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Medications and Drugs

GENERIC NAME: azelastine

BRAND NAME: Astelin

DRUG CLASS AND MECHANISM: Azelastine is an anti-histamine, a chemical that blocks the effects of histamine, another chemical that is responsible for some of the symptoms in allergic reactions. Azelastine is chemically different from other anti-histamines and is used only as a nasal inhaler for the treatment of symptoms of seasonal allergic rhinitis, such as runny nose, sneezing and nasal itching in adults and children 12 years of age and older. Azelastine was approved by the FDA in 1996.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Nasal spray: 137 mcg per spray.

STORAGE: The nasal spray should be stored at room temperature, between 15 and 30°C (59-86°F).

PRESCRIBED FOR: Azelastine is used to treat symptoms associated with allergic rhinitis, such as runny nose, sneezing and nasal itching.

DOSING: Azelastine generally is used as 2 sprays in each nostril twice daily.

DRUG INTERACTIONS: Azelastine can promote the sedating effects of other medications that cause sedation. Such drugs include narcotic pain relievers (e.g., Percocet), barbiturates, sedatives such as alprazolam (Xanax) or clonazepam (Klonopin), and ethanol.

PREGNANCY: Abnormalities in bones of the skeleton have been noted in animals receiving more than 240 times the human dose of azelastine. There are no adequate studies in pregnant women. Azelastine should be used during pregnancy only if the physician feels that the benefit justifies the potential risk to the fetus.

NURSING MOTHERS: It is not known whether azelastine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azelastine is used by a nursing woman.

SIDE EFFECTS: The most common side effect noted with azelastine is a bitter taste that develops in 1 of 5 persons using it. Tiredness occurs in 1 of 9. Weight gain has been reported in 1 of 50 and muscle pain in 1 of 75. Other reported side effects include headache, nasal irritation, sore throat, dry mouth, and sneezing.

Reference: FDA Prescribing Information


Last Editorial Review: 1/16/2000 12:51:00 PM




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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