NIZCRÈME® cream
SCHEDULING STATUS
Schedule 1
PROPRIETARY NAME
(and dosage form)
NIZCRÈME® cream
COMPOSITION
Each gram cream contains 20mg of the active ingredient ketoconazole, and 0,2% (w/w) sodium sulphite (antioxidant).
PHARMACOLOGICAL CLASSIFICATION
A.20.2.2 Fungicides.
PHARMACOLOGICAL ACTION
NIZCRÈME (ketoconazole), a synthetic imidazole dioxolane, has an antimycotic activity against dermatophytes such as Trichophyton spp., Epidermophyton floccosum and Microsporum spp. and against yeasts.
NIZCRÈME does not produce detectable blood levels after topical application.
INDICATIONS
NIZCRÈME is indicated for topical application in the treatment of dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manus and tinea pedis due to Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis andEpidermophyton floccosum, as well as in the treatment of cutaneous candidiasis and tinea (pityriasis) versicolor.
CONTRA-INDICATIONS
NIZCRÈME is contra-indicated in individuals who have shown hypersensitivity to any of its ingredients.
WARNINGS
NIZCRÈME is not for ophthalmic use.
DOSAGE AND DIRECTIONS FOR USE
NIZCRÈME should be applied to affected areas once daily. Treatment should be continued for a sufficient period, at least until a few days after disappearance of all symptoms. The diagnosis and/or treatment should be reconsidered if no clinical improvement is noted after 4weeks of therapy. General measures in regard to hygiene should be observed to control sources of infection or re-infection.
The usual duration of treatment is: tinea versicolor (2 - 3weeks), yeast infections (2 - 3weeks), tinea cruris (2 - 4weeks), tinea corporis (3 - 4weeks), tinea pedis (4 - 6weeks).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Pruritus, irritation, and burning sensation have been reported during treatment with NIZCRÈME. Also, in rare circumstances, allergic local skin phenomena, such as contact dermatitis, have been associated with NIZCRÈME cream or one of its components, namely sodium sulphite or propylene glycol.
Precautions:
Irritation may occur when NIZCRÈME is used immediately after prolonged treatment with topical corticosteroids. Therefore, to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid in the morning and to apply NIZCRÈME in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2 - 3weeks.
Pregnancy:
The safety in pregnancy and lactation has not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Excessive topical application may lead to erythema, oedema and a burning sensation.
IDENTIFICATION
White odourless cream.
PRESENTATION
NIZCRÈME is supplied in 20g aluminium tubes.
STORAGE INSTRUCTIONS
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER
S/20.2.2/161
NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 1980/11122/07)
15th Road, Halfway House 1685
www.janssencilag.co.za
DATE OF PUBLICATION OF THIS PACKAGE INSERT
18 September 1986.
Code No.: 024392 2003H
Updated on this site: October 2003
Source: Pharmaceutical Industry |
