Salbutamol Tablets Bp 4mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salbutamol 4 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4.82 mg of salbutamol sulphate For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablets
Pink, flat bevel edged tablets marked ‘APS’ or plain on one side and ‘4’ over ‘1508’ on the reverse
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Salbutamol is a beta-adrenergic stimulant which has a selective action on the beta-adrenergic receptors in bronchial muscle.
Salbutamol may be used in the management of bronchial asthma, and other conditions with associated reversible airways obstruction.
Salbutamol tablets may also be used, following the administration of salbutamol as a continuous intravenous infusion, for the management of premature labour during the third trimester of pregnancy. Once the uterine contractions have ceased and the infusion has been withdrawn, maintenance therapy may be continued with salbutamol tablets.
4.2 Posology and method of administration
For oral administration.
Patients should be warned against increasing the prescribed dosage without medical advice. If the prescribed dose becomes less effective, they should be instructed to seek medical advice.
A single dose of salbutamol is usually effective for 4-6 hours in most patients.
Adults
The minimum starting dose for adults is 2 mg 3 times daily. The usual effective dose is 4 mg three or four times daily. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8 mg. However, it has been established that some patients obtain adequate relief with 2 mg three or four times daily.
Salbutamol tablets must be swallowed whole with a glass of water.
Children
2 - 6 years: The starting dose is half a 2 mg tablet three times daily. The
dose can be increased to one 2 mg tablet taken three times daily if necessary.
6 - 12 years: A starting dose of one 2 mg tablet should be administered three times daily.
Over 12 years: A starting dose of one 2 mg tablet should be given three times daily. This may be increased to two 2 mg tablets given three or four times daily if necessary.
Salbutamol is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose.
The Elderly
The starting dose for elderly patients or those known to be unusually sensitive to betadrenergic stimulant drugs is 2 mg three or four times a day.
Premature labour
In the management of premature labour, after uterine contractions have been controlled by intravenous salbutamol and the infusion has been withdrawn, maintenance therapy may be continued with salbutamol tablets. The usual dosage is 4 mg three or four times daily.
Oral treatment should not be used initially to try and arrest premature labour.
4.3 Contraindications
Pregnancy
Although intravenous salbutamol and salbutamol tablets are used in the management of premature labour, uncomplicated by conditions such as placenta praevia, antepartum haemorrbage or toxaemia of pregnancy, salbutamol presentations should not be used for threatened abortion.
Hypersensitivity
Salbutamol preparations should not be administered to patients known to be hypersensitive to salbutamol itself or any of the preparations components.
4.4 Special warnings and precautions for use
As with other B-adrenergic agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Diabetic patients may not be able to compensate for this increase and the development of ketoacidosis has been reported. Concomitant administration of corticosteroids can exaggerate this effect.
Maternal pulmonary oedema has been reported during or following treatment of premature labour with B-adrenoceptor agonists, so careful attention to fluid balance should be given and cardio-respiratory function monitored.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in these patients.
Patients taking salbutamol may also be receiving short-acting inhaled bronchodilators to relieve symptoms. 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. Similarly, if patients find that treatment with salbutamol becomes less effective, medical attention should be sought.
In these situations, patients should be reassessed and consideration given to the need of the increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.
Salbutamol and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol should be administered cautiously to patients with thyrotoxicosis.
Potentially serious hypokalaemia may result from Beta-2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, and hypoxia. It is recommended that serum potassium levels are monitored in such situations.
4.5. Interactions with other medicinal products and other forms of interaction
Potentially serious hypokalaemia may result from B2-agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
Concomitant administration of high doses of corticosteroids may exacerbate adverse metabolic effects of salbutamol.
The effects of salbutamol are antagonised by beta-adrenoceptor blocking agents. Aminophylline may enhance the effects of salbutamol.
The likelihood of arrhythmias in digitalised patients is increased by salbutamol.
4.6 Pregnancy and lactation
As with the majority of drugs, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy but in animal studies, there was evidence of some harmful effects on the foetus at very high dose levels. Therefore, the use of salbutamol during pregnancy should be avoided, except for the management of premature labour.
As salbutamol is probably excreted in breast milk, its use in nursing mothers requires careful consideration. It is not know 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.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Potentially serious hypokalaemia may result from B2-agonist therapy.
Other side effects include fine tremor of skeletal muscle, which occurs in some patients; usually the hands are most obviously affected. This effect is dose related and is common to all beta-adrenergic stimulants. A few patients feel tense - this is due to the effects on skeletal muscle and not to direct CNS stimulation. Tachycardia with or without peripheral vasodilatation may rarely occur. In common with other p2 agonists, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported in association with the use of salbutamol, usually in susceptible patients. Occasionally, headaches have been reported.
Rarely, patients may experience muscle cramps, very rarely hypersensitivity reactions such as angioedema, urticaria, bronchospasm, hypotension and collapse.
As with other B2-agonists hyperactivity in children has been reported rarely.
4.9 Overdose
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent, but such agents should be used with caution in patients with a history of bronchospasm.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: R03C C02 (selective beta-2-adrenoceptor agonists)
Salbutamol is selective Beta-2 adrenoceptor agonist. At therapeutic doses, it acts on the Beta-2 adrenoceptors of bronchial muscle.
5.2 Pharmacokinetic properties
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partiy by metabolism to the inactive 4’-0- sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion, salbutamol is bound to plasma proteins to the extent of 10%.
After oral administration, salbutamol is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted mainly in the urine. The bioavailability of orally administered salbutamol is about 50%.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of Salbutamol has been established after many years of clinical use. Please refer to section 4.
6 PHARMACEUTICAL PARTICULARS
6.1
List of excipients
The tablets contain
Lactose Maize starch Povidone (E1201)
Dispersed pink (containing E127, E131)
Magnesium stearate (E572)
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Store below 25°C. Protect from light.
6.5 Nature and Contents of Container
Polypropylene containers with polyethylene security closures, or HDPE containers with LDPE lids or child resistant caps in packs of 50, 100 or 500 tablets.
PVdC coated PVC film with hard temper aluminium foil blister strips in packs of 7, 10, 14, 21,28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 or 168 tablets.
Not all pack sizes may be marketed
6.6 Instruction for use, handling and disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Ltd, Eastbourne, BN22 9AG, United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 00289/0065
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/09/2005
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DATE OF REVISION OF THE TEXT
11/11/2012