Ganazole - treatment of mycoses - 6 vaginal ovules 150 mg

Product Description

Ovules

Composition:

Vaginal cream - 100 g of cream contain: Active ingredient: Econazole nitrate 1.00 g. Excipients: METHYL P-HYDROXYBENZOATE, PROPYL P-HYDROXYBENZOATE For the full list of excipients, see section 6.1 Ovules - each ovule contains: Active ingredient: Econazole nitrate 150 mg. For the full list of excipients, see section 6.1 Vaginal solution - each 150 ml bottle contains: Active ingredient: Econazole 150 mg. Excipients: METHYL P-HYDROXYBENZOATE, PROPYL P-HYDROXYBENZOATE For the full list of excipients, see section 6.1

Excipients

Vaginal cream: Polyglycolic ester of saturated fatty acids - Propylene glycol - Methyl p-hydroxybenzoate - Propyl p-hydroxybenzoate - Deionized water. Ovules: Semi-synthetic triglycerides. Vaginal solution: Propylene glycol - Lactic acid - Methyl p-hydroxybenzoate - Propyl p-hydroxybenzoate - Trimethylcetylammonium p-toluenesulfonate - Lavender scent - Deionized water.

Therapeutic indications

Vaginal cream - Ovules: Vulvovaginal mycosis, Mycotic balanitis. Vaginal solution: adjuvant in the treatment of vulvovaginal conditions of fungal and/or bacterial origin sensitive to chemotherapy.

Contraindications

Hypersensitivity to the product components or to other chemically related substances.

Dosage

(Unless otherwise prescribed by your doctor) Vaginal cream: Insert an applicator filled with vaginal cream (5 cc) deeply into the vagina for 15 days every evening before going to bed, preferably in the supine position. Treatment must continue even after subjective complaints (itching, leukorrhea) have disappeared. Partner treatment: Apply the cream once a day for 15 consecutive days after washing the glans and foreskin with warm water. Pessaries: Insert one pessaries deeply into the vagina, preferably in the supine position, every evening before going to bed, for three consecutive days. In case of recurrence or if the control culture is positive one week after treatment, a second cycle of therapy should be repeated. Vaginal solution: administered using the single-dose package and disposable cannula. The recommended dosage is one douche per day for five days and then another five douches on alternate days. The dosage must, however, be adjusted by the doctor based on the severity of the clinical condition and adapted to its variations.

Warnings and precautions

The concomitant use of latex condoms or diaphragms with anti-infective preparations may reduce the effectiveness of rubber contraceptives. Therefore, products such as GANAZOLO should not be used concomitantly with diaphragms or latex condoms. Patients using spermicidal contraceptives should consult their doctor, as local vaginal treatments may inhibit the effectiveness of the spermicide. GANAZOLE should not be used concomitantly with other products for the internal or external treatment of the genitals. If marked irritation or sensitivity occurs, discontinue treatment. Sensitivity to econazole nitrate has also been reported in patients with sensitivity to imidazole. Do not use for ophthalmic or oral use. Vaginal solution: the product is a ready-to-use solution, and a vaginal irrigation cannula is available for each single-dose container. Before use, remove the closing stem from the cap and insert a cannula into the hole in the cap, applying light pressure. Vaginal irrigation must be performed delicately, both when inserting the cannula into the vagina and when applying pressure to the container to push the liquid into the vaginal canal. The container and cannula should be discarded after use.

Interactions

Econazole is a known inhibitor of cytochromes CYP3A4/2C9. Despite poor systemic availability after vaginal application, clinically significant interactions may occur and have been observed in patients taking anticoagulants, such as warfarin or acenocoumarol. Caution should be exercised in these patients and the INR should be monitored more frequently. During treatment with econazole and after its discontinuation, it may be necessary to adjust the dosage of the oral anticoagulant.

Side effects

The most frequent side effects reported in clinical studies were application site reactions, such as burning and stinging, itching, and erythema. Vaginal burning and irritation, pelvic cramps, skin rashes, and headaches have been reported with medications of this type in the early stages of treatment. In these cases, treatment should be discontinued and appropriate therapy initiated. Other possible adverse drug reactions, reported from post-marketing experience, with unknown frequency, may include the following: angioedema, rash, urticaria, and hypersensitivity.

Pregnancy and breastfeeding

Pregnancy: In animal studies, econazole nitrate has not shown teratogenic effects, but has been shown to be fetotoxic at high doses. The relevance of this effect in humans is unknown. Due to vaginal absorption, GANAZOLE should not be used during the first trimester of pregnancy unless the physician considers it necessary for the patient's health. GANAZOLE may cause serious side effects. It should be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus. Breastfeeding. After oral administration of econazole nitrate to lactating rats, econazole and/or its metabolites were excreted in milk and were detected in the pups. It is not known whether econazole nitrate is excreted in human milk. Use GANAZOLE with caution when administered to breastfeeding patients.