ZIDOVAL * VAG GEL 40G 0.75%+ 5APP
Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.
Dosage and method of use
Vaginal administration. Adults: One application of Zidoval vaginal gel (5 g) in the vagina once a day, before going to bed, for 5 consecutive days. Instructions for Use: puncture 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 common in elderly patients and consequently a clinical evaluation has not been made in patients in this age group. Little 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.
Zidoval vaginal gel is contraindicated in patients with a history of hypersensitivity to metronidazole, other nitroimidazoles, parabens or any other component of the gel.
In controlled clinical studies involving 759 patients, the most commonly reported adverse events were those affecting the urogenital system (26%) and the gastrointestinal tract (14%).
| Municipalities (> 1/100, || 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, || Psychiatric: depression, fatigue, irritability, sleep disturbances. Nervous system: paraesthesia. Gastrointestinal system: diarrhea, constipation, meteorism / 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 disorders / irregularities, vaginal discharge / bleeding, dressing leaking. General: cramps. |
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 therapy with Zidoval vaginal gel. 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 Zidoval vaginal gel.
Pregnancy and breastfeeding
Pregnancy: Data concerning the treatment of a large number of patients (several hundred) 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 Zidoval vaginal gel in pregnant women. Therefore, caution should be exercised when prescribing to pregnant women. Feeding time: The ratio of plasma concentrations of vaginal Zidoval gel to those of oral metronidazole is approximately 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 Zidoval vaginal gel to breastfeeding women.
Expiration and retention
Store at a temperature not exceeding 25 ° C.
Interactions with other drugs
Oral metronidazole exhibits a similar reaction to that of disulfiram when combined with alcohol. Acute psychotic reactions and states of confusion have occurred during concomitant use of metronidazole and disulfiram. The possibility of such reactions at the low serum concentrations achieved with the use of Zidoval vaginal gel is unlikely, but cannot be excluded. Oral metronidazole has been found to increase 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.
There are no reported cases of overdose in humans with Zidoval vaginal gel and there is no specific treatment. Metronidazole is readily removed from plasma by hemodialysis.
Metronidazole 0.75 % w / w, 7.5 mg / g For excipients see section 6.1.
Carbomer (Carbopol) 974P, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, purified water.