L-Hist Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Montelukast Na 10 mg, levocetirizine HCl 5 mg

Indications/Uses

Relief of symptoms associated w/ seasonal & perennial allergic rhinitis.

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Dosage/Direction for Use

Adult, adolescent & childn >15 yr 1 tab of montelukast 10 mg + levocetirizine HCl 5 mg once daily. Adult including elderly & childn ≥12 yr w/ mild renal impairment (CrCl 50-80 mL/min) 1 tab of montelukast 10 mg + levocetirizine HCl 2.5 mg once daily, moderate renal impairment (CrCl 30-50 mL/min) 1 tab of montelukast 10 mg + levocetirizine HCl 2.5 mg once daily, every other day.

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Severe renal (CrCl <10 mL/min) or hepatic impairment. Pregnancy & lactation. Childn 6-11 yr w/ renal impairment.

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Special Precautions

Levocetirizine HCl: Simultaneous administration w/ alcohol or other CNS depressants may have effects on CNS in sensitive patients. Patients intending to drive, engage in potentially hazardous activities or operate machinery. Not recommended in infants & toddlers <2 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Asthenia/fatigue, abdominal pain; headache. Montelukast: Fever, trauma; dyspepsia, infectious gastroenteritis, dental pain; dizziness; nasal congestion, cough, flu; rash; increased ALT & AST, pyuria. Levocetirizine HCl: Somnolence, dry mouth.

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Drug Interactions

Montelukast: Decreased AUC w/ phenobarb. Caution particularly in childn when co-administered w/ inducers of CYP 3A4 eg, phenytoin, phenobarb & rifampicin. Levocetirizine HCl: Small decrease in clearance of cetirizine (racemate compd) w/ theophylline. Ritonavir increased plasma AUC, t_½ & decreased clearance of cetirizine.

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Storage

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Description

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Action

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MIMS Class

Antihistamines & Antiallergics

ATC Classification

R03DC53 - montelukast, combinations ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.

Regulatory Classification

Presentation/Packing

Form

L-Hist FC tab

Packing/Price

30's

L-Hist

Manufacturer:

Magbro Healthcare

Distributor:

Alkem Lab