Montelukast is the generic equivalent of the brand-name drug Montelukast. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Montelukast through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS & USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukas…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Neuropsychiatric Events [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥ 5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Macle…
Drug Interactions
7 DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, fexofenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology ( 12.3 )].
Dosage & Administration
2 DOSAGE & ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 15 years of age and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 15 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 15 years and older ( 2.3 ). Perennial allergic rhinitis: Once daily for patients 15 years and older ( 2.3 ). Dosage (by age): 15 years and older: one 10-mg tablet. Patients with both asthma…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Advise patients about the potential risk for serious neuropsychiatric symptoms and behavioral changes with montelukast sodium use [see Warnings and Precautions ( 5.1 )]. Discuss the benefits and risks of montelukast sodium with patients when prescribing or continuing treatment with montelukast sodium [see Warnings and Precautions ( 5.1 )]. Advise patients to monitor for changes in behavior or neuropsychiatric symptoms in patients taking montelukas…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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