Brodil ® Accucap

Salbutamol
Brodil ® Accucap

Prescribing Details



Description
Brodil ® Accucap dry powder inhaler is a preparation of Salbutamol sulfate. Salbutamol is a relatively selective ß 2 adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic ß 2 receptors. Salbutamol is a sympathomimetic agent which has a highly selective action on ß adrenergic receptors in bronchial muscle. It provides short-acting (4 to 6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airway obstruction. ß 2 adrenoceptor agonist is used in the treatment of asthma and other forms of diffuse reversible airways obstruction.

Uses
No Data

Indications
Brodil ® Accucap inhaler is indicated for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema.
It may be used to relieve attacks of acute dyspnoea and may also be taken prophylactically before exertion or to prevent exercise-induced asthma. It is also suitable for treating bronchospasm in patients with coexisting heart disease or hypertension, including those taking beta 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.

Dosage and administration
Brodil ® Accucap inhaler is administered by the inhaled route only. It is suitable for patients including those who cannot use metered dose inhaler successfully.
Adults
For the relief of acute bronchospasm and for managing intermittent episodes of asthma:
one or two (200-400 mcg) Brodil ® Accucap as a single dose.
For chronic maintenance or prophylactic therapy: one or two (200-400 mcg) Brodil ® Accucap up to four times daily. For prevention of exercise induced bronchospasm: two (400 mcg) Brodil ® Accucap before exertion.
Elderly
The dosage is same as that for adults.
Children
For the relief of acute bronchospasm, management of episodic asthma and for prevention of
exercise induced bronchospasm: one (200 mcg) Brodil ® Accucap may be administered as a single dose.
For routine maintenance and prophylaxis: one (200 mcg) Brodil ® Accucap up to four times daily

Use in pregnancy & lactation
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. 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.

Geriatric use
No Data

Precautions
Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. In the event of previously effective dose of salbuatmol 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.

Side effects
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.

Warnings
The management of asthma should normally a stepwise programme, and patient response should be monitored clinically and by lung function test. Increasing use of short-acting inhaled ? 2 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.

Contraindications
Salbuatmol inhaler is contraindicated in patients with a history of hypersensitivity to any of its components. Although intravenous salbutamol, and occasionally salbutamol tablets, is used in the management of premature labour uncomplicated by conditions such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy, salbutamol inhaler preparations are not appropriate for managing premature labour. Salbutamol preparation should not be used for threatened abortion during the first or second trimesters of pregnancy.

Drug interactions
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 vascular system may be potentiated. The effects of Salbutamol are inhibited by ? antagonists such as propranolol. Other sympathomimetic 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 deleterious cardiovascular effects. Treatment with diuretics may augment the hypokalemia that occurs with large doses of Salbutamol.

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

Preparation
No Data

Pharmaceutical precautions
Brodil ® Acucap must not be swallowed and can be used with any inhaler device. Remove Acucap capsule from the blister pack just prior to use, as Acucap exposed to moisture may not tear easily.
Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from children.

Presentation
No Data

Package quantities
Brodil ® Accucap Inhaler: Each box contains 30 capsules in alu-alu blister strips. Each Acucap capsule contains 200 mcg of Salbutamol BP (as Sulfate).