Neo-Penotran Forte l supp Wag N7
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Active ingredients
Metronidazole + Miconazole
Release form
Suppositories
Composition
In 1 suppositories: Metronidazole (metronidazole) 750 mg; miconazole 200 mg; lidocaine (lidocaine) 100 mg. In the presence of adjuvants: Witepsol S55 1436.75 mg.
Pharmacological effect
Suppositories Neo-Penotran Forte-L contain miconazole, which has antifungal effects, metronidazole, which has antibacterial and antitrihomonadnoe effects, as well as lidocaine, which gives a local anesthetic effect. Miconazole, which is a synthetic imidazole derivative, has antifungal activity and has a wide range of antifungal activity and a wide range of antifungal activity. Especially effective against pathogenic fungi, including Candidaalbicans. In addition, miconazole is effective against gram-positive bacteria. The action of miconazole is the synthesis of ergosterol in the cytoplasmic membrane. It alters the permeability of miconazole mycotic Candidaspeciesi cells inhibits glucose uptake in vitro.Metronidazol representing the 5-nitroimidazole derivative is antiprotozoal and antibacterial agent effective against several infections caused by anaerobic bacteria and protozoa, such as Trichomonasvaginalis, Gardnerellavaginalisi anaerobic bacteria, ie. h anaerobic streptococci. Mikonazol and metronidazole do not have a synergistic or antagonistic effect while taking. Lidocaine stabilizes the neural membrane by inhibiting the ionic fluxes necessary for the emergence and conduction of impulses, thereby exerting a local anesthetic effect.
Pharmacokinetics
Miconazole nitrate: the absorption of miconazole nitrate with intravaginal administration is very small (approximately 1.4% of the dose). Miconazole nitrate can be determined in plasma within three days after the intravaginal administration of the suppositories Neo-Penotran Forte-L.Metronidazole: the bioavailability of metronidazole with intravaginal administration is 20% compared with oral administration. The equilibrium plasma concentration of metronidazole is 1.1–5.0 mcg / ml after daily intravaginal administration of the suppositories Neo-Penotran Forte-L for 3 days. Metronidazole is metabolized in the liver by oxidation. The major metabolites of metronidazole, hydroxy derivatives and compounds of acetic acid, are excreted by the kidneys. The biological activity of hydroxy metabolites is 30% of the biological activity of metronidazole. T1 / 2 metronidazole is 6-11 hours.After oral or IV injection of metronidazole, 60-80% of the dose is excreted by the kidneys (about 20% - unchanged, and as metabolites). Lidocaine: the action begins in 3-5 minutes. Lidocaine is absorbed by superficial application to damaged skin and mucous membrane and is rapidly metabolized in the liver. Metabolites and the drug in unchanged form (10% of the administered dose) is excreted through the kidneys. After daily intravaginal administration of the suppositories Neo-Penotran Forte-L for 3 days, lidocaine is absorbed in a minimum amount, and its plasma levels are 0.04-1 μg / ml.
Indications
Vaginal candidiasis caused by Candida albicans; bacterial vaginitis caused by anaerobic bacteria and Gardnerella vaginalis, trichomonas vaginitis caused by Trichomonas vaginalis; mixed vaginal infections.
Contraindications
I trimester of pregnancy; porphyria; epilepsy; severe abnormal liver function; hypersensitivity to the drug.
Precautionary measures
Not recommended for use in children and virgins.
Use during pregnancy and lactation
Metronidazole and lidocaine belong to category B, miconazole - to category C. After the first trimester of pregnancy, Neo-Penotran Forte-L can be used under the supervision of a physician in cases where the intended benefit exceeds the potential risk to the fetus. Breastfeeding should be stopped because . metronidazole passes into breast milk. Feeding can be resumed within 24-48 hours after the end of treatment. It is not known whether lidocaine penetrates into breast milk. A nursing woman should take lidocaine with caution.
