Pevaryl 50 mg - antifungal 15 vaginal ovules

Product Description

Composition

PEVARYL 1% vaginal cream 100 g of vaginal cream contain: active ingredient: econazole nitrate 1g PEVARYL 50 mg ovules 1 ovule contains: active ingredient: econazole nitrate 50 mg PEVARYL 150 mg ovules 1 ovule contains: active ingredient: econazole nitrate 150 mg PEVARYL 150 mg prolonged-release ovules 1 prolonged-release ovule contains: active ingredient: micronized econazole nitrate 150 mg PEVARYL 1% cutaneous solution for external genitalia 100 ml of cutaneous solution for external genitalia contain: active ingredient: econazole 1.033 g For the full list of excipients, see section 6.1.

Excipients

Vaginal cream: mixture of esters Stearic acid with glycols, mixture of fatty acids with macrogol, vaseline oil, butylhydroxyanisole, benzoic acid, purified water. 50 mg ovules: mixture of synthetic triglycerides, mixture of synthetic glycerides. 150 mg ovules: mixture of synthetic triglycerides, mixture of synthetic glycerides. 150 mg prolonged-release ovules: galactomannan polysaccharide, colloidal silica, mixture of triglycerides of saturated fatty acids, mixture of synthetic triglycerides, stearyl heptanoate. Cutaneous solution for external genitalia: 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 n.4074, purified water.

Therapeutic indications

Vulvovaginal mycosis, Mycotic balanitis

Contraindications

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

Dosage

Women Vaginal cream: 1 applicator (5 cc) filled with vaginal cream inserted into the vagina for 15 days every evening before going to bed. Treatment must be continued even after subjective complaints (itching, leukorrhea) have disappeared. 50 mg ovules: One ovule inserted deeply into the vagina, preferably in the supine position, every evening for 15 days. Treatment must be continued even after subjective complaints (itching, leukorrhea) have disappeared. 150 mg ovules: One ovule inserted deeply into the vagina, preferably in the supine position, every evening for three consecutive days. In case of recurrence or if the control culture is positive one week after treatment, a second cycle of therapy must be repeated. 150 mg prolonged-release ovules: The therapy involves a one-day treatment and consists of deeply inserting one ovule into the vagina, preferably in the supine position, in the morning and in the evening. Cutaneous solution for external genitalia: This pharmaceutical form is a suitable complement to therapy with ovules or vaginal cream. Cleanse the external genitals with 10 cc (1 dose) of solution dissolved in warm water. The treatment can be performed once or twice a day. Treatment of the partner: both the vaginal cream and the cutaneous solution for external genitals 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 warm 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

Pevaryl Vaginal Cream and Ovules 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 cause allergic reactions. decrease the effectiveness of latex contraceptives. Therefore, products such as PEVARYL should not be used together with latex diaphragms or condoms. Patients using spermicides should consult their doctor as any local vaginal treatment may inactivate the spermicide. PEVARYL should not be used together with other products for the internal or external treatment of the genitals. If marked irritation or sensitization occurs, treatment should be discontinued. Patients sensitive to imidazoles may be sensitive to econazole nitrate.

Interactions

Econazole is a known inhibitor of cytochromes CYP3A4 and CYP2C9. 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. Caution should be exercised in patients taking oral anticoagulants such as warfarin or acenocoumarol, and the anticoagulant effect should be monitored. Dosage adjustment of the oral anticoagulant may be necessary during treatment with econazole and after its discontinuation.

Undesirable effects

The safety of Pevaryl gynecological formulations has been evaluated in 3630 patients in 32 clinical studies. Based on the safety data collected from these clinical studies, the most commonly reported adverse drug reactions (ADRs) (incidence > 1%) were (with an incidence of 1%): pruritus (1.2%) and burning sensation of the skin (1.2%). The table below lists the ADRs of PEVARYL gynecological formulations, derived from both clinical studies and post-marketing experience, including the adverse reactions already reported 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).