Azelastine hydrochloride

What is Azelastine hydrochloride?

• Azelastine hydrochloride nasal spray is an H1-receptor antagonist used for the relief of the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis.

Azelastine

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What are the uses of this medicine?

• Azelastine hydrochloride nasal spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in patients 6 years of age and older and year-round allergic rhinitis in people age 6 years and older.
• Azelastine hydrochloride nasal spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

How does this medicine work?

• Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity in isolated tissues, animal models, and humans.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided.
• Cimetidine (400 mg twice daily) increased the mean Cmax and AUC of orally administered azelastine hydrochloride (4 mg twice daily) by approximately 65%.

Is this medicine FDA approved?

• Azelastine was patented in 1971 and came into medical use in 1986.

How should this medicine be used?

Recommended dosage: Seasonal Allergic Rhinitis

• Children 6 to 11 years of age: azelastine hydrochloride nasal spray, 0.15%, 1 spray per nostril twice daily.
• Adults and adolescents 12 years of age and older: azelastine hydrochloride nasal spray, 0.15%, 1 or 2 sprays per nostril twice daily. Azelastine hydrochloride nasal spray, 0.15% may also be administered as 2 sprays per nostril once daily.

Perennial Allergic Rhinitis

• Children 6 to 11 years of age: azelastine hydrochloride nasal spray, 0.15%, 1 spray per nostril twice daily.
• Adults and adolescents 12 years of age and older: azelastine hydrochloride nasal spray, 0.15%, 2 sprays per nostril twice daily.

Administration:

• An adult should help a young child use azelastine hydrochloride nasal spray.
• Spray azelastine hydrochloride nasal spray in your nose only. Do not spray it into your eyes or mouth.
• Use azelastine hydrochloride nasal spray exactly as your healthcare provider tells you to use it.
• Do not use more than your healthcare provider tells you.
• Throw away your azelastine hydrochloride nasal spray, 0.15% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
• If you use too much or a child accidentally swallows azelastine hydrochloride nasal spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Nasal spray solution available in one dosage strength:

• Azelastine hydrochloride nasal spray, 0.15% (with sweetener): 205.5 mcg of azelastine hydrochloride in each 0.137 mL spray

This medicine is available in fallowing brand namesː

• Astepro ; Astelin

What side effects can this medication cause?

The most common side effects of this medicine include:

• fever
• unusual taste
• nose pain or discomfort
• nosebleeds
• headache
• sneezing
• fatigue
• sleepiness
• upper respiratory tract infections
• cough
• vomiting
• middle ear infection
• skin rash
• sore throat

What special precautions should I follow?

Azelastine hydrochloride nasal spray can cause sleepiness:

• Do not drive, operate machinery, or do other dangerous activities until you know how azelastine hydrochloride nasal spray affects you.
• Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine hydrochloride nasal spray. It may make your sleepiness worse.

• Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence

Management of overdosage:

• General supportive measures should be employed if overdosage occurs.
• There is no known antidote to azelastine hydrochloride nasal spray.
• Oral ingestion of antihistamines has the potential to cause serious adverse effects in children.
• Accordingly, azelastine hydrochloride nasal spray should be kept out of the reach of children.

Can this medicine be used in pregnancy?

• Azelastine hydrochloride nasal spray 0.15% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of azelastine hydrochloride nasal spray 0.15% have been established for seasonal allergic rhinitis in pediatric patients 6 to 17 years of age and perennial allergic rhinitis in pediatric patients 6 to 17 years of age.
• The safety and effectiveness of azelastine hydrochloride nasal spray 0.15% in pediatric patients below 6 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: azelastine hydrochloride
• Inactive ingredients: benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol and sucralose.

Who manufactures and distributes this medicine?

• Mfg by:

Apotex Inc. Toronto, Ontario Canada

• Mfg for:

Apotex Corp. Weston, FL

What should I know about storage and disposal of this medication?

• Keep azelastine hydrochloride nasal spray upright at (68°F to 77°F) 20°C to 25°C.
• Do not freeze azelastine hydrochloride nasal spray.
• Do not use azelastine hydrochloride nasal spray after the expiration date “EXP” on the medicine label and box.

• Dailymed label info on Azelastine hydrochloride
• FDA Azelastine hydrochloride

Azelastine hydrochloride Resources
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• Brompheniramine
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• Chlorcyclizine
• Chlorpheniramine
• Clemastine
• Cyclizine
• Cyproheptadine
• Dexbrompheniramine
• Dexchlorpheniramine
• Dimenhydrinate
• Diphenhydramine
• Doxylamine
• Hydroxyzine
• Meclizine
• Phenyltoloxamine
• Promethazine
• Triprolidine

Second Generation Antihistamines

• Acrivastine
• Cetirizine
• Fexofenadine
• Levocetirizine
• Loratadine
• Desloratadine