Sandoz Ketoconazole

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

Sandoz Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

For topical administration.

Ketoconazole shampoo 2% is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Prophylaxis:

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea (pityriasis) versicolor: It is recommended that Sandoz Ketoconazole Cream 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis: Sandoz Ketoconazole Cream 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Known hypersensitivity to ketoconazole or any of the excipients.

Sandoz Ketoconazole Cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Sandoz Ketoconazole 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

WARNINGS

Sandoz Ketoconazole Cream 2% is not for ophthalmic use.

Sandoz Ketoconazole Cream 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS

General

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Sandoz Ketoconazole; these effects have not been seen with topical Sandoz Ketoconazole.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Sandoz Ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames'Salmonella microsomal activator assay was also negative.

Pregnancy

Teratogenic effects : Pregnancy Category C

Sandoz Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Sandoz Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Sandoz Ketoconazole Cream 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children have not been established.

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence >1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention:

Very common (>1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated form the available clinical trial data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

During clinical trials 45 (5.0%) of 905 patients treated with Sandoz Ketoconazole Cream 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Sandoz Ketoconazole Cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Sandoz Ketoconazole Cream or one of its excipients, namely sodium sulfite or propylene glycol.

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

No information provided.