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Azelastine Hydrochloride (Astepro)

Trade Name : Astepro

Meda Pharmaceuticals

SPRAY, METERED

Strength 205.5 ug/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azelastine Hydrochloride (Astepro) which is also known as Astepro and Manufactured by Meda Pharmaceuticals. It is available in strength of 205.5 ug/1 per ml. Read more

Azelastine Hydrochloride (Astepro) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
  • ASTEPRO is an H-receptor antagonist indicated for the relief of the symptoms of:
  • No data
  • Seasonal allergic rhinitis
  • Perennial allergic rhinitis
  • ASTEPRO is a nasal spray solution available in two dosage strengths:
  • Nasal spray solution available in two dosage strengths:
  • None.
  • None. ()
  • In clinical trials, the occurrence of somnolence has been reported in some patients taking ASTEPRO []. 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 ASTEPRO. Concurrent use of ASTEPRO 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 [].
  • Use of ASTEPRO has been associated with somnolence [].
  • The most common adverse reactions (u22652% incidence) are: pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • No data
  • There have been no reported overdosages with ASTEPRO. 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 ASTEPRO 0.1% contains up to 30 mg of azelastine hydrochloride and one 30-mL bottle of ASTEPRO 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 ASTEPRO. Oral ingestion of antihistamines has the potential to cause serious adverse effects in children. Accordingly, ASTEPRO should be kept out of the reach of children.
  • ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is an antihistamine (H receptor antagonist) formulated as a metered-spray solution for intranasal administration. ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is an antihistamine (H receptor antagonist) 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 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 CHClNOu2022HCl with the following chemical structure:
  • ASTEPRO 0.1% contains 0.1% 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 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The 30-mL (net weight 30 gm of solution) bottle provides 200 metered sprays.
  • ASTEPRO 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.
  • 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 180 and 160 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 75 and 65 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 180 times the MRHDID in adults on a mg/mbasis). At 68.6 mg/kg (approximately 410 times the MRHDID on a mg/mbasis), 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, pre-implantation loss was not increased.
  • No data
  • ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is supplied as a 30-mL package (NDC 0037-0242-30) 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 blue safety clip and a blue 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. 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.
  • ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is supplied as a 30-mL package (NDC 0037-0243-30) 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 blue safety clip and a blue 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.
  • ASTEPRO should not be used after the expiration date u201cEXPu201d printed on the medicine label and carton.
  • Storage:
  • Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). Protect from freezing.
  • See FDA-approved patient labeling ( and).
  • Activities Requiring Mental Alertness
  • Somnolence has been reported in some patients taking ASTEPRO. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of ASTEPRO [].
  • Concurrent Use of Alcohol and other Central Nervous System Depressants
  • Avoid concurrent use of ASTEPRO with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [].
  • Common Adverse Reactions
  • Inform patients that the treatment with ASTEPRO may lead to adverse reactions, most common of which include pyrexia, dysgeusia, nasal discomfort, epistaxis, headache, sneezing, fatigue, somnolence, upper respiratory infection, cough, rhinalgia, vomiting, otitis media, contact dermatitis, and oropharyngeal pain. [].
  • Priming
  • Instruct patients to prime the pump before initial use and when ASTEPRO has not been used for 3 or more days [].
  • Arrayn- Keep Spray Out of Eyes
  • Instruct patients to avoid spraying ASTEPRO into their eyes.
  • Keep Out of Childrenu2019s Reach
