Each sachet (1 g) contains: Montelukast Sodium Eq. to Montelukast 4 mg.
Pharmacology: Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It is usually administered orally. Montelukast is a CysLT1 antagonist; that is it blocks the action of leukotriene D4 on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene, and results in less inflammation.
Pharmacokinetics: Peak plasma concentrations of montelukast are achieved in 3 to 4 hours after oral doses. The mean oral bioavailability is 64%. Montelukast is more than 99% bound to plasma proteins. It is extensively metabolised in the liver by cytochrome P450 isoenzymes CYP3A4, CYP2A6, and CYP2C9, and is excreted principally in the faeces via the bile.
In the management of chronic asthma, allergic rhinitis, and as prophylaxis for exercise-induced asthma.
One sachet of MONTELUKAST 4 mg granules to be taken, evening time.
Or as prescribed by the physician.
Known hypersensitivity to the active substance or to any of the excipients.
Contraindicated in hepatic impairment and no dose adjustment is considered necessary in mild to moderate hepatic impairment.
Use in Pregnancy: Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Use in Lactation: Montelukast is excreted in milk. It is not known if montelukast is excreted in human milk. Montelukast may be used in breast-feeding only if it is considered to be clearly essential.
Use in Pregnancy: Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Use in Lactation: Montelukast is excreted in milk. It is not known if montelukast is excreted in human milk. Montelukast may be used in breast-feeding only if it is considered to be clearly essential.
Adverse effects reported of montelukast included oedema, agitation and restlessness, allergy (including anaphylaxis, angioedema, and urticaria), chest pain, tremor, dry mouth, vertigo, and arthralgia. Further suspected adverse effects included nightmares, sedation, palpitations, and increased sweating.
Caution recommends when potent inducers of the cytochrome P450 isoenzyme CYP3A4 such as phenytoin, phenobarbital, or rifampicin are given with montelukast.
Direction for Use: Empty sachet contents into a small cup containing 2 tablespoon of water. Do not use other liquids or food. Stir well and drink immediately. Refill cup with water and drink.
Store at temperatures not exceeding 30°C.
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Pediair granules for oral soln 4 mg
20's
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