Pevaryl 1% JANSSEN-CILAG Skin Powder 30g

Pevaryl 1% Skin Powder JANSSEN-CILAG - Medical Device

Pevaryl is an antifungal for the local treatment of all fungal infections, including mixed infections with Gram-positive bacteria.

Indications

Pevaryl non-alcoholic cutaneous solution has been specially developed for the treatment of Pityriasis Versicolor; the treatment of the entire body surface makes it possible to eliminate the fungus even where the skin is still apparently healthy.

Pevaryl is indicated in the therapy of:

• cutaneous mycoses caused by dermatophytes, yeasts or molds and infections caused by Gram-positive bacteria;
• mycosis of the ear canal (limited to the emulsion form) and of the nails;
• Pityriasis Versicolor.

Contraindications

PEVARYL is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.

Dosage

PEVARYL cutaneous powder should be used as a complementary therapy of PEVARYL cream and cutaneous spray alcoholic solution. In the case of intertrigo, the use of PEVARYL cutaneous powder may be sufficient.

Warnings

All pharmaceutical forms of PEVARYL are indicated for external use only. PEVARYL is not for ophthalmic or oral use. In case of sensitization or irritation reaction, discontinue use of the product. Econazole nitrate powder contains talc. Avoid inhalation to prevent irritation of the airways, especially in children and infants. The application of the spray forms must be done avoiding inhaling the product and making excessive and improper use of it. Important information about some of the ingredients PEVARYL contains butylated hydroxyanisole. It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. PEVARYL contains benzoic acid. Slightly irritating to the skin, eyes and mucous membranes. PEVARYL contains propylene glycol. It can cause skin irritation.

Interactions

Econazole is a known inhibitor of CYP3A4 and CYP2C9 cytochromes. Despite limited systemic availability after cutaneous application, clinically relevant interactions with other medicinal products may occur and some have been reported in patients receiving oral anticoagulants, such as warfarin and acenocoumarol. In patients receiving oral anticoagulants, caution should be exercised and the INR should be monitored more frequently. A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

Side effects

Data from clinical studies. The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 12 clinical studies involving 470 subjects, who received administration of at least one of the formulations. Based on the safety data collected from these clinical studies, the most commonly reported adverse drug reactions (ADRs) (incidence ≥ 1%), were (with incidence%): pruritus (1.3%), burning sensation of the skin (1.3%) and pain (1.1%). The ADRs reported with the use of PEVARYL dermatological formulations both in clinical studies, including the adverse reactions listed above, and in post-marketing experience are listed below. Frequencies are reported according to the following convention: Very common (≥1 / 10); Common (≥1 / 100, <1/10); Uncommon (≥1 / 1,000 to <1/100); Rare (≥1 / 10,000, <1 / 1,000); Very rare (<1 / 10,000), Not known (cannot be estimated from the available data). In the table below, which lists the adverse reactions of the dermatological formulations of Pevaryl, all ADRs with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence come from post-marketing data.

Table 1: Adverse Drug Reactions

The use of products for topical use, especially if prolonged, can give rise to sensitization phenomena. In case of hypersensitivity reactions it is necessary to interrupt the treatment and institute a suitable therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy

Pregnancy Animal studies have shown reproductive toxicity (see section 5.3). The risk in humans is unknown. (see section 5.3) In humans, after topical application to intact skin, the systemic absorption of econazole is poor (<10%). There are no adequate and controlled studies, nor epidemiological data, on the undesirable effects resulting from the use of PEVARYL in pregnancy. Due to systemic absorption, PEVARYL should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the patient's health.PEVARYL can be used during the second and third trimester of pregnancy if the potential benefit for the mother overcomes the possible risks to the fetus.

Lactation After oral administration of econazole nitrate to lactating rats, econazole and / or its metabolites were excreted in breast milk and detected in pups. It is not known whether dermal administration of PEVARYL can result in sufficient systemic absorption of econazole to produce detectable concentrations of the same in human breast milk. Caution should be used when PEVARYL is administered to breastfeeding women.

Fertility Results from animal reproduction studies did not show effects on fertility (see section 5.3).

Format

Jar of 30 g.