Trade Name: EPINASTINE 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

EPINASTINE HYDROCHLORIDE Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [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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  • Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
  • Epinastine HCl Ophthalmic Solution is an H histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
  • The recommended dosage is one drop in each eye twice a day.
  • Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
  • The recommended dosage is one drop in each eye twice a day.
  • Solution containing 0.5 mg/mL epinastine HCl.
  • Ophthalmic solution containing 0.5 mg/mL epinastine HCl.
  • None
  • None
  • No data
  • To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. ()
  • Epinastine HCl should not be used to treat contact lens-related irritation. ()
  • Remove contact lenses prior to instillation of epinastine HCl.()
  • The most common ocular adverse reactions (incidence occurring in approximately 1% to 10% of epinastine HCl-treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus.u00a0 The most common non-ocular adverse reactions, occurring in 10% epinastine HCl-treated eyes, were infection (cold symptoms and upper respiratory infections).
  • To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.
  • Epinastine HCl is represented by the following structural formula:
  • CHNHClu00a0u00a0 Mol. Wt. 285.78
  • Chemical Name:
  • Each mL contains:n- Active:n- Preservative:n- Inactives:
  • No data
  • In 18-month or 2-year dietary carcinogenicity studies in mice or rats, respectively, epinastine was not carcinogenic at doses up to 40 mg/kg [approximately 30,000 times higher than the MROHD, assuming 100% absorption in humans and animals].
  • Epinastine in newly synthesized batches was negative for mutagenicity in the Ames / Salmonella assay and chromosome aberration assay using human lymphocytes. Positive results were seen with early batches of epinastine in two chromosomal aberration studies conducted in the 1980s with human peripheral lymphocytes and with V79 cells, respectively. Epinastine was negative in the clastogenicity studies, including the mouse micronucleus assay and chromosome aberration assay in Chinese hamsters. Epinastine was also negative in the cell transformation assay using Syrian hamster embryo cells, V79/HGPRT mammalian cell point mutation assay, and / unscheduled DNA synthesis assay using rat primary hepatocytes.
  • Epinastine had no effect on fertility of male rats.u00a0 Decreased fertility in female rats was observed at an oral dose up to approximately 90,000 times the MROHD.
  • Epinastine HCl 0.05% has been shown to be significantly superior to vehicle for improving ocular itching in patients with allergic conjunctivitis in clinical studies using two different models: (1) conjunctival antigen challenge (CAC) where patients were dosed and then received antigen instilled into the inferior conjunctival fornix; and (2) environmental field studies where patients were dosed and evaluated during allergy season in their natural habitat.u00a0 Results demonstrated a rapid onset of action for epinastine HCl 0.05% within 3 to 5 minutes after conjunctival antigen challenge. Duration of effect was shown to be 8 hours, making a twice daily regimen suitable. This dosing regimen was shown to be safe and effective for up to 8 weeks, without evidence of tachyphylaxis.
  • Epinastine HCl ophthalmic solution 0.05% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white polypropylene caps as follows:
  • 5 mL in 10 mL bottle; individually packaged NDC 70069--01
  • Storage:
  • No data
  • 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 EPINASTINE HYDROCHLORIDE (EPINASTINE HYDROCHLORIDE) which is also known as EPINASTINE HYDROCHLORIDE and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 0.5 mg/mL.

EPINASTINE HYDROCHLORIDE (EPINASTINE 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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