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Ventolin Information Ventolin Information

VENTOLIN™

Salbutamol Inhaler
100mcg

VENTOLIN FORTE™

Salbutamol Inhaler
200mcg

Qualitative and Quantitative Composition

Ventolin Inhaler

Ventolin Inhaler consists of a white microfine suspension of Salbutamol BP in a non-chlorofluorohydrocarbon propellant mixture packed under its own vapour pressure in an aluminium can which is sealed with a metering valve.

Ventolin Inhaler is a metered-dose aerosol which delivers 100mcg Salbutamol BP per actuation, into the mouthpiece of a specially designed actuator.

Ventolin Forte Inhaler

Ventolin Forte Inhaler consists of a white microfine suspension of Salbutamol BP in a non-chlorofluorohydrocarbon propellant mixture packed under its own vapour pressure in an aluminium can which is sealed with a metering valve.

Ventolin Forte Inhaler is a metered-dose aerosol which delivers 200mcg Salbutamol BP per actuation, into the mouthpiece of a specially designed actuator.

Clinical Particulars

Therapeutic indications

Salbutamol is a selective b2 adrenoceptor agonist. At therapeutic doses it acts on the b2 adrenoceptors of bronchial muscle, with little or no action on the b-1 adrenoceptors of the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in mild asthma and for the treatment of acute exacerbations in moderate and severe asthma.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (e.g >1mg/day beclomethasone dipropionate) or oral corticosteroid therapy. With this primary background corticosteroid treatment, Ventolin provides essential rescue medication for a severe asthmatic in treating acute exacerbations. Failure to respond promptly or fully to such rescue medication, signals a need for urgent medical advice and treatment.

Salbutamol provides short-acting (4 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. It is suitable for long-term use in the relief and prevention of asthmatic symptoms.

Ventolin should be used to relieve symptoms when they occur and to prevent them in those circumstances recognised by the patient to precipitate an asthmatic attack (e.g. before exercise or unavoidable allergen exposure).

Ventolin is particularly valuable as rescue medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy.

Posology and method of administration

Ventolin Inhaler is administered by the inhaled route only.

Salbutamol has a duration of action of 4 to 6 hours in most patients.

Increasing use of b2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.

In patients who find co-ordination of a pressurised metered-dose inhaler difficult a Volumatic spacer may be used with Ventolin Inhaler.

As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.

Relief of acute bronchospasm:

Adults: 100 or 200mcg.
Children: 100mcg, the dose may be increased to 200mcg if required.

Prevention of exercise-induced bronchospasm:

Adults: 200mcg before exertion
Children: 100mcg before exertion, the dose may be increased to 200mcg if required.

Chronic therapy:

Adults: Up to 200mcg four times daily
Children: Up to 200mcg four times daily

On demand use of Ventolin should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma (see precautions).

Contra-indications

Ventolin Inhaler is contra-indicated in patients with a history of hypersensitivity to any of its components.

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, inhaled salbutamol presentations are not appropriate for managing premature labour. Salbutamol preparations should not be used for threatened abortion.

Special warnings and special precautions for use

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 inhaled b2 agonists to control 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.

In the event of a previously effective dose of inhaled salbutamol 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.

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.

Salbutamol should be administered cautiously to patients with thyrotoxicosis.

Potentially serious hypokalaemia may result from b2 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.

Interaction with other medicaments and other forms of interaction

Salbutamol and non-selective b-blocking drugs, such as propranolol, should not usually be prescribed together.

Salbutamol is not contra-indicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

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.

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.

Because no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.

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.

Undesirable effects

Ventolin Inhaler may cause a fine tremor of skeletal muscle, usually the hands are most obviously affected. This effect is dose related and is common to all b-adrenergic stimulants.

Occasionally headaches have been reported.

Peripheral vasodilatation and a compensatory small increase in heart rate may occur in some patients.

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

There have been very rare reports of muscle cramps.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Ventolin Inhaler should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

Potentially serious hypokalaemia may result from b2 agonist therapy.

As with other b2 agonists hyperactivity has been reported rarely in children.

Mouth and throat irritation may occur with inhaled salbutamol.

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.

Tachycardia may occur in some patients.

Overdose

The preferred antidote for overdosage with Salbutamol is a cardioselective b-blocking agent. Beta-blocking agents 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

Pharmacodynamic properties

Salbutamol is a selective b2 adrenoceptor agonist. At therapeutic doses it acts on the b2 adrenoceptors of bronchial muscle, with little or no action on the b-1 adrenoceptors of cardiac muscle.

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%.

After administration by the inhaled route between 10 and 20% of the dose reaches the lower airways. The remainder is retained in the delivery system or is deposited in the oropharynx from where it is swallowed. The fraction deposited in the airways is absorbed into the pulmonary tissues and circulation but is not metabolised by the lung.

On reaching the systemic circulation it becomes accessible to hepatic metabolism and is excreted, primarily in the urine, as unchanged drug and as the phenolic sulphate.

The swallowed portion of an inhaled dose is absorbed from the gastrointestinal tract and undergoes considerable first-pass metabolism to the phenolic sulphate. Both unchanged drug and conjugate are excreted primarily in the urine.

Pre-clinical safety data

In common with other potent selective b2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5 mg/kg, 4 times the maximum human oral dose. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.