Ketaconazole (Ketaconazole)

Trade Name : Ketaconazole

Mylan Pharmaceuticals Inc.

AEROSOL, FOAM

Strength 20 mg/g

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

Delivery Process

Submit a Request

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

Submit a Request

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.

Product information is meant for

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 Ketaconazole (Ketaconazole) which is also known as Ketaconazole and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 20 mg/g per ml. Read more

Ketaconazole (Ketaconazole) 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.

Inquire directly from our website and get 5% off on any medicine!

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.

Read more

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.

Read more
  • 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 for treatment of fungal infections have not been established.
  • Ketoconazole foam is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older (). n
  • Limitations of Use
  • Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
  • Ketoconazole foam should be applied to the affected area(s) twice daily for four weeks.
  • Hold the container upright, and dispense ketoconazole foam 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 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 may be applied directly to the skin (rather than on the hair).
  • Avoid contact with the eyes and other mucous membranes. Ketoconazole foam 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.
  • Nonen
  • No data
  • 5.1n- 6.2
  • The most common adverse reactions observed in clinical studies (incidence > 1%) were application site burning and application site reaction ().
  • No data
  • Ketoconazole foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.n
  • The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1-imidazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, - with the molecular formula CHClNO and a molecular weight of 531.43. The following is the chemical structure: n
  • Ketoconazole foam contains 20 mg of 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. n
  • 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. n
  • 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 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 and 420 subjects received vehicle foam. Subjects applied ketoconazole foam 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.
  • Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows:
  • NDC 0378-7007-5050 g aluminum can
  • NDC 0378-7007-01100 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 ().
  • Instruct patients on a proper use of ketoconazole foam
  • This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
  • u00a0
  • u00a0
  • INSTRUCTIONS FOR USE
  • Ketoconazole Foam(keeu2033 toe konu2032 a zole)
  • Important Information: Ketoconazole foam is for use on the skin only. Do not use ketoconazole foam in your eyes, mouth or vagina.
  • How should I store ketoconazole foam?
  • Keep ketoconazole foam and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n San Antonio, TX 78215 U.S.A.
  • 141031-0918
  • Revised: 9/2018DPT:KTCZFOG:R1
  • NDC 0378-7007-50
  • KetoconazoleFoam2%
  • FOR TOPICAL USE ONLY
  • Rx only 50 g
  • NOT FOR OPHTHALMIC, ORAL,OR INTRAVAGINAL USE.
  • Hold the can at anupright angle andthen press firmlyto dispense.
  • Description:n- tert-
  • Usual Dosage:
  • Warning: FLAMMABLE. AVOID FIRE,FLAME, OR SMOKING DURING ANDIMMEDIATELY FOLLOWINGAPPLICATION.
  • Contents under pressure. Do not punctureand/or incinerate container. n
  • Do not store in direct sunlight.
  • Avoid contact with eyes. Keep thisand all medication out of the reachof children.
  • Do not store in the refrigerator.Store at 20u00ba to 25u00baC (68u00ba to 77u00baF).[See USP Controlled Room Temperature.]
  • CFC FREE
  • Manufactured for:n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n San Antonio, TX 78215 U.S.A.
  • For more information, callMylan at 1-877-446-3679(1-877-4-INFO-RX)
  • 117545-0918DPT:7007:50:1C:R1
  • Mylan.com

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.