Relisma

Salbutamol (as Sulfate) is an almost colorless suspension, actuated as aerosol, filled in an aluminum canister, and fitted with a metered valve.
Each actuation contains: Salbutamol (as Sulfate), BP 100 mcg.

Pharmacology: Pharmacodynamics: Salbutamol inhaler is a beta-2-adrenoreceptor agonist; bronchodilator. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion. Salbutamol sulphate relaxes the muscles in the walls of small air passages in the lungs. Salbutamol is used in the treatment of asthma and other forms of reversible airways obstruction.
Pharmacokinetics: Absorption: After administration through the inhaled route, between 10% to 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx, from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolized by the lung.
Distribution: Salbutamol (as Sulfate) is bound to plasma proteins to the extent of 10%.
Metabolism: The drug is excreted unchanged in the urine.
Elimination: The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours primarily in the urine.

For the relief of acute bronchospasm and for managing intermittent episodes of asthma; for chronic maintenance or prophylactic therapy of asthma and to prevent exercise induced bronchospasm.

See table.

Click on icon to see table/diagram/image

Hypokalemia may occur following overdose with salbutamol. Serum potassium levels should be monitored. The preferred antidote for salbutamol overdose is a cardioselective beta-blocking agent, however beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Salbutamol inhaler is contraindicated in patients with the history of hypersensitivity to any of its ingredients.

Salbutamol inhaler, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders especially coronary insufficiency, cardiac arrhythmias and hypertension in patients with convulsive disorder, hyperthyroidism, or diabetes mellitus.

Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. Salbutamol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Labor and Delivery: Use of Salbutamol inhaler for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Use in Lactation: It is not known whether this drug is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Immune system disorders: Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders: Rare: Hypokalemia. Potentially serious hypokalemia may result from beta2 agonist therapy.
Nervous system disorders: Common: Tremor, headache
Very rare: Hyperactivity.
Cardiac disorders: Common: Tachycardia.
Uncommon: Palpitations.
Very rare: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).
Unknown: Myocardial ischemia.
Vascular disorders: Rare: Peripheral vasodilatation, respiratory, thoracic and mediastinal disorders.
Very rare: Paradoxical bronchospasm.
Gastrointestinal disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and connective tissue disorders: Uncommon: Muscle cramps.

Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with Salbutamol inhaler. If additional adrenergic drugs are administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. During use of Monoamine Oxidase Inhibitors or Tricyclic Antidepressants, Beta-blockers, Diuretics and Digoxin, patients should use Salbutamol inhaler cautiously.

Special Precautions for Disposal and Other Handling: The canister contains a pressurized liquid. Do not expose the product to temperatures higher than 30°C. Do not pierce the canister, it should not be broken, punctured or burnt even when empty. Unused and unneeded medications should be properly disposed in accordance with local requirements. Consult a pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.

Store at temperatures not exceeding 30°C.

Antiasthmatic & COPD Preparations

R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

Rx