Monvex-L Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage 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, childn & adolescent ≥15 yr 1 tab once daily. Adult & childn ≥12 yr w/ mild renal impairment (CrCl 50-80 mL/min) 1 tab once daily (containing montelukast 10 mg + levocetirizine 2.5 mg); moderate renal impairment (CrCl 30-50 mg mL/min) 1 tab every other day (containing montelukast 10 mg + levocetirizine 2.5 mg).

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Overdosage

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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

Simultaneous administration w/ alcohol & other CNS depressants. Patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the medicinal product into account. Not recommended during pregnancy & lactation. Not recommended in infants or toddlers <2 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

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

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Drug Interactions

Montelukast: Decreased AUC w/ phenobarb. CYP3A4 inducers eg, phenytoin, phenobarb & rifampicin. Levocetirizine: Small decrease in clearance w/ theophylline. Increased plasma AUC, t_1/2 & decreased clearance w/ ritonavir.

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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

Monvex-L tab

Packing/Price

100's;30's

Monvex-L

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma