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Bafna Pharma
[Mundipharma]
Regulatory Class: Rx
C: Montelukast Na 10 mg, levocetirizine diHCl 5 mg
CI: Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Severe renal impairment (CrCl <10 mL/min). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
SP: 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.