Generic equivalent of MONTELUKAST SODIUM
16 SKUs available · Available to order · NABP accredited · DSCSA compliant
Montelukast sodium is the generic equivalent of the brand-name drug MONTELUKAST SODIUM. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Montelukast sodium through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Montelukast sodium is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months 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 Montelukast sodium…
6 ADVERSE REACTIONS 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 Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse reactions are described elsewher…
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 )] .
2 DOSAGE AND ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 12 months and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ) Perennial allergic rhinitis: Once daily for patients 6 months and older ( 2.3 ). Dosage (by age): 15 years and older: one 10-mg tablet ( 2 ). 6 to 14 years: one 5-mg che…
17 PATIENT COUNSELING INFORMATION For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). For the oral granules, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). • 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 w…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| MONTELUKAST 10 MG 30 TAB | 2-Day |
| MONTELUKAST 10MG 1000 TAB Accord Healthcare Inc. | 2-Day |
| MONTELUKAST 10MG 1000TABS Camber Pharmaceuticals, Inc. | 2-Day |
| MONTELUKAST 10MG 90 TAB | 2-Day |
| MONTELUKAST TABS 10 MG 30CT | 2-Day |
| MONTELUKAST TABS 10 MG 90CT Camber Pharmaceuticals, Inc. | 2-Day |
| MONTELUKAST 4MG 90 CHEW TAB Camber Pharmaceuticals, Inc. | 2-Day |
| MONTELUKAST CHEW TABS 4 MG 30CT | 2-Day |
| MONTELUKAST SODIUM CHEWABLE TABS 4 MG 30 TAB | 2-Day |
| MONTELUKAST SODIUM CHEWABLE TABS 4 MG 90 | 2-Day |
| MONTELUKAST SODIUM CHEWABLE TABS 4 MG 90 TAB | 2-Day |
| MONTELUKAST SODIUM ORAL GRANULES 4 MG 30CT | 2-Day |
| MONTELUKAST 5MG 30 CHEW TAB Camber Pharmaceuticals, Inc. | 2-Day |
| MONTELUKAST 5MG 90 CHEW TAB | 2-Day |
| MONTELUKAST SODIUM CHEWABLE TABS 5 MG 30 TAB | 2-Day |
| MONTELUKAST SODIUM CHEWABLE TABS 5 MG 90 TAB | 2-Day |
Premier Pharma stocks 16 Montelukast sodium SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Montelukast sodium is the generic equivalent of MONTELUKAST SODIUM. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Montelukast sodium in 10 mg/1, 4 mg/1, 4 mg/500mg, 5 mg/1 and GRANULE, TABLET, CHEWABLE, TABLET, FILM COATED. Available from manufacturers including Accord Healthcare Inc., Camber Pharmaceuticals, Inc..
Montelukast sodium carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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