VENTAIR®–Montelukast Sodium BP

Chemical Name: : sodium;2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate

Description: Montelukast is a leukotriene receptor antagonist used as part of an asthma therapy regimen, to prevent exercise induced bronchoconstriction, and to treat seasonal allergic rhinitis. It is generally less preferred for this use than inhaled corticosteroids in severe cases.

Other uses include allergic rhinitis and hives of long duration. For allergic rhinitis it is a second-line treatment.

— 5 mg 2×10 tablets
— 10 mg 3×10 tablets

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VENTAIR®–Montelukast Sodium BP

COMPOSITION
5 mg Tablet: Each coated tablet contains Montelukast Sodium BP equivalent to 5 mg Montelukast.
10 mg Tablet: Each coated tablet contains Montelukast Sodium BP equivalent to 10 mg Montelukast.

PHARMACOLOGY
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CyslT1 receptor. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma (such as, airway edema, smooth muscle contraction and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma).

INDICATION
Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients of 6 months of age and older. It is also indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients.

DOSAGE AND ADMINISTRATION
Prophylaxis & Treatment of Asthma:
Children (6 months to 5 years): 4 mg once daily to be taken in the evening.
Children (6 to 14 years): 5 mg once daily to be taken in the evening.
Adults (15 years & older): 10 mg once daily to be taken in the evening.

Seasonal allergic rhinitis:
Adults & age over 15 years: 10 mg once daily to be taken in the evening.
The safety and efficacy of Montelukast was demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.

SIDE EFFECT
The common side effects are dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia, rash and upper respiratory tract infection.

PRECAUTION
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established.

CONTRAINDICATION
Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

DRUG INTERACTION
Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAID, while taking Montelukast. In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.

USE IN PREGNANCY AND LACTATION
In Pregnancy: There are no adequate and well-controlled studies of Montelukast in pregnant women.
As animal reproductive studies are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed.
Use of montelukast during lactation is ill-advised.

STORAGE
Store tablet at or below 30°C. Protect from light & moisture. Keep out of the reach of children.

PACKAGING
VENTAIR®: Coated Tablet 5 mg: Each box contains 2 strips of 10 tablets in blister pack.

VENTAIR®: Coated Tablet 10 mg: Each box contains 3 strips of 10 tablets in blister pack.

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