Indications

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 ... Read more 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 Hydrochloride eye drop is indicated in the treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older.

Composition

Pharmacology

Azelastine Eye drops contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye. Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that Azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin.

Dosage & Administration

Nasal Spray- 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. Eye drop- Seasonal allergic conjunctivitis : The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine hydrochloride Eye drops, solution should be administered prophylactically, prior to the exposure. Non-seasonal (perennial) allergic conjunctivitis : The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.

Contraindications

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

Side Effects

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

Pregnancy & Lactation

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. It is not known whether Azelastine is excreted in human milk. However, caution should be exercised when Azelastine is administered to a nursing mother.

Precautions & Warnings

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.

Therapeutic Class

Nasal Anti-histamine preparations

Storage Conditions

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