Philcet Plus 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

Allergic reactions eg, chronic urticaria, obstructive airway diseases & rhinitis.

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Dosage/Direction for Use

Chronic asthma Adult 10 mg once daily in the evening. Childn >15 yr 10 mg once daily, 6-14 yr 5 mg daily, 2-5 yr 4 mg daily. All doses to be taken in the evening. Allergic rhinitis Adult 10 mg once daily in the evening. Prophylaxis of exercise-induced asthma Adult & childn >15 yr 10 mg at least 2 hr prior to exercise; do not administer additional doses w/in 24 hr.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to montelukast Na, levocetirizine or cetirizine. Patients w/ completely impaired renal function (anuria).

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Special Precautions

Inhibits response to allergy skin tests; a wash-out period (of 3 days) is required before the test. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; contains lactose monohydrate. Concurrent intake of alcohol. Pregnancy & lactation. Not recommended in childn <6 yr; use a paed formulation of levocetirizine. Levocetirizine: Patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia); epilepsy & patients at risk of convulsion. Pruritus. Montelukast: Never use oral dosage form to treat acute asthma attacks. Use a short-acting inhaled β-agonist if an acute attack occurs. Do not substitute abruptly for inhaled or oral corticosteroids. Do not alter treatment w/ the need for patients w/ aspirin-sensitive asthma to avoid taking aspirin & other NSAIDs. Neuropsychiatric events in adults, adolescents, & childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, & somnolence. Hypersensitivity, irritability, restlessness, insomnia, vomiting & diarrhoea.

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Drug Interactions

Levocetirizine: Increased extent of exposure w/ & slightly altered disposition of ritonavir. Decreased rate of absorption w/ food. Concurrent administration w/ alcohol or other CNS depressants may cause additional reductions in alertness & impairment of performance. Montelukast: Decreased AUC w/ phenobarb. Co-administration w/ inducers of CYP3A4, 2C8, & 2C9 eg, phenytoin & rifampicin. Increased systemic exposure w/ gemfibrozil or other potent inhibitors of CYP2C8.

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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

Philcet Plus FC tab

Packing/Price

30's (P24/film-coated tab, P720/box)

Philcet Plus

Manufacturer:

Globela Pharma

Distributor:

Bell-Kenz Pharma

Marketer:

AMB HK