Montelukast Sodium

MONTELUKAST SODIUM — montelukast sodium granule
Aurobindo Pharma Limited

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1)].
Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3)]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Asthma

Montelukast sodium oral granules are indicated for the prophylaxis and chronic treatment of asthma in pediatric patients 12 months of age and older.

1.3 Allergic Rhinitis

Montelukast sodium oral granules 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 6 months of age and older. Because the benefits of montelukast sodium oral granules may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies.

1.4 Limitations of Use

Montelukast sodium oral granules are not indicated for the treatment of an acute asthma attack.

2 DOSAGE AND ADMINISTRATION

2.1 Asthma

For asthma, administer montelukast sodium oral granules orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing.

The following doses are recommended:

Table 1: Recommended Dosage in Asthma
*Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
Age Dose
Pediatric patients 2 to 5 years of age one packet of 4 mg oral granules
Pediatric patients 12 to 23 months of age* one packet 4 mg oral granules

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.3 Allergic Rhinitis

For allergic rhinitis, administer montelukast sodium oral granules orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs.

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

Table 3: Recommended Dosage in Seasonal Allergic Rhinitis
* Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
Age Dose
Pediatric patients 2 to 5 years of age* one packet of 4 mg oral granules

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

Table 4: Recommended Dosage in Perennial Allergic Rhinitis
* Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
Age Dose
Pediatric patients 2 to 5 years of age one packet of 4 mg oral granules
Pediatric patients 6 to 23 months of age* one packet of 4 mg oral granules

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.4 Asthma and Allergic Rhinitis

For patients with both asthma and allergic rhinitis, administer only one montelukast sodium dose orally once daily in the evening.

Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.

2.5 Instructions for Administration of Oral Granules

Montelukast sodium 4 mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, montelukast sodium oral granules must not be stored for future use. Discard any unused portion. Montelukast sodium oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. Montelukast sodium oral granules can be administered without regard to the time of meals.

3 DOSAGE FORMS AND STRENGTHS

  • Montelukast Sodium Oral Granules USP, 4 mg are white to off white granules with 500 mg net weight, packed in a child-resistant foil packet.

4 CONTRAINDICATIONS

Montelukast sodium oral granules are contraindicated in patients with hypersensitivity to any of its components.

5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Events

Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. Animal studies showed that montelukast distributes into the brain in rats [see Clinical Pharmacology (12.3)] ; however, the mechanisms underlying montelukast sodium-associated NP events are currently not well understood. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of NP events with montelukast sodium use.

Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3)]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

Discuss the benefits and risks of montelukast sodium use with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or for new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium. Therefore, continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with montelukast sodium if such events occur.

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