Montulair 4/Montulair 10

Montulair 4/Montulair 10

montelukast

Manufacturer:

Unison

Distributor:

Medline

Marketer:

Medline
Concise Prescribing Info
Contents
Montelukast
Indications/Uses
Prophylaxis & chronic treatment of asthma including prevention of day- & nighttime symptoms, treatment of aspirin-sensitive asthmatic patients, & prevention of exercise-induced bronchoconstriction in adult & ped patients ≥6 mth. Symptomatic relief of day- & nighttime allergic rhinitis (seasonal allergic rhinitis in adult & ped patients ≥2 yr & perennial allergic rhinitis in adults & ped patients ≥6 mth).
Dosage/Direction for Use
FC tab Adult One 10-mg tab once daily Ped ≥15 yr One 10-mg tab daily, 6-14 yr 5 mg (½ of 10-mg tab) daily. Oral granules Ped 6 mth to 5 yr 4 mg (1 packet) daily.
Administration
May be taken with or without food. Granule: May be administered directly in mouth or dissolved in 5 mL of cold or room temp baby formula/breast milk, or mixed w/ a spoonful of cold or room temp food (applesauce, carrots, rice, or ice cream only). Administer w/in 15 min of opening packet & discard unused portion.
Special Precautions
Not for reversal of bronchospasm in acute asthma attacks including status asthmaticus. Not to substitute abruptly for inhaled or oral corticosteroids. Consider alternative therapy, monitoring & discontinuation if serious neuropsychiatric events including suicidal thoughts or completed suicides (some occurring after discontinuation of therapy) in adult, adolescent & ped patients w/ & w/o history of psychiatric disorder are reported. Eosinophilic conditions including systemic eosinophilia & vasculitis consistent w/ Churg-Strauss syndrome in patients w/ asthma. Avoid aspirin or NSAIDs in aspirin-sensitive patients. Severe hepatic impairment or hepatitis. Pregnancy & lactation.
Adverse Reactions
Abdominal pain, diarrhea; headache; otitis, otitis media; cough, nasal discharge, pharyngitis, sinusitis, upper resp infection; fever, flu. Eosinophilic granulomatosis w/ polyangiitis; disorientation, attention disturbance, insomnia, memory impairment, stuttering, tic, tremor; aggressive behavior, agitation, anxiety, depression, dream disorder, hallucinations, irritability, nightmares, obsessive-compulsive disorder, restlessness, sleep walking disorder, suicidal behavior & thoughts.
Drug Interactions
MIMS Class
Antiasthmatic & COPD Preparations / Antihistamines & Antiallergics
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Form
Montulair 10 FC tab 10 mg
Packing/Price
10 × 10's
Form
Montulair 4 oral granules 4 mg
Packing/Price
28 × 1's
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