Pevaryl 150 mg - 6 antifungal vaginal ovules

Product Description

A single ovule contains: active ingredient: econazole nitrate 150 mg

Excipients

150 mg ovules: mixture of synthetic triglycerides, mixture of synthetic glycerides.

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

150 mg ovules: 1 ovule inserted deeply into the vagina, preferably in a supine position, every evening for three consecutive days. In case of recurrence or if the control culture is positive after one week from treatment, a second cycle of therapy must be repeated.

Warnings and precautions

Pevaryl Ovules are for intravaginal use only. 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 together with diaphragms or latex 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 must 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, clinically relevant interactions may occur, which have been reported in patients taking 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.