Prox-S

Clear, strawberry flavored, cherry-red colored syrup.
Each 5 mL contains: Salbutamol (as Sulfate) 2 mg.

Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists. ATC Code: R03CC02.
Pharmacology: Pharmacodynamics: As a beta-adrenergic stimulant for relief of bronchospasm such as occurs with asthma, bronchitis, emphysema. It has a highly selective action on the receptors in bronchial muscle and in therapeutic dosage, little or no action on the cardiac receptors.
Pharmacokinetics: Salbutamol is readily absorbed from the gastro-intestinal tract and is subject to first pass metabolism in the liver. Peak plasma concentrations occur within one to four hours after oral administration. After multiple oral doses of salbutamol 2 mg four times a day, steady-state plasma concentrations are obtained after 3 days. About half is excreted in the urine as an inactive sulfate conjugate following oral administration. The bioavailability of orally administered salbutamol is about 50%.

For the treatment of asthma and other associated with reversible airways obstruction; pre-mature labor.

Children: 2-6 years: 2.5 mL (½ teaspoon).
7-12 years: 5 mL (1 teaspoon).
13 years & above: 5-10 mL (1-2 teaspoon).
To be taken three times a day, or as prescribed by the physician.

Symptoms: The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalemia.
Salbutamol overdose may lead to hypokalemia (abnormally low potassium concentration in the blood). Serum potassium levels should therefore be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Nausea, vomiting and hyperglycemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment: The preferred antidote for overdose with salbutamol sulfate is a cardio-selective beta-blocking agent, which should be used with caution in patients with a history of bronchospasm. Further management should be as clinically indicated or as recommended by the national poisons center, where available.

It is contraindicated in patients with hypertension, myocardial insufficiency, and hyperthyroidism. The excessive use of spray containing salbutamol should be avoided as it may lead to fatal results. Salbutamol should not be administered with non-selective beta-adrenoreceptor blocking drugs such as propranolol or oxprenolol.

Pregnancy: Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
As with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose levels.
Breastfeeding: As salbutamol is probably secreted in breast milk its use in nursing mothers requires careful consideration.
It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

The most common side effect of Salbutamol Syrup 2 mg/5 mL is fine tremor of the hands, which may interfere with precise manual work. Tension, restlessness and a rapid heart-beat may also occur. There have been very rare reports of muscle cramps. Hypersensitivity reactions such as angioedema, urticaria, bronchospasm, hypotension and collapse have rarely been reported. Potentially serious hypokalemia may result from β2-agonist therapy. Occasional headaches have also been reported. As with other drugs in this class, rare reports of hyperactivity in children have been reported.

Salbutamol oral preparations and non-selective beta-blocking drugs, such as propranolol should not usually be prescribed together.
The effects of this product may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

Store and transport not above 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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