  • Instruct patients to keep ASTEPRO out of the reach of children. If a child accidentally ingests ASTEPRO, seek medical help or call a poison control center immediately.
  • Manufactured for: n Somerset, New Jersey 08873-4120
  • u00a92018 Meda Pharmaceuticals Inc.
  • ASTEPRO and MEDA PHARMACEUTICALS are registered trademarks of Meda Pharmaceuticals Inc. or a related entity.
  • U.S. Patents 8,071,073; 8,518,919
  • PATIENT INFORMATION
  • ASTEPRO []
  • (azelastine hydrochloride)
  • Nasal Spray 0.1%
  • Nasal Spray 0.15%
  • What is ASTEPRO Nasal Spray?
  • It is not known if ASTEPRO is safe and effective in children under 6 months of age.
  • What should I tell my healthcare provider before using ASTEPRO?
  • Before using ASTEPRO, tell your healthcare provider if you are:
  • Tell your healthcare provider about all the medicines you take,
  • How should I use ASTEPRO?
  • What should I avoid while using ASTEPRO?
  • ASTEPRO can cause sleepiness:
  • What are the possible side effects of ASTEPRO?
  • The most common side effects of ASTEPRO 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 ASTEPRO. 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 ASTEPRO?
  • Keep ASTEPRO and all medicines out of reach of children.
  • General information about the safe and effective use of ASTEPRO.
  • Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use ASTEPRO for a condition for which it was not prescribed. Do not give ASTEPRO 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 ASTEPRO. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ASTEPRO that is written for health professionals.
  • For more information, go to or call 1-800-598-4856.
  • What are the ingredients in ASTEPRO?
  • Active ingredient: azelastine hydrochloride
  • Inactive ingredients: sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride, and purified water.
  • u00a0
  • u00a0
  • Instructions for Use n- ASTEPRO []n- (azelastine hydrochloride) n- Nasal Spray 0.1% n- Nasal Spray 0.15%
  • For the correct dose of medicine:
  • Figure A identifies the parts of your ASTEPRO Nasal Spray pump
  • Before you use ASTEPRO for the first time, you will need to prime the bottle.
  • For use in young children:
  • Priming your ASTEPRO
  • Remove the blue dust cover over the tip of the bottle and the blue safety clip just under the u201cshouldersu201d of the bottle ().
  • Now your pump is primed and ready to use.
  • Using your ASTEPRO
  • For use in young children:
  • Step 1.
  • Step 2.
  • Step 3. n- See Figure D
  • Step 4.n- See Figure E
  • Step 5. n- Step 3n- Step 4
  • Step 6n- Steps 2 through 4
  • Step 7.n- do not tilt your head back
  • Step 8
  • Cleaning the Spray Tip of your ASTEPRO
  • This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured for: n n Somerset, New Jersey 08873-4120
  • u00a92018 Meda Pharmaceuticals Inc.
  • ASTEPRO and MEDA are registered trademarks of Meda Pharmaceuticals Inc. or a related entity
  • U.S. Patents 8,071,073; 8,518,919
  • IN-023D6-XXu00a0u00a0u00a0Revised: 9/2018
  • NDC 0037-0243-30u00a0u00a0u00a0u00a0u00a030 mL
  • Asteprou00a00.15%n n
  • FOR INTRANASAL USE ONLYDO NOT SPRAY IN EYES
  • Asteprou00ae Nasal Spray 0.15%Delivers 200 Metered Sprays
  • Initial priming: 6 sprays; Repriming: 2 spraysor until a fine mist appears.
  • Store upright at controlled room temperature20u00b0-25u00b0C (68u00b0-77u00b0F). Protect from freezing.
  • IMPORTANT: Dispense with enclosedPATIENT INSTRUCTIONS FOR USE.
  • Usual Dosage: See enclosedfull Prescribing Information.
  • Keep bottle upright, tightly closed,and away from children.
  • Arrayn- Dosing Instructions
  • CLEAR YOURNOSEn
  • LOOK DOWNn
  • SNIFF GENTLYn
  • *For patients 12 years and older, who are instructedby your doctor, repeat second spray in each nostril.
  • Read PATIENT INSTRUCTIONS FOR USE for additionalinformation on how to use the product.
  • For assistance call 1-866-210-5951
  • Astepro.com
  • Also contains sorbitol, sucralose,hypromellose, sodium citrate, edetatedisodium, benzalkonium chloride, andpurified water (pH 6.4).
  • Each spray delivers 0.137 mL(205.5 mcg azelastine hydrochloride).
  • Rx Only
  • Manufactured byMEDAPHARMACEUTICALSn Somerset, New Jersey 08873-4120
  • u00a9 2014 Meda Pharmaceuticals Inc.
  • UC-023E6-07u00a0u00a0u00a0u00a0u00a0Rev. 4/2014
  • U.S. Patents 8,518,919; 8,071,073; D447,419
  • ASTEPRO and MEDA PHARMACEUTICALS areregistered trademarks of Meda Pharmaceuticals Inc.or a related entity.

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