Drug Catalog - Product Detail
AZELASTINE HYDROCHLORIDE 0.15%205.5MCG NASAL SPRAY 30ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0706-84 | AMNEAL PHARMACEUTICALS | 30 | 0.15% | SOLUTION |
PACKAGE FILES
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Description
11 DESCRIPTION Azelastine HCl nasal spray, 0.15% is an antihistamine (H 1 receptor antagonist) formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.36. 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 C 22 H 24 ClN 3 O•HCl with the following chemical structure: Azelastine HCl nasal spray, 0.15% contains 0.15% azelastine HCl, USP in an isotonic aqueous solution containing benzalkonium chloride (125 mcg/mL), edetate disodium, hypromellose, purified water, sodium citrate, sorbitol solution and sucralose. Hydrochloric acid or sodium hydroxide may be added for adjustment of pH (pH 6.4). After priming [see Dosage and Administration (2.3) ] , each metered spray delivers a 0.137 mL mean volume containing 205.5 mcg of azelastine HCl, USP (equivalent to 187.6 mcg of azelastine base). The 30 mL (net weight 30 gm of solution) bottle provides 200 metered sprays. 07996fed-figure-01
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Azelastine HCl nasal spray, 0.15% is supplied as a 30 mL package (NDC 65162-706-84) 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 white or clear 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 HCl, USP. After priming [see Dosage and Administration (2.3) ] , each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine HCl, USP. 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 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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
1 INDICATIONS AND USAGE Azelastine HCl nasal spray, 0.15% is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older. Azelastine hydrochloride (HCl) nasal spray, 0.15% is an H 1 -receptor antagonist indicated for the relief of the symptoms of: Seasonal allergic rhinitis in patients 6 years of age and older. (1.1) Perennial allergic rhinitis in patients 6 years of age and older. (1.1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For intranasal use only (2.3) . Seasonal allergic rhinitis : 6 to 11 years: Azelastine HCl nasal spray, 0.15%: 1 spray per nostril twice daily (2.1) Adults and adolescents 12 years of age and older: Azelastine HCl nasal spray, 0.15%: 1 or 2 sprays per nostril twice daily (2.1) , or Azelastine HCl nasal spray, 0.15%: 2 sprays per nostril once daily (2.1) Perennial allergic rhinitis : 6 to 11 years: Azelastine HCl nasal spray, 0.15%: 1 spray per nostril twice daily (2.2) Adults and adolescents 12 years of age and older: Azelastine HCl nasal spray, 0.15%: 2 sprays per nostril twice daily (2.2) Prime azelastine HCl nasal spray, 0.15% before initial use and when it has not been used for 3 or more days. (2.3) 2.1 Recommended Dosage for Seasonal Allergic Rhinitis Children 6 to 11 years of age : Azelastine HCl nasal spray, 0.15%, 1 spray per nostril twice daily. Adults and adolescents 12 years of age and older : Azelastine HCl nasal spray, 0.15%, 1 or 2 sprays per nostril twice daily. Azelastine HCl nasal spray, 0.15% may also be administered as 2 sprays per nostril once daily. 2.2 Recommended Dosage for Perennial Allergic Rhinitis Children 6 to 11 years of age : Azelastine HCl nasal spray, 0.15%, 1 spray per nostril twice daily. Adults and adolescents 12 years of age and older : Azelastine HCl nasal spray, 0.15%, 2 sprays per nostril twice daily. 2.3 Important Administration Instructions Administer azelastine HCl nasal spray, 0.15% by the intranasal route only. Avoid spraying azelastine HCl nasal spray, 0.15% into the eyes. Priming or re-priming : Prime azelastine HCl nasal spray, 0.15% before initial use by releasing 6 sprays or until a fine mist appears. When azelastine HCl nasal spray, 0.15% has not been used for 3 or more days, re-prime with 2 sprays or until a fine mist appears.