DOSAGE AND ADMINISTRATION
Oral

Adults
10 - 20 ml thrice daily.

Children (6 - 12 years)
10 ml thrice daily.

Children (under 6 years)
5 - 10 ml thrice daily.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Salbutamol 1 mg and Guaiphenesin 50 mg Expectorant is indicated for clinical relief of cough associated with bronchitis, bronchial asthma, emphysema and other broncho-pulmonary disorders where bronchospasm, mucous plugging and problems of expectoration coexist.

(iii) DESCRIPTION OF DOSAGE FORM

Salbutamol is a beta-adrenergic stimulant which has a highly selective action on the b2 - receptors in bronchial muscle resulting in bronchodilation, and in therapeutic doses, little or no action on the b1 cardiac receptors.
Guaiphenesin, by increasing respiratory tract fluid, reduces the viscosity of tenacious secretions and acts as an expectorant. Another possible mechanism by which it acts is by increasing the water bonding in the sputum, thereby decreasing its viscosity and leading to an increase in mucokinesis. Guaiphenesin is effective in both productive and nonproductive coughs.

(iv) CONTRAINDICATIONS

Hypersensitivity to the components of the formulation.

WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS
Sympathomimetic agents: Concomitant use of Health 2000 Salbutamol 1 mg and Guaiphenesin 50 mg Expectorant with other oral sympatho-mimetic agents is not recommended.
Beta-receptor blocking agents and Salbutamol inhibit the effect of each other. Monoamine oxidase inhibitors: Salbutamol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants since the action of Salbutamol on the vascular system may be potentiated.

PREGNANCY
The drug is not recommended for use in pregnancy.

NURSING MOTHERS
It is not known whether this drug is secreted in breast milk.

PAEDIATRIC USE
Safety and effectiveness in children under the age of two years has not yet been adequately demonstrated.

OTHERS
Health 2000 Salbutamol 1 mg and Guaiphenesin 50 mg Expectorant should be used with caution in patients with diabetes mellitus, serious cardiovascular disorders, hypertension, hyperthyroidism and peptic ulcers.

(v) SIDE EFFECTS

These are generally mild and very rare. However, in isolated cases, fine finger tremors, palpitation and gastrointestinal disturbances may be seen.

(vi) TOXIC EFFECTS

MUTAGENICITY, CARCINOGENICITY, TERATOGENICITY

Salbutamol
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.
There is no evidence of teratogenicity.

Guaiphenesin
Guaiphenesin (Category C) May be unsafe in first trimester*"Adequate and well-controlled studies in pregnant women have not been done" and "it is not known whether Guaiphenesin is distributed into breast milk." We do know that one group of babies whose mothers took Guaiphenesin during the first trimester of pregnancy had an increased incidence of inguinal (groin) hernias. However, a couple of larger groups showed no problems that were "strongly associated" with Guaiphenesin.
Guaiphenesin has never been tested in animals for "carcinogenicity, tumorigenicity, or mutagenicity"