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Singulair Review Article

 

Montelukast (trade name Singulair) is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It is usually administered orally. Montelukast is a CysLT1 antagonist; that is it blocks the action of leukotriene D4 on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene, and results in less inflammation. Because of its method of operation, it is not useful for the treatment of acute asthma attacks. Again because of its very specific focus of operation, it does not interact with other allergy medications such as theophylline. Another leukotriene receptor antagonist is zafirlukast (Accolate), taken twice daily. Zileuton (Zyflo), an asthma drug taken four times per day, blocks leukotriene synthesis by inhibiting 5-lipoxygenase, an enzyme of the eicosanoid synthesis pathway. The Mont in Montelukast stands for Montreal, the place where Merck developed the drug.

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Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.

Montelukast sodium is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2­quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.

The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18.
Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.

Each 10-mg film-coated SINGULAIR tablet contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide, yellow ferric oxide, and carnauba wax.

Each 4-mg and 5-mg chewable SINGULAIR tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.

Each packet of SINGULAIR 4-mg oral granules contains 4.2 mg montelukast sodium, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, and magnesium stearate.


Indications:

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

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction in patients 15 years of age and older.

SINGULAIR is indicated for the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older).


Dosage and administration:

Dosage Information
The dosage for adults and adolescents 15 years of age and older is one 10-mg tablet.

The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable tablet.

The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable tablet or one packet of 4-mg oral granules.

The dosage for pediatric patients 6 to 23 months of age is one packet of 4-mg oral granules.

Asthma in Patients 12 Months of Age and Older
SINGULAIR should be taken once daily in the evening. Safety and effectiveness in pediatric patients less than 12 months of age have not been established.

Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older
For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking one 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 ?-agonist. Safety and effectiveness in patients younger than 15 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 exercise-induced bronchoconstriction.

Allergic Rhinitis
Seasonal Allergic Rhinitis in Patients 2 Years and Older
Perennial Allergic Rhinitis in Patients 6 Months and Older
For allergic rhinitis SINGULAIR should be taken once daily. The time of administration may be individualized to suit patient needs.

Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis and less than 6 months of age with perennial allergic rhinitis have not been established.

Asthma and Allergic Rhinitis in Patients 12 Months of Age and Older
Patients with both asthma and allergic rhinitis should take only one tablet daily in the evening.

Administration of SINGULAIR 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:
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.
No. 3796 —SINGULAIR Tablets, 4 mg, are pink, ov al, bi-convex-shaped chewable tablets, with code MRK 711 on one side and SINGULAIR on the other. They are supplied as follows:
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. 3760 — SINGULAIR Tablets, 5 mg, are pink, round, bi-convex-shaped chewable tablets, with code MRK 275 on one side and SINGULAIR on the other. They are supplied as follows:
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 non­child-resistant white plastic closure with a wax paper/pulp liner, an aluminum foil induction seal, and silica gel desiccant.
No. 3761 — SINGULAIR Tablets, 10 mg, are beige, rounded square-shaped, film-coated tablets, with code MRK 117 on one side and SINGULAIR on the other. They are supplied as follows:
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 non­child-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°Ced to 15-30°C Temperature]. Protect from moisture and light. Store in original package.


Singulair notes:

Sigulair(singulaire) generic name montelukast is a leukotriene inhibitor. It is used to prevent asthma attacks in adults and children as young as 12 months old. Leukotrienes are chemicals body releases when you breathe in an allergen (such as pollen) which cause swelling in lungs and tightening of the muscles around airways causing asthma symptoms.

Singulair is also used for the relief of symptoms of allergic rhinitis. Montelukast sodium is the active ingredient in singulair.

Singulair side effects includes skin rash, bruising, severe tingling, numbness, muscle weakness, mood or behavior changes, anxiety, depression, thoughts about suicide, severe sinus pain, swelling, heartburn, upset stomach, nausea, diarrhea, tooth pain, fever, stuffy nose, sore throat, cough, hoarseness.

Cingular PDA Software provides the guide to Off-Label prescription drugs i.e. not yet approved by FDA. It also gives helpful information for patients with allergies and sensitivities.

Store singulair at room temperature away from moisture and heat.


 

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