Gynocaps vaginal capsules 100mg/100mg №5×2

Name:
Gynocaps caps.vag.100mg/100mg
Description:
Capsules are soft gelatinous ovoid-shaped capsules with a pointed end, with a seam, elastic, opaque, light brown in color. The main active substance Metronidazole + miconazole Release formSoft gelatin capsules, 5 capsules in a blister pack, 2 or 3 blister packs together with a leaflet in a pack. Dosage 100 mg. Indications for use Ginocaps is used for local treatment of infectious diseases of the vagina caused by Trichomonas and/or Candida: – bacterial vaginosis; – trichomoniasis; – candidal vaginitis. Dosage and administration Ginocaps is used intravaginally and injected deep into the vagina. With trichomoniasis, 1 vaginal capsule is prescribed 1 time / day in the evening before bedtime for 10 days in combination with metronidazole intake. In case of bacterial vaginosis, 1 vaginal capsule is prescribed 1-2 times / day for 10 days, if necessary, in combination with taking metronidazole orally. With vulvovaginal candidiasis, 1 vaginal capsule is injected deep into the vagina 1 time per day for 10 days. Patients with renal / hepatic insufficiency: Renal insufficiency: the half-life of metronidazole does not change. Dose reduction is not required. However, in severe cases requiring hemodialysis, dose adjustment is necessary. In cases of severe hepatic insufficiency, the clearance of metronidazole may be impaired. At high levels of metronidazole in blood plasma, an increase in the symptoms of encephalopathy can be observed, so metronidazole should be used with caution in patients with hepatic encephalopathy. The daily dose in patients with hepatic encephalopathy should be reduced to 1/3. For the treatment of trichomonas vaginitis, it is advisable to combine vaginal Ginocaps capsules with oral forms of metronidazole or other systemic trichomonacid preparations. At the same time, it is necessary to treat the sexual partner with metronidazole tablets or other systemic trichomonacid drugs. Children: not recommended for children. During therapy, other vaginal agents (tampons, syringe, spermicidal agents) should not be used. It is possible to change the results when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood. High doses and long-term systemic use of metronidazole can cause peripheral neuropathy and epilepsy. Do not swallow or otherwise apply! Use during pregnancy and lactation In the first trimester of pregnancy, the use of the drug is contraindicated. Metronidazole crosses the hematoplacental barrier. Tests were carried out on rats, in which it was determined that when a five-fold dose was administered to rats, there was no negative effect of the drug on either the fertility of adult rats or on the fetus. When the usual dose recommended for human treatment was administered intraperitoneally to pregnant mice, an increase in fetotoxicity was noted, but when the same dose was administered orally, no abnormalities were found. Despite this, studies on pregnant women have not been conducted. A meta-analysis of studies was conducted with the introduction of metronidazole in the first three months of pregnancy and it was concluded that there was no increase in the negative effect on the fetus. Despite this, metronidazole should only be used during pregnancy after a careful assessment of the expected benefits and disadvantages of the drug. Breast-feeding: Oral metronidazole is found in human milk at a concentration equal to its plasma concentration. It can give milk a bitter taste. In order to avoid the negative effect of the drug on the child, it is necessary to stop either breastfeeding for the duration of treatment and after stopping the course for another 1-2 days, or the use of the drug, depending on how important the course of therapy is for the mother. Precautions During treatment with the drug and for at least one day after treatment, the use of alcohol is prohibited (disulfiram-like reactions may develop: spastic abdominal pain, nausea, vomiting, headache, sudden flushing of the face) and abstinence from sexual intercourse is recommended. In the treatment of trichomoniasis, it is advisable to simultaneously treat the sexual partner with metronidazole tablets for oral administration. It is advisable to prescribe vaginal capsules in combination with oral forms of metronidazole. In the case of the use of the drug in conjunction with metronidazole for oral administration, especially with a repeated course, it is necessary to control the picture of peripheral blood (danger of leukopenia). With caution: pregnancy (II-III trimesters), history of leukopenia. Interaction with other drugs Contraindications – severe liver dysfunction; – epilepsy; – I trimester of pregnancy, lactation period; – Hypersensitivity to the components of the drug; – porphyria; – in patients who drink alcohol during treatment or within 3 days after the end of treatment; – in patients taking disulfiram during treatment or planning to use it within 2 weeks after the end of treatment. Composition One capsule contains: metronidazole – 100.0 mg, miconazole nitrate – 100.0 mg. Excipients: lecithin (Solek B-10, soybean liquid), purified water, yellow beeswax, sunflower oil. The composition of the shell of the gelatin capsule: gelatin, glycerin, methyl parahydroxybenzoate E-218, propyl parahydroxybenzoate E-216, purified water, titanium dioxide E-171, sunset yellow dye E-110. Overdose There are no data on overdose with intravaginal use of metronidazole. After intravaginal administration, metronidazole may be absorbed in sufficient amounts to cause systemic effects. Symptoms: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, parestension, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, dark urine. Treatment: in case of accidental ingestion, if necessary, gastric lavage can be performed. There is no specific antidote. Symptomatic and supportive therapy is recommended. Side effects Local: rarely – irritation of the vaginal mucosa and hypersensitivity reactions. Systemic effects may develop: From the gastrointestinal tract: nausea, vomiting, loss of appetite, cramping pain in the lower abdomen, diarrhea, tongue fur, bitter, metallic taste in the mouth. From the hematopoietic system: reversible neutropenia (leukopenia). From the side of the central nervous system: peripheral neuropathy (feeling of numbness of the extremities), rarely and only with prolonged use, headaches, convulsions, drowsiness, dizziness, impaired coordination, ataxia, confusion occur. Allergic reactions: skin rash, urticaria, skin itching, erythema multiforme exudative, angioedema and anaphylactic reaction were very rare. The effect of the drug on the liver: rarely reported increased activity of liver enzymes, cholestasis, jaundice. Others: fever, dark urine (causes a metabolite of metronidazole, has no clinical significance). In the event of side effects, treatment with Ginocaps should be discontinued. Storage conditions Store in a place protected from moisture and light at a temperature of 15 ° C to 25 ° C. Store in a place inaccessible to children. Buy Gynocaps vaginal capsules 100mg/100mg №5×2