Medications and Drugs
Pharmacy Author: Omudhome Ogbru, PharmD
Medical Editor: Jay Marks, MD
GENERIC NAME: montelukast
BRAND NAME: Singulair
DRUG CLASS AND MECHANISM: Montelukast is an oral leukotriene
receptor antagonist for the treatment of
asthma and seasonal allergic rhinitis (hay fever). Leukotrienes are a group
of naturally occurring chemicals in the body that promote inflammation in asthma
and seasonal allergic rhinitis and in other diseases in which inflammation is
important (such as allergy).
They are formed by cells, released, and then bound to other cells, and it is the
binding to these other cells that stimulates the cells to promote inflammation.
Montelukast works in a manner similar to
zafirlukast
(Accolate), blocking the binding of some leukotrienes. Unlike zafirlukast,
montelukast does not inhibit CYP2C9 or CYP3A4, two enzymes in the liver that are
important in breaking down and eliminating many drugs. Therefore, unlike
zafirlukast, montelukast is not expected to affect the elimination of other
drugs. The safety and effectiveness of montelukast has been demonstrated in
children as young as 6 months of age. It was approved by the FDA in 1998.
GENERIC AVAILABLE: Yes
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 10mg. Chewable tablets: 4mg and 5mg.
STORAGE: Tablets should be stored at room temperature, 15-30 C
(59-86 F).
PRESCRIBED FOR: Montelukast is used for the treatment of asthma and
seasonal allergic rhinitis. Montelukast begins working after 3 to 14 days of
therapy. Therefore, it should not be used for the treatment of an acute
asthmatic attack.
DOSING: The recommended dose of montelukast is 4, 5, or 10 mg daily.
The 4 and 5 mg tablets are used in children. Montelukast should be taken in the
evening with or without food.
DRUG INTERACTIONS: Phenobarbital increases the blood concentration
of montelukast by about 40%. Rifampin may have the same effect. Therefore, the
dose of montelukast may need to be reduced when given concurrently with these
drugs.
PREGNANCY: Montelukast crosses the placenta into the fetus following
oral administration to animals, but there have been no adequate studies in
pregnant women to determine the effects on the fetus. Physicians may prescribe
zafirlukast during pregnancy if it is felt that its benefits outweigh the
potential but unknown risks to the fetus.
NURSING MOTHERS: Studies in animals have shown that montelukast is
excreted in milk; however, it is not known if montelukast is secreted into
breast milk in humans.
SIDE EFFECTS: The most common side effects with montelukast are
headache, dizziness,
abdominal pain, sore throat,
and rhinitis (inflammation of the inner lining of the nose). These side effects
occur in 1 in 50 to 1 in 7 persons who take montelukast. Rarely, patients may
experience nose bleeds.
Reference: FDA Prescribing Information
Last Editorial Review: 10/16/2005
Report Problems to the Food and Drug Administration
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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