DOSAGE FORM:

Each 100 ml of syrup contains:

Albuterol sulfate equivalent to 40 mg .................................
salbutamol
Each 100 g of suspension aerosol contain:
Salbutamol .............................................. 0.11475 g or 0.12745 g
INDICATIONS:
It is used in the treatment of bronchial asthma, reversible bronchospasm and other
processes associated with reversible airway obstruction as bronchitis and emphysema,
bronchiectasis and lung infections.
Relief crisis acute dyspnea due to bronchoconstriction.
SALBUTAMOL is useful in the prophylaxis of bronchial asthma, bronchospasm
induced by exercise or exposure to a known allergen and inevitable.
CONTRAINDICATIONS
Hypersensitivity to SALBUTAMOL.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING
Pregnancy:
Risk Category C: Studies on mice using subcutaneous and oral doses several times
higher than the maximum human inhalation dose, have been cleft palate and other
malformations.
In rabbits using doses (2,800 times the human dose) for inhalation is registered
cranioschisis. There are no adequate and well-controlled studies in humans. However,
beta-adrenergic agonists by inhalation has been used successfully in the treatment of
asthma in pregnant. It has been reported that SALBUTAMOL intravenously or orally
inhibits uterine contractions may delay delivery term; however, although this effect
seems unlikely to use inhalation should be taken into account during the third quarter.
Lactation: It is unknown whether SALBUTAMOL is excreted in breast milk. Animal
studies have shown that this drug is potentially tumorigenic, it is recommended to
discontinue nursing or administration SALBUTAMOL avoid.
ADVERSE REACTIONS:
It found reports slight tremor and headache. Usually disappear with continued
treatment. There have been reports of transient muscle cramps. In patients
hypersensitive peripheral vasodilation may occur with compensatory tachycardia,
and hypersensitivity reactions. On rare occasions it has been reported hyperactivity in
children. Also tachycardia, headache, and insomnia neviosismo.
DRUG INTERACTIONS:
SALBUTAMOL sulfate should not be administered with beta-blockers such as
propranolol nonselective. The xanthine derivatives can aggravate asthma attacks
themselves, so it is suggested not manage them together or with MAO
inhibitors. Methyldopa and theophylline enhances its effect.
PRECAUTIONS IN RELATION TO EFFECTS CARCINOGENESIS,
MUTAGENESIS, IMPAIRMENT OF FERTILITY
So far teratogenic, carcinogenic, mutagenic and fertility effects are unknown.
DOSAGE AND ADMINISTRATION: Oral.
SYRUP
Adults: 4 mg or 10 ml, 3 or 4 times daily, is not obtained properly
bronchodilation. Each individual dose may be gradually increased as much as
8 mg. In hypersensitive and senile patients, it may be sufficient deliver 5 mL every 3
to 4 times daily. It is recommended to handle this starting dose and adjust according to
response.
Children: The drug should be administered every 6 or 8 hours
From 2 to 5 years: 2.5 ml.
From 6 to 12 years: 5 ml.
More than 12 years: 5-10 ml 3-4 times each day.
SUSPENSION SPRAY
The inhaler bottle has 200 doses, each dose provides 100 mcg.
Adults:
Relief of acute bronchospasm and intermittent periods of coma: 1 inhalation (100-
114 mcg) single dose can be increased to 2 inhalations if necessary. Maximum dose
(200-228 mcg) every 4-6 hours.
Bronchospasm by exercise or exposure to allergen: 1 or 2 inhalations 15 minutes
before.
Children:
Relief of acute bronchospasm and intermittent periods of exercise-induced
asthma: 1 inhalation increasing the dose if the response is inadequate. Do not exceed
4 puffs daily.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR
ACCIDENTAL INGESTION
Overdose is manifested by tachycardia and tremor by action on skeletal muscle. This
effect can be controlled by reducing the dose of the drug. In severe cases it can be
seen tachycardia, seizures, angina, hypertension, headache, arrhythmias, palpitations,
nausea, fatigue and insomnia. If overdose careful use of a beta-blocker may be
necessary, bearing in mind that there is always the risk of triggering an asthma
attack. Like other sympathomimetic aerosol have been reported cases of fatal
overdose with salbutamol sulphate aerosol.
STORAGE RECOMMENDATIONS
Store at room temperature to no more than 30 C and dry temperature.
LEGENDS OF PROTECTION
Exclusively for medical literature. Its sale requires a prescription.
Keep out of reach of children.
NAME AND ADDRESS OF LABORATORY:
See presentation or presentations.
PRESENTATION AND PRESENTATIONS:


Salbutamol Aerosol (suspension)'s leaflet


BECLOMETHASONE DIPROPIONATE INHALER BP

NAME AND STRUCTURE

NAME Salbutamol Inhalation Aerosol BP

MOLECULAR FORMULA C13H21NO3

MOLECULAR WEIGHT 239.31

CHARACTERISTICS
Salbutamol Inhalation Aerosol is a kind of white or slight yellow suspension mixed with just right
quantity of propellant and kept in a pressurised canister with a metered valve system.

PHARMACOLOGICAL ACTION
Salbutamol Inahalation Aerosol is an adrenomimetic which mainly exerts an effect on2 adrenergic
receptors, possessing the effect of relaxing bronchial smooth muscle and removing bronchospasm with little
influence on cardiovascular system.

PHARMACOKINETICS
The inspired aerosol's effect begins to act in 5 minutes and results in maximum plasma concentrations
occurring within 2 to 4 hours. The total effective period lasts for 4-6 hours. salbutamol has an elimination half-
life of 3.8 hours. Approximately 72% of the inhaled dose is excreted within 24 hours in the urine, and consists
of 28% as unchanged drug and 44% as metabolite.

INDICATIONS
It is indicated in the treatment and prophylaxis of bronchospasm in bronchial asthma, chronic bronchitis
and emphysema.

DOSAGE AND ADMINISTRATION
Adult: 1-2 doses each time. 2-4 times a day.
Children: 1/2 the adult dose or follow the physician's directions.
On demand, maximum 8 doses in 24hours

ADVERSE REACTION
Xerostomia, cough, vomiting. Dizziness and palpitation.

CONTRAINDICATIONS
It is contraindicated in patients with a history of hypersensitivity to salbutamol or any of its components.

CAUTION
It should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes
mellitus; and in patients who are unusually responsive to sympathomimetic amines.