Prophylaxis and chronic treatment of asthma in patients 12 months of age and older . Acute prevention of exercise-induced bronchoconstriction in patients 6 years of age and older.
Leukotriene Antagonist; Antiasthmatic
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
ORAL Chronic asthma: Adult: 10 mg once daily in the evening. Child: 2-5 yr: 4 mg daily; 6-14 yr: 5 mg daily; 15 yr: 10 mg once daily. All doses to be taken in the evening. Allergic rhinitis: Adult: 10 mg once daily in the evening. Prophylaxis of exercise-induced asthma: Adult: 10 mg at least 2 hr prior to exercise; do not admin additional doses w/ in 24 hr. Child: 15 yr: 10 mg at least 2 hr prior to exercise; do not admin additional doses w/ in 24 hr.
Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug interaction studies, the recommended clinical dose of Montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin. Although additional specific interaction studies were not performed, Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast approximately 40% following a single 10mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as phenobarbital or rifampin, are co-administered with Montelukast.
Not for the relief of acute bronchospasm. Not to be used as monotherapy for the prevention of exercise-induced bronchospasm. Patients in whom asthma is precipitated by aspirin or other NSAIDs should continue to avoid aspirin & NSAIDs. Do not abruptly substitute for oral or inhaled corticosteroids. Be alert for any signs of Churg-Strauss syndrome. Pregnancy & lactation. Children <6 mth.
Dizziness, fatigue, fever; rash; abdominal pain, dyspepsia, dental pain, gastroenteritis; increased AST; weakness; cough, nasal congestion. Aggression, agitation, angioedema, arthralgia, bleeding tendency, bruising, cholestasis, diarrhoea, dream abnormalities, drowsiness, oedema, eosinophilia, hallucinations, hepatic eosinophilic infiltration (rare), hepatitis, hypersensitivity. hypoaesthesia, insomnia, irritability, muscle cramps, myalgia, nausea, palpitation, pancreatitis, paraesthesia, pruritus, restlessness, seizure, urticaria, vasculitis, vomiting. Anaphylaxis, Churg-Strauss syndrome.
It is safe to use montelukast during your pregnancy. Using montelukast, more commonly known as Singulair, during pregnancy is probably okay for your developing baby. If montelukast is required by the mother, it is not a reason to discontinue breastfeeding. Because there is no published experience with montelukast during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. 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.
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
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