KETOCONAZOLE shampoo

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ketoconazole (UNII: R9400W927I) (ketoconazole - UNII:R9400W927I)

Dostępny od:

Patriot Pharmaceuticals, LLC

INN (International Nazwa):

ketoconazole

Skład:

ketoconazole 20 mg in 1 mL

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Ketoconazole 2% shampoo 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 2% shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Podsumowanie produktu:

Ketoconazole 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle (NDC 10147-0750-4). Ketoconazole 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle in a carton of one (NDC 10147-0750-5). Storage conditions: Store at a temperature not above 25°C (77°F). Protect from light. Keep out of reach of children For more information call 1-800-667-8570 Product of Belgium Manufactured by: Janssen Pharmaceutica NV Beerse, Belgium Manufactured for: Patriot Pharmaceuticals, LLC Horsham, PA 19044 ©2005 Patriot Edition: December 2017

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

KETOCONAZOLE- KETOCONAZOLE SHAMPOO
PATRIOT PHARMACEUTICALS, LLC
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KETOCONAZOLE 2% SHAMPOO
DESCRIPTION
Ketoconazole 2% shampoo 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 monolauryl ether
sulfosuccinate, F.D.&C. Red
No. 40, hydrochloric acid, imidurea, laurdimonium hydrolyzed animal
collagen, macrogol 120 methyl
glucose dioleate, perfume bouquet, sodium chloride, sodium hydroxide,
sodium lauryl ether sulfate,
and purified water.
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 2% 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
2% shampoo 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 an