Azelastine 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.
Therapeutic Class
Nasal Anti-histamine preparations
Pharmacology
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.
Dosage
Adult and children 12 years and older: 2 sprays in each nostril twice daily.
Children 5-11 years of age: 1 spray in each nostril twice daily.
Children 5-11 years of age: 1 spray in each nostril twice daily.
Administration
Initial pump priming requires seven
sprays of the pump. If used regularly as recommended, no further priming
is required. If not used more than 24 hours, the pump will require 2
sprays, or if not used for more than seven days, the pump will require 7
sprays.
Interaction
It is especially important to check
before combining Azelastine nasal spray with Alcohol, CNS depressants,
Cimetidine & Ketoconazole.
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
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.
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.
Precautions
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 Special Population
Use in children: The safety and
effectiveness of Azelastine nasal spray in patients below 5 years of age
have not been established.
Storage Conditions
Keep out of reach of children. Store in a cool and dry place protected from light. Do not freeze.
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