Azelast
Azelastine Hydrochloride BP

Presentation
Azelast Nasal Spray: Each bottle contains 120 metered doses of Azelastine Hydrochloride. Each actuation delivers Azelastine Hydrochloride BP 137mcg. (Equivalent to 125 mcg of Azelastine)

Description
Azelastine Hydrochloride, 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.

Indications and Uses
Azelast Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older.

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

Dosage And Administration
Adults and children 12 years of age and older: Two sprays per nostril twice daily.

Children 5 years to 11 years of age: One spray per nostril twice daily.


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

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

Use in pregnancy & lactation
Pregnancy: There are no adequate and well-controlled clinical studies in pregnant women. Azelastine Hydrochloride Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Azelastine Hydrochloride is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azelastine Hydrochloride Nasal Spray is administered to a nursing mother.

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

Commercial Pack
Azelast Nasal Spray: Each bottle contains 120 metered dose spray.;