Trade Name: Azelastine Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: SOLUTION/ DROPS, HUMAN PRESCRIPTION DRUG

Strength: 0.5 mg/mL

Storage and handling

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

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Azelastine hydrochloride ophthalmic solution, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H-receptor antagonist for topical administration to the eyes. Azelastine hydrochloride is a white crystalline powder with a molecular weight of 418.37. Azelastine hydrochloride is sparingly soluble in water, methanol and propylene glycol, and slightly soluble in ethanol, octanol, and glycerine. Azelastine hydrochloride is a racemic mixture with a melting point of 225u00b0C. The chemical name for azelastine hydrochloride is (u00b1)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, mono hydrochlorideu00a0 and is represented by the following chemical structure:
  • Empirical chemical structure: CHClNOu2022HClu00a0
  • Each mL of Azelastine hydrochloride ophthalmic solution contains: 0.5 mg azelastine hydrochloride, equivalent to 0.457 mg of azelastine base; 0.125 mg benzalkonium chloride; u00a0disodium edetate dihydrate, hypromellose, sorbitol solution, sodium hydroxide and water for injection. It has a pH of approximately 5.0 to 6.5 and an osmolarity of approximately 271 to 312 mOsmol/L.
  • Azelastine hydrochloride is a relatively selective histamine Hantagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on in-vitro studies using human cell lines, inhibition of other mediators involved in allergic reactions (e.g. leukotrienes and PAF) has been demonstrated with azelastine hydrochloride. Decreased chemotaxis and activation of eosinophils has also been demonstrated.
  • Azelastine hydrochloride is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
  • Azelastine hydrochloride is contraindicated in persons with known or suspected hypersensitivity to any of its components.u00a0
  • Azelastine hydrochloride is for ocular use only and not for injection or oral use.
  • No data
  • In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild.
  • The following events were reported in 1u201310% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied.
  • The recommended dose is one drop instilled into each affected eye twice a day.
  • Azelastine hydrochloride ophthalmic solution, 0.05% is supplied as follows:
  • 6 mL (NDC # 70069-091-01) solution in 10 mL natural HDPE bottle plugged with natural LDPE nozzle and white HDPE screw cap.
  • Storage
  • Store UPRIGHT between 2u00b0 and 25u00b0C (36u00b0 and 77u00b0F).
  • Rx Only
  • For Product Inquiry call +1-800-417-9175
  • Manufactured by:u00a0
  • Wintac Limited
  • Bangalore 562 123
  • India
  • Code No.: KR/DRUGS/KTK/28/289/97
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Somerset, NJ 08873
  • Issued:
  • ST-AZL11/P/00
  • Container Label
  • Carton Label

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Azelastine Hydrochloride (Azelastine Hydrochloride) which is also known as Azelastine Hydrochloride and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 0.5 mg/mL.

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.

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