COMPOSITION
Each tablet contains:
- Levocetirizine Dihydrochloride IP: 5 mg
- Montelukast Sodium IP eq. to Montelukast: 10 mg
CLINICAL PHARMACOLOGY
Levocetirizine is a selective H1-receptor antagonist that blocks the effects of histamine, relieving allergic symptoms. Montelukast is a leukotriene receptor antagonist that inhibits airway inflammation and bronchoconstriction.
INDICATIONS AND USAGE
- Allergic rhinitis (seasonal and perennial)
- Chronic idiopathic urticaria
- Asthma as adjunct therapy
CONTRAINDICATIONS
- Hypersensitivity to either ingredient
- Severe renal impairment (for levocetirizine)
- History of neuropsychiatric disorders (use with caution)
PRECAUTIONS
- Monitor for behavioral changes (Montelukast)
- Caution in hepatic impairment
- Avoid alcohol with Levocetirizine
DRUG INTERACTIONS
- CNS depressants enhance sedation
- Montelukast may interact with phenobarbital, rifampin
PREGNANCY & LACTATION
- Category B: Use if clearly needed
- Montelukast is excreted in breast milk; caution advised
DOSAGE AND ADMINISTRATION
Adults and adolescents >=15 years: 1 tablet once daily, preferably in the evening
ADVERSE REACTIONS
- Drowsiness, dry mouth, fatigue (Levocetirizine)
- Headache, abdominal pain, neuropsychiatric events (Montelukast)