SALBUTAMOL Tablets Ref.[7085] Active ingredients: Salbutamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS

Therapeutic indications

Salbutamol Tablets are indicated in adults, adolescents and children aged 2 to 12 years.

  1. For the relief of bronchospasm in bronchial asthmas of all types.
  2. Chronic bronchitis.
  3. Emphysema.

Posology and method of administration

Posology

Adults

The usual effective dose is 4mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2mg three or four times daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2mg three or four times per day.

Children

The following doses should be administered three or four times daily.

2-6 years: 1-2mg.

6-12 years: 2mg.

Over 12 years: 2-4mg.

The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased.

Method of administration

For oral use.

Overdose

The preferred antidote for overdosage with salbutamol is a cardioselective beta blocking agent, but beta blocking drugs should be used with caution in patients with a history of bronchospasm.

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store below 25°C in a dry place.

Nature and contents of container

Polypropylene tubes with low density polyethylene caps. Packing material: high density polyethylene film.

28s, 30s, 56s, 60s, 84s, 100s, 250s, 500s, 1000s

Polyethylene container with a polypropylene lid.

28s

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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