Kastair EZ Tab/Kastair Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings 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

Indications/Uses

Tab: Relief of symptoms of seasonal allergic rhinitis in adults & childn ≥2 yr; perennial allergic rhinitis in adults & childn ≥6 mth. Prophylaxis & chronic treatment of asthma in adults & childn ≥6 mth. Alone or in combination w/ other agents for the management of chronic asthma. Montelukast & inhaled corticosteroids may be used concomitantly to control asthma or reduce inhaled corticosteroid dose required by patients w/ moderate to severe asthma. Prevention of exercise-induced bronchoconstriction in adults & childn ≥2 yr. Oral granules: Prophylaxis & chronic treatment of asthma in childn 6 mth to 5 yr; seasonal allergic rhinitis in childn 2-5 yr; perennial allergic rhinitis in childn 6 mth to 5 yr; prevention of exercise-induced bronchoconstriction in childn 2-5 yr.

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Dosage/Direction for Use

4-mg tab Childn 6 mth-5 yr 1 tab once daily. 5-mg tab Allergic rhinitis, asthma &/or exercise-induced bronchoconstriction Childn >15 yr 2 tab once daily, 6-14 yr 1 tab once daily. Oral granules Childn 6 mth-5 yr 1 sachet once daily.

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Overdosage

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Administration

May be taken with or without food: Tab: Dissolve in mouth or chew before swallowing. Oral granules: May be administered directly into the mouth or mixed w/ a spoonful of cold or room temp soft foods (eg, applesauce, mashed carrots, rice or ice cream) or dissolved in 1 tsp (5 mL) of cold or room temp baby formula or breast milk. Administer immediately (w/in 15 min) after opening of sachet. Not intended to be dissolved in liqd other than baby formula or breast milk for administration.

Contraindications

Hypersensitivity.

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Warnings

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Special Precautions

Avoid NSAIDs while taking montelukast in patients w/ aspirin sensitivity. Not be used to treat acute asthma attacks including status asthmaticus; as monotherapy for prevention of exercise-induced bronchospasm. Should not be abruptly substituted for inhaled or oral corticosteroids. Possible neuropsychiatric events. Discontinue treatment if changes or new neuropsychiatric symptoms occur. Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, &/or neuropathy consistent w/ Churg-Strauss syndrome. Pregnancy & lactation. Childn <6 mth. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Upper resp infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, flu, rhinorrhea, sinusitis & otitis.

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Drug Interactions

Decreased area under plasma conc-time curve w/ phenobarb. Caution w/ CYP enzyme inducers eg, phenytoin & rifampicin. 4-mg tab: Increased systemic exposure w/ gemfibrozil. 5-mg tab/oral granules: Avoid aspirin & other NSAIDs.

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Storage

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Description

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Action

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MIMS Class

Antiasthmatic & COPD Preparations

ATC Classification

R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.

Regulatory Classification

Presentation/Packing

Form

Kastair oral granules 4 mg

Packing/Price

4 mg x 28 × 1's (P30/sachet)

Form

Kastair EZ Tab tab 4 mg

Packing/Price

28's (P27/tab)

Form

Kastair EZ Tab tab 5 mg

Packing/Price

28's (P32/tab)

Kastair EZ Tab/Kastair

montelukast

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc