients with suicidal tendencies. Additive Effects: Since CNS-suppressant effects of meprobamate and alcohol or meprobamate and other psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. Addiction potential: See WARNINGS. Usage in Pregnancy and Lactation: See WARNINGS. Usage in children: See WARNINGS. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Suicidal attempts with meprobamate have resulted in drowsiness, lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratory collapse. Some suicidal attempts have been fatal. General supportive measures should be employed along with gastric lavage, I.V. fluids should be administered, and an adequate airway maintained. Diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and haemodialysis have been used successfully. Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Relapse and death, after initial recovery, have been attributed to incomplete gastric emptying and delayed absorption.

IDENTIFICATION: EQUANIL tablets are white, flat tablets with bevelled edges containing not more than a slight characteristic odour, having the word WYETH impressed on both halves of the scored face and the letter Wwithin a shield impressed on the other face.

TOFRANIL Rx Generic Name and Formulations: Imipramine HCl 10mg, 25mg, 50mg; tabs. Mood disorders Clinical Charts: Overactive Bladder & Urinary Incontinence Treatments

Mood Disorder Treatments Psychiatric Disorders Resource Center Indications for TOFRANIL: Depression. Adult Dose for TOFRANIL: Initially 75mg/day; max 200mg/day. Adolescents or elderly: initially 3040mg/day; max 100mg/day. Children's Dose for TOFRANIL: Not recommended. See Also: TOFRANIL-PM Pharmacological Class: Tricyclic. Contraindications: During or within 14 days of MAOIs. Acute post-MI. Warnings/Precautions: Urinary retention. Glaucoma. Cardiovascular disease. Epilepsy. Suicidal tendencies. ECT. Psychosis. Mania/hypomania. Bipolar disorder. Diabetes. Hyperthyroidism. Renal or hepatic disorders. Pregnancy (Cat.C). Nursing mothers: not recommended. Interactions: Hyperpyretic crisis, convulsions, death with MAOIs. Potentiates alcohol, sympathomimetics, CNS depressants. Potentiated by methylphenidate, CYP2D6 inhibitors; monitor plasma levels with cimetidine, SSRIs, phenothiazines, type 1C antiarrhythmics (eg, quinidine). Antagonized by barbiturates, carbamazepine, phenytoin. Paralytic ileus, hyperpyrexia with anticholinergics. Increased cardiovascular effects with methylphenidate. Blocks guanethidine, clonidine. Adverse Reactions: Drowsiness, anticholinergic effects, CNS overstimulation, arrhythmias, extrapyramidal symptoms, hypo- or hypertension, nausea, fatigue, rash, increased perspiration, headache, changes in blood sugar, photosensitivity, edema, blood dyscrasias (discontinue if occurs), jaundice.

Marplan - General Information: An MAO inhibitor that is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in the treatment of panic disorder and the phobic disorders. Pharmacology: Marplan is a non-selective hydrazine monoamine oxidase (MAO) inhibitor used to treat depression. In vivo and in vitro studies demonstrated inhibition of MAO in the brain, heart, and liver. Depression is a complicated disease that is not fully understood. It is thought that depression may be linked to an imbalance of chemicals within the brain. When depression occurs, there may be a decrease in the amount of chemicals released from nerve cells in the brain. These chemicals are called monoamines. Monoamines are broken down by a chemical called monoamine oxidase. Marplan prevents monoamine oxidase from breaking down the monoamines. This results in an increased amount of active monoamines in the brain. By increasing the amount of monoamines in the brain, the imbalance of chemicals thought to be caused by depression is altered. This helps relieve the symptoms of depression. Marplan for patients Patients should be instructed to report promptly the occurrence of headache or other unusual symptoms, i. e., palpitation and or tachycardia, a sense of constriction in the throat or chest, sweating, dizziness, neck stiffness, nausea, or vomiting. Patients should be warned against eating the foods listed under CONTRAINDICATIONS while on Marplan therapy and should also be told not to drink alcoholic beverages. The patient should also be warned about the possibility of hypotension and faintness, as well as drowsiness sufficient to impair performance of potentially hazardous tasks, such as driving a car or operating machinery. Patients should also be cautioned not to take concomitant medications, whether prescription or over-the- counter drugs such as cold, hay fever, or weight-reducing preparations, without the advice of a physician. They should be advised not to consume excessive amounts of caffeine in any form. Likewise, they should inform their physicians and their dentist about the use of Marplan. Marplan Interactions Isocarboxazid should be administered with caution to patients receiving Antabuse (disulfiram, Wyeth-Ayerst Laboratories). In a single study, rats given high intraperitoneal doses of an MAO inhibitor plus disulfiram experienced severe toxicity, including convulsions and death. Concomitant use of Isocarboxazid and other psychotropic agents is generally not recommended because of possible potentiating effects. This is especially true in patients

