Pevaryl 1% JANSSEN-CILAG Gynecological Solution 60ml

Pevaryl 1% Gynecological Solution - Medical Device

Pearyl solution what it is for

Composition of Pevaryl

Excipients Contents

Contraindications with the use of Pevaryl

How is Pevaryl used

Warnings and precautions with the use of Pevaryl

Pevaryl Interactions

Side effects for Pevaryl

Pevaryl in Pregnancy and breastfeeding

Pevaryl format

Pearyl solution what it is for

Peravyl 1% is a cutaneous solution for external genitalia

Vulvovaginal mycoses Fungal balanitis.

Composition of Pevaryl

Pevaryl 1% cutaneous solution for external genitalia 100 ml cutaneous solution for external genitalia contain: active substance: econazole 1.033 g For the full list of excipients, see section 6.1.

Excipients Contents

Polysorbate 20; benzyl alcohol; sorbitan monolaurate; N- [2-hydroxyethyl] -N- [2- (laurylamino) -ethyl] -aminoacetic acid sodium salt of 3,6,9-trioxadocosyl sulfate; macrogol 6000 distearate; lactic acid; perfume 4074; purified water.

Contraindications with the use of Pevaryl

Pevaryl is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.

How is Pevaryl used

The recommended dosage is as follows:

It is recommended to cleanse the external genitals with 10 cc (1 dose) of solution dissolved in hot water. The treatment can be done once or twice a day. Partner Treatment: Both vaginal cream and cutaneous solution for external genitalia can be used. The cream is applied once a day for 15 days after washing the glans and foreskin with warm water. The solution is used dissolved in hot water. Do not rinse. Children (2-16 years) Safety and efficacy in children have not been established. Elderly There are insufficient data on the use of PEVARYL in elderly patients over 65 years of age.

Warnings and precautions with the use of Pevaryl

Pevaryl Vaginal Cream and Pessaries are for intravaginal use only. Pevaryl is not for ophthalmic or oral use. The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may decrease the effectiveness of the latex contraceptive. Therefore, products such as PEVARYL should not be used in conjunction with latex diaphragms or condoms. Patients using spermicides should consult their doctor as any local vaginal treatment can render the spermicide inactive. PEVARYL must not be used together with other products for internal or external treatment of the genitals. Should marked irritation or sensitization occur, treatment should be discontinued. Patients sensitive to imidazoles may be sensitive to econazole nitrate.

Pevaryl Interactions

Econazole is a known inhibitor of CYP3A4 and CYP2C9 cytochromes. Despite the limited systemic availability of the product after vaginal application (see section 5.2 Pharmacokinetic properties), clinically relevant interactions may occur which have been reported in patients receiving oral anticoagulants. In patients taking oral anticoagulants such as warfarin or acenocoumarol, caution should be used and the anticoagulant effect should be monitored. A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

Side effects for Pevaryl

The safety of the gynecological formulations of Pevaryl was evaluated in 3630 patients in 32 clinical studies. Based on the safety data collected from these clinical trials, the most commonly reported Adverse Drug Reactions (ADRs) (incidence> 1%) were (with% incidence): pruritus (1.2%) and burning sensation of the skin (1.2%) The table below shows the ADRs of the gynecological formulations of PEVARYL, deriving from both clinical studies and post-marketing experience, including the adverse reactions already mentioned above. Frequencies are reported according to the following convention: Very common (1/10); Common (1/100, <1/10); Uncommon (1 / 1,000, <1/100); Rare (1 / 10,000, <1 / 1,000); Very rare (<1 / 10,000), Not known (cannot be estimated from the available data).

Table 1: Adverse Drug Reactions

Cases of local allergic reactions have also been reported. With the skin solution, in particular, local sensitization phenomena may occur. 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.

Pevaryl in Pregnancy and breastfeeding

Use in Pregnancy Econazole nitrate has not shown teratogenic effects in animal studies but has been shown to be foetotoxic at high doses (see section 5.3. Preclinical safety data). The importance of this effect in humans is unknown. Due to vaginal absorption, PEVARYL should not be used in 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 trimesters if the potential benefits outweigh the possible risks to the fetus. Use in Lactation After oral administration of econazole nitrate to lactating rats, econazole and its metabolites were excreted in milk and found in pups. It is not known whether econazole nitrate is excreted in human milk. Use PEVARYL with caution in breastfeeding patients.

Pevaryl format

Peravyl 1% is sold in packaging with 60 ml bottle.

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