SINGULAIR - Dosage montelukast sodium

SINGULAIR (montelukast sodium tablet, film coated) comes in different strengths and amounts, which is referred to as the dosing of SINGULAIR. The appearance of SINGULAIR can differ based on the dosing. Your doctor may change the dosage and prescription of SINGULAIR to get you the best results possible.

Dosage & 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 chewable tablet (2).
  • 2 to 5 years: one 4-mg chewable tablet or one packet of 4-mg oral granules (2).
  • 6 to 23 months: one packet of 4-mg oral granules (2).

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening (2.4). For oral granules: Must administer within 15 minutes after opening the packet (with or without mixing with food) (2.5).

asthma

For asthma, administer SINGULAIR 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
Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of oral granules
Pediatric patients 12 to 23 months of age
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
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.

exercise-induced bronchoconstriction (eib)

For prevention of EIB, administer a single dose of SINGULAIR orally at least 2 hours, before exercise. The following doses are recommended:

Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB)
Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age
Safety and effectiveness in patients younger than 6 years of age have not been established.
one 5 mg chewable tablet

An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking SINGULAIR 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.

Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

allergic rhinitis

For allergic rhinitis, administer SINGULAIR 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
Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
one 4 mg chewable tablet or 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
Age Dose
Adult and adolescent patients 15 years of age and older one 10 mg tablet
Pediatric patients 6 to 14 years of age one 5 mg chewable tablet
Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of 4 mg oral granules
Pediatric patients 6 to 23 months of age
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
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.

asthma & allergic rhinitis

For patients with both asthma and allergic rhinitis, administer only one SINGULAIR 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.

instructions for administration of oral granules

SINGULAIR 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, SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR 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. SINGULAIR oral granules can be administered without regard to the time of meals.

Dosage Form & Strengths

  • Tablets: 10 mg, beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other.
  • Chewable Tablets: 5 mg, pink, round, bi-convex-shaped, with code MSD 275 on one side and SINGULAIR on the other.
  • Chewable Tablets: 4 mg, pink, oval, bi-convex-shaped, with code MSD 711 on one side and SINGULAIR on the other.
  • Oral Granules: 4 mg, white granules with 500 mg net weight, packed in a child-resistant foil packet.
  • Tablets: 10 mg (3)
  • Chewable tablets: 5 mg and 4 mg (3)
  • Oral granules: 4 mg (3)

Overdosage

No specific information is available on the treatment of overdosage with SINGULAIR. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.

Storage & Handling

SINGULAIR 4 mg Oral Granules: white granules with 500 mg net weight, packed in a child-resistant foil packet.

NDC 0006-3841-30 unit of use carton with 30 packets.

SINGULAIR 4 mg Tablets: pink, oval, bi-convex-shaped chewable tablets, with code MSD 711 on one side and SINGULAIR on the other.

NDC 0006-1711-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant.

SINGULAIR 5 mg Tablets: pink, round, bi-convex-shaped chewable tablets, with code MSD 275 on one side and SINGULAIR on the other.

NDC 0006-9275-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant.

SINGULAIR 10 mg Tablets: beige, rounded square-shaped, film-coated tablets, with code MSD 117 on one side and SINGULAIR on the other.

NDC 0006-9117-31 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant

NDC 0006-9117-54 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant.

Storage

Store SINGULAIR 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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