KETOCONAZOLE shampoo, suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

KETOCONAZOLE

Sammensetning:

KETOCONAZOLE 20 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ). 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.

Produkt oppsummering:

Ketoconazole Shampoo, 2% is a red-orange liquid and is available as follows: 4 fl. oz. nonbreakable plastic bottle (NDC 54868-5645-0) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from light. Made in Israel Manufactured by Perrigo Yeruham 80500, Israel Distributed By Perrigo® Allegan, MI 49010 www.perrigo.com Rev. 12/10 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK        74146

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

KETOCONAZOLE - KETOCONAZOLE SHAMPOO, SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
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
cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-
4-yl]methoxy]phenyl]piperazine and has the following structural
formula:
CLINICAL PHARMACOLOGY
Tinea (pityriasis) versicolor is a non-contagious infection of the
skin caused by _Pityrosporum orbiculare_
(_Malassezia furfur_). 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 con