Montelukast

MONTELUKAST — montelukast sodium tablet, film coated
Camber Pharmaceuticals, Inc.

1 INDICATIONS & USAGE

1.1 Asthma

Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and adolescent patients 15 years of age and older.

1.2 Exercise-Induced Bronchoconstriction (EIB)

Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.

1.3 Allergic Rhinitis

Montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.

2 DOSAGE & ADMINISTRATION

2.1 Asthma

Montelukast sodium tablet should be taken once daily in the evening. The following doses are recommended:

For adults and adolescents15 years of age and older: one 10 mg tablet.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

2.2 Exercise-lnduced Bronchoconstriction (EIB)

For prevention of EIB, a single 10 mg dose of montelukast sodium tablet should be taken at least 2 hours before exercise.

The following doses are recommended:

For adults and adolescents 15 years of age and older: one 10 mg tablet.

An additional dose of montelukast sodium tablet should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium tablet daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium tablet for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

2.3 Allergic Rhinitis

For allergic rhinitis, montelukast sodium tablet should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.


The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:


For adults and adolescents 15 years of age and older: one 10 mg tablet.


Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.


The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10 mg tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

2.4 Asthma and Allergic Rhinitis

Patients with both asthma and allergic rhinitis should take only one montelukast sodium tablet dose daily in the evening.

3 DOSAGE FORMS & STRENGTHS

  • Montelukast sodium (equivalent to10 mg montelukast) tablets are beige, rounded square-shaped, film coated tablets debossed with ‘I’ on one side and ’114′ on the other side.

4 CONTRAINDICATIONS

  • Hypersensitivity to any component of this product.

5 WARNINGS AND PRECAUTIONS

5.1 Acute Asthma

Montelukast sodium tablet is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with montelukast sodium tablet can be continued during acute exacerbations of asthma. Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist.

5.2 Concomitant Corticosteroid Use

While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast sodium tablet should not be abruptly substituted for inhaled or oral corticosteroids.

5.3 Aspirin Sensitivity

Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium tablets. Although montelukast sodium tablets are effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients [see Clinical Studies (14.1)].

5.4 Neuropsychiatric Events

Neuropsychiatricevents have been reported in adult and adolescent taking montelukast sodium tablets. Post-marketing reports with montelukast sodium tablets use include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, and tremor. The clinical details of some post-marketing reports involving montelukast sodium tablets appear consistent with a drug-induced effect.

Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with montelukast sodium tablets if such events occur [see Adverse Reactions (6.2)].

5.5 Eosinophilic Conditions

Patients with asthma on therapy with montelukast sodium tablets may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between montelukast sodium tablets and these underlying conditions has not been established [see Adverse Reactions (6.2)].

6 ADVERSE REACTIONS

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, influenza, rhinorrhea, sinusitis, otitis.
Adults and Adolescents 15 Years of Age and Older with Asthma
Montelukast sodium tablets have been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with montelukast sodium tablets occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo: Table 1: Adverse Experiences Occurring in ≥1% of Patients with an Incidence Greater than that in Patients Treated with Placebo

Montelukast sodium tablets(equivalent to10 mg montelukast/day)(%)(n=1955) Placebo(%)(n=1180)
Body As A Whole
Pain, abdominal 2.9 2.5
Asthenia/fatigue 1.8 1.2
Fever 1.5 0.9
Trauma Digestive System Disorders Dyspepsia 1.02.1 0.8
1.1
Pain, dental 1.7 1.0
Gastroenteritis, infectious 1.5 0.5
Nervous System/Psychiatric
Headache 18.4 18.1
Dizziness 1.9 1.4
Respiratory System Disorders
Influenza 4.2 3.9
Cough 2.7 2.4
Congestion, nasal 1.6 1.3
Skin/Skin Appendages Disorder
Rash 1.6 1.2
Laboratory Adverse Experiences* 2.1 2.0
ALT increased 1.6 1.2
AST increased 1.0 0.9
Pyuria

*Number of patients tested (montelukast sodium tablets and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159.

The frequency of less common adverse events was comparable between montelukast sodium tablets and placebo.

The safety profile of montelukast sodium tablets, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium tablets.

Cumulatively, 569 patients were treated with montelukast sodium tablets for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse experience profile did not significantly change.
Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis

Montelukast sodium tablets have been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials. Montelukast sodium tablets administered once daily in the morning or in the evening had a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following event was reported with montelukast sodium tablets with a frequency ≥1 % and at an incidence greater than placebo: upper respiratory infection, 1.9% of patients receiving montelukast sodium tablets vs. 1.5% of patients receiving placebo. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.

Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis

Montelukast sodium tablets have been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received montelukast sodium tablets in two, 6-week, clinical studies. Montelukast sodium tablets administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, the following events were reported with montelukast sodium tablets with a frequency ≥1 % and at an incidence greater than placebo: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT. The incidence of somnolence was similar to that of placebo.

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