Select therapeutic use:

Allergies:

Indications for SINGULAIR ORAL GRANULES:

To relieve symptoms of seasonal allergic rhinitis (for patients ≥2yrs) and perennial allergic rhinitis (for patients ≥6 months). Reserve use for those who have an inadequate response or intolerance to alternative therapies due to benefits may not outweigh the risk of neuropsychiatric symptoms (see full labeling).

Adults and Children:

Take granules by mouth within 15mins of opening packet; may dissolve in 5mL of cold or room temperature baby formula or breast milk, or mix in spoonful of soft applesauce, carrots, rice, or ice cream. <6mos w/perennial allergic rhinitis or <2yrs w/seasonal allergic rhinitis: not established. 6–23mos: one 4mg granule packet. 2–5yrs: one 4mg chew tab or granule packet. 6–14yrs: one 5mg chew tab. ≥15yrs: one 10mg tab. For all: take once daily.

Boxed Warning:

Serious neuropsychiatric events.

Warnings/Precautions:

Risk of serious neuropsychiatric (NP) events; monitor and discontinue if changes in behavior, new NP symptoms, or suicidal thoughts occur. In asthma or EIB: consider benefits vs risks prior to prescribing. Not for reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Caution when withdrawing from oral steroids. Avoid abrupt substitution with inhaled or oral steroids. Aspirin sensitivity. Eosinophilic conditions. Chew tabs: Phenylketonuria. Pregnancy. Nursing mothers.

Pharmacologic Class:

Leukotriene receptor antagonist.

Interactions:

Monitor with potent CYP450 inducers (eg, phenobarbital, rifampin).

Adverse Reactions:

Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis.

Metabolism:

Hepatic (CYP3A4, CYP2C9, CYP2C8). >99% protein bound.

Elimination:

Fecal.

Generic Availability:

YES

How Supplied:

Tabs—30, 90; Chew tabs, Oral granules—30

Asthma/COPD:

Indications for SINGULAIR ORAL GRANULES:

Prophylaxis and chronic treatment of asthma (for patients ≥12 months old). Prevention of exercise-induced bronchoconstriction (EIB) (for patients ≥6yrs old).

Adults and Children:

Take granules by mouth within 15mins of opening packet; may dissolve in 5mL of cold or room temperature baby formula or breast milk, or mix in spoonful of soft applesauce, carrots, rice, or ice cream. <12mos w/asthma or <6yrs w/EIB: not established. 12–23mos: one 4mg granule packet. 2–5yrs: one 4mg chew tab or granule packet. 6–14yrs: one 5mg chew tab. ≥15yrs: 10mg. For asthma: take once daily in the PM. For EIB: Take at least 2hrs before exercise (max 1 dose/day). Do not take an additional dose within 24hrs of a previous dose or if already taking a daily dose for another indication (including chronic asthma).

Boxed Warning:

Serious neuropsychiatric events.

Warnings/Precautions:

Risk of serious neuropsychiatric (NP) events; monitor and discontinue if changes in behavior, new NP symptoms, or suicidal thoughts occur. In asthma or EIB: consider benefits vs risks prior to prescribing. Not for reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Caution when withdrawing from oral steroids. Avoid abrupt substitution with inhaled or oral steroids. Aspirin sensitivity. Eosinophilic conditions. Chew tabs: Phenylketonuria. Pregnancy. Nursing mothers.

Pharmacologic Class:

Leukotriene receptor antagonist.

Interactions:

Monitor with potent CYP450 inducers (eg, phenobarbital, rifampin).

Adverse Reactions:

Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis.

Metabolism:

Hepatic (CYP3A4, CYP2C9, CYP2C8). >99% protein bound.

Elimination:

Fecal.

Generic Availability:

YES

How Supplied:

Tabs—30, 90; Chew tabs, Oral granules—30