1. Name Of The Medicinal Product
Ventolin Injection 500 micrograms (0.5mg) in 1ml
2. Qualitative And Quantitative Composition
Ventolin Injection 500 micrograms (0.5mg) in 1ml (500 micrograms/ml) is presented as ampoules of 1ml, each containing 500 micrograms salbutamol as salbutamol sulphate BP in a sterile isotonic solution.
3. Pharmaceutical Form
A colourless or faintly straw coloured solution for injection.
4. 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.
Slow intravenous injection:
250 micrograms (4 micrograms/kg bodyweight) injected slowly. If necessary the dose may be repeated.
The use of Ventolin Injection 500 micrograms in 1ml (500 micrograms/ml, for intravenenous administration may be facilitated by dilution to 10ml with Water for Injection BP (final concentration of 50 micrograms/ml) and 5mls of the diluted preparation (250 micrograms/5ml) administered by slow intravenous injection.
Children:
At present there are insufficient data to recommend a dosage regimen for routine use.
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened using the following instructions:
hold with one hand the bottom part of the ampoule as indicated in Picture 1
put the other hand on the top of the ampoule positioning the thumb above the coloured point and press as indicated in Picture 2
Picture 1
Picture 2
4.3 Contraindications
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 β2-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).
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 salbutamol. 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.
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
Potentially serious hypokalaemia may result from β2-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 β-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.
Lactic acidosis has been reported in association with high therapeutic doses of intravenous and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation (see Section 4.8). Increase in lactate levels may lead to dyspnoea and compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure and lead to inappropriate intensification of short-acting beta-agonist treatment. It is therefore recommended that patients are monitored for the development of elevated serum lactate and consequent metabolic acidosis in this setting.
As maternal pulmonary oedema has been reported during or following management of premature labour with β2-agonists, careful attention should be given to fluid balance and cardio-respiratory function should be monitored. If signs of pulmonary oedema develop, discontinuation of treatment should be considered (see section 4.8).
4.5 Interaction With Other Medicinal Products 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
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (
Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders
Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta-agonist therapy.
Unknown: Lactic acidosis (see section 4.4)
Nervous system disorders
Very common: Tremor.
Common: Headache.
Very rare: Hyperactivity.
Cardiac disorders
Very common: Tachycardia.
Common: Palpitations.
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
Unknown: Myocardial ischaemia* ( see section 4.4)
Vascular disorders
Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders
Uncommon: Pulmonary oedema.
In the management of pre-term labour, Ventolin Injection has uncommonly been associated with pulmonary oedema. Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.
Gastrointestinal disorders
Unknown: Nausea, vomiting *.
Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Injury, poisoning and procedural complications
Unknown: Slight pain or stinging on i.m. use of undiluted injection*.
* reported spontaneously in post-marketing data therefore frequency regarded as unknown.
4.9 Overdose
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia and lactic acidosis (see sections 4.4 and 4.8).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses it acts on β2-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 the other sections of the Summary of Product Characteristics.
6. 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 keep the ampoule in the outer container.
6.5 Nature And Contents Of Container
Clear, neutral glass ampoules, packed in plastic trays with a cardboard sleeve over the trays.
Pack size: 1ml ampoules in plastic trays of 5.
6.6 Special Precautions For Disposal And Other 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
trading as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
8. Marketing Authorisation Number(S)
PL 10949/0084
9. Date Of First Authorisation/Renewal Of The Authorisation
6 September 2000
10. Date Of Revision Of The Text
31 July 2009
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