KETOCONAZOLE ZYDUS 2 % Gel single-dose sachet 8Sach

Ketoconazole..................................................................................................................................120 mg

For one sachet-dose of 6 g.

Excipient with known effect: sodium laurilsulfate 540 mg per sachet-dose

This medicine is indicated for the treatment of seborrhoeic dermatitis in adults and adolescents.

The use of Ketoconazole Zydus 2 %, sachet-dose gel is reserved for adults and adolescents.

The safety and efficacy of Ketoconazole Zydus 2 %, sachet-dose gel have not been established in children under 12 years of age. No data are available.

Dosage

1 sachet-dose is sufficient for one application.

During the first month of treatment, the dosage is usually 2 applications per week.

A maintenance treatment may be deemed necessary by the physician; it is usually one application per week or every two weeks depending on the results obtained.

Method of administration

Cutaneous application to the scalp and/or skin.

• Thoroughly wet the affected areas, skin and/or scalp.
• Apply the gel, lather thoroughly, paying particular attention to the affected areas.
• Avoid contact with the eyes.
• Leave in place for 5 minutes. For good efficacy, it is important to respect this minimum duration.
• Then rinse the skin and/or scalp thoroughly, and not only the hair.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition

Special warnings

When using KETOCONAZOLE ZYDUS 2 %, sachet-dose gel in patients who have received prolonged treatment with topical corticosteroids, it is recommended to gradually discontinue corticosteroid therapy over a period of 2 to 3 weeks in order to avoid any potential rebound effect.

Precautions for use

Avoid contact with the eyes. In case of accidental contact with the eye, rinse with water.

Excipient

This medicine contains sodium laurilsulfate (540 mg per sachet-dose) and may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.

Given the low systemic exposure to ketoconazole after application of Ketoconazole Zydus 2 %, sachet-dose gel, clinically significant drug interactions are unlikely.

Pregnancy

No effect of KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet during pregnancy is expected since maternal systemic exposure is negligible. KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet may therefore be used during pregnancy.

Breast-feeding

No effect of KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet in the breastfed newborn or infant is expected, since maternal systemic exposure is negligible. KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet may therefore be used during breastfeeding.

Fertility

Not applicable.

The tolerability of ketoconazole administered to the scalp and/or skin was evaluated in 2890 patients during 22 clinical trials. Based on the pooled tolerability data from these clinical trials, no adverse reaction with an incidence of ≥ 1% was reported.

The adverse reactions reported with Ketoconazole, 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: www.signalement-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: Antifungals for topical use – 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 Malassezzia furfur (Pityrosporum ovale).

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

Plasma concentrations of ketoconazole are not detectable after topical administration of KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet on the scalp.

Low but occasionally measurable plasma levels (from 11 to 33 ng/ml with an assay detection limit of 5 ng/ml) were observed in 3 out of 6 patients with a Pityriasis versicolor after topical administration of KETOCONAZOLE ZYDUS 2 %, gel in single-dose sachet over the whole body (estimated dose of 400 mg for 5 minutes).

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.

18 months.

Do not store above +25°C.

No special requirements.