Azelastine Hydrochloride (Nasal Spray)

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.

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.

Seasonal Allergic Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

Vasomotor Rhinitis: The recommended dosage of Azelastine Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily. Administer Azelastine Nasal Spray by the intranasal route only.

Priming: Prime Azelastine Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine Nasal Spray into the eyes.

Administration

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

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

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

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.

Nasal Anti-histamine preparations

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

Keep out of reach of children. Store in a cool and dry place protected from light. Do not freeze.