Singulair

Singulair

montelukast

Manufacturer:

Organon

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Montelukast Na
Indications/Uses
Prophylaxis & chronic treatment of asthma including the prevention of day & nighttime symptoms, treatment of aspirin-sensitive asthmatics & prevention of exercise-induced bronchoconstriction in adult & ped patients ≥6 mth. Alone or in combination w/ other agents for the maintenance treatment of chronic asthma. Singulair & inhaled corticosteroids may be used concomitantly to control asthma or reduce inhaled corticosteroid dose while maintaining clinical stability. Relief of day & nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in adults & ped patients ≥2 yr, & perennial allergic rhinitis in adult & ped patients ≥6 mth) including nasal congestion, rhinorrhea, nasal itching, sneezing; nasal congestion upon awakening, difficulty going to sleep & nighttime awakenings; tearing, itchy, red & puffy eyes.
Dosage/Direction for Use
Asthma &/or allergic rhinitis Adult ≥15 yr 10 mg tab once daily. Childn 6-14 yr 5-mg chewable tab daily, 2-5 yr 4-mg chewable tab or 4-mg oral granules daily. Childn 6 mth-2 yr w/ asthma or perennial allergic rhinitis 1 packet of 4-mg oral granules daily. Patients w/ both asthma & allergic rhinitis 1 tab daily in the evening. Allergic rhinitis Individualized time of administration. All doses to be taken once daily.
Administration
May be taken with or without food: Oral granules may be administered directly into the mouth or mixed w/ a spoonful of cold or room temp soft foods (eg, applesauce) 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 packet. Not intended to be dissolved in liqd other than baby formula or breast milk for administration.
Contraindications
Special Precautions
Should not be used to treat acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Possible neuropsychiatric events. Appropriate clinical monitoring is recommended in patients receiving montelukast treatment. Pregnancy & lactation. Childn <6 mth.
Adverse Reactions
Upper resp infection; increased bleeding tendency, thrombocytopenia; hypersensitivity reactions including anaphylaxis; agitation including aggressive behavior/hostility, anxiousness, depression, disorientation, attention disturbance, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, memory impairment, obsessive-compulsive symptoms, psychomotor hyperactivity (including irritability, restlessness & tremor), somnambulism, suicidal thinking & behavior (suicidality), tic; dizziness, drowsiness, paraesthesia/hypoesthesia; palpitations; epistaxis, pulmonary eosinophilia; diarrhea, dyspepsia, nausea, vomiting; increased ALT & AST; angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, urticaria; arthralgia, myalgia including muscle cramps; enuresis in childn; asthenia/fatigue, edema, pyrexia.
Drug Interactions
Decreased AUC by approx 40% w/ phenobarb. Increased systemic exposure w/ gemfibrozil.
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.
Presentation/Packing
Form
Singulair chewable tab 5 mg
Packing/Price
28's (P1,169.05/pack)
Form
Singulair film-coated tab 10 mg
Packing/Price
28's (P1,402.86/pack)
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