Montelukast sodium 4 mg/1

Montelukast sodium · TABLET, CHEWABLE · Macleods Pharmaceuticals Limited

No Recall HistoryCurrently in Shortage

Plain English

Montelukast sodium is a tablet, chewable containing montelukast sodium at 4 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.

Key Facts

Brand Name: Montelukast sodium
Generic Name: Montelukast sodium
NDC Code (Product): 33342-110
Manufacturer: Macleods Pharmaceuticals Limited
Strength: 4 mg/1
Dosage Form: TABLET, CHEWABLE
Route: ORAL
Marketing Status
Application #: ANDA203582
Drug Class: Leukotriene Receptor Antagonist [EPC]
Marketing Start: 03/13/2015

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years 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 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). 1.1 Asthma Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 of age and olde…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administration (by indications): • Asthma ( 2.1 ): Once daily in the evening for patients 2 years and older. • Acute prevention of EIB ( 2.2 ): One tablet at least 2 hours before exercise for patients 6 years of age and older. • Seasonal allergic rhinitis ( 2.3 ): Once daily for patients 2 years and older. • Perennial allergic rhinitis ( 2.3 ): Once daily for patients 2 years and older. Dosage (by age) ( 2 ): • 15 years and older: one 10-mg tablet. • 6 to 14 years: one 5-mg chewable tablet. • 2 to 5 years: one 4-mg chewable tablet. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ). 2.1 Asthma Montelukast sodium should be taken once daily in the evening. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10-mg tablet. For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet. For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. who miss a dose should take the next dose at their regular time and should not take 2 doses at…

Contraindications

4 CONTRAINDICATIONS • Hypersensitivity to any component of this product. • Hypersensitivity to any component of this product ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, 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 )] .

Adverse Reactions

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 Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 05/2020 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenz…

Frequently Asked Questions

What is Montelukast sodium used for?

Montelukast sodium contains Montelukast sodium. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Montelukast sodium a controlled substance?

Montelukast sodium is not classified as a controlled substance by the DEA.

What is the generic name for Montelukast sodium?

The generic name for Montelukast sodium is Montelukast sodium. There are 12 other brand versions of Montelukast sodium.

What is the NDC code for Montelukast sodium 4 mg/1?

The NDC (National Drug Code) for Montelukast sodium 4 mg/1 is 33342-110, listed by Macleods Pharmaceuticals Limited.

Product NDC

33342-110

Package NDC

33342-110-07

Other Montelukast Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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