who may subject themselves to an overdosage of drugs. If combination therapy is needed, careful consideration should be given to the pharmacology of all agents to be used. The monoamine oxidase inhibitory effects of Isocarboxazid may persist for a substantial period after discontinuation of the drug, and this should be borne in mind when another drug is prescribed following Isocarboxazid. To avoid potentiation, the physician wishing to terminate treatment with Isocarboxazid and begin therapy with another agent should allow for an interval of 10 days. Marplan Contraindications Marplan (isocarboxazid) should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative or anesthetic drugs, buproprion HCL, buspirone HCL, dextromethorphan, cheese or other foods with a high tyramine content; or excessive quantities of caffeine. Marplan (isocarboxazid) should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache. Contraindicated Patient Populations Hypersensitivity Pheochromocytoma Liver Disease Renal Impairment

ArtanePronunciation Generic Name: trihexyphenidyl (Oral route) Schizophrenia Commonly used brand name(s) In the U.S. Artane Trihexane Tritane Available Dosage Forms:

Tablet Capsule, Extended Release Elixir Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Anticholinergic

Uses For Artane

Trihexyphenidyl is used alone or together with other medicines (e.g., levodopa) to treat Parkinson's disease. By improving muscle control and reducing stiffness, this medicine allows more normal movements of the body as the disease symptoms are reduced. Before Using Artane In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Pediatric Geriatric

Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other

medicines you take. Potassium Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Betel Nut Chlorpromazine Haloperidol Perphenazine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Bowel or stomach blockage or Enlarged prostate or Glaucoma or Hypertension (high blood pressure) or Urinary blockageUse with caution. May make these conditions worse. Kidney disease or Liver diseaseUse with caution. Effects may be increased because of slower removal of the medicine from the body. Proper Use of trihexyphenidyl This section provides information on the proper use of a number of products that contain trihexyphenidyl. It may not be specific to Artane. Please read with care. Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine before or after food, although it is usually taken with meals. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (elixir or tablets): For Parkinson's disease: AdultsAt first, 1 milligram (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg per day, given in divided doses 3 or 4 times per day. ChildrenUse and dose must be determined by your doctor. For side effects caused by other medicines: Adults5 to 15 milligrams (mg) per day, given in divided doses 3 or 4 times per day. ChildrenUse and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Artane It is important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects. Before using this medicine, your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor). Trihexyphenidyl may increase your risk of having glaucoma. Check with your doctor right away if you have blurred vision or any change in vision while taking this medicine. Trihexyphenidyl may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

CogentinPronunciation Generic Name: benztropine (Oral route) BENZ-troe-peen Commonly used brand name(s) In the U.S. Cogentin Available Dosage Forms: Solution Tablet Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Anticholinergic This medicine is available only with your doctor's prescription. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Betel Nut Chlorpromazine Haloperidol Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Enlarged prostate or Glaucoma or Paralytic ileus (bowel blockage) or Psychosis (mental disorder) or Tachycardia (fast heartbeat) or Urinating problems (e.g., painful or difficult urination, urinary retention)Use with caution. May make these conditions worse. Glaucoma, angle-closure or

