CREMA 30G 2G/100G

SERTADERM 2 G/100 G CREMA

active ingredients

100 grams of cream contain: Active ingredient: Sertaconazole nitrate 2 g

Excellent

Polyethyleneglycol palmilo stearati (Tefose 63), lauropalmitostearic polyxyethylene glycerides (Labrafil M–2130–CS), moron glycerol–di–isostearate, vaseline oil, p–hydroxybenzoate methyl, sorbic acid, purified water.

Therapeutic indications

Topical treatment of skin mycosis such as dermatofitosis, Tinea pedis, Tinea capitis, Tinea cruris, Tinea corporis, Tinea barbae and Tinea manus; Candidiasis (Moniliasi) and Pityriasis versicolor (Malassezia furfur, Pityrosporum orbiculare).

Contraindications

Hypersensitivity to the active ingredient or any excipient

Population

Recommended average dose: the cream must be applied slightly and evenly one or twice a day on the affected areas, covering even 1 cm of healthy surrounding skin. The amount to be applied is variable and in relation to the extension of the sick zone. The duration of treatment to obtain healing varies from one patient to another, depending on the etiological agent and the location of the infection. In general, 4 weeks of treatment are recommended to ensure complete healing, although in many cases clinical–microbiological healing is already carried out between the second and fourth week.

Conservation

Store at a temperature not exceeding 25°C in the closed container.

Warnings

There are currently no studies on the use of the drug in pediatrics. Keep out of reach of children.

Interactions

No interactions with other substances have been reported.

Effects

An excellent tolerance in the local application has been observed and no toxic or photosensitizing effect has been reported. During the first days of treatment there was no evidence of any local and transitory erythematose reaction, so as to stop treatment. As with all imidazolics, after prolonged use, episodes of local irritation may occur (such as burning and itching), especially in skin areas with eczematous characteristics. The use of products for topical administration, especially if protracted, can give rise to awareness phenomena. In case of hypersensitivity reactions, it is necessary to stop treatment and establish suitable therapy.

Overdosing

The concentration of the active ingredient and the way of administration are such as to make intoxication impossible, however, in case of accidental ingestion the appropriate symptomatic treatment will proceed.

After topical application of large quantities of the drug has never been found trace at plasma level; in spite of this it is not yet demonstrated the perfect harmlessness in pregnant women, therefore the risk/benefit ratio must be assessed before applying the product in pregnancy and nursing.

Source: Farmadati