Ketoconazole (Ketoconazole)

Trade Name : ketoconazole

Perrigo New York Inc

AEROSOL, FOAM

Strength 2 g/100g

KETOCONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Ketoconazole (Ketoconazole) which is also known as ketoconazole and Manufactured by Perrigo New York Inc. It is available in strength of 2 g/100g per ml. Read more

Ketoconazole (Ketoconazole) 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
  • Ketoconazole Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
  • Limitations of Use
  • Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established.
  • Ketoconazole Foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.
  • Limitations of Use
  • Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established.
  • Ketoconazole Foam, 2% should be applied to the affected area(s) twice daily for four weeks.
  • Hold the container upright, and dispense Ketoconazole Foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Ketoconazole Foam, 2% with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Ketoconazole Foam, 2% may be applied directly to the skin (rather than on the hair).
  • Avoid contact with the eyes and other mucous membranes. Ketoconazole Foam, 2% is not for ophthalmic, oral or intravaginal use.
  • Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram, supplied in 50 g and 100 g containers.
  • Foam: 2% ketoconazole in 50 g and 100 g containers.
  • None.
  • None.
  • No data
  • The most common adverse reactions observed in clinical studies (incidence >1%) were application site burning and application site reaction (6.1).
  • To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or www.perrigo.com and FDA at 1-800-FDA-1088 or .
  • No data
  • Ketoconazole Foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.
  • The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1-imidazol-1-ylmethyl)-1, 3-dioxolan-4-yl]methoxy]phenyl]-, - with the molecular formula CHCINO and a molecular weight of 531.43.
  • The following is the chemical structure:
  • Ketoconazole Foam, 2% contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with -butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.
  • No data
  • Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of ketoconazole foam, 2%.
  • In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the MRHD based on BSA comparisons. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential.
  • In animal fertility studies, oral ketoconazole impaired both male and female fertility in rats in a dose and duration dependent manner. In females, oral doses up to 40 mg/kg (2.4 times the MRHD based on BSA comparisons) had no effect on fertility, while doses of 75 mg/kg (4.5 times the MRHD based on BSA comparisons) and higher decreased the pregnancy rate and number of implantation sites. In male rats, oral dosing at 200 mg/kg/day (12 times the MRHD based on BSA comparisons) for three days decreased fertility and 400 mg/kg/day (24 times the MRHD based on BSA comparisons) for three days resulted in a complete loss of fertility. When administered for longer durations (up to 3 months), decreased fertility in male rats was observed at doses as low as 24 mg/kg/day (1.4 times the MRHD based on BSA comparisons). In male beagle dogs, an oral dose of 25 mg/kg/day ketoconazole for up to 4 weeks (5.2 times the MRHD based on BSA comparisons) resulted in decreased sperm motility, decreased sperm count, increased abnormal sperm and atrophy of the testes. These effects were reversed subsequent to withdrawal of treatment.
  • The safety and efficacy of ketoconazole foam, 2% were evaluated in a randomized, double-blind, vehicle-controlled trial in subjects 12 years and older with mild to severe seborrheic dermatitis. In the trial, 427 subjects received ketoconazole foam, 2% and 420 subjects received vehicle foam. Subjects applied ketoconazole foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigatoru2019s Static Global Assessment (ISGA) scale.
  • Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.
  • Table 2: Efficacy Results
  • Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows:
  • NDC 45802-532-32
  • 50 g aluminum can
  • NDC 45802-532-33
  • 100 g aluminum can
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature].
  • Do not store under refrigerated conditions.
  • Contents are flammable. Do not expose containers to heat and/or store at temperatures above 49u00b0C (120u00b0F).
  • Contents under pressure. Do not puncture and/or incinerate container.
  • Keep out of reach of children.
  • See FDA-approved patient labeling (Patient Package Insert).
  • Instruct patients on a proper use of Ketoconazole Foam, 2%.
  • Made in Israel
  • Manufactured By Perrigo
  • Yeruham, Israel
  • Distributed By
  • Perrigou00ae
  • Allegan, MI 49010
  • www.perrigo.com
  • Rev 08-18
  • 5K200RCJ3
  • Ketoconazole Foam, 2%
  • Important Information: Ketoconazole Foam, 2% is for use on the skin only. Do not use Ketoconazole Foam, 2% in your eyes, mouth or vagina.
  • How should I store Ketoconazole Foam, 2%?
  • Keep Ketoconazole Foam, 2% and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Rx Only
  • Made in Israel
  • Manufactured By Perrigo
  • Yeruham, Israel
  • Distributed By
  • Perrigou00ae
  • Allegan, MI 49010
  • www.perrigo.com
  • Rev 08-18
  • Ketoconazole Foam, 2%
  • Important Information: Ketoconazole Foam, 2% is for use on the skin only. Do not use Ketoconazole Foam, 2% in your eyes, mouth or vagina.
  • What is Ketoconazole Foam, 2%?
  • Ketoconazole Foam, 2% is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in people 12 years of age and older with a normal immune system.
  • It is not known if Ketoconazole Foam, 2% is safe and effective when used to treat fungal infections.
  • It is not known if Ketoconazole Foam, 2% is safe and effective in children less than 12 years of age.
  • Before using Ketoconazole Foam, 2%, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take
  • How should I use Ketoconazole Foam, 2%?
  • What should I avoid while using Ketoconazole Foam, 2%?
  • What are the possible side effects of Ketoconazole Foam, 2%?
  • Ketoconazole Foam, 2% may cause serious side effects, including:
  • The most common side effects of Ketoconazole Foam, 2% include,
  • These are not all of the possible side effects of Ketoconazole Foam, 2%.
  • 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 Ketoconazole Foam, 2%?
  • General information about the safe and effective use of Ketoconazole Foam, 2%.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ketoconazole Foam, 2% for a condition for which it was not prescribed. Do not give Ketoconazole Foam, 2% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ketoconazole Foam, 2% that is written for health professionals.
  • What are the ingredients in Ketoconazole Foam, 2%?
  • Active ingredient:
  • Inactive Ingredients:n- tert
  • For more information, call Perrigo at 1-866-634-9120
  • This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
  • Rx Only
  • 45802-532-32
  • Ketoconazole Foam, 2%
  • For Topical Use Only.
  • Not For Ophthalmic, Oral, or Intravaginal Use.
  • 100 g
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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