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Emedastine Difumarate (Emadine)

Trade Name : EMADINE

Alcon Laboratories, Inc.

SOLUTION/ DROPS

Strength 0.5 mg/mL

EMEDASTINE DIFUMARATE Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [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 Emedastine Difumarate (Emadine) which is also known as EMADINE and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 0.5 mg/mL per ml. Read more

Emedastine Difumarate (Emadine) 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
  • EMADINE (emedastine difumarate ophthalmic solution) 0.05% is a sterile ophthalmic solution containing emedastine, a relatively selective, H1-receptor antagonist for topical administration to the eyes. Emedastine difumarate is a white, crystalline, water-soluble fine powder with a molecular weight of 534.57. The chemical structure is presented below:
  • Structural Formula:
  • Chemical Name:
  • 1H-benzimidazole,1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl),(E)-2-butenedioate (1:2)
  • Each mL of EMADINE (emedastine difumarate ophthalmic solution) 0.05% contains: Active: n- Preservative: n- Inactives:
  • Emedastine is a relatively selective, histamine H1 antagonist. examinations of emedastine's affinity for histamine receptors (H1: Ki = 1.3u00a0nM, H2: Ki = 49,067u00a0nM, and H3: Ki = 12,430u00a0nM) demonstrate relative selectivity for the H1-histamine receptor. have shown concentration-dependent inhibition of histamine-stimulated vascular permeability in the conjunctiva following topical ocular administration.
  • Emedastine appears to be devoid of effects on adrenergic, dopaminergic and serotonin receptors.n Following topical administration in man, emedastine was shown to have low systemic exposure. In a study involving 10 normal volunteers dosed bilaterally twice daily for 15 days with emedastine ophthalmic solution 0.05%, plasma concentrations of the parent compound were generally below the quantitation limit of the assay (less than 0.3u00a0ng/mL).
  • Samples in which emedastine was quantifiable, ranged from 0.30 to 0.49 ng/mL. The elimination half-life of oral emedastine in plasma is 3-4 hours. Approximately 44% of the oral dose is recovered in the urine over 24 hours with only 3.6% of the dose excreted as parent drug. Two primary metabolites, 5- and 6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms. The 5u2019-oxoanalogs of 5- and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites.
  • In an environmental study, patients with allergic conjunctivitis were treated with EMADINE (emedastine difumarate ophthalmic solution) 0.05% for six weeks. The results demonstrated that EMADINE (emedastine difumarate ophthalmic solution) 0.05% provides relief of the signs and symptoms of allergic conjunctivitis. In conjunctival antigen challenge studies, in which subjects were challenged with antigen both initially and up to four hours after dosing, EMADINE (emedastine difumarate ophthalmic solution) 0.05% was demonstrated to be significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis.
  • EMADINE (emedastine difumarate ophthalmic solution) 0.05% is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis.
  • EMADINE (emedastine difumarate ophthalmic solution) 0.05% is contraindicated in persons with a known hypersensitivity to emedastine difumarate or any of its components.
  • FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION OR ORAL USE.
  • No data
  • Emedastine has been identified in breast milk in rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, caution should be exercised when EMADINE (emedastine difumarate ophthalmic solution) 0.05% is administered to a nursing mother.
  • In controlled clinical studies of EMADINE (emedastine difumarate ophthalmic solution) 0.05% lasting for 42 days, the most frequent adverse reaction was headache 11%. The following adverse experiences were reported in less than 5% of patients: Abnormal dreams, asthenia, bad taste, blurred vision, burning or stinging, corneal infiltrates, corneal staining, dermatitis, discomfort, dry eye, foreign body sensation, hyperemia, keratitis, pruritus, rhinitis, sinusitis and tearing. Some of these events were similar to the underlying disease being studied.
  • Somnolence and malaise have been reported following daily oral administration. Oral ingestion of the contents of a 15u00a0mL DROP-TAINER dispenser would be equivalent to 7.5u00a0mg. In case of overdosage, treatment is symptomatic and supportive.
  • The recommended dose is one drop in the affected eye up to four times daily.
  • EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:
  • 5u00a0mL in opaque, plastic DROP-TAINER dispenser.
  • 5 mL: NDC 0065-0325-05
  • STORAGE
  • Rx Only
  • u00a92002, 2003, 2009, 2018 Novartis
  • Distributed by:
  • ALCON LABORATORIES, INC.
  • Fort Worth, Texas 76134 USA
  • Alconn
  • a Novartis company
  • Revised:
  • T2018-34
  • No data

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