Montelukast Sandoz

Montelukast Sandoz

montelukast

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Montelukast Na
Indications/Uses
Prophylaxis & chronic treatment of asthma, including the 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 daytime & nighttime allergic rhinitis (seasonal allergic rhinitis in adult & ped patients ≥2 yr & perennial allergic rhinitis in adult & ped patients ≥6 mth).
Dosage/Direction for Use
Ped patient 6-14 yr 1 chewable tab daily in the evening.
Administration
Should be taken on an empty stomach: Take 1 hr before or 2 hr after meals.
Special Precautions
Not to be used for acute asthma attacks. Does not alter the need for patients w/ aspirin-sensitive asthma to avoid taking aspirin & other NSAIDs. Not to be abruptly substituted for inhaled or oral corticosteroids. Not recommended as monotherapy in patients w/ moderate persistent asthma. Systemic eosinophilia, w/ vasculitis consistent w/ Churg-Strauss syndrome. Neuropsychiatric events. Reassess & evaluate treatment regimens for patients who develop eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, &/or neuropathy. Periodically evaluate patients for asthma control. Consider as alternative treatment option to low-dose inhaled corticosteroids for childn w/ mild persistent asthma only for those who do not have recent history of serious asthma attacks that required oral corticosteroid use & who have demonstrated incapability of using inhaled corticosteroid. May affect ability to drive & use machines. Severe hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Upper resp infection. Diarrhoea, nausea, vomiting; elevated serum transaminases levels (ALT, AST); rash; pyrexia.
Drug Interactions
Decreased AUC w/ phenobarb. Concomitant use w/ CYP3A4, 2C8 & 2C9 inducers eg, phenytoin, phenobarb & rifampicin. Increased systemic exposure by gemfibrozil.
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
Montelukast Sandoz chewable tab 5 mg
Packing/Price
4 × 7's
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