Azelastine Hydrochloride (Azelastine Hydrochloride)

Trade Name

Azelastine Hydrochloride

Active Ingredient

Power

137 ug/1

Type / form

Tablets

Status

Manufacturer

West-Ward Pharmaceuticals Corp.

Storage and handling for Azelastine Hydrochloride

AZELASTINE HYDROCHLORIDE Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azelastine Hydrochloride (Azelastine Hydrochloride) which is also known as Azelastine Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 137 ug/1 per ml. Read more

Azelastine Hydrochloride (Azelastine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • Azelastine hydrochloride 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.
  • Azelastine hydrochloride nasal spray is an H-receptor antagonist 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. ()
  • No data
  • Arrayn- Array
  • Azelastine hydrochloride nasal spray is a nasal spray. Each spray of azelastine hydrochloride nasal spray delivers a volume of 0.137 mL spray containing 137 mcg of azelastine hydrochloride.
  • Azelastine Hydrochloride Nasal Spray: 137 mcg of azelastine hydrochloride in each 0.137 mL spray. ()
  • None.
  • None. ()
  • In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride [n ]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of azelastine hydrochloride. Concurrent use of azelastine hydrochloride 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 [].
  • The most common adverse reactions (u22652% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. ()n
  • Concurrent use of azelastine hydrochloride with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [.
  • No data
  • There have been no reported overdosages with azelastine hydrochloride 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 hydrochloride 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 hydrochloride nasal spray. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, azelastine hydrochloride nasal spray should be kept out of the reach of children.
  • Azelastine Hydrochloride Nasal Spray 137 micrograms (mcg), is an antihistamine formulated as a metered-spray for intranasal administration. Azelastine hydrochloride occurs as a white to almost white solid. 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 225u00b0C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (u00b1)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is CHClNOu00b7HCl with the following chemical structure:
  • Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 u00b1 0.3. It also contains benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride.
  • After priming [], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.
  • No data
  • Two-year carcinogenicity studies in Crl:CD(SD)BR rats and NMRI mice were conducted to assess the carcinogenic potential of azelastine hydrochloride. No evidence of tumorigenicity was observed in rats at doses up to 30 mg/kg day (approximately 270 and 240 times the MRHDID for adults and children, respectively, on a mg/m basis). No evidence for tumorigenicity was observed in mice at doses up to 25 mg/kg (approximately 110 and 100 times the MRHDID for adults and children, respectively, on a mg/m basis).
  • Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.
  • There were no effects on male or female fertility and reproductive performance in male and female rats at oral doses up to 30 mg/kg (approximately 270 times the MRHDID in adults on a mg/m basis). At 68.6 mg/kg (approximately 610 times the MRHDID on a mg/m basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, preu2011implantation loss was not increased.
  • No data
  • Azelastine Hydrochloride Nasal Spray, is supplied as a package delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Patient instructions are also provided. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. 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 Hydrochloride Nasal Spray should not be used after the expiration date u201cEXPu201d printed on the medicine label and carton.
  • NDC 0054-0293-99: Bottle of 30 mL
  • Storage
  • Store upright between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from freezing.
  • Keep bottle upright, tightly closed, and away from children.
  • See FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Activities Requiring Mental Alertness:n- seen- Warnings and Precautions ()
  • Concurrent Use of Alcohol and Other Central Nervous System Depressants:n- see Warnings and Precautions ()
  • Common Adverse Reactions:n- see Adverse Reactions ()
  • Priming:n- see Dosage and Administration ()
  • Keep Spray Out of Eyes:
  • Keep Out of Childrenu2019s Reach:
  • Distr. by n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724n
  • 10006248/06
  • Revised October 2018
  • Azelastine (a zelu2019 as teen) Hydrochloride Nasal Spray
  • What is Azelastine Hydrochloride Nasal Spray?
  • It is not known if azelastine hydrochloride nasal spray is safe and effective in pediatric patients with seasonal allergic rhinitis under 5 years of age or in adolescent patients with vasomotor rhinitis under 12 years of age.
  • What should I tell my healthcare provider before using azelastine hydrochloride nasal spray?
  • Before using azelastine hydrochloride nasal spray, tell your healthcare provider if you are:
  • Tell your healthcare provider about all the medicines you take,
  • How should I use azelastine hydrochloride nasal spray?
  • What should I avoid while using azelastine hydrochloride nasal spray?
  • Azelastine hydrochloride nasal spray can cause sleepiness:
  • What are the possible side effects of azelastine hydrochloride nasal spray?
  • The most common side effects of azelastine hydrochloride nasal spray include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all of the possible side effects of azelastine hydrochloride nasal spray. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store azelastine hydrochloride nasal spray?
  • Keep azelastine hydrochloride nasal spray and all medicines out of reach of children.
  • General information about the safe and effective use of azelastine hydrochloride nasal spray.
  • Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use azelastine hydrochloride nasal spray for a condition for which it was not prescribed. Do not give azelastine hydrochloride nasal spray to other people, even if they have the same symptoms that you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about azelastine hydrochloride nasal spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azelastine hydrochloride nasal spray that is written for health professionals.
  • What are the ingredients in Azelastine Hydrochloride Nasal Spray?
  • Active ingredient: azelastine hydrochloride
  • Inactive ingredients: benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride.
  • Distr. by n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724n
  • 10006248/06
  • Revised October 2018
  • Azelastine (a zelu2019 as teen) Hydrochloride Nasal Spray
  • For the correct dose of medicine:
  • Figure A identifies the parts of your Azelastine Hydrochloride Nasal Spray pump.
  • Figure A
  • Before you use Azelastine Hydrochloride Nasal Spray for the first time, you will need to prime the bottle.
  • Priming your Azelastine Hydrochloride Nasal Spray
  • Remove the white dust cover over the tip of the pump and the white safety clip just under the u201cshouldersu201d of the pump ().
  • Figure B
  • Hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and
  • Now your pump is primed and ready to use.
  • Figure C
  • Using your Azelastine Hydrochloride Nasal Spray:
  • Step 1.
  • Step 2.
  • Step 3.
  • Figure D
  • Figure D
  • Step 4.
  • Figure E
  • Figure E
  • Step 5.
  • Step 3
  • Step 4
  • Step 6.
  • Steps 2 through 4
  • Step 7.
  • do not tilt your head back
  • Step 8.
  • Cleaning the Spray Tip of your Azelastine Hydrochloride Nasal Spray:
  • Figure F Figure G
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006248/06
  • Revised October 2018
  • No data

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