Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Insert one pessary high into the vagina at night prior to retiring.

Child Dosage

Gyno-Pevaryl 1 pessary is not indicated for use in children under the age of 16 years.

Elderly Dosage

No specific dosage recommendations or precautions apply

Contra Indications

Hypersensitivity to any imidazole preparation, other vaginal antifungal products, or to any ingredients of Gyno-Pevaryl 150mg vaginal pessaries.

Special Precautions

This preparation is not for oral use.

Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued.

Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.

Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.

Gyno-Pevaryl 150mg vaginal pessaries should not be used in conjunction with other internal or external treatment of the genitalia.

Interactions

Although not studied, based on the chemical similarity of econazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists. Due to the limited systemic availability after vaginal application, clinically relevant interactions are unlikely to occur. In patients on oral anticoagulants, such as warfarin and acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.

Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole

Adverse Reactions

The most frequently reported adverse events in clinical trials were application site reactions, such as burning and stinging sensations, pruritus, and erythema.

Including the above mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of Gynaecological Formulation from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:

Very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data). All ADRs with a known incidence (common or uncommon) are from clinical trial data and all ADRs with an unknown incidence are from post-marketing data.

Adverse Drug Reactions

Manufacturer

Drug Availability

Updated