Tardive dyskinesia (movement disorder)Should not be used in patients with this condition. Ads by Google Rejoice Shampoo Quality Shampoo for All Hair Types. Learn more at Rejoice Facebook Facebook.com/RejoicePhilippines

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Schizophrenia Alternative Mental Health Care. Where hope happens. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For Idiopathic parkinsonism: AdultsAt first, 0.5 to 1 milligram (mg) at bedtime. Your doctor may increase your dose as needed. The dose is usually not more than 6 mg. Children 3 years of age and aboveUse and dose must be determined by your doctor. Children below 3 years of ageUse is not recommended.

For Parkinson-like symptoms caused by other medicines: AdultsAt first, 1 to 4 milligrams (mg) once or twice a day. Your doctor may increase your dose as needed. Children 3 years of age and aboveUse and dose must be determined by your doctor. Children below 3 years of ageUse is not recommended. For Postencephalitic parkinsonism: AdultsAt first, 0.5 to 2 milligrams (mg) at bedtime. Your doctor may increase your dose as needed. The dose is usually not more than 6 mg. Children 3 years of age and aboveUse and dose must be determined by your doctor. Children below 3 years of ageUse is not recommended. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Cogentin It is important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects. Benztropine may cause dizziness, trouble in controlling movements, or trouble in thinking or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well. Do not stop taking this medicine without first checking with your doctor. Your doctor

may want you to gradually reduce the amount you are using before stopping completely. This medicine may make you sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. This medicine may cause muscle weakness. If you have concerns about this, check with your doctor. If you develop any unusual or strange thoughts and behavior while receiving benztropine, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability. This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine. Cogentin Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known Abdominal or stomach cramps or pain aggressive and violent behavior being forgetful bloating burning while urinating confusion about identity, place, and time constipation decrease in frequency of urination decrease in urine volume

diarrhea difficult or painful urination difficulty in passing urine (dribbling) difficulty with speaking difficulty with swallowing discouragement dizziness dry mouth extremely high fever or body temperature fast, pounding, or irregular heartbeat or pulse fast, shallow breathing fast, weak heartbeat feeling sad or empty fever headache hot, dry skin irritability lack of appetite lack of sweating listlessness loss of interest or pleasure mood or mental changes muscle cramps muscle weakness nervousness numbness of the fingers pale, clammy skin

seeing things that are not there thirst tiredness trouble concentrating trouble with sleeping vomiting Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Blindness blurred vision change in consciousness cold clammy skin decreased vision dizziness eye pain holding false beliefs that cannot be changed by fact lightheadedness loss of consciousness muscle weakness nausea or vomiting no breathing nosebleeds numbness or tingling in the face, arms, or legs shakiness and unsteady walk sweating tearing

unsteadiness, trembling, or other problems with muscle control or coordination unusual excitement, nervousness, or restlessness vision problems wheezing Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Incidence not known Enlarged pupils loss of appetite skin rash weight loss Other side effects not listed may also occur in some patients. If you notice any other effects,

AKINETON Tablets biperiden hydrochloride

DESCRIPTION Each AKINETON Tablet for oral administration contains 2 mg biperiden hydrochloride. Other ingredients may include corn syrup, lactose, magnesium stearate, potato starch and talc. Each 1 mL AKINETON Ampule for intramuscular or intravenous administration contains 5 mg biperiden lactate in an aqueous 1.4 percent sodium lactate solution. No added preservative. AKINETON is an anticholinergic agent. Biperiden is (alpha)-5-Norbornen-2-yl-(alpha)-phenyl-1-piperidine propanol. It is a white, crystalline, odorless powder, slightly soluble in water and alcohol. It is stable in air at normal temperatures. The structual formula is:

INDICATIONS AND USES

As an adjunct in the therapy of all forms of parkinsonism (idiopathic, postencephalitic, arteriosclerotic) Control of extrapyramidal disorders secondary to neuroleptic drug therapy (e.g., phenothiazines)

DOSAGE AND ADMINISTRATION Drug-Induced Extapyramidal Symptoms: Oral: One tablet one to three times daily. Parkinsons Disease: Oral: The usual beginning dose is one tablet three or four times daily. The dosage should be individualized with the dose titrated upward to a maximum of 8 tablets (16 mg) per 24 hours.

