Zidoval 0.75% Meda Vaginal Gel 40g 5 Disposable Applicators

Zidoval 0.75% Meda Vaginal Gel

It is indicated for the treatment of bacterial vaginosis.

Contraindications / Side Effects

It is contraindicated in patients with a history of hypersensitivity to metronidazole, other nitroimidazoles, parabens or any other component of the gel.

Dosage

Vaginal administration. Adults: one application of the product (5 g) in the vagina once a day, before going to bed, for 5 consecutive days. Instructions for use: pierce the sealed end of the tube and screw the open end of the applicator tight. Squeeze the tube filling the applicator with gel. Remove the applicator from the tube and gently insert its full length into the vagina. Push the plunger to release the gel. Discard the applicator according to the instructions provided. Elderly patients: bacterial vaginosis is not frequent in elderly patients and consequently no clinical evaluation has been made in patients belonging to this age group. Girls: in girls and adolescents under 18 years of age the use of the product is not recommended as the safety and efficacy have not been established.

Warnings

Use during the menstrual period is not recommended. Known or previously undiagnosed candidiasis may manifest an accentuation of symptoms and require therapy with a specific agent during drug therapy. Metronidazole is a nitroimidazole and should be used with caution in patients with a history of blood dyscrasias. As with all vaginal infections, sexual intercourse should be avoided during infection and during treatment with the product.

Interactions

Oral metronidazole exhibits a similar reaction to disulfiram when combined with alcohol. Acute psychotic reactions and states of confusion have occurred during concomitant use of metronidazole and disulfiram. The possibility of similar reactions, at the low serum concentrations reached with the use of the drug, is unlikely, but cannot be excluded. Oral metronidazole has been found to increase the plasma concentrations of warfarin, lithium, cyclosporine and 5-fluorouracil. Given the low plasma concentrations achieved after vaginal administration, similar effects are not expected but cannot be completely excluded. Metronidazole can interfere with the determination of some blood chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and glucose hexokinase. Values close to zero can be observed.

Side effects

In controlled clinical studies, conducted on 759 patients, the most commonly reported adverse events were those affecting the urogenital tract (26%) and the gastrointestinal tract (14%). Common (> 1/100, <1/10): nervous system: headache, dizziness; gastrointestinal system: gastrointestinal disorders, abdominal cramps, nausea and / or vomiting, altered sense of taste and perception of flavors, decreased appetite; urogenital system: vaginal candidiasis, itching / irritation / burning / vaginal sensation loss, pelvic discomfort, vaginal discharge. Uncommon (> 1/1000, <1/100): psychiatric: depression, fatigue, irritability, sleep disturbances; nervous system: paraesthesia; gastrointestinal tract: diarrhea, constipation, bloating / aerophagia, flatulence, thirst / dry mouth, sensation of metallic taste; skin: itching; urinary system: symptoms of urinary tract infection, dark-colored urine; urogenital system: vulvar swelling, menstrual disturbances / irregularities, vaginal discharge / bleeding, medication leakage; general: cramps.

Pregnancy and breastfeeding

Pregnancy: data concerning the treatment of a large number of patients (several hundreds) during pregnancy have shown the absence of side effects of metronidazole on the fetus and the newborn; however, no specific studies have been performed with the product on pregnant women. Therefore, caution should be exercised when prescribing to pregnant women. Lactation: the ratio between the plasma concentrations of the product and those of oral metronidazole is about 0.02. Metronidazole is excreted in breast milk at concentrations similar to those in plasma and the ratio of plasma concentrations of metronidazole in the nursing infant to the mother is approximately 0.15. Caution should be exercised when prescribing the product to breastfeeding women.

Format

40g tube with 5 disposable applicators