VENTOLIN Syrup Ref.[28325] Active ingredients: Salbutamol

Route of administration: oral.

Adults

The minimum starting dose is 2 mg three times a day given as 5 ml syrup. The usual effective dose is 4 mg (10 ml syrup) three or four times a day, which may be increased to a maximum of 8 mg (20 ml syrup) three or four times a day if adequate bronchodilation is not obtained.

Elderly

In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose.

Paediatric Population

2-6 years: the minimum starting dose is 1 mg as 2.5 ml of syrup three times daily. This may be increased to 2 mg as 5 ml of syrup three or four times daily.

6-12 years: the minimum starting dose is 2 mg as 5 ml syrup three times daily. This may be increased to four times daily.

Over 12 years: the minimum starting dose is 2 mg three times daily given as 5 ml syrup. This may be increased to 4 mg as 10 ml syrup three or four times daily.

Ventolin is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose.

For lower doses the syrup may be diluted with freshly prepared purified water BP.

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 hypokalaemia (see sections 4.4 and 4.8).

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should 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 hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

36 months.

Store at a temperature not exceeding 30°C.

Protect from light.

Ventolin syrup may be diluted with freshly Purified Water BP. The diluted mixture must be protected from light and stored below 25°C. Discard after 28 days.

Type III amber glass bottle with plastic, child resistant, pilfer-proof caps with low density polyethylene polyvinylidene chloride low density polyethylene (LDPE-PVDC-LDPE) faced liners.

Pack size: 150 ml.

Ventolin syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within 28 days.

A 50% v/v dilution of Ventolin syrup has been shown to be adequately preserved against microbial contamination. However, to avoid the possibility of introducing excessive microbial contamination, the Purified Water used for dilution should be recently prepared or alternatively it should be boiled and cooled immediately before use.

Admixture of Ventolin syrup with other liquid preparation is not recommended.