RiteMED Salbutamol

Each tablet contains: Salbutamol (as sulfate) 2 mg.

Pharmacology: Pharmacodynamics: Salbutamol is a selective short-acting beta₂-adrenergic agonist with preferential effect on beta₂-adrenergic receptors in the respiratory tract. It stimulates adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP); cAMP mediates cellular responses such as bronchial smooth muscle relaxation resulting in bronchodilation.
Pharmacokinetics: Salbutamol is readily absorbed from the gastrointestinal tract after oral administration. Salbutamol's onset of action is within 30 minutes, peaks in 2 to 3 hours and persists for 4 to 6 hours after a dose; the plasma half-life of is from 4-6 hours. It is extensively metabolized in the liver, being converted to salbutamol 4'-O-sulfate. Salbutamol and its metabolites are rapidly excreted in urine and feces. After oral administration of Salbutamol to healthy individuals, about 75% of a single dose is excreted in urine within 72 hours, mainly as the major metabolite about 4% of the dose is excreted in feces.
Animal studies show that Salbutamol can cross the blood-brain barrier and the placenta. It may be secreted in breast milk, but concentrations are not known.

For the prevention and relief of bronchospasm associated with obstructive airways disease: bronchial asthma, chronic obstructive pulmonary disease (COPD).

See table.

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Symptoms of Salbutamol overdose include extensions of the common undesirable effects (e.g., tremor, nervousness, headache, dizziness, sleeplessness or insomnia, hypertension or hypotension, palpitation, tachycardia, arrhythmia, angina, dry mouth, and nausea). Hypokalemia has also been reported; thus, plasma potassium concentrations should be monitored.
Discontinue Salbutamol and institute appropriate symptomatic therapy in cases of Salbutamol overdosage. Administration of a beta-adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic. There is no adequate evidence to support the use of dialysis in the treatment of Salbutamol overdose.

Hypersensitivity to any ingredient in the product.

If a previously effective dose fails to provide the usual relief or the usual duration of effect is reduced, consult a physician for medical advice as this may be a sign of worsening of asthma that would require reassessment of therapy.
Paradoxical bronchospasm, a pontentially life-threatening event, may occur with the administration of oral Salbutamol. If it occurs, discontinue use of the product immediately.
Use with caution in acute severe asthma where concomitant therapy with steroids, xanthine derivatives, or diuretics, and by hypoxia may result in hypokalemia; plasma potassium concentrations should be monitored in severe asthma.
Treatment with Salbutamol and other beta₂-agonists may decrease plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular adverse effects.
Use with caution in patients with the following conditions: Cardiovascular disorders including coronary sufficiency, cardiac arrhythmias or hypertension; Convulsive disorders; Hyperthyroidism; Diabetes mellitus; In patients who are unusually responsive to synpathomimetic amines.

Pregnancy: There have been reports of congenital anomalies (e.g., cleft palate and limb defects) in children of patients treated with Salbutamol. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship between the use of Salbutamol and the development of congenital anomalies cannot be established. Therefore, Salbutamol should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Salbutamol may be secreted in breast milk. Therefore, do not administer to the breastfeeding women unless, in the opinion of a physician, the potential benefits of the drug justify the possible risk to the baby.

The most frequent adverse reactions of oral Salbutamol include tremors (particularly the hands), nervousness, headache, dizziness, sleeplessness or insomnia, weakness, drowsiness, restlessness, irritability, tachycardia, palpitation, peripheral vasodilation, flushing, chest discomfort, nausea, dyspepsia, difficulty in micturition, and rarely muscle cramps.
Erythema multiforme or Stevens-Johnson syndrome has been reported rarely with administration of oral Salbutamol in children.
Potentially serious hypokalemia has also been reported.
Hypersensitivity reactions (including urticaria, angioedema, rash, paradoxical bronchospasm, anaphylaxis, oropharyngeal edema, and collapse) and arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) have been observed with the use of Salbutamol.
Salbutamol, like other sympathomimetic agents, can cause vertigo, central nervous system stimulation, angina, hypertension, unusual taste, and drying and irritation of the oropharynx.

Do not use with other oral sympathomimetic bronchodilators or Epinephrine to avoid deleterious cardiovascular effects.
Concurrent administration with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants may increase the risk of cardiac arrhythmia, tachycardia and increased or decreased blood pressure.
Do not administer with beta-blockers since these agents inhibit Salbutamol's effect.

Store at temperatures not exceeding 30°C.

Antiasthmatic & COPD Preparations

R03CC02 - salbutamol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

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