Product Summary - Ventolin Injection
1. Trade Name of the Medicinal Product
Ventolin Injection 250 micrograms (0.25mg) in 5ml
2. Qualitative and Quantitative Composition
Ventolin Injection 250 micrograms (0.25mg) in 5ml (50 micrograms/ml) is presented as ampoules of 5ml, each containing 250 micrograms salbutamol as salbutamol sulphate BP in a sterile isotonic solution.
3. Pharmaceutical Form
A colourless or faintly straw coloured solution for injection.
Clinical Particulars
4.1 Therapeutic Indications
Ventolin Injection provides short-acting (4-6 hour) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. It is indicated for the relief of severe bronchospasm.
4.2 Posology and Method of Administration
Ventolin Injection may be administered by the subcutaneous, intramuscular or intravenous route, under the direction of a physician.
Adults:
Subcutaneous route: 500 micrograms (8 micrograms/kg body weight) and repeated every four hours as required.
Intramuscular route: 500 micrograms (8 micrograms/kg body weight) and repeated every four hours as required.
Intravenous route: 250 micrograms (4 micrograms/kg body weight) injected slowly. If necessary the dose may be repeated.
Ventolin Injection 250 micrograms in 5ml (50 micrograms/ml) is a suitably dilute preparation for slow intravenous injection, but if Ventolin Injection 500 micrograms in 1ml (500 micrograms/ml) is used, the injection may be facilitated by dilution with Water for Injections BP.
Children:
At present there are insufficient data to recommend a dosage regimen for routine use.
4.3 Contra-indications
Although intravenous salbutamol, and occasionally salbutamol tablets, are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, salbutamol preparations should not be used for threatened abortion.
Ventolin Injection is contra-indicated in patients with a history of hypersensitivity to any of the components.
4.4 Special Warnings and Precautions for Use
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 the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients.
The dosage or frequency of administration should only be increased on medical advice.
Patients being treated with Ventolin Injection may also be receiving short-acting inhaled bronchodilators to relieve symptoms. Increasing use of bronchodilators, in particular short-acting inhaled ß2-agonists to relieve symptoms, indicates deterioration of asthma control.
The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required. In this situation the patient should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
Potentially serious hypokalaemia may result from ß2-agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.
Severe exacerbations of asthma must be treated in the normal way.
The use of Ventolin Injection in the treatment of severe bronchospasm does not obviate the requirement for corticosteroid therapy as appropriate. When practicable, administration of oxygen concurrently with Ventolin Injection is recommended. In common with other ß-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as hypokalaemia and 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.
4.5 Interaction with other Medicaments and other forms of Interaction
Salbutamol and non-selective beta-blocking drugs such as propranolol, should not usually be prescribed together.
4.6. Pregnancy and Lactation
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
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.
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. In such situations the use of the inhaled route may be preferable although it is not known whether salbutamol has a harmful effect on the neonate.
4.7 Effects on Ability to Drive and Use Machines
Not applicable.
4.8 Undesirable Effects
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.
Enhancement of physiological tremor may occur with Ventolin Injection. This effect is caused by a direct action on skeletal muscle and is common to all ß-adrenergic stimulants.
Tachycardia, with or without dilatation of peripheral arterioles leading to a small reduction in arterial pressure, may occur. Increases in heart rate are more likely to occur in patients with normal heart rates and these increases are dose-dependent. In patients with pre-existing sinus tachycardia, especially those in status asthmaticus, the heart rate tends to fall as the condition of the patient improves.
In common with other ß2-agonists, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported with the use of salbutamol, usually in susceptible patients.
Headaches have occasionally been reported.
There have been very rare reports of muscle cramps.
Potentially serious hypokalaemia may result from ß2-agonist therapy.
Intramuscular use of the undiluted injection may produce slight pain or stinging.
4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent, but ß-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.
Pharmacological Properties
5.1 Pharmacodynamic Properties
Salbutamol is a selective ß2-adrenoceptor agonist. At therapeutic doses it acts on the ß2-adrenoceptors of bronchial muscle providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction.
5.2 Pharmacokinetic Properties
Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared partly renally and partly by metabolism to the inactive 4'-O-sulphate (phenolic sulphate) which is also excreted primarily in the urine. The faeces are a minor route of excretion. The majority of a dose of salbutamol given intravenously, orally or by inhalation is excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of 10%.
5.3 Preclinical Safety Data
There are no additional preclinical safety data other than are provided in other sections of the Summary of Product Characteristics.
Pharmaceutical Particulars
6.1 List of Excipients
Sodium chloride
Sodium hydroxide pellets
Dilute sulphuric acid
Water for injections
Nitrogen (oxygen free)
6.2 Incompatibilities
None stated
6.3 Shelf Life
36 months
24 hours - shelf life of admixtures with infusion fluids.
6.4 Special Precautions for Storage
Store below 30°C and protect from light.
6.5 Nature and Contents of Container
Clear, neutral glass ampoules, packed in plastic trays with a cardboard sleeve over the trays.
Pack size: 5ml ampoules in plastic trays of 10.
6.6 Instructions for Use/Handling
The only recommended diluents for Ventolin Injection are Water for Injections BP, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP or Dextrose Injection BP.
All unused admixtures of Ventolin Injection should be discarded 24 hours after preparation.
Ventolin Injection should not be administered in the same syringe as any other medication.
Administrative Data
7. Marketing Authorisation Holder
Glaxo Wellcome UK Ltd,
Stockley Park West,
Uxbridge,
Middlesex,
UB11 1BT.
8. Marketing Authorisation Number
PL 10949/0083
9. Date of First Authorisation/Renewal of Authorisation
8 November 1993/20 October 1995/6 September 2000
10. Date of (Partial) Revision of Text
6 September 2000
11. Legal Status
POM.
Cost
50 micrograms/ml-10 x 5ml, £5.70