HOW SUPPLIED AKINETON (biperiden hydrochloride) Tablets, 2 mg each, white, embossed on one face with a triangle, bisected on the reverse and imprinted with the number 11. Bottles of 100 NDC # 49884-693-01

Storage: Store at 25C (77F); excursions permitted to 15- 30C (59-86F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in USP.

CLINICAL PHARMACOLOGY AKINETON is a weak peripheral anticholinergic agent. It has, therefore, some antisecretory, antispasmodic and mydriatic effects. In addition, AKINETON possesses nicotinolytic activity. Parkinsonism is thought to result from an imbalance between the excitatory (cholinergic) and inhibitory (dopaminergic) systems in the corpus striatum. The mechanism of action of centrally active anticholinergic drugs such as AKINETON is considered to relate to competitive antagonism of acetylcholine at cholinergic receptors in the corpus striatum, which then restores the balance. The parenteral form of AKINETON is an effective and reliable agent for the treatment of acute episodes of extrapyramidal disturbances sometimes seen during treatment with neuroleptic agents. Akathisia, akinesia, dyskinetic tremors, rigor, oculogyric crisis,

spasmodic torticollis, and profuse sweating are markedly reduced or eliminated. With parenteral AKINETON, these drug-induced disturbances are rapidly brought under control. Subsequently, this can usually be maintained with oral doses which may be given with tranquilizer therapy in psychotic and other conditions requiring an uninterrupted therapeutic program. Pharmacokinetics and Metabolism: Only limited pharmacokinetic studies of biperiden in humans are available The serum concentration at 1 to 1.5 hours following a single, 4 mg oral dose was 4-5 ng/mL. Plasma levels (0.1-0.2 ng/mL) could be determined up to 48 hours after dosing. Six hours after an oral dose of 250 mg/kg in rats, 87% of the drug had been absorbed. The metabolism of AKINETON is also incompletely understood, but does involve hydroxylation. In normal volunteers a single 10 mg intravenous dose of biperiden seemed to cause a transient rise in plasma cortisol and prolactin. No change in GH, LH, FSH, or TSH levels were seen. Biperiden lactate (10 mg/mL) was not irritating to the tissue of rabbits when injected intramuscularly (1.0 mL) into the sacrospinalis muscles and intradermally (0.25 mL) and subcutaneously (0.5 mL) into the shaved abdominal skin.

SIDE EFFECTS Atropine-like side effects such as dry mouth; blurred vision; drowsiness; euphoria or disorientation; urinary retention; postural hypotension; constipation; agitation; disturbed behavior may been seen. A case of generalized choreic movements has been reported in a Parkinson's disease patient when biperiden was added to carbidopa/ levodopa. A reduction in rapid eye movement (REM) sleep, characterized by increased REM latency and decreased percentage of REM sleep, has been reported. There usually are no significant changes in blood pressure or heart rate in patients who have been given the parenteral form of AKINETON. Mild transient postural hypotension and bradycardia may occur. These side effects can be minimized or avoided by slow intravenous administration. No local tissue reactions have been reported following intramuscular injection. If gastric irritation occurs following oral administration, it can be avoided by administering the drug during or after meals.

The central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic medication. See OVERDOSAGE section for signs and symptoms of the central anticholinergic syndrome, and for treatment.