Dosage and administration
Unless otherwise recommended by the doctor, 1 suppository is injected deep into the vagina overnight for 7 days. In case of recurrent disease or vaginitis resistant to another treatment, it is recommended to extend the course of treatment to 14 days. Suppositories should be inserted in the supine position deep into the vagina using the attached disposable fingertips.
Side effects
In rare cases, hypersensitivity reactions (skin rashes) and side effects such as abdominal pain, headache, vaginal itching, burning and irritation of the vagina are observed. The frequency of onset of systemic side effects is very low.since the vaginal application of metronidazole contained in the vaginal suppositories Neo-Penotran Forte-L, plasma concentration of metronidazole is very low (2-12% compared with oral administration). Miconazole nitrate, like all other antifungal agents based on imidazole derivatives, which are introduced into the vagina, can cause vaginal irritation (burning, itching) (2-6%). Such symptoms can be eliminated by the local anesthetic effect of lidocaine. In case of severe irritation, treatment should be discontinued. Side effects caused by the systemic use of metronidazole include hypersensitivity reactions (rarely), leukopenia, ataxia, psycho-emotional disorders, peripheral neuropathy with overdose and prolonged use, convulsions; diarrhea (rarely), constipation, dizziness, headache, loss of appetite, nausea, vomiting, pain or cramps in the abdominal cavity, change in taste (rarely), dry mouth, metallic or unpleasant taste, increased fatigue. These side effects occur in extremely rare cases, since blood levels of metronidazole with intravaginal use are very low.
Overdose
Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, paresthesia, convulsions, leukopenia, darkening of urine. Symptoms in an overdose of miconazole nitrate are nausea, vomiting, dryness in the larynx and mouth, anorexia, headache, diarrhea. Treatment: if you accidentally ingest a large dose of the drug, you can do a gastric lavage if necessary. No special antidote; applied symptomatic treatment. Treatment should be prescribed to individuals taking a dose of 12 g of metronidazole.
Interaction with other drugs
As a result of the absorption of metronidazole, the following interactions can be observed: Alcohol: disulfiram-like reactions. Oral anticoagulants: increased anticoagulant effect. Phenytoin: increased phenytoin levels and decreased levels of metronidazole in the blood. Phenobarbital: decreased levels of metronidazole in the blood. (for example, mental reactions). Cimetidine: possible increase in the level of metronidazole in the blood and, consequently, increased risk of neurological side effects.Lithium: possible increase in the toxicity of lithium. Astemizole and terfenadine: metronidazole and miconazole inhibit the metabolism of these compounds and increase their concentration in the blood plasma. The effect of hepatic enzymes, glucose (when measured by the hexokinase method), theophylline and procainamide is observed
special instructions
Alcohol intake should be avoided during treatment and, at least, within 24-48 hours after the end of the course due to possible disulfiram-like reactions. Large doses and long-term systematic use of the drug can cause peripheral neuropathy and convulsions. Caution should be exercised when using suppositories at the same time as contraceptive diaphragms and condoms due to the possible interaction of rubber with the suppository base. Patients diagnosed with trichomonas vaginitis require simultaneous treatment of the sexual partner. In renal failure, the dose of metronidazole should be reduced. metronidazole. Metronidazole may cause symptoms of encephalopathy due to elevated plasma levels and This should be used with caution in patients with hepatic encephalopathy. In patients with hepatic encephalopathy, the daily dose of metronidazole should be reduced to 1 / 3. In patients with reduced liver function, the half-life of lidocaine may increase by two or more times. Reduced kidney function does not affects the pharmacokinetics of lidocaine, but can cause accumulation of metabolites. Effects on the ability to drive vehicles and control mechanisms. Suppositories of Neo-Penotran Forte-L do not affect the ability to pack driving and working with mechanisms. Pre-clinical safety data Pre-clinical safety studies, pharmacology, repeated admission toxicity, genotoxicity, carcinogenic potential, toxicity for reproduction, revealed no potential risk to humans.