Properties
What is it?
Composition Vaginal suppositories contain: Active substance: Metronidazole 750mg, Miconazole nitrate 200mg. Excipients: Hard fat (Witepsol S55). Pharmacotherapeutic group Anti-infective and antiseptic agents for gynecological use, imidazole derivatives. Pharmacological properties Pharmacodynamics Limenda - a combined antimicrobial preparation, whose action is due to the content of metronidazole and miconazole. Metronidazole is an antimicrobial and antiprotozoal agent effective against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococci and Trichomonas vaginalis. Miconazole nitrate has a broad spectrum of action and is particularly effective against pathogenic fungi, including Candida albicans; in addition, miconazole nitrate is effective against Gram-positive bacteria. Pharmacokinetics The bioavailability of metronidazole with intravaginal use is 20% compared to oral administration. After vaginal administration, at steady state, the plasma concentration of metronidazole was 1.6 – 7.2 mcg/ml. When miconazole nitrate is administered in this way, systemic absorption is very low (approximately 1.4% of the dose), and miconazole nitrate was not detected in plasma. Metronidazole is metabolized in the liver. Its hydroxyl metabolite is active. The half-life of metronidazole is 6-11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys. Indications for use - Vaginal candidiasis - Bacterial vaginosis; - Trichomonal vaginitis; - Vaginitis caused by mixed infections. Dosage and administration 1 suppository of the preparation is inserted intravaginally, at night, for 7 days. For recurrent vaginitis or vaginitis resistant to other treatments, Limenda should be used for 14 days. Vaginal suppositories should be inserted deep into the vagina using the disposable finger cots provided in the packaging. Elderly patients over 65 years of age do not require dose adjustment. Contraindications - Hypersensitivity to the components of the preparation or other imidazole derivatives; - Severe liver dysfunction; - Epilepsy; - Porphyria; - First trimester of pregnancy. Adverse reactions Rarely, hypersensitivity reactions (skin rash) and adverse reactions such as increased fatigue, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, metallic taste, vaginal itching, vaginal burning, and irritation may occur. During vaginitis, due to inflammation of the vaginal mucosa, vaginal irritation (burning, itching) may intensify after the first suppository or on the third day of treatment. Such complications quickly disappear with continued treatment. In case of severe irritation, treatment should be discontinued. Special instructions For intravaginal use only. The preparation is not recommended for use in virgins. Alcohol consumption must be avoided during treatment, as well as for at least 24-48 hours after the end of the course of treatment, due to possible disulfiram-like reactions. When using gynecological preparations containing miconazole, the effectiveness of latex contraceptives (condoms or diaphragms) may be reduced. Therefore, Limenda and latex condoms or latex diaphragms should not be used simultaneously. There are reports of serious hypersensitivity reactions, including anaphylaxis and angioedema, during treatment with miconazole. Treatment should be discontinued if adverse reactions indicating hypersensitivity or mucosal irritation develop. In patients with trichomonal vaginitis, simultaneous treatment of the sexual partner is necessary. Effects on ability to drive and use machines Caution should be exercised when driving or operating potentially dangerous machinery due to possible adverse reactions. Use during pregnancy and lactation Pregnancy The preparation may be used after the first trimester of pregnancy under medical supervision, provided that the expected benefit to the mother outweighs the potential risk to the fetus. Lactation Breastfeeding should be discontinued during treatment, as metronidazole passes into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment. Fertility There is no evidence of negative effects on fertility with the separate use of metronidazole and miconazole. Use in pediatrics There is no data on the safety and efficacy of the preparation in children and adolescents under 18 years of age. Interactions with other medicinal products Due to the absorption of metronidazole, the following medicinal interactions may occur when used with the drugs listed below: Alcohol: Alcohol intolerance (risk of disulfiram-like reactions). Amiodarone: Increased risk of cardiotoxicity (QT interval prolongation, Torsades de Pointes, cardiac arrest). Astemizole and terfenadine: Inhibition of metabolism of these compounds and increased plasma concentrations may occur. Carbamazepine: Risk of increased plasma concentration of carbamazepine. Cimetidine: Risk of increased plasma concentration of metronidazole, resulting in an increased risk of adverse reactions affecting the central nervous system. Cyclosporine: Increased risk of toxic effects of cyclosporine may occur. Disulfiram: Central nervous system disturbances (e.g., psychotic reactions) may occur. Lithium: Increased risk of lithium toxicity. Phenytoin: Increased plasma concentration of phenytoin and decreased concentration of metronidazole may occur. Phenobarbital: Decreased concentration of metronidazole may occur. Fluorouracil: Risk of increased plasma concentration of fluorouracil and its toxic effects. Oral anticoagulants: Potentiation of anticoagulant effect may occur (high risk of bleeding). May affect levels of liver enzymes, glucose (when determined by the hexokinase method), theophylline, and procainamide in the blood. Due to the absorption of miconazole nitrate, the following interactions may occur: Acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin: Increased risk of bleeding may occur. Astemizole, cisapride, terfenadine: Inhibition of metabolism of these drugs and increased plasma concentrations may occur. Carbamazepine: Reduced clearance of carbamazepine may occur. Cyclosporine: Increased risk of toxic effects (renal dysfunction, cholestasis, paresthesias). Fentanyl: Prolonged effect of opioid drugs may occur (central nervous system and respiratory depression). Phenytoin and fosphenytoin: Risk of toxic effects (ataxia, hyperreflexia, nystagmus, tremor). Glimepiride: Potentiation of hypoglycemic effect may occur. Oxybutynin: Reduced clearance of oxybutynin may occur, leading to increased plasma concentration. Oxycodone: Increased risk of plasma concentration of oxycodone and reduced clearance. Pimozide: Cardiotoxic effects may occur (QT interval prolongation, Torsades de Pointes, cardiac arrest). Tolterodine: Increased bioavailability may occur in patients with reduced activity of cytochrome P450 isoenzyme 2D6. Trimetrexate: Increased risk of toxic effects (bone marrow suppression, impaired renal and liver function, gastrointestinal ulceration). Overdose Data on overdose with vaginal use of metronidazole are not available. After vaginal administration, a sufficient amount of metronidazole may be absorbed to cause systemic effects. Symptoms: Nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, motor disorders (ataxia), dizziness, paresthesias, convulsions, peripheral neuropathy (including after prolonged use at high doses), leukopenia, darkening of urine. Treatment: In case of accidental oral intake, gastric lavage may be performed if necessary. There is no specific antidote. Symptomatic and supportive therapy is recommended. Dosage form Vaginal suppositories. 7 suppositories in a strip. 1 or 2 strips together with finger cots (7 or 14 pieces respectively) and a leaflet in a cardboard box. Storage conditions Store in a protected place from light at a temperature not exceeding 25°C. Keep out of reach of children! Shelf life 3 years from the date of manufacture. Do not use after the expiry date. Dispensing category: Pharmaceutical product group II, dispensed by prescription form N3.