DRUG INTERACTIONS Drug Interactions: The central anticholinergic syndrome can occur when anticholinergic agents such as AKINETON are administered concomitantly with drugs

that have secondary anticholinergic actions, e.g., certain narcotic analgesics such as meperidine, the phenothiazines and other antipsychotics, tricyclic antidepressants, certain antiarrhythmics such as the quinidine salts, and antihistamines. See OVERDOSAGE section for signs and symptoms of the central anticholinergic syndrome, and for treatment. WARNINGS Isolated instances of mental confusion, euphoria, agitation and disturbed behavior have been reported in susceptible patients. Also, the central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic medication, although it is more frequently due to overdosage. It may also result from concomitant administration of an anticholinergic agent and a drug that has secondary anticholinergic actions (see Drug Interactions and OVERDOSAGE sections). Caution should be observed in patients with manifest glaucoma, though no prohibitive rise in intraocular pressure has been noted following either oral or parenteral administration. Patients with prostatism, epilepsy or cardiac arrhythmia should be given this drug with caution.

Occasionally, drowsiness may occur, and patients who drive a car or operate any other potentially dangerous machinery should be warned of this possibility. As with other drugs acting on the central nervous system, the consumption of alcohol should be avoided during AKINETON therapy. PRECAUTIONS Drug Interactions: The central anticholinergic syndrome can occur when anticholinergic agents such as AKINETON are administered concomitantly with drugs that have secondary anticholinergic actions, e.g., certain narcotic analgesics such as meperidine, the phenothiazines and other antipsychotics, tricyclic antidepressants, certain antiarrhythmics such as the quinidine salts, and antihistamines. See OVERDOSAGE section for signs and symptoms of the central anticholinergic syndrome, and for treatment.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with AKINETON. It is also not known whether AKINETON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AKINETON should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AKINETON is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children have not been established.

OVERDOSE

Signs and Symptoms: Overdosage with AKINETON produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Correct diagnosis depends upon recognition of the peripheral signs of parasympathetic blockade including dilated and sluggish pupils; warm, dry skin; facial flushing; decreased secretions of the mouth, pharynx, nose, and bronchi; foul-smelling breath; elevated temperature, tachycardia, cardiac arrhythmias, decreased bowel sounds, and urinary retention. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations, illusions, confusion, incoherence, agitation, hyperactivity, ataxia, loss of memory, paranoia, combativeness, and seizures may be present. The condition can progress to stupor, coma, paralysis, and cardiac and respiratory arrest and death.

Treatment: Treatment of acute overdose revolves around symptomatic and supportive therapy. If AKINETON was administered orally, gastric lavage or other measures to limit absorption should be instituted. A small dose of diazepam or a short acting barbiturate may be administered if CNS excitation is observed. Phenothiazines are contraindicated because the toxicity may be intensified due to their antimuscarinic action, causing coma. Respiratory support, artificial respiration or vasopressor agents may be necessary. Hyperpyrexia must be reversed, fluid volume replaced and acid-base balance maintained. Urinary catheterization may be necessary.

Routine use of physostigmine for overdose is controversial. Delirium, hallucinations, coma, and supraventricular tachycardia (not ventricular tachycardias or conduction defects) seem to respond. If indicated, 1 mg (half this amount for children or elderly) may be given intramuscularly or by slow intravenous infusion. If there is no response within 20 minutes, an additional 1 mg dose may be given; this may be repeated until a total of 4 mg has been administered, a reversal of the toxic effects occur or excessive cholinergic signs are seen. Frequent monitoring of clinical signs should be done. Since physostigmine is rapidly destroyed, additional injections may be required every one or two hours to maintain control. The relapse intervals tend to lengthen as the toxic anticholinergic agent is metabolized, so the patient should be carefully observed for 8 to 12 hours following the last relapse. CONTRAINDICATIONS

1) Hypersensitivity to biperiden 2) Narrow angle glaucoma 3) Bowel obstruction 4) Megacolon

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