Azelastine Hydrochloride (Nasal Spray)

• Vasomotor rhinitis

Azelastine Hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

N/A

Contraindicated in patients with a known hypersensitivity to Azelastine or any of its components.

Azelastine, a phthalazinone derivative, exhibits histamine H1 receptor antagonist activity in isolated tissues, animal models and humans. It is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in invitro studies. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity.

It is especially important to check before combining Azelastine nasal spray with Alcohol, CNS depressants, Cimetidine & Ketoconazole.

Headache, dizziness, sneezing, nosebleed, nausea, stinging or itching in nose, dry mouth, sore throat, bitter taste etc.

Use in pregnancy: The effects of Azelastine during pregnancy have not been adequately studied. Azelastine should be administered during pregnancy, if the potential benefit justifies the potential risks to fetus.Use in nursing mother: It is not known whether Azelastine is excreted in human milk. However, caution should be exercised when Azelastine is administered to a nursing mother.

In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine nasal spray; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of this nasal spray with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Use in children: The safety and effectiveness of Azelastine nasal spray in patients below 5 years of age have not been established.