- Freegest 4 mg Tablet: Each chewable tablet contains Montelukast Sodium USP equivalent to Montelukast 4 mg.
- Freegest 5 mg Tablet: Each chewable tablet contains Montelukast Sodium USP equivalent to Montelukast 5 mg.
- Freegest 10 mg Tablet : Each tablet contains Montelukast Sodium USP equivalent to Montelukast 10 mg.
Freegest (Montelukast) is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. Cysteinyl leukotrienes and leukotriene receptors 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 contributes to the signs and symptoms of asthma).
Indications and Uses
- Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
- Montelukast is contraindicated to patients with hypersensitivity to any component of this product.
- Dosage and 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.
- The safety and efficacy of Montelukast were demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.
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 to avoid aspirin or other NSAIDs 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 church-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. The 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.
Generally, Montelukast is well tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia, rash, and upper respiratory tract infection.
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, 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.
Overdosage: 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 an 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.
- Freegest 4 mg Tablet : Each box contains 3 Alu-Alu blister pack of 10 tablets.
- Freegest 5 mg Tablet : Each box contains 3 Alu-Alu blister pack of 10 tablets.
- Freegest 10 mg Tablet : Each box contains 3 Alu-Alu blister pack of 10 tablets.