INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADCO-CLOTRIMAZOLE
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-CLOTRIMAZOLE
TOPICAL CREAM

COMPOSITION:
Each 5 g cream contains clotrimazole 50 mg and benzyl alcohol 1% (m/m) (as a preservative)

PHARMACOLOGICAL CLASSIFICATION:
A. 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
A broad spectrum antimycotic acting as a fungicide. Clotrimazole possesses fungicidal activity on Candida species. Clotrimazole is an imidazole antifungal agent.

INDICATIONS:
Vaginitis or vulvo-vaginitis due to fungi, mainly candida. The range of indications is:
1. All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
2. All dermatomycoses due to yeasts (e.g. Candida species).
3. Dermatomycoses due to moulds and other fungi.
4. Skin disease with secondary infection by these fungi.
The dermatomycoses mentioned under 1 - 4 include among others:
1. Mycoses of the skin and skin folds.
2. Ringworm.
3. Interdigital mycoses, e.g. athlete's foot.
4. Candida vulvitis.
5. Candida balanitis.
6. Pityriasis versicolor.
7. Erythrasma.
8. Paronychias (associated with nail mycoses).

CONTRA-INDICATIONS:
Possible allergy to clotrimazole or any other imidazole agent. Safety in pregnancy has not been established.

WARNINGS:
For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Apply thinly to the affected areas two to three times daily and rub in. A small amount of cream is usually sufficient for an area about the size of the palm. Successful treatment demands that ADCO-CLOTRIMAZOLE TOPICAL CREAM be applied correctly and over a sufficiently long period of time.
The duration of treatment varies.
In general, it is three to four weeks in the case of dermatomycoses due to dermatophytes and yeasts; in Candida vulvitis and Candida balanitis, one to two weeks; and approximately two to four weeks in Erythrasma and one to three in Pityriasis versicolor. TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROXIMATELY TWO WEEKS AFTER THE DISAPPEARANCE OF ALL SYMPTOMS DESPITE A RAPID, SUBJECTIVE IMPROVEMENT, IN ORDER TO PREVENT RELAPSE.
Athlete's foot: Always dry the feet carefully, especially between the toes.
ADCO-CLOTRIMAZOLE TOPICAL CREAM preparations are odourless, can be washed off and do not stain. ADCO-CLOTRIMAZOLE TOPICAL CREAM is not indicated for ophthalmic use. Use with caution around the eyes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions, including irritation and burning may occur. Contact allergic dermatitis has been reported. If this occurs, treatment should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See ''Side-effects and Special Precautions”. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
Smooth, white cream, soft to the touch.

PRESENTATION:
ADCO-CLOTRIMAZOLE TOPICAL CREAM - Tubes of 20 g.

STORAGE INSTRUCTIONS:
Store below 25°C in well closed containers. Keep out of reach of children.

REGISTRATION NUMBER:
28/20.2.2/0322.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 January 1995

New addition to this site: April 2004
Source: Pharmaceutical Industry

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