NIZORAL® (KETOCONAZOLE) 2% SHAMPOO

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Janssen Pharmaceuticals, Inc.

INN (International Name):

ketoconazole

Composition:

ketoconazole 20 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NIZORAL® (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. NIZORAL® (ketoconazole) 2% Shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Product summary:

NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle (NDC 50458-680-08). Storage conditions: Store at a temperature not above 25°C (77°F). Protect from light. Keep out of reach of children

Authorization status:

New Drug Application

Summary of Product characteristics

NIZORAL- KETOCONAZOLE SHAMPOO
JANSSEN PHARMACEUTICALS, INC.
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NIZORAL (KETOCONAZOLE) 2% SHAMPOO
DESCRIPTION
NIZORAL
(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.
NIZORAL
(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 2%
shampoo was significantly less than that of 2.5% selenium sulfide
shampoo.
A human sensitization test, a phototoxicity study, and a photoallergy
study