NIZORAL Cream
KetoconazoleTopical Antifungal
Pharmacology:
In vitro
studies suggest that the antifungal properties of ketoconazole
may be related to its ability to impair the synthesis of
ergosterol, a component of fungal and yeast cell membranes.
Without the availability of this essential sterol, there are
morphological alterations of the fungal and yeast cell
membranes manifested as abnormal membranous inclusions between
the cell wall and the plasma membrane. The inhibition of
ergosterol synthesis has been attributed to interference with
the reactions involved in the removal of the 14-a-methyl group
of the precursor of ergosterol, lanosterol.
Indications:
For the topical
treatment of tinea pedis, tinea corporis and tinea cruris
caused by T. rubrum, T. mentagrophytes and E. floccosum; and
in the treatment of tinea versicolor (pityriasis) caused by M.
furfur (P. orbiculare); and in the treatment of seborrheic
dermatitis caused by P. ovale; and in the treatment of
cutaneous candidiasis caused by C. albicans.
Contraindications:
In persons who
have shown hypersensitivity to the active or excipient
ingredients of this formulation.
Warnings:
Ketoconazole
cream should never be employed for the treatment of infections
of the eye.
Precautions:
If a reaction
suggesting sensitivity or chemical irritation should occur,
use of ketoconazole cream should be promptly discontinued.
Pregnancy and Lactation:
Limited
short-term studies in animals and in human volunteers on whom
limited quantities of the cream were tested have failed to
demonstrate absorption of ketoconazole in detectable amounts.
Due to the teratogenic nature of the active ingredient,
ketoconazole, caution should be exercised when ketoconazole
cream is administered to pregnant or nursing women.
Cross sensitivity
with miconazole and other imidazoles may exist and caution is
suggested when ketoconazole cream is employed in patients with
known sensitivities to imidazoles.
Adverse Effects:
Short-term
studies indicate that ketoconazole cream is well tolerated by
the skin. During clinical trials, 43 (5.0%) of 867 patients
treated with the cream and 3 (1.8%) of 167 patients treated
with placebo reported side effects consisting mainly of severe
irritation, pruritus and stinging. One of the patients treated
with ketoconazole cream 2% developed a painful allergic
reaction (swelling of the foot).
Overdose:
Symptoms and
Treatment: There has been no experience with overdosage of
ketoconazole cream. Treatment should include general
supportive measures.
Dosage:
When clinically
warranted, therapy with ketoconazole cream may be initiated
while results of culture and susceptibility tests are pending.
Treatment should be adjusted according to the findings.
The cream should be
applied to the affected and immediate surrounding area in
patients with the following conditions: Tinea pedis: Use once
daily for 4 to 6 weeks.
Tinea corporis: Use
once daily for 3 to 4 weeks.
Tinea cruris: Use
once daily for 2 to 4 weeks.
Tinea versicolor:
Use once daily for 2 to 3 weeks.
Cutaneous
candidiasis: Use once daily for 2 to 3 weeks.
More resistant
cases may be treated twice daily depending on patient
response.
Seborrheic
dermatitis: Use twice daily for 4 weeks.
The full course of
therapy should be followed to reduce the possibility of
recurrence. If however, there is no response within the
recommended treatment period, the diagnosis should be
re-evaluated.
The safety of
ketoconazole cream has not been established with treatment
periods exceeding those recommended; therefore, treatment must
not exceed the recommended duration of therapy indicated
above.
Supplied:
