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Sertaconazole Nitrate (Ertaczo)

Trade Name : Ertaczo

Bausch Health US LLC

CREAM

Strength 20 mg/g

Storage and handling for Ertaczo

SERTACONAZOLE NITRATE Azole Antifungal [EPC],Azoles [CS]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sertaconazole Nitrate (Ertaczo) which is also known as Ertaczo and Manufactured by Bausch Health US LLC. It is available in strength of 20 mg/g per ml. Read more

Sertaconazole Nitrate (Ertaczo) 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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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.

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
  • ERTACZO (sertaconazole nitrate) cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by , and [see ].
  • ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older caused by and . ()
  • In the treatment of interdigital tinea pedis, ERTACZO cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of ERTACZO cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis.
  • Not for ophthalmic, oral, or intravaginal use.
  • ERTACZO cream, 2% should be applied to the affected and immediate surrounding area(s) twice daily for 4 weeks. ()
  • Not for ophthalmic, oral, or intravaginal use. ()
  • Cream, 2%. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base.
  • Cream, 2%. ()
  • None.
  • None. ()
  • If irritation develops, treatment should be discontinued and appropriate therapy instituted.
  • Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to be sensitive to azole antifungals since cross-reactivity may occur.
  • Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.
  • Sertaconazole nitrate is designated chemically as (u00b1)-1-[2,4-dichloro-u03b2-[(7-chlorobenzo-[]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is CHClNOS HNO, and the structural formula is as follows:
  • Sertaconazole nitrate is a white or almost white powder. It is practically insoluble in water, soluble in methanol, and sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid.
  • No data
  • In a rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream for up to 102 weeks did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (approximately 200 times the maximum recommended human dose based on a body surface area comparison).
  • No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was considered nonclastogenic in the mouse sister chromatid exchange assay. There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures.
  • At oral doses up to 60 mg/kg/day (16 times the maximum recommended human dose based on a body surface area comparison), sertaconazole nitrate exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.
  • In two randomized, double-blind clinical trials, subjects 12 years and older with interdigital tinea pedis applied either ERTACZO cream, 2%, or vehicle, twice daily for 4 weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (6 weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis.
  • Treatment outcomes are summarized in the table below.
  • In clinical trials, complete cure in sertaconazole-treated subjects was achieved in 32 of 160 (20%) subjects with , in 7 of 28 (25%) subjects with and in 1 of 13 (15%) subjects with .
  • ERTACZO cream, 2%, is white in color and supplied in tubes in the following size:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).The patient should be instructed to:
  • Manufactured for:
  • By:
  • Ertaczo is a trademark of Valeant Pharmaceuticals International, Inc.or its affiliates.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • 9378101
  • PATIENT INFORMATION
  • ERTACZO (er-tack-zo)n- (sertaconazole nitrate) cream, 2%
  • What is ERTACZO cream?
  • ERTACZO cream is a prescription medicine used on the skin (topical) to treat athlete's foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older with normal immune systems.
  • It is not known if ERTACZO cream is safe and effective in children under 12 years of age.
  • What should I tell my healthcare provider before using ERTACZO cream?
  • Before using ERTACZO cream, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take,
  • How should I use ERTACZO cream?
  • What are the possible side effects of ERTACZO cream?
  • The most common side effects of ERTACZO cream include:
  • These are not all the possible side effects of ERTACZO cream. 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 ERTACZO cream?
  • General information about the safe and effective use of ERTACZO cream
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ERTACZO cream that is written for health professionals. Do not use ERTACZO cream for a condition for which it was not prescribed. Do not give ERTACZO cream to other people, even if they have the same symptoms you have. It may harm them.
  • For more information, call 1-800-321-4576.
  • What are the ingredients in ERTACZO cream?
  • Active ingredient:
  • Inactive ingredients:
  • Manufactured for:
  • By:
  • Ertaczo is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • 9378101
  • Rev. 11/17
  • PRINCIPAL DISPLAY PANEL - 60 g Tube
  • NDC
  • Arrayn- (sertaconazole nitrate) cream, 2%
  • For Topical Dermatologic Use Only u2013 Not for Oral, Ophthalmic, or Intravaginal Use
  • Rx only
  • Net Wt. 60 g

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