Name:
Rumizol supp.vag.500mg/100mg cont cell pack No. 7×2
Description:
Suppositories are torpedo-shaped, yellowish-white in color. Color heterogeneity in the form of marbling and the presence of a funnel-shaped depression are allowed. The main active ingredient Metronidazole + miconazole Release form Vaginal suppositories Dosage 500 mg / 100 mg Indications for use Local treatment: vaginal candidiasis; trichomonas vulvovaginitis; bacterial vaginosis; mixed vaginal infection. Dosage and administration The suppository should be removed from the shell and inserted deep into the vagina. Rumizol® is prescribed 1 vaginal suppository at night and 1 vaginal suppository in the morning for 7 days. With recurrent vaginitis or vaginitis resistant to previous therapy, the course of treatment should be increased to 14 days. In the treatment of trichomonas infection, metronidazole is administered orally at the same time. Elderly patients (over 65 years): Same recommendations as for younger adult patients. Children: not recommended for children. 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. Do not take orally or otherwise other than intravaginally! Application during pregnancy and lactation After the first trimester of pregnancy, Rumizol® suppositories can be used in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. During treatment with Rumizol® suppositories, breastfeeding should be discontinued, since metronidazole is excreted in breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment. Precautions Caution should be given to persons with hepatic and renal insufficiency, diseases of the nervous system, hematopoietic disorders. During treatment, it is possible to change the results in the determination of liver enzymes, glucose (hexokinase method), theophylline and procainamide. During treatment, it is recommended to refrain from sexual activity. With the simultaneous use of Rumizol® and a contraceptive diaphragm or condom, the suppository base may interact with rubber. In order to avoid re-infection, simultaneous treatment of the sexual partner is necessary. In the treatment of trichomonas vaginitis, the simultaneous use of metronidazole preparations for systemic use is recommended. In parallel, it is necessary to treat the sexual partner with trichomonacid agents for systemic use. During treatment and at least within 72 hours after the end of the course, it is forbidden to drink alcohol (disulfiram-like reactions occur). With severe irritation of the vagina, treatment should be discontinued. Features of use in patients with impaired liver and kidney function Renal failure: 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. Features of use in elderly patients Due to age-related changes in the pharmacokinetics of metronidazole in elderly patients, dose adjustment of the drug may be required, especially when used simultaneously with systemic action of metronidazole. Use in children It is not recommended to use the drug in virgins, in children under the age of 18 years. The effect of the drug on psychomotor reactions Systemic use of metronidazole may affect the ability to drive vehicles and work with complex mechanisms. In contrast to systemic use, with topical use of metronidazole, the drug is absorbed from the vagina in small concentrations. Patients should be warned about the possibility of developing dizziness, ataxia, fatigue and weakness. If these symptoms appear, you should refrain from driving a car and working with complex mechanisms. Interactions with other drugs As a result of the absorption of metronidazole and miconazole nitrate, interactions with the drugs listed below may occur: Alcohol: the interaction of metronidazole with alcohol causes disulfiram-like reactions. Glimepiride: increased hypoglycemic effect. Oral anticoagulants: the effect of indirect anticoagulants is enhanced, which increases the risk of bleeding. Phenytoin and fosphenytoin: the level of phenytoin in the blood increases, the risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor) increases, the level of metronidazole in the blood decreases. Phenobarbital: reduces the level of metronidazole in the blood. Fentanyl: Increased long-term opioid effects (CNS depression, respiratory depression). Carbamazepine: Decreased metabolism of carbamazepine. Disulfiram: there may be changes in the central nervous system (mental reactions). Cimetidine: blood levels of metronidazole may increase and therefore increase the risk of neurological side effects. Cyclosporine: increased risk of cyclosporine toxicity (renal dysfunction, cholestasis, paresthesia). Oxybutynin: increased plasma concentration (exposure) of oxybutynin (dry mouth, constipation, headache). Contraindications hypersensitivity to the components of the drug and its derivatives; I trimester of pregnancy; lactation (breastfeeding); children’s age up to 18 years; virginity; epilepsy; porphyria; severe liver dysfunction. Use in patients who drink alcohol during treatment or plan to use it within 3 days after the end of treatment: the interaction of metronidazole with alcohol causes disulfiram-like reactions. Use in patients taking disulfiram during treatment or planning to use it within 2 weeks after the end of treatment: there may be changes in the central nervous system (mental reactions). Composition Composition per suppository active substances: metronidazole – 500 mg, miconazole nitrate – 100 mg; excipients: macrogol cetostearyl ether, solid fat. Overdose There are no data on overdose in humans with intravaginal use of metronidazole. After intravaginal administration, metronidazole may be absorbed in sufficient amounts to cause systemic effects. In case of accidental ingestion of large doses of the substance, if necessary, gastric lavage can be performed. Treatment can be given to persons who have taken 12 g of metronidazole orally. There is no specific antidote. Symptomatic and supportive therapy is recommended. Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, leukopenia, dark urine color. Symptoms of an overdose of miconazole nitrate: nausea, vomiting, inflammation of the throat and mouth, loss of appetite, headache, diarrhea. Side effects Side effects caused by the systemic use of metronidazole include hypersensitivity reactions (rarely); leukopenia; ataxia; psychoemotional disorders; peripheral neuropathy in overdose and prolonged use; convulsions; diarrhea; dizziness (rare); headache; loss of appetite; nausea; vomit; pain or cramps in the abdomen; change in taste sensations (rare); constipation; dry mouth, metallic taste; increased fatigue. These side effects are observed very rarely, due to the low concentration of metronidazole in the blood during the intravaginal use of Rumizol® suppositories. Miconazole nitrate is not absorbed after the introduction of Rumizol® suppositories into the vagina. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children! Buy Rumizol vaginal suppositories 500mg/100mg No. 7×2 Price for Rumizol vaginal suppositories 500mg/100mg No. 7×2
INN | METRONIDAZOL+MICONAZOL |
---|---|
The code | 49 793 |
Barcode | 4 810 243 001 926 |
Dosage | 500mg/100mg |
Active substance | metronidazole, miconazole |
Manufacturer | Rubicon LLC, Belarus |
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