Salbutamol Tablets Bp 4mg
SUMMARY 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. Excipient(s) with known effect:
Lactose
For the full list of excipients, see section 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.
4.2 Posology and method of 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.
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.
A starting dose of one 2 mg tablet should be administered three times daily.
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.
Children 2 - 6 years:
6 - 12 years: Over 12 years:
Salbutamol is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose.
Older People
The starting dose for older patients or those known to be unusually sensitive to beta-adrenergic stimulant drugs is 2 mg three or four times a day.
Oral treatment should not be used initially to try and arrest premature labour.
4.3 Contraindications
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.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires 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 that usual, medicinal 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). Sever 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.
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol.
There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists.
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.
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.
Lactose warning
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 Fertility, pregnancy and lactation
As with the majority of drugs, there is little published eveidence 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.
As salbutamol is probably excreted in breast milk, its use in nursing mothers requires careful consideration. It is now known whether salbutamol has a harmful effect of 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 P2 -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.
Unknown : Myocardial ischaemia* (see section 4.4)
reported spontaneously in post-marketing data therefore frequency regarded as unknown
As with other B2-agonists hyperactivity in children has been reported rarely. Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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.
6.1 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
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/09/2005
10 DATE OF REVISION OF THE TEXT
23/11/2015