Azmet Syrup, Tablet

Azmet is a selective beta2-adrenoceptor agonist. At therapeutic doses, it acts on the beta2-adrenoceptors of bronchial smooth muscle, with little or no action on the ß1-adrenoceptors of cardiac muscle. Azmet provides short acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. It also has an anti-inflammatory effect on mast cells causing inhibition of release of bronchoconstrictor mediators including histamine, neutrophil chemotactive factor (NCF) and prostaglandin D2.

Uses

Azmet Respirator Solution is used for the treatment of severe acute asthma (status asthmaticus) and also forms of bronchospasm.

Azmet tablet/injection is used for a bronchodilator for use in Asthma, Chronic Bronchitis, Emphysema and other conditions associated with airways obstruction.

Azmet inhaler is used for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema.

Azmet inhaler may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-induced asthma.

Azmet inhaler is suitable for treating bronchospasm in patients with coexisting heart disease or hypertension, including those taking beta blockers, because of its selective action on the bronchial receptors and lack of effects on the cardiovascular system. At therapeutic levels, it has little effect on cardiac receptors.

Azmet is also used to associated treatment for these conditions: Asthma, Asthmatic Bronchitis, Bronchial Asthma, Bronchospasm, Chronic Asthma, Chronic Bronchitis, Cough, Emphysema, Exercise-Induced Bronchospasm, Hyperkalemia, Wheezing, Excess mucus or phlegm, Airway secretion clearance therapy, Bronchodilation

Trade Name Azmet
Generic Salbutamol
Other Names Albuterol, Salbutamol, Salbutamolum
Weight 2mg/5ml, 4mg
Type Syrup, Tablet
Formula C13H21NO3
Weight Average: 239.3107
Monoisotopic: 239.152143543
Protein binding

Salbutamol is only weakly bound to plasma proteins.

Therapeutic Class Short-acting selective β2-adrenoceptor stimulants
Manufacturer Medicon Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:25 am

Dosage

Azmet dosage

Azmet Oral-

Children:

  • 2-6 years: 2.5 ml syrup, 3-4 times daily
  • 6-12 years: 5 ml syrup, 3-4 times daily
  • Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)

Adults: 2-4 mg tablet, 3-4 times daily. Maximum single dose is 8 mg tablet.

Injection-

salbutamol Injection may be administered by the subcutaneous, intramuscular or intravenous route, under the direction of a physician.

Adults:

  • Subcutaneous route: 500 mcg (8 mcg/kg) and repeated every four hours as required.
  • Intramuscular route: 500 mcg (8 mcg/kg) and repeated every four hours as required.

Slow intravenous injection: 250 mcg (4 mcg/kg) injected slowly. If necessary the dose may be repeated. The use of salbutamol Injection 500 mcg in 1 ml (500 mcg/ml, for intravenenous administration may be facilitated by dilution to 10 ml with Water for Injection BP (final concentration of 50 mcg/ml) and 5 ml of the diluted preparation (250 mcg/5 ml) administered by slow intravenous injection.

Pediatric Population: The safety and efficacy of salbutamol Injection in children under the age of 12 has not been established. From the available data no recommendation on posology can be made.

Children aged 12 years and over: Dose as per adult population

Azmet inhaler is administered by the inhaled route only. Shake Azmet Inhaler well before each spray. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

Adults:

  • For the relief of acute bronchospasm and for managing intermittent episodes of asthma: One or two puffs as a single dose
  • For chronic maintenance or prophylactic therapy: Two puffs three or four times daily
  • For prevention of exercise induced bronchospasm: Two puffs before exertion
  • For prevention of exercise induced bronchospasm: Two puffs should be taken at least 15 minutes before exertion

Children:

  • For the relief of acute bronchospasm, management of episodic asthma and for prevention of exercise induced bronchospasm: One puff may be administered as a single dose. Only for the use of medical professionals
  • For routine maintenance and prophylaxis: One puff three or four times daily, increasing if necessary to two puffs three or four times daily

Elderly: The dosage is the same as that for adults.

