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Azelastine

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Overview

What is Azelastine?

Azelastine HCl Nasal Spray, 137 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-[(4chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is CHClNO•HCl with the following chemical structure: Azelastine HCl Nasal Spray contains 0.1% azelastine hydrochloride, USP in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, citric acid, dibasic sodium phosphate, sodium chloride, and purified water.

After priming [], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride, USP (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.



What does Azelastine look like?



What are the available doses of Azelastine?

Azelastine HCl Nasal Spray is a nasal spray . Each spray of Azelastine HCl Nasal Spray delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP.

What should I talk to my health care provider before I take Azelastine?

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

How should I use Azelastine?

Azelastine HCl Nasal Spray is 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.

The recommended dosage of Azelastine HCl 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 HCl Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.


What interacts with Azelastine?

Sorry No Records found


What are the warnings of Azelastine?

Sorry No Records found


What are the precautions of Azelastine?

Sorry No Records found


What are the side effects of Azelastine?

Sorry No records found


What should I look out for while using Azelastine?

None.


What might happen if I take too much Azelastine?

There have been no reported overdosages with Azelastine HCl Nasal Spray. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of Azelastine HCl Nasal Spray contains 30 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 reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to Azelastine HCl Nasal Spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, Azelastine HCl Nasal Spray should be kept out of the reach of children.


How should I store and handle Azelastine?

Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Used testosterone topical solution bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets.Azelastine HCl Nasal Spray , 137 mcg is supplied as a 30-mL package (NDC 67877-477-50)  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 white safety clip and a transparent plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride, USP. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays 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 Spray should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage:Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. Azelastine HCl Nasal Spray , 137 mcg is supplied as a 30-mL package (NDC 67877-477-50)  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 white safety clip and a transparent plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride, USP. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays 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 Spray should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage:Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. Azelastine HCl Nasal Spray , 137 mcg is supplied as a 30-mL package (NDC 67877-477-50)  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 white safety clip and a transparent plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride, USP. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays 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 Spray should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage:Store at controlled room temperature 20° to 25°C (68° to 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 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 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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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