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VENTOLIN is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ventolin Injection is indicated in adults and adolescents. Ventolin Injection provides short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. It is indicated for the relief of severe bronchospasm.
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Paediatric Population The safety and efficacy of Ventolin Injection in children under the age of 12 has not been established. From the available data no recommendation on posology can be made.
Children aged 12 years and over:
Dose as per adult population. 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
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000). Very common and common events were generally determined from clinical trial data.
Rare, very rare and unknown events were generally determined from spontaneous data.
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. 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. 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.
4. Special Warnings and Special 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.
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.
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.
3. 1. v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Albuterol in United Kingdom.
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Gastrointestinal disorders Unknown:
Nausea, vomiting *.
Musculoskeletal and connective tissue disorders Common:
Muscle cramps.
Injury, poisoning and procedural complications Unknown:
Slight pain or stinging on intramuscular use of undiluted injection*. * reported spontaneously in post-marketing data therefore frequency regarded as unknown. 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. uk/yellowcard.
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. Diabetic patients and those concurrently receiving corticosteroids should be monitored frequently.
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.
8). This medicine contains less than 1 mmol sodium (23 mg) per 5ml ampoule, that is to say essentially ‘sodium free’