By Intermittent Administration:

Adult: salbutamol Respirator Solution 0.5-4.0 ml should be diluted to final volume of 2.0-4.0 ml with normal saline for injection. The resulting solution is inhaled from a suitably driven nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source this should take about 10 minutes.Azmet Respirator Solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebuliser and the patient allowed to inhale until bronchodilatation is achieved. This usually takes 3-5 minutes. Some adult patients may require higher doses of salbutamol upto 10 mg in which case nebulisation may continue until aerosol generation ceases.

Children under 12 years age: 0.5 ml of the solution diluted to 2-4 ml with normal saline. Some children may however require higher doses of upto 1 ml of the solution. Intermittent treatment may be repeated four times a day.

By Continuous Administration:

Azmet Respirator Solution is diluted with normal saline for injection, 1-2 ml solution made upto 100 ml with diluent. The diluted solution is administered as an aerosol by a suitably driven nebuliser. The usual rate of administration is 1 to 2 mg/hour. Delivery of the aerosol may be by face mask or via an endotracheal tube. Intermittent positive pressure may be used but is rarely necessary. When there is risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

Side Effects

Azmet may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.

Mild tremor and headache have been rarely reported. These usually disappear with continuous treatment. There have been very rare reports of transient muscle cramp. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted.

Precaution

Azmet should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Azmet may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed-angle glaucoma, and in those receiving antihypertensive therapy.

Azmet should be administered cautiously to patients suffering from thyrotoxicosis. In the event of previously effective dose of salbuatmol inhaler failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.

The management of asthma should normally a stepwise programme, and patient response should be monitored clinically and by lung function test. Increasing use of short acting inhaled agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient’s therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted. Patients inhaler techinique should be checked to make sure that aerosl actuation is synchronized with inspiration of breath for optimum delivery of the drugs to the lungs.

Interaction

Azmet and non-selective beta-blocking drugs such as propranolol should generally not be prescribed together. Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.

Food Interaction

No interactions found.

Volume of Distribution

The volume of distribution recorded for intravenously administered salbutamol has been recorded as 156 +/- 38 L.

Half Life

The elimination half-life of inhaled or oral salbutamol has been recorded as being between 2.7 and 5 hours while the apparent terminal plasma half-life of albuterol has been documented as being approximately 4.6 hours.

Clearance

The renal clearance of salbutamol has been documented as 272 +/- 38 ml/min after oral administration and 291 +/- 70 ml/min after intravenous administration. Furthermore, the renal clearance of the predominant sulfate conjugate metabolite was recorded as 98.5 +/- 23.5 ml/min following oral administration.

Pregnancy & Breastfeeding use

Azmet is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated, therefore the drug should not be used in pregnant women, or those likely to become pregnant, unless the expected benefit outweighs any potential risk. Oral administration of salbutamol to rats and rabbits during pregnancy showed no teratogenic effects in offspring, but evidence of retardation of fetal development was recorded in an inhalational teratology study in rabbits at an estimated dose of 149 μg/kg/day. Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of uncomplicated premature labour, Azmet presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. 

Intravenous salbutamol is contra-indicated in cases of ante-partum haemorrhage because of the risk of further haemorrhage from an atonic uterus and there is the risk of the same problem arising inadvertently in asthmatics using salbutamol. Profuse uterine bleeding following spontaneous abortion has been reported after the use of salbutamol. Special care is required in pregnant diabetic women. As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefit to the mother is greater than any possible risk to the infant.

Contraindication

History of hypersensitivity to any of its components. Azmet presentation should not be used for threatened abortion during the first or second trimester of pregnancy. It should be used with care in patients known to have received large doses of other sympathomimetic drugs.

Azmet tablet/injection is contraindicated in patients with a history of hypersensitivity to Azmet or any of its components.

Salbuatmol inhaler is contraindicated in patients with a history of hypersensitivity to any of its components. Although intravenous salbutamol, and occasionally salbutamol tablets, is used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, salbutamol inhaler preparations are not appropriate for managing premature labour. Azmet preparation should not be used for threatened abortion during the first or second trimesters of pregnancy.

Acute Overdose

The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Azmet is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Storage Condition

Store at a cool & dry place, protected from light. Once a bottle has been opened the contents should be discarded after one month.

Azmet contains Salbutamol see full prescribing information from innovator Monograph