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Singulair Oral Granules Generic Name & Formulations
Legal Class
Rx
General Description
Montelukast (as sodium) 4mg; per packet.
Pharmacological Class
Leukotriene receptor antagonist.
See Also
How Supplied
Tabs—30, 90; Chew tabs, Oral granules—30
Manufacturer
Generic Availability
YES
Singulair Oral Granules Indications
Indications
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).
Singulair Oral Granules Dosage and Administration
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.
Singulair Oral Granules Contraindications
Not Applicable
Singulair Oral Granules Boxed Warnings
Boxed Warning
Serious neuropsychiatric events.
Singulair Oral Granules Warnings/Precautions
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. Avoid abrupt substitution with inhaled or oral steroids. Aspirin sensitivity. Eosinophilic conditions. Chew tabs: Phenylketonuria. Pregnancy. Nursing mothers.
Singulair Oral Granules Pharmacokinetics
See Literature
Singulair Oral Granules Interactions
Interactions
Monitor with potent CYP450 inducers (eg, phenobarbital, rifampin).
Singulair Oral Granules Adverse Reactions
Adverse Reactions
Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis.
Singulair Oral Granules Clinical Trials
See Literature
Singulair Oral Granules Note
Not Applicable
Singulair Oral Granules Patient Counseling
See Literature
Singulair Oral Granules Generic Name & Formulations
Legal Class
Rx
General Description
Montelukast (as sodium) 4mg; per packet.
Pharmacological Class
Leukotriene receptor antagonist.
See Also
How Supplied
Tabs—30, 90; Chew tabs, Oral granules—30
Manufacturer
Generic Availability
YES
Singulair Oral Granules Indications
Indications
Prophylaxis and chronic treatment of asthma (for patients ≥12 months old). Prevention of exercise-induced bronchoconstriction (EIB) (for patients ≥6yrs old).
Limitations of Use
Not for the treatment of an acute asthma attack.
Singulair Oral Granules Dosage and Administration
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: one 10mg tab. 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).
Singulair Oral Granules Contraindications
Not Applicable
Singulair Oral Granules Boxed Warnings
Boxed Warning
Serious neuropsychiatric events.
Singulair Oral Granules Warnings/Precautions
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. Avoid abrupt substitution with inhaled or oral steroids. Aspirin sensitivity. Eosinophilic conditions. Chew tabs: Phenylketonuria. Pregnancy. Nursing mothers.
Singulair Oral Granules Pharmacokinetics
See Literature
Singulair Oral Granules Interactions
Interactions
Monitor with potent CYP450 inducers (eg, phenobarbital, rifampin).
Singulair Oral Granules Adverse Reactions
Adverse Reactions
Upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis.
Singulair Oral Granules Clinical Trials
See Literature
Singulair Oral Granules Note
Not Applicable
Singulair Oral Granules Patient Counseling
See Literature
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