SALBUTAMOL TABLETS BP 2mg

Each tablet contains 2.4mg salbutamol sulphate equivalent to 2mg salbutamol.

Tablets for oral administration.

1. For the relief of bronchospasm in bronchial asthmas of all types.

2. Chronic bronchitis.

3. Emphysema.

4. Inhibition of premature labour in selected patients where a definite benefit is likely to occur.

Route of administration Oral.

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.

In the management of premature labour after uterine contractions have been controlled by intravenous infusion of salbutamol and the infusion has been withdrawn maintenance therapy can be continued with oral salbutamol. The usual dose is 4mg three or four times daily.

1. Although salbutamol tablets are used in the management of premature labour salbutamol should not be used for threatened abortion during the first or second trimester of pregnancy.

2. Salbutamol and beta-blocking drugs such as propranolol should not usually be prescribed together.

3. Salbutamol tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

4. Salbutamol should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.

Increasing use of bronchodilators in particular short-acting inhaled beta₂-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Constant monitoring of potassium levels in patients with severe asthma is essential, potentially serious hypokalaemia may result from beta-2 agonist therapy.

There is a risk of pulmonary oedema after treatment with salbutamol for inhibition of premature labour.

In common with other β-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Tocolysis

Salbutamol should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered. Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. Salbutamol should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3).

Respiratory indications

Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

The effects of salbutamol may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants and monoamine oxidase inhibitors. There is an increased risk of hypokalaemia if high doses of theophylline or high doses of corticosteroids are given with higher doses of salbutamol.

Salbutamol should only be used during pregnancy if it is considered essential by the physician.

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.

None known.

The only side effect of significance is a fine tremor of skeletal muscle, which occurs in some patients, usually the hands and the effects are dose related. A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. With doses of salbutamol higher than those recommended or in patients who are unusually sensitive to beta-adrenergic stimulants, peripheral vasodilation and a compensatory increase in heart rate may occur.

Occasionally headaches have been reported. Lactic acidosis, myoclonus, pulmonary oedema, hypokalaemia, cardiac arrhythmias may also occur and very rarely hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

There have been spontaneously reports of myocardial ischemia in post-marketing experience (frequency unknown, see section 4.4).

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.

Salbutamol is a selective Beta-2-adrenergic agonist administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases. Because of its relative specificity for β₂ receptors, salbutamol relaxes smooth muscle of the bronchi, uterus and vascular supply to the skeletal muscle, but generally has much less stimulant action on the heart than does isoproterenol which has powerful action on all beta receptors.

Salbutamol is readily absorbed from the gastrointestinal tract. Its effects occur within 15 minutes and last for about 14 hours. The drug is excreted in urine in about 24 hours, 50% of the drug being excreted within 4 hours. The peak plasma concentration of salbutamol and its metabolites is 5.1-11.7μg% at 2.5-3 hours after an oral dose of 4mg. Salbutamol does not cross the blood brain barrier to a significant extent, but it crosses the placental barrier.

None stated.

The tablets also contain: maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171)), sodium starch glycollate, talc, magnesium stearate.

None known.

2 years

Store below 25°C in a dry place.

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

None stated.

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

PL 0142/0485

18 December 1998/23 October 2000

26/04/2010