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

Available in single dosage form:

Ventair 5 Chewable Tablet: Each chewable tablet contains Montelukast Sodium BP equivalent to 5 mg Montelukast.

Ventair 10 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 5 Chewable Tablet: Each box contains 2 strips of 10 tablets in blister pack.

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

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