API

Levocetirizine (5mg) + Montelukast (10mg)

Drug classification

Antiallergic; Levocetirizine: second-generation antihistamine, Montelukast: leukotriene receptor antagonist.

Dosage form

Film-coated oral tablet containing levocetirizine 5mg and montelukast 10mg.

API strength per dosage

Dose

Montina-L Tablet typically contains levocetirizine 5 mg and montelukast 10 mg, taken once daily in adults. In children, dosing varies by age and weight; consult product guidelines. Use caution or adjust dose in moderate to severe renal impairment; not recommended in end-stage renal disease. No specific adjustment for mild hepatic impairment; use caution in severe cases.

Mechanism of action

Levocetirizine selectively antagonizes peripheral H1 histamine receptors, reducing allergic symptoms. Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene type 1 (CysLT1) receptors, inhibiting leukotriene-mediated bronchoconstriction and inflammation. Together, they decrease allergic inflammation, nasal congestion, and bronchospasm.

Indications

Treatment of Sneezing and runny nose due to allergiesTreatment of Hay feverTreatment of Allergic skin conditions

Side effects

Nausea Diarrhea Dryness in mouth Fatigue Headache Skin rash Sleepiness Vomiting

Pregnancy category

Levocetirizine and montelukast should be used in pregnancy only if clearly needed; limited human data, animal studies show no major teratogenicity. Consult physician.

Precautions

Avoid in severe renal impairment, monitor for neuropsychiatric symptoms, caution in patients with epilepsy, assess for allergic reactions, avoid alcohol and CNS depressants, monitor for drowsiness, use with caution in elderly, not for acute asthma attacks, review for drug interactions, assess liver function in hepatic impairment.

Contraindications

Hypersensitivity to levocetirizine, cetirizine, montelukast, or any excipients, severe renal impairment (creatinine clearance <10 mL/min), end-stage renal disease, children with impaired renal function, hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption.