KETOCONAZOLE VIATRIS 2 % Cream T/15g

Ketoconazole..................................................................................................................................................20 mg

For 1 g of cream.

Excipients with known effect: 1 g of cream contains 200 mg of propylene glycol (E1520), 75 mg of stearyl alcohol, 20 mg of cetyl alcohol, 1 mg of polysorbate 80 (E433) and 15 mg of polysorbate 60 (E435).

This medicine is indicated for the topical treatment of dermatophyte skin infections, cutaneous candidiasis and Pityriasis versicolor in adults.

The use of KETOCONAZOLE VIATRIS 2 %, cream is reserved for adults.

Cutaneous candidiasis, dermatophytoses of the body skin, inguinal dermatophytoses, dermatophytoses of the hand, athlete's foot and pityriasis versicolor : it is recommended that KETOCONAZOLE VIATRIS 2%, cream be applied once or twice daily to cover the affected area and its immediate periphery.  

The usual duration of treatment is: from 2 to 3 weeks for pityriasis versicolor, for 2 to 3 weeks for cutaneous yeast infection, for 2 to 4 weeks for inguinal dermatophytosis, for 3 to 4 weeks for cutaneous body dermatophytosis, for 4 to 6 weeks for athlete's foot.  

Paediatric population

The safety and efficacy of KETOCONAZOLE VIATRIS 2%, cream, in children aged less than 18 years, have not been established.

Hypersensitivity to the active substance (ketoconazole) or to any of the excipients listed in the section Composition.

Special warnings

The cream is not suitable for ophthalmic use.

In patients receiving a topical corticosteroid as prolonged treatment, application of a low-potency topical corticosteroid should be continued in the morning and KETOCONAZOLE VIATRIS 2 %, cream applied in the evening, then corticosteroid therapy should be gradually discontinued over a period of 2 to 3 weeks in order to avoid a potential rebound effect.

• Candidiasis: it is not recommended to use an acidic pH soap (pH favouring the multiplication of candida).

• The low rate of cutaneous absorption makes the occurrence of systemic effects unlikely. However, over a large surface area and/or on damaged skin, caution is required.

Precautions for use

Excipients

This medicine contains 200 mg of propylene glycol per 1 g of cream, cetyl alcohol and stearyl alcohol.

Propylene glycol may cause skin irritation.

Cetyl alcohol and stearyl alcohol may cause local skin reactions (for example contact dermatitis).

Polysorbate 80 (E 433) and polysorbate 60 (E 435) may cause allergic reactions.

Given the low systemic exposure to ketoconazole after application of KETOCONAZOLE VIATRIS 2 %, cream, drug interactions are unlikely to be clinically significant.

Pregnancy

No effect of KETOCONAZOLE VIATRIS 2 %, cream during pregnancy is expected since maternal systemic exposure is negligible. KETOCONAZOLE VIATRIS 2 %, cream may therefore be used during pregnancy.

Breast-feeding

No effect of KETOCONAZOLE VIATRIS 2 %, cream on the breastfed newborn or infant is expected, since maternal systemic exposure is negligible. KETOCONAZOLE VIATRIS 2 %, cream may therefore be used during breastfeeding.

The tolerability of ketoconazole 2 %, cream administered to the skin was evaluated in 1079 subjects during 30 clinical trials.

Based on the pooled tolerability data from these clinical studies, the most frequently reported adverse reactions (incidence ≥ 1%) were: pruritus at the application site (2%), burning sensation of the skin (1,9%) and erythema at the application site (1%).

The adverse effects reported with ketoconazole 2 %, cream, either during clinical studies or after marketing, are listed below by frequency category, according to 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) and frequency not known (cannot be estimated from the available 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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/ .

Ingestion

In case of accidental ingestion, treatment will be limited to supportive and symptomatic measures. To avoid aspiration of gastric contents, do not perform gastric lavage or induce vomiting.

Pharmacotherapeutic class: topical antifungals, imidazole and triazole derivatives, ATC code: D01AC08.

Ketoconazole is an antifungal of the imidazole group.

It has potent antifungal activity against:

• dermatophytes: in particular Trichophyton sp., Epidermophyton sp., Microsporum sp.,

• yeasts: in particular Candida sp. and Malassezia furfur (Pityrosporum ovale).

In vitro and in vivo in animals, ketoconazole inhibits the synthesis of leukotrienes.

Plasma concentrations of ketoconazole are not detectable after administration of 2 % ketoconazole cream to the skin in adults.

In a study in children with seborrhoeic dermatitis (n=19), plasma concentrations of ketoconazole were detected in 5 children at 32 to 133 ng/mL after daily application of 40 g of 2 % ketoconazole cream over 40% of the body surface.

Non-clinical data from conventional studies, including primary ocular or skin irritation, skin sensitisation and repeated-dose dermal toxicity, did not reveal any particular risk for humans.

Ketoconazole is teratogenic in rats by oral route from doses of 80 mg/kg; however, by dermal route the plasma concentrations of ketoconazole are 6000 times lower than those found by oral route for a dose of 40 mg/kg in rats.

3 years.

To be kept for 1 month after opening.

This medicine does not require any particular storage precautions.

No special requirements.