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Azelastine Hydrochloride (Azelastine Hydrochloride)

Trade Name : Azelastine Hydrochloride

Akorn, Inc.

SOLUTION/ DROPS

Strength 0.5 mg/mL

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 (Azelastine Hydrochloride) which is also known as Azelastine Hydrochloride and Manufactured by Akorn, Inc.. It is available in strength of 0.5 mg/mL 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • 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)-, monohydrochloride and is represented by the following chemical structure:n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • Empirical chemical structure: CHClNOu2022HClu00a0Each mL of Azelastine Hydrochloride Ophthalmic Solution contains: azelastine hydrochloride 0.5 mg, equivalent to 0.457 mg of azelastine base; benzalkonium chloride 0.125 mg; disodium 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 Hn antagonist and an inhibitor of the release of histamine and other mediators from cells (e.g. mast cells) involved in the allergic response. Based on 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.
  • Pharmacokinetics and Metabolism
  • Based on intravenous and oral administration, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours, 14.5 L/kg and 0.5 L/h/kg, respectively. Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine. Azelastine hydrochloride is oxidatively metabolized to the principal metabolite, N-desmethylazelastine, by the cytochrome P450 enzyme system. studies in human plasma indicate that the plasma protein binding of azelastine and N-desmethylazelastine are approximately 88% and 97%, respectively.
  • Clinical Trialsn
  • In environmental studies, adult and pediatric patients with seasonal allergic conjunctivitis were treated with Azelastine Hydrochloride for two to eight weeks. In these studies, Azelastine Hydrochloride Ophthalmic Solution was more effective than its vehicle in relieving itching associated with allergic conjunctivitis.
  • Azelastine Hydrochloride Ophthalmic Solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
  • Azelastine Hydrochloride Ophthalmic Solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
  • Azelastine Hydrochloride Ophthalmic Solution is for ocular use only and not for injection or oral use.
  • Information for Patientsn
  • Patients should be advised not to wear a contact lens if their eye is red. Azelastine Hydrochloride Ophthalmic Solution should not be used to treat contact lens related irritation. The preservative in Azelastine Hydrochloride Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and , should be instructed to wait at least ten minutes after instilling Azelastine Hydrochloride Ophthalmic Solution before they insert their contact lenses.u00a0
  • Carcinogenesis, Mutagenesis, Impairment of Fertility:n
  • 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. Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 25,000 times the maximum recommended ocular human use level. At 68.6 mg/kg/day (57,000 times the maximum recommended ocular human use level), the duration of the estrous cycle was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, the implantation ratio was not affected.u00a0
  • Pregnancy:n n- Array
  • There are no adequate and well-controlled studies in pregnant women. Azelastine Hydrochloride Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Arrayn- Array
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  • To report SUSPECTED ADVERSE REACTIONS, contact Akorn at 1-800-932-5676 or FDA at 1-800-FDA-1088 or n- www.fda.gov/medwatchn- .
  • 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 available in 6 mL in 10 mL HDPE container with LDPE dropper tip and au00a0white screw cap as follows:
  • NDC 17478-718-10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 6 mL in 10 mL bottle.n n Store at 2u00ba to 25u00baC (36u00b0 to 77u00b0F). n
  • u00a0
  • Rx Only
  • AKORN
  • Manufactured by: n
  • Lake Forest, IL 60045
  • AZ00Nu00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. 11/16
  • Principal Display Panel Text for Container Label:
  • NDC 17478-718-10Azelastine HClOphthalmic Solution0.05%FOR USE IN THEEYES ONLYEye Logo
  • Principal Display Panel Text for Carton Label:
  • NDC 17478-718-10Azelastine HClOphthalmic Solution0.05%FOR USE IN THE EYES ONLYEye Logo6 mLRx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Akorn Logo

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Validated Cold Chain Shipment

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