INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
KEZ (liquid)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

KEZ (liquid)

COMPOSITION:
Each 1 gram liquid contains ketoconazole 20 mg.
Preservative: Imidurea 0,3% m/m.

PHARMACOLOGICAL CLASSIFICATION:
A: 20.2.2 Fungicides.

PHARMACOLOGICAL ACTION:
Ketoconazole is a synthetic imidazole dioxalane derivative having a potent antifungal activity against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp. and yeasts, such as Candida sp. and Malassezia furfur (Pityrosporum ovale).
Even after chronic use, the percutaneous absorption of KEZ is negligible as blood levels cannot be detected.

INDICATIONS:
Kez is indicated for the:
Treatment of infections due to the yeast Pityrosporum, such as pityriasis versicolor, seborrhoeic dermatitis and pityriasis capitis (dandruff).
Prophylactic treatment of seborrhoeic dermatitis.

CONTRA-INDICATIONS:
Individuals who are hypersensitive to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
TOPICAL APPLICATION.
For external use only.
Apply KEZ to the affected areas of the wet skin or the wet hair and rub in lightly. Leave on for 3 to 5 minutes before rinsing thoroughly.
Treatment:

Pityriasis versicolor:	Use once daily for a maximum of 5 days.
Seborrhoeic dermatitis and pityriasis capitis (dandruff):	Use twice weekly (every 3 to 4 days) for 2 to 4 weeks.
Prophylactic seborrhoeic dermatitis:	Use once a week. Regular shampoo should be used on other occasions.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
After topical administration, irritation, dermatitis, or a burning sensation has occurred. Less frequently, mainly in patients with chemically damaged hair or grey hair, hair discolouration has been observed. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and this has also been reported, though rarely with the use of KEZ.
When KEZ is used immediately after prolonged treatment with topical corticosteroids, irritation may occur. To prevent a rebound effect after stopping prolonged topical corticosteroid treatment, the following is recommended:
        continue applying a mild topical corticosteroid in the morning and apply KEZ in the evening,
        and subsequently and gradually withdraw the corticosteroid therapy over a 2 to 3 week period.
Pregnancy and lactation
As safety has not been established, it is not recommended during pregnancy and lactation although KEZ is not absorbed through the skin.
Avoid contact in the eyes. However, if this happens, rinse the eyes with water.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions".
Supportive measures should be carried out in the event of accidental ingestion. Neither emesis nor gastric lavage should be performed in order to prevent aspiration.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, pink, thick solution.

PRESENTATION:
White, plastic bottles of 100 mL and 150 mL, containing 80 mL and 150 mL respectively.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep well closed. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
33/20.2.2/0472

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharma Dynamics (Pty) Ltd.
F02 Grapevine House
Steenberg Office Park
WESTLAKE
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 October 1999

Updated on this site: November 2002         Source: Industry

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