Montair Tablet 10mg

PRESENTATION

Montair 10 Tablet : Each tablet contains Montelukast Sodium INN equivalent to Montelukast 10 mg.

Montair 4 ODT : Each orodispersible tablet contains Montelukast Sodium BP equivalent to Montelukast 4 mg.

Montair 5 ODT : Each orodispersible tablet contains Montelukast Sodium BP equivalent to Montelukast 5 mg.

DESCRIPTION

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).

INDICATIONS

Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients from 6 months of age

and older.

DOSAGE & ADMINISTRATION

Adults (15 years of age or over): 10 mg daily to be taken in the evening.

Children (6-14 years of age): 5 mg daily to be taken in the evening.

Children (6 months-5 years of age): 4 mg daily to be taken in the evening.

Safety and effectiveness of Montelukast in pediatric patients younger than two years of age have not been established.

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 EFFECTS

Generally, Montelukast is well-tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough,

fever, asthenia, rash and upper respiratory tract infection.

PRECAUTIONS

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus).

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. 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.

USE IN PREGNANCY & LACTATION

Pregnancy: There are no adequate and well-controlled studies of Montelukast in pregnant women. Because animal reproductive studies

are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed.

Lactation: It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, so caution

should be exercised when Montelukast is given to a nursing mother.

DRUG INTERACTION

Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no

appropriate increase in adverse reactions.

Cytochrome P-450 inducers: Although Phenobarbital induces hepatic metabolism, no dosage adjustment for Montelukast is recommended.

It is reasonable to employ appropriate clinical monitoring when potent cytochrome P-450 enzyme inducers, such as Phenobarbital or

Rifampin, are co-administered with Montelukast.

OVER DOSE

There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed

were thirst, mydriasis, hyperkinesia, and abdominal pain. In the event of overdose, it is reasonable to employ the usual

supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute

supportive therapy, if required.

COMMERCIAL PACK

Montair 4 : Each box contains 3 Alu-Alu blister strip of 10 chewable tablets.

Montair 5 : Each box contains 3 Alu-Alu blister strip of 10 chewable tablets.

Montair 10 : Each box contains 3 Alu-Alu blister strip of 10 tablets.

MontairTM 4 ODT : Each box contains 3 Alu-Alu blister strips of 10 Orodispersible tablets.

MontairTM 5 ODT : Each box contains 3 Alu-Alu blister strips of 10 Orodispersible tablets