Brodil ^® HFA Inhaler

Brodil HFA inhaler is a preparation of Salbutamol Sulphate which is CFC free inhaler Salbutamol is a relatively selective ß2 adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic ß2 receptors.

Mechanism of action: Brodil HFA is a sympathomimetic agent which has a highly selective action on ß adrenergic receptors in bronchial muscle. It provides short acting (4 to 6 hours) bronchodilation with fast onset (within 5 minutes) in reversible airway obstruction. ß2 adrenoreceptor agonist is used in the treatment of asthma and other forms of diffuse reversible airways obstruction.

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Brodil HFA inhaler is indicated for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema.

Brodil HFA inhaler may be used to relieve attacks of acute dyspnea and may also be taken prophylactically before exertion or to prevent exercise induced asthma.

Brodil HFA inhaler is suitable for treating bronchospasm in patients with coexisting heart disease or hypertension, including those taking ß blockers, because of its selective action on the bronchial receptors and lack of effects on the cardiovascular system. At therapeutic levels, it has little effect on cardiac receptors.

Route of administration: Brodil HFA inhaler is administered by the inhaled route only. Shake Brodil HFA inhaler well before each spray.

Adults
For the relief of acute bronchospasm and for managing intermittent episodes of asthma: One or two puffs as single dose.

For chronic maintenance or prophylactic therapy: Two puffs three or four times daily.

For prevention of exercise induced bronchospasm: Two puffs should be taken at least 15 minutes before exertion.

Children
For the relief of acute bronchospasm, management of episodic asthma and for prevention of exercise induced bronchospasm: One puff may be administered as single dose.

For routine maintenance and prophylaxis: One puff three or four times daily, increasing if necessary to two puffs three or four times daily.

Elderly
The dosage is the same as that for adults.

Pregnancy: Salbutamol is known to cross the placental barrier in humans. Safety for use in pregnancy has not been demonstrated, therefore the drug should not be used in pregnant women or those likely to become pregnant, unless the expected benefit outweighs any potential risk. Salbutamol tablets are used in the management of uncomplicated premature labour, salbutamol presentations should not be used for threatened abortion during the first or second trimesters of pregnancy. Intravenous salbutamol is contraindicated in cases of ante-partum hemorrhage because of the risk of further hemorrhage from an atonic uterus and there is the risk of the same problem arising inadvertently in asthmatics using salbutamol. Profuse uterine bleeding following spontaneous abortion has been reported after the use of salbutamol. Special care is required in pregnant diabetic women.

Lactation: As salbutamol is probably secreted in breast milk, its use in nursing mothers is not recommended unless the expected benefit to the mother is greater than any possible risk to the infant.

The management of asthma should be normally a stepwise program and patient response should be monitored clinically and by lung function test. Increasing use of short acting inhaled ß2 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. Patients' inhaler technique should be checked to make sure that aerosol actuation is synchronized with inspiration of breath for optimum delivery of the drugs to the lungs. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. In the event of previously effective dose of salbutamol inhaler 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.

Mild tremor and headache have been rarely reported. These usually disappear with continuous treatment. There have been very rare reports of transient muscle cramp. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted.

Salbutamol inhaler is contraindicated in patient with known hypersensitivity to salbutamol or any components of this product. Although intravenous salbutamol and occasionally salbutamol tablets are used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum hemorrhage or toxemia of pregnancy, salbutamol inhaler preparations are not appropriate for managing premature labour.

Drug interaction with drug: Salbutamol should be administered with caution to patients being treated with monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, since the action of salbutamol on the ascular system may be potentiated. The effects of salbutamol are inhibited by ß antagonists such as propranolol. Other sympathomimetic erosol bronchodilator should not be used concomitantly with salbutamol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid eleterious cardiovascular effects. Treatment with diuretics may augment the hypokalemia that occurs with large doses of salbutamol.

Drug interaction with food and others: Not applicable.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse. The preferred antidote for overdose with salbutamol inhaler is cardioselective ß-blocker, such as metoprolol tartarate. But ß -blockers should be used with caution in patients with a history of bronchospasm. Dialysis is not appropriate treatment for overdose of salbutamol inhalation aerosol.

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Do not puncture, break or incinerate pressurized canister even when apparently empty.
Avoid storage in direct sunlight or heat.
Store below 30°C.
Keep away from eyes.
Keep away from children.

Brodil HFA Inhaler: Each canister contains 200 measured doses, each containing 100micrograms of Salbutamol BP.

Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach children. Keep away from eyes. Do not puncture, break or incinerate pressurized canister even when apparently empty.

Packing
Brodil HFA inhaler: Each canister contains 200 metered doses, each actuation delivers Salbutamol BP (as Sulphate) 100 micrograms.