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Singulair

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Singulair

Indications
Dosage
How Supplied

INDICATIONS

Asthma

SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

Exercise-Induced Bronchoconstriction (EIB)

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.

Allergic Rhinitis

SINGULAIR is 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.

DOSAGE AND ADMINISTRATION

Asthma

SINGULAIR 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 or one packet of 4-mg oral granules.

For pediatric patients 12 to 23 months of age: one packet of 4-mg oral granules.

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.

Exercise-Induced Bronchoconstriction (EIB)

For prevention of EIB, a single dose of SINGULAIR 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.

For pediatric patients 6 to 14 years of age: 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. Safety and efficacy in patients younger than 6 years of age have not been established. 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, SINGULAIR 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.

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 or one packet of 4-mg oral granules.

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.

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 or one packet of 4-mg oral granules.

For pediatric patients 6 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

Asthma And Allergic Rhinitis

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

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.

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

No. 3841 — SINGULAIR Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows:

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

SINGULAIR Tablets, 4 mg, are pink, oval, bi-convex-shaped chewable tablets. They are supplied as either No. 3796 or No. 6628:

No. 3796 — with code MRK 711 on one side and SINGULAIR on the other:

NDC 0006-0711-31 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 0006-0711-54 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

NDC 0006-0711-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister packs of 100.

No. 6628 — 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

NDC 0006-1711-54 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.

SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets. They are supplied as either No. 3760 or No. 6543:

No. 3760 — with code MRK 275 on one side and SINGULAIR on the other:

NDC 0006-0275-31 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 0006-0275-54 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

NDC 0006-0275-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister packs of 100

NDC 0006-0275-82 bulk packaging high-density polyethylene (HDPE) bottles of 1000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant.

No. 6543 — 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

NDC 0006-9275-54 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

NDC 0006-9275-82 bulk packaging high-density polyethylene (HDPE) bottles of 1000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant.

SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets. They are supplied as either No. 3761 or No. 6558:

No. 3761 — with code MRK 117 on one side and SINGULAIR on the other:

NDC 0006-0117-31 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 0006-0117-54 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

NDC 0006-0117-28 unit dose paper and aluminum foil-backed aluminum foil peelable blister pack of 100

NDC 0006-0117-80 bulk packaging high-density polyethylene (HDPE) bottles of 8000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant.

No. 6558 — 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

NDC 0006-9117-80 bulk packaging high-density polyethylene (HDPE) bottles of 8000 with a non-child-resistant white plastic closure with a wax paper/pulp liner, 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Storage For Bulk Bottles

Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. W hen product container is subdivided, repackage into a well-closed, light-resistant container.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: 12/2013

Last reviewed on RxList: 1/9/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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