| DESCRIPTION |
Brizy® is a single isomer b2 agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.id), Vitamin E (as acetate), Nicotinamide and Cod liver oil.
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| INDICATIONS |
Brizy® is indicated for the treatment and prevention of bronchospasm in adults, adolescents and children over 6 years of age with reversible obstructive airway disease.
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| DOSAGE AND ADMINISTRATION |
Brizy® tablets:
*Adults and adolescents above 12 years: 1 - 2 mg three times a day.
*Children (6 - 11 years): 1 mg three times a day.
Brizy® syrup:
*Adults and adolescents above 12 years: 5 - 10 ml three times a day.
*Children (6 - 11 years): 5 ml three times a day.
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| CONTRAINDICATIONS |
Hypersensitivity to any of the components of the formulation.
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| PRECAUTIONS |
Potentially serious hypokalemia may result from b2 agonist therapy. 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. Serum potassium levels should be monitored in such situations.
Levosalbutamol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure. Although such effects are uncommon after administration of levosalbutamol at recommended doses, if they occur, the drug may need to be discontinued. Oral levosalbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias or hypertension.
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| USE IN PREGNANCY AND LACTATION |
The use of levosalbutamol in pregnant women or lactating mothers should be considered only if the expected benefit to the mother outweighs the possible risk to the fetus or the infant.
It is not known whether levosalbutamol is excreted in human milk. Caution should be exercised when oral levosalbutamol is administered to nursing mother.
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| DRUG INTERACTIONS |
Potentially serious hypokalemia may result from b2 agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscles cramps may occur. The other likely side effects are gastrointestinal disturbances such as nausea, vomiting, burning substernal or epigastric pain and diarrhoea. In some cases nervousness, headache, fatigue and sleeplessness may occur.
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| SIDE-EFFECTS |
Potentially serious hypokalemia may result from b2 agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscles cramps may occur. The other likely side effects are gastrointestinal disturbances such as nausea, vomiting, burning substernal or epigastric pain and diarrhoea. In some cases nervousness, headache, fatigue and sleeplessness may occur.
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| OVERDOSAGE |
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under side effects e.g. tachycardia, nervousness, headache, tremor, nausea, dizziness, fatigue and sleeplessness. Hypokalemia also may occur.
Treatment consists of discontinuation of oral levosalbutamol together with appropriate symptomatic therapy. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.
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| PHARMACEUTICAL PRECAUTION |
Store in a cool (below 30°C) , dry place and protect from light. Keep out of reach of children.
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| PACKAGING |
Brizy® 1 tablet : Box containing 5 strips of 10 tablets each. Each tablet contains levosalbutamol sulfate INN equivalent to levosalbutamol 1 mg.
Brizy® 2 tablet : Box containing 5 strips of 10 tablets each. Each tablet contains levosalbutamol sulfate INN equivalent to levosalbutamol 2 mg.
Brizy® syrup : Bottle containing levosalbutamol 60 ml syrup. Each 5 ml syrup contains levosalbutamol sulfate INN equivalent to levosalbutamol 1 mg.

Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK
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