Salbutamol Syrup 2mg/5ml
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1.
NAME OF THE MEDICINAL PRODUCT
Salbutamol Syrup 2mg/5ml
QUALITATI VE AND
QUANTITATIVE COMPOSITION
Each 5 ml contains Salbutamol Sulphate BP equivalent to 2 mg of Salbutamol.
3 PHARMACEUTICAL FORM
Oral solution - Raspberry Cola flavoured, sugar-free syrup.
4.1. Therapeutic Indications
Salbutamol is indicated in adults, adolescents and children aged 2 to 12 years.
Salbutamol is a selective p2-agonist broncodilator which provides short acting bronchodilation in reversible airways obstruction. Salbutamol Salbutamol is used to rapidly treat asthma, bronchospasm and reversible airways obstruction by widening the airways of the lungs. Salbutamol - Salbutamol Syrup 2mg/5ml is suitable for children and adults who are unable to use an inhaler device.
Should not be used in patients hypersensitive to any of the product ingredients.
4.2 Posology and Method of Administration
For oral administration. Shake the bottle before use. An oral syringe may be used to measure doses less than 5ml.
The usual adult dose is (4mg) two 5 ml spoonfuls (10ml), 3 or 4 times per day which may be increased to a maximum of (8mg) four 5 ml spoonfuls (20ml), 3 or 4 times per day. The minimum starting dose is (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.
In elderly patients and patients who are unusually sensitive to this class of medicine treatment may be initiated with (2mg) one 5 ml spoonful (5ml), 3 or 4 times per day.
Paediatric population
2- 6 years: the minimum starting dose is 1mg as 2.5 ml of syrup three times daily. This may be increased to 2mg as 5 ml of syrup three or four times daily.
6 - 12 years: the minimum starting dose is 2 mg as 5 ml of syrup three times daily. This may be increased to four times daily.
Over 12 years: the minimum starting dose is 2mg three times daily given as 5 ml syrup. This may be increased to 4 mg as 10 ml syrup three or four times daily.
4.3. Contra-indications
Although intravenous salbutamol and occasionally salbutamol syrup are used in the management of uncomplicated premature labour, salbutamol presentations should not be used for threatened abortion during the first or second trimester of pregnancy.
Should not be used in patients hypersensitive to any of the product ingredients.
4.4. Special Warnings and Precautions for Use
Patients should be warned that if either the usual relief is diminished or the usual duration of action is reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.
Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients suffering from angina, severe tachycardia or thyrotoxicosis.
Caution should be exercised in its use with anaesthetic agents such as chloroform, cyclopropane, halothane and other halogenated agents.
Salbutamol should not cause difficulty in micturition (urination) because unlike sympathomimetic drugs such as ephedrine, it does not stimulate a-adrenoceptors. However, there have been reports of difficulty in micturition in patients with prostatic enlargement.
Salbutamol should only be used during pregnancy if considered essential by the physician.
Use with caution in diabetic patients as this product may cause an increase in blood sugar levels. The development of ketoacidosis has been reported as diabetic patients may be unable to compensate for the increase in blood glucose. This effect can be exaggerated by concurrent administration of corticosteroids.
Salbutamol does not contain sugars.
This product should not be diluted.
In patients with severe or unstable asthma, bronchodilators should not be the only or main treatment. With severe asthma regular medical assessment is necessary, including lung-function testing as patients are at risk of severe attacks or possibly death. For the treatment of such patients, physicians should consider using the max recommended dose of inhaled corticosteroids and/or oral corticosteroids.
P2-agonist therapy (from parenteral and nebulised administration) may result in potentially serious hypokalaemia. Special caution is required in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, diuretics and steroids. It is important to monitor serum potassium levels in such situations.
Patients taking Salbutamol may also be using short-acting inhaled bronchodilators to alleviate symptoms. A decrease in asthma control is indicated by an increase in the use of bronchodilators in particular short acting inhaled P-agonists. In such cases medical advice should be sought. Higher doses of inhaled corticosteroids or a course of oral corticosteroids may be considered.
Severe exacerbations of asthma must be treated in the usual manner.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.
4.5. Interactions with other Medicaments and other forms of Interaction
Caution should be exercised during use with anaesthetic agents such as chloroform, cyclopropane, halothane and other halogenated agents.
The effects of this product may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants.
Salbutamol oral preparations and beta-blocking drugs, such as propranolol should not usually be prescribed together.
Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOI’s)
4.6. Pregnancy and Lactation
Salbutamol should only be used in pregnancy and lactation if considered essential by the physician.
Salbutamol should only be used during pregnancy/lactation if the expected benefits to the mother are greater than any potential risks to the foetus/neonate.
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.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
The most common side effect of Salbutamol is fine tremor of the hands, which may interfere with precise manual work. Tension, restlessness and a rapid heart beat may also occur. There have been very rare reports of muscle cramps. Hypersensitivity reactions such as angiodema, urticaria, bronchospasm, hypotension and collapse have rarely been reported. Potentially serious hypokalaemia may result from p2-agonist therapy. Occasional headaches have also been reported. As with other drugs in this class rare reports of hyperactivity in children have been reported.
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
The preferred antidote for overdose with salbutamol sulphate is a cardioselective beta-blocking agent, which should be used with caution in patients with a history of bronchospasm. Salbutamol overdose may lead to Hypokalaemia (abnormally low potassium concentration in the blood). Serum potassium levels should therefore be monitored.
5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
As a beta-adrenergic stimulant for relief of bronchospasm such as occurs with asthma, bronchitis, emphysema. It has a highly selective action on the receptors in bronchial muscle and in therapeutic dosage, little or no action on the cardiac receptors.
5.2.
Pharmacokinetic Properties
Salbutamol is readily absorbed from the gastro-intestinal tract and is subject to first pass metabolism in the liver. Peak plasma concentrations occur within one to four hours after oral administration. After multiple oral doses of salbutamol 4mg four times a day, steady-state plasma concentrations are obtained after 3 days. About half is excreted in the urine as an inactive sulphate conjugate following oral administration. The bioavailability of orally administered salbutamol is about 50%.
5.3. Preclinical Safety Data
additional to that in other
safety in the elderly of some harmful effects
There are no preclinical data of relevance to the prescriber which are sections of the SmPC.
As with the majority of drugs, there is little published evidence of its stages of human pregnancy, but in animal studies there was evidence on the foetus at very high dose levels.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Xanthan Gum (E415)
Glycerol (E422)
Sodium Citrate (E331)
Saccharin Sodium (E954)
Sodium Benzoate (E211)
Citric Acid Monohydrate
Raspberry Cola Flavour HSE (containing Ethanol, Propylene Glycol (E1520), Polysorbate (E432), Nutmeg Oil, Safrole and Cinnamic aldehyde)
Purified Water
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
36 months - amber glass bottle and HDPE bottle
6.4.
Special Precautions for Storage
Do not store above 25°C. Store in the original container.
100 ml, 150 ml and 200 ml type III amber glass bottle with Pilfer-Proof cap, screw cap or child resistant closure.
100 ml and 150 ml HDPE bottle with screw cap, tamper evident cap or child resistant closure
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited
Trading as: Pinewood Healthcare
Ballymacarbry
Clonmel
Co Tipperary
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 04917/0033
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/12/2008
10 DATE OF REVISION OF THE TEXT
09/07/2015