Montelukast Sandoz

Montelukast Sandoz

montelukast

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Montelukast
Indications/Uses
Treatment of asthma & prevention of asthma symptoms. 4-mg tab For 2-5 yr patients who are not adequately controlled on their medication & need additional therapy. Alternative treatment to inhaled corticosteroids for 2-5 yr patients who have not recently taken oral corticosteroids for their asthma & are unable to use inhaled corticosteroids. Prevents the narrowing of airways triggered by exercise for patients ≥2 yr. 5-mg tab For 6-14 yr patients who are not adequately controlled on their medication & need additional therapy. Alternative treatment to inhaled corticosteroids for 6-14 yr patients who have not recently taken oral corticosteroids for their asthma & are unable to use inhaled corticosteroids. Prevents the narrowing of airways triggered by exercise for patients ≥6 yr. 10-mg FC tab Add-on therapy for adult & adolescent ≥15 yr w/ mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids & in whom "as-needed" short acting β-agonists provide inadequate clinical control of asthma. Symptomatic relief of seasonal allergic rhinitis for ≥15 yr patients. Prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction for patients ≥15 yr. 4-mg oral granule For 6 mth to 5 yr patients who are not adequately controlled on their medication & need additional therapy. Alternative treatment to inhaled corticosteroids for 2-5 yr patients who have not recently taken oral corticosteroids for their asthma & are unable to use inhaled corticosteroids. Prevents the narrowing of airways triggered by exercise for patients ≥2 yr.
Dosage/Direction for Use
5-mg tab Childn 6-14 yr 1 tab daily in the evening. 4-mg tab Childn 2-5 yr 1 tab daily in the evening. 10-mg FC tab Adult & adolescent ≥15 yr 1 tab daily in the evening. 4-mg oral granule Childn 6 mth to 5 yr 1 sachet each evening.
Administration
May be taken with or without food: Chewable tab: Take at least 1 hr before or 2 hr after a meal. Oral granules: May be administered directly into the mouth or mixed w/ a spoonful of cold or room temp soft foods (eg, applesauce/ice cream/carrots/rice). Not intended to be dissolved in other liqd. May take liqd after swallowing the granules.
Special Precautions
Do not use as treatment for acute asthma attacks. Should not be substituted for inhaled or oral corticosteroids. Evaluate treatment regimen in case of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complication &/or neuropathy. May affect ability to drive or operate machinery. 4- & 5-mg tab Chewable tab contains aspartame & phenylalanine. Concomitant use w/ acetylsalicylic acid or anti-inflammatory medicines. 10-mg FC tab Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. 4-mg chewable tab Childn <2 yr. 5-mg chewable tab Childn <6 yr. 10-mg FC tab Childn <15 yr. Oral granules Childn <6 mth.
Adverse Reactions
4-mg tab Abdominal pain, thirst. 5-mg tab Headache. 10-mg FC tab Headache, abdominal pain. Oral Granules Diarrhea, hyperactivity, asthma, scaly & itchy skin, rash.
Drug Interactions
Decreased AUC w/ CYP3A4 inducers eg, phenobarb, phenytoin, rifampicin.
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Form
Montelukast Sandoz chewable tab 5 mg
Packing/Price
28's
Form
Montelukast Sandoz chewable tab 4 mg
Packing/Price
28's
Form
Montelukast Sandoz oral granules 4 mg
Packing/Price
28's
Form
Montelukast Sandoz FC tab 10 mg
Packing/Price
28's
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