Regulatory Class: ℞
Generic Name: Montelukast Sodium, Levocetirizine dihydrochloride
Formulations: Montelukast Na 10 mg, levocetirizine diHCl 5 mg
Indications or Uses Chronic allergic conditions eg, seasonal allergic rhinitis, perennial allergic rhinitis, rhinitis associated w/ asthma.
Dosage and Directions for Use: Adult >15 yrs. 1 tab once daily.
Administration: Take with or without food. Take in the morning or evening.
Contraindication: Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Severe renal impairment (CrCl < 10 mL/min). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Special Precaution: May impair ability to drive or operate machinery. Renal & hepatic impairment. Pregnancy & lactation. Childn < 15 yr. Elderly. Montelukast: Not for the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Not to be used as monotherapy for the treatment & management of exercise-induced bronchospasm. Avoid concurrent treatment w/ aspirin & NSAIDs. Levocetirizine diHCl: Avoid alcohol intake. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reaction: Montelukast: Dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, trauma, cough, nasal congestion, flu. Levocetirizine: Somnolence, fatigue, nasopharyngitis, dry mouth & pharyngitis
Interactions: Montelukast: Decrease AUC w/ phenobarb or rifampin.
Presentation/Packaging: Film coated tablet 100's .
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