Each film-coated tablet contains: Montelukast (as sodium) 10 mg.
Chemical Name: 2-[1-[[1-[3-[2-[(7-Chloro-2-quinolyl)]vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]-propyl]sulfanylmethyl]cyclopropyl]acetic acid sodium salt.
Molecular Weight: 608.17
Molecular Formula: C35H35ClNNaO3S
Pharmacology: Montelukast (Aeromax) is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene (CysLT1) receptor. It binds with affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as prostanoid, cholinergic, or beta-adrenergic receptor).
Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to CysLT receptors found in the human airway. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma and allergic rhinitis.
Pharmacokinetics: Peak plasma concentrations of montelukast are achieved in 2 to 4 hours after oral doses. The mean oral bioavailability is 64%. Montelukast is more than 99% bound to plasma proteins. It is extensively metabolized in the liver by cytochrome P450 isoenzymes CYP3A4, CYP2A6, and CYP2C9, and is excreted principally in the faeces via the bile. Metabolism was reduced and the elimination half-life prolonged in patients with mild to moderate hepatic impairment.
Montelukast (Aeromax) is used in the management of chronic asthma, allergic rhinitis and as prophylaxis for exercise-induced asthma.
Usual adult dose: 10 mg given once daily in the evening.
For children aged 2 to 5 years: 4 mg chewable tablet once daily in the evening.
For children aged 6 to 14 years: 5 mg chewable tablet once daily in the evening.
The most frequent adverse experiences observed were thirst, somnolence, mydriasis, hyperkinesia, and abdominal pain.
In the event of overdose, it is reasonable to employ the usual supportive measures: Remove unabsorbed material from the GI tract, employ clinical monitoring and institute supportive therapy if required.
Montelukast (Aeromax) is contraindicated to patients who have a known hypersensitivity reactions to any component of this product.
Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled beta-agonists as prophylaxis and have a short-acting inhaled beta-agonist available for rescue.
Patients on therapy with montelukast may present with systemic eosinophilia.
Do not abruptly substitute montelukast for inhaled or oral corticosteroids.
Avoid aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast in patients with known aspirin sensitivity.
Do not use in the treatment of acute asthma attacks.
There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.
It is not known if montelukast is excreted in human milk. Exercise caution when administering to a nursing mother.
Central Nervous System:
Abdominal pain, dyspepsia, infectious gastroenteritis.
Influenza, cough, nasal congestion.
Fatigue, dental pain, rash, fever, trauma.
Licensed product information recommends clinical monitoring when potent hepatic enzyme inducers such as phenytoin, phenobarbital, or rifampicin are given with montelukast.
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.
FC tab 10 mg x 30's, 100's.