PHARMACOLOGICAL ACTION Ketoconazole, a synthetic imidazole dioxolane derivative, has 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).
Percutaneous absorption of NizShampoo is negligible since blood levels cannot be detected, even after chronic use.
INDICATIONS Treatment of infections in which the yeast Pityrosporum is involved, such as pityriasis versicolor, seborrhoeic dermatitis and pityriasis capitis.
CONTRA-INDICATIONS NizShampoo is contra-indicated in individuals who have shown hyper-sensitivity to any of its ingredients. Safety in pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE
For external use only. The affected areas of the skin or the hair should be washed with NizShampoo which should be left for 3 to 5 minutes before rinsing. Treatment
Pityriasis versicolor: once daily for a maximum of 5 days.
Seborrhoeic dermatitis and pityriasis capitis (dandruff): twice weekly for 2 to 4 weeks.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS A local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported with the use of NizShampoo. In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed.
Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely with the use of NizShampoo.
Irritation may occur when NizShampoo 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 NizShampoo in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Although ketoconazole is not absorbed through the skin, the use of NizShampoo is not recommended during pregnancy, as safety in pregnancy and lactation has not been established. (See contra-indications.)
Avoid contact in the eyes. If this happens, however, rinse the eyes with water.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT See "Side-effects and special precautions". Treatment is symptomatic and supportive. In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be performed.
IDENTIFICATION Pink, viscous liquid.
PRESENTATION NizShampoo is supplied in 100 mL plastic bottles containing 80 mL of NizShampoo solution.
STORAGE INSTRUCTIONS Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER V/20.2.2/251
NAME AND BUSINESS ADDRESS OF THE APPLICANT JANSSEN-CILAG logo
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
DATE OF PUBLICATION OF THIS PACKAGE INSERT 4 November 2002
Code No.: 024311
Updated on this site: March 2004 Source: Pharmaceutical Industry