Ventolin

Syrup: Salbutamol (Ventolin) 2 mg/5 mL Syrup, orange flavour: Each 5 mL of orange flavoured, orange-coloured, sugar-free syrup contains 2 mg Salbutamol (as sulfate).
Inhaler: Each Salbutamol (Ventolin) Inhaler is a pressurised metered-dose inhaler which delivers salbutamol sulfate equivalent to 100 mcg Salbutamol per actuation, into the mouthpiece of a specially designed actuator. The inhaler also contains the CFC-free propellant HFA 134a. Each canister contains at least 200 actuations.
Nebules: Salbutamol (Ventolin Nebules) Solution for Inhalation 1 mg/mL is in a plastic ampoule containing a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulphate, in 1 mL). Each Salbutamol (Ventolin Nebules) Solution for Inhalation contains 2.5 mL of solution equivalent to 2.5 mg salbutamol.

Anti-asthma, Bronchodilator.

Salbutamol is a selective beta₂ adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema.
Inhaler/Nebules: For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to Salbutamol (Ventolin), treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with Salbutamol (Ventolin) may signal a need for urgent medical advice or treatment.
Syrup: Salbutamol (Ventolin) syrup is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema.
Salbutamol (Ventolin) Syrup is suitable oral therapy for children or those adults who prefer liquid medicines.
Nebules: Salbutamol (Ventolin Nebules) are indicated for the routine management of chronic bronchospasm (unresponsive to conventional therapy) and treatment of acute severe asthma (status asthmaticus).

Salbutamol (Ventolin) has a duration of action of 4 to 6 hours in most patients.
Inhaler/Nebules: Increasing use of beta₂ agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant corticosteroid therapy should be considered. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
Syrup: Adults: The usual effective dose is 10 ml salbutamol (4 mg of salbutamol) 3 or 4 times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 20 ml of syrup (8 mg salbutamol).
Some patients obtain adequate relief with 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily).
Children: 2-6 years 2.5 to 5 ml of syrup (1 to 2 mg salbutamol) 3 or 4 times daily.
6-12 years 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily.
Over 12 years 5 to 10 ml of syrup (2 to 4 mg salbutamol) 3 or 4 times daily.
Special patient groups: In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 5 ml of syrup (2 mg salbutamol) 3 or 4 times per day.
Inhaler: Salbutamol (Ventolin) Inhaler is administered by the inhaled route only. In patients who find co-ordination of a pressurised metered-dose inhaler difficult a spacer may be used with Salbutamol (Ventolin) Inhaler.
Babies and young children using the Salbutamol (Ventolin) Inhaler may benefit from the use of a paediatric spacer device with a face mask (for example the BABYHALER).
Relief of Acute Bronchospasm: Adults: 100 or 200 micrograms.
Children: 100 micrograms. The dose may be increased to 200 micrograms if required.
Prevention of Allergen or Exercise-Induced Bronchospasm: Adults: 200 micrograms before challenge or exertion.
Children: 100 micrograms before challenge or exertion. The dose may be increased to 200 micrograms if required.
Chronic Therapy: Adults: Up to 200 micrograms 4 times daily.
Children: Up to 200 micrograms 4 times daily.
On demand use of Salbutamol (Ventolin) should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see Precautions).
Nebules: Salbutamol (Ventolin Nebules) are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using sterile normal saline as a diluent may be required.
Salbutamol (Ventolin Nebules) are to be used with a nebuliser, under the direction of a physician.
The solution must not be injected, or swallowed.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. Salbutamol (Ventolin Nebules) should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers in the same space at the same time.
Adults and Children: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated four times daily. In adults higher dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.
Clinical efficacy of nebulised Salbutamol (Ventolin) in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

The most common signs and symptoms of overdose with Salbutamol (Ventolin) are transient beta agonist pharmacologically mediated events (see Precautions and Adverse Reactions).
Hypokalaemia may occur following overdosage with Salbutamol (Ventolin). Serum potassium levels should be monitored.
Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Syrup: Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when Salbutamol (Ventolin) overdose has been taken via the oral route.
Treatment: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

Salbutamol (Ventolin) is contraindicated in patients with a history of hypersensitivity to any of its components.
Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion.

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Increasing use of short-acting bronchodilators, in particular beta-2 agonists to relieve symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed.
Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Salbutamol (Ventolin) should be administered cautiously to patients with thyrotoxicosis.
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 by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur, resulting in an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator, if immediately available. Salbutamol (Ventolin) should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In the event of a previously effective dose of inhaled Salbutamol (Ventolin) failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken.
Syrup/Inhaler/Nebules: Effects on Ability to Drive and Use Machines: None reported.
Syrup: In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin) can induce reversible metabolic changes, for example increased blood sugar levels. The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Long term treatment with Salbutamol (Ventolin) Syrup (Sugar-containing formulation) increases the risk of dental caries. It is important that adequate dental hygiene is maintained.
Syrup/Nebules: Patients should be warned that if either the usual relief is diminished or the usual duration of action reduced, the patient should not increase the dose or its frequency of administration, but should seek medical advice.
Inhaler: Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of the drug to the lungs.
Nebules: Salbutamol (Ventolin Nebules) must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.
Salbutamol (Ventolin Nebules) should be used with caution in patients known to have received large doses of other sympathomimetic drugs.
A small number of cases of acute angle closure glaucoma have been reported in patients treated with a combination of nebulised Salbutamol (Ventolin) and ipratropium bromide. A combination of nebulised Salbutamol (Ventolin) with nebulised anticholinergics should therefore be used cautiously. Patients should receive adequate instruction in correct administration and be warned not to let the solution or mist enter the eye.
Salbutamol (Ventolin Nebules) should be discontinued, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
In common with other beta-adrenoceptor agonists, Salbutamol (Ventolin) can induce reversible metabolic changes, for example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.
Lactic acidosis has been reported very rarely 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 Adverse Reactions). 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.

Fertility: There is no information on the effects of Salbutamol (Ventolin) on human fertility. There were no adverse effects on fertility in animals.
Pregnancy: 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. During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies. As no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%, a relationship with salbutamol use cannot be established.
Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.

Syrup: Very common: tremor; Common: headache, tachycardia, palpitations, muscle cramps; Rare: hypokalaemia, cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, peripheral vasodilatation; Very rare: hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse, hyperactivity, feeling of muscle tension.
Inhaler: Common: Tremor, headache, tachycardia; Uncommon: palpitations, mouth and throat irritation, muscle cramps; Rare: hypokalaemia, peripheral vasodilatation; Very Rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse, hyperactivity, cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, paradoxical bronchospasm.
Nebules: Common: tremor, headache, tachycardia; Uncommon: palpitations, muscle cramps, mouth and throat irritation; Rare: hypokalaemia, peripheral vasodilatation; Very rare: cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, hyperactivity, paradoxical bronchospasm, lactic acidosis, hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Salbutamol (Ventolin) and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.
Salbutamol (Ventolin) is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

Syrup/Nebules: Store below 30°C. Protect from light.
Inhaler: Replace the mouthpiece cover firmly and snap it into position.
Store at temperatures not exceeding 30°C. Protect from frost and direct sunlight.
As with most inhaled medications in aerosol canisters, the therapeutic effect of this medication may decrease when the canister is cold.
Pressurised container. Do not expose to temperatures higher than 50°C. The canister should not be broken, punctured or burnt, even when apparently empty.

Antiasthmatic & COPD Preparations

R03AC02 - salbutamol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
R03CC02 - salbutamol ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

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