KETOCONAZOLE shampoo, suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

NuCare Pharmaceuticals,Inc.

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle ( NDC 68071-1735-4 Bottle of 4oz Storage conditions: Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured and Distributed by: TOLMAR Inc. Fort Collins, CO 80526 04006031 Rev. 0 06/16

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

KETOCONAZOLE- KETOCONAZOLE SHAMPOO, SUSPENSION
NUCARE PHARMACEUTICALS,INC.
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KETOCONAZOLE SHAMPOO
KETOCONAZOLE SHAMPOO, 2%
_FOR TOPICAL APPLICATION ONLY._
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: sodium laureth sulfate, disodium laureth
sulfosuccinate, cocamide diethanolamide,
hydrochloric acid, PEG-120 methyl glucose dioleate, imidurea, sodium
chloride, sodium hydroxide,
fragrance, FD&C red No. 40, and purified water.
Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1
H-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
femal