KETOCONAZOLE shampoo suspension

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Preferred Pharmaceuticals, Inc.

INN (আন্তর্জাতিক নাম):

KETOCONAZOLE

রচনা:

KETOCONAZOLE 20.5 mg in 1 mL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

KETOCONAZOLE- KETOCONAZOLE SHAMPOO, SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
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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-(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 showe