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Azelastine HCl

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Overview

What is azelastine hcl nasal?

Azelastine HCl Nasal Solution (Nasal Spray), 0.15%, 205.5 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration.

Azelastine hydrochloride occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone, 4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is CHClNO•HCl with the following chemical structure:

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% contains 0.15% azelastine hydrochloride in an isotonic aqueous solution containing sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride (125 mcg/mL), and purified water (pH 6.4).

After priming [], each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine hydrochloride (equivalent to 187.6 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.



What does azelastine hcl nasal look like?



What are the available doses of azelastine hcl nasal?

Azelastine HCl Nasal Solution (Nasal Spray), 0.15%: 205.5 mcg of azelastine hydrochloride in each 0.137 mL spray (3)

What should I talk to my health care provider before I take azelastine hcl nasal?

• Pregnancy: Based on animal data, may cause fetal harm (8.1)

How should I use azelastine hcl nasal?

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is an H-receptor antagonist indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older. (1.1)

In adults and adolescents 12 years of age and older, the recommended dose of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is 1 or 2 sprays per nostril twice daily. Azelastine HCl Nasal Solution (Nasal Spray), 0.15% may also be administered as 2 sprays per nostril once daily.

Pediatric use information for patients ages 6 to 11 years of age for treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis is approved for Meda Pharmaceuticals’ azelastine hydrochloride nasal spray product. However, due to Meda Pharmaceuticals’ marketing exclusivity rights, this drug product is not labeled with that pediatric information.


What interacts with azelastine hcl nasal?

Sorry No Records found


What are the warnings of azelastine hcl nasal?

Sorry No Records found


What are the precautions of azelastine hcl nasal?

Sorry No Records found


What are the side effects of azelastine hcl nasal?

Sorry No records found


What should I look out for while using azelastine hcl nasal?

None.


What might happen if I take too much azelastine hcl nasal?

There have been no reported overdosages with azelastine HC nasal solution (nasal spray). Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence, since one 30-mL bottle of Azelastine HCl Nasal Solution (Nasal Spray), 0.15% contains up to 45 mg of azelastine hydrochloride. Clinical trials in adults with single doses of the oral formulation of azelastine hydrochloride (up to 16 mg) have not resulted in increased incidence of serious adverse events. General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine HCl nasal solution (nasal spray). Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should be kept out of the reach of children.


How should I store and handle azelastine hcl nasal?

Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is supplied as a 30-mL package (NDC 45802--83) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a violet safety clip and a violet plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton.Storage:Store upright at controlled room temperature 20° - 25°C (68° - 77°F). Protect from freezing.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is supplied as a 30-mL package (NDC 45802--83) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a violet safety clip and a violet plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton.Storage:Store upright at controlled room temperature 20° - 25°C (68° - 77°F). Protect from freezing.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is supplied as a 30-mL package (NDC 45802--83) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a violet safety clip and a violet plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton.Storage:Store upright at controlled room temperature 20° - 25°C (68° - 77°F). Protect from freezing.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% is supplied as a 30-mL package (NDC 45802--83) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a violet safety clip and a violet plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.Azelastine HCl Nasal Solution (Nasal Spray), 0.15% should not be used after the expiration date “EXP” printed on the medicine label and carton.Storage:Store upright at controlled room temperature 20° - 25°C (68° - 77°F). Protect from freezing.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine HCl nasal solution (nasal spray) is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in studies. The major metabolite, desmethylazelastine, also possesses H-receptor antagonist activity.

Non-Clinical Toxicology
None.

Use of azelastine HCl nasal solution (nasal spray) has been associated with somnolence [].

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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