(i) ROUTE OF ADMINISTRATION
Inhalation
DOSAGE AND ADMINISTRATION
Adults
For the relief of acute episodes of broncho-spasm 1 or 2 puffs as necessary.
On demand, maximum 8 puffs in 24 hours.
To prevent allergen or exercise-induced broncho-spasm Two inhalations 15 minutes prior to exercise, or exposure to allergen.
Children
Half the adult dose.
For chronic maintenance
or prophylactic therapy Adults: 1 or 2 puffs 4 times daily. Children: Half
the adult dose
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Health 2000 Salbutamol inhaler 100 mcg Inhalers and Rotacaps are indicated
in the treatment and prophylaxis of bron-chospasm in bronchial asthma, chronic
bronchitis and emphysema.
(iii) DESCRIPTION OF DOSAGE FORM
Salbutamol is a beta-adrenergic stimulant which has a highly selective action on the b2 -receptors in bronchial muscle and in therapeutic doses, little or no action on the b1-cardiac receptors.
(iv) CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation.
WARNING AND PRECAUTIONS
Health 2000 Salbutamol inhaler 100 mcg preparations should be used with caution in patients suffering from thyrotoxicosis. Health 2000 Salbutamol inhaler 100 mcg and non-selective beta-blocking drugs such as propranolol, should not be usually prescribed together.
Potentially serious hypokalaemia may result from b2-agonist therapy. Particular caution is advised in acute, severe asthma as this effect may be potentiated by con-comitant treatment with xanthine deriva-tives, steroids, diuretics, and by hypoxia. It is recommended that serum potassium levels are monitored in such situations
NURSING
MOTHERS
As salbutamol is probably secreted in breast milk, its use by nursing mothers
requires careful consideration.
PREGNANCY
Administration of the drug during preg-nancy should only be considered if
the expected benefit to the mother is greater than any possible risk to the
foetus.
(v) SIDE EFFECTS
Mild tremor and headache have been rarely reported. These usually disappear with continued treatment. As with other inhalation therapy the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the therapy should be discontinued immediately and alter-native therapy instituted.
(vi) TOXIC EFFECTS
Mutagenicity
and Carcinogenicity
Mutagenicity and carcinogenicity: No mutagenic potential was found in “in
vitro” tests and no carcinogenic effects were seen in mice; in rats
at very high doses an increase of benign mesovarian leiomyomas was found,
as an expression of the excessive b-blocker pharmacological activity.
Teratogenicity
Teratogenic Effects: Salbutamol are known teratogens
in rodent species.
Teratogenicity studies have been carried out by the inhaled and oral routes
in mice, rats and rabbits. In mice and rabbits, salbutamol showed effects
at high dose levels typical of a potent corticosteroid, e.g., retardation
of fetal growth and cleft palate. There are no adequate and well-controlled
studies in pregnant women.during worldwide marketing experience, various congenital
anomalies, including cleft palate and limb defects, have been reported in
the offsprings of patients being treated with salbutamol.