Ketoconazole (Ketoconazole)

Trade Name : Ketoconazole

Perrigo New York Inc

SHAMPOO, SUSPENSION

Strength 20 mg/mL

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

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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 20 mg/mL 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
  • Rx Only
  • Ketoconazole Shampoo, 2% is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate.
  • Ketoconazole is -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazine and has the following structural formula:
  • Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by (). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.
  • Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months).
  • An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole shampoo, 2% was significantly less than that of 2.5% selenium sulfide shampoo.
  • A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to ketoconazole shampoo, 2%.
  • Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by (also known as or )n
  • Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
  • Ketoconazole Shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
  • Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of ketoconazole shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
  • No data
  • Ketoconazole Shampoo, 2% is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should not be performed to avoid aspiration.
  • Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.
  • One application of the shampoo should be sufficient.
  • Ketoconazole Shampoo, 2% is a red-orange liquid and is available as follows:
  • 4 fl. oz. (120 mL) nonbreakable plastic bottle (NDC 45802--64)
  • Store at 20-25u00b0C (68-77u00b0F) [see USP Controlled Room Temperature].
  • Protect from light.
  • Made in Israel
  • Manufactured By Perrigo
  • Yeruham, Israel
  • OR
  • Manufactured By Perrigo
  • Bronx, NY 10457
  • Distributed By
  • Perrigou00ae
  • Allegan, MI 49010
  • www.perrigo.com
  • 4L926RCF5
  • Rev 03-17
  • OR
  • 2P326RCF6
  • Rev 08-14
  • Rx Only
  • Ketoconazole Shampoo, 2%
  • For Topical Application Only
  • 4 FL OZ
  • 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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