Neo-Penotran forte vaginal suppositories N7
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Active ingredients
Metronidazole + Miconazole
Release form
Suppositories
Composition
In 1 suppositories: Mmetronidazole (metronidazole) 750 mg; miconazole 750 mg. Excipients: Witepsol S55 - 1.55 g.
Pharmacological effect
Drug with antibacterial, anti-shake and other antifungal effects for local gynecology nitrate has a wide spectrum of action. Particularly active against pathogenic fungi, including Candida albicans, also active against gram-positive bacteria.
Pharmacokinetics
Absorption The bioavailability of metronidazole with intravaginal use is 20% compared with ingestion. After vaginal administration, when the equilibrium state was reached, plasma concentration of metronidazole was 1.6-7.2 μg / ml. The systemic absorption of miconazole nitrate with this method of administration is very low (approximately 1.4% of the dose), miconazole plasma nitrate was not detected. Metabolism and excretion of Metronidazole is metabolized in the liver. The hydroxyl metabolite is active. T1 / 2 metronidazole is 6-11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys.
Indications
Vaginal candidiasis; bacterial vaginosis; trichomonas vaginitis; vaginitis caused by mixed infections.
Contraindications
I trimester of pregnancy; porphyria; epilepsy; severe abnormal liver function; patients under the age of 18 years due to insufficient data on the use in this age group, a virgin; hypersensitivity to the active components of the drug or their derivatives.
Precautionary measures
It is necessary to avoid taking alcohol during treatment and at least within 24-48 hours after the end of the course due to the development of possible disulfiram-like reactions.
Use during pregnancy and lactation
The drug can be used after the first trimester of pregnancy under the supervision of a physician, provided that the intended benefit to the mother outweighs the potential risk to the fetus. At the time of treatment, breastfeeding should be stopped because metronidazole passes into breast milk. Breast-feeding can be resumed 24-48 hours after the end of treatment.
Dosage and administration
The drug is administered intravaginally in 1 suppository for the night for 7 days. In recurrent vaginitis or vaginitis resistant to other types of treatment, Neo-Penotran; Forte should be used within 14 days. Vaginal suppositories should be inserted deep into the vagina using disposable fingertips contained in the package. For elderly patients over 65 years of age, dosing regimen adjustment is not required.
Side effects
In rare cases, hypersensitivity reactions (skin rash) and side effects such as abdominal pain, headache, vaginal itching, burning and irritation of the vagina may occur. Local reactions: 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%). Due to inflammation of the mucous membrane of the vagina during vaginitis, vaginal irritation (burning, itching) may increase after the introduction of the first suppository or by the third day of treatment. These complications quickly disappear as treatment continues. With severe irritation, treatment should be discontinued. Systemic side effects are very rare, since the level of metronidazole in plasma is very low during vaginal absorption. Side effects associated with systemic absorption of metronidazole include: hypersensitivity reactions (rarely), leukopenia, ataxia, mental changes (anxiety, lability of mood), convulsions; rarely - diarrhea, dizziness, headache, loss of appetite, nausea, vomiting, pain or cramps in the abdomen, change in taste, constipation, dry mouth, metallic taste, increased fatigue.
Overdose
Data on overdose in humans with intravaginal use of metronidazole are missing. However, when introduced into the vagina, metronidazole can be absorbed in quantities sufficient to cause systemic effects. Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, motor disturbances (ataxia), dizziness, paresthesias, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, darkening of urine. Symptoms of miconazole nitrate overdose have not been identified. Treatment: if accidentally taken orally If necessary, a gastric lavage can be performed if necessary.Improvement of the condition after that can be achieved in persons who ingested up to 12 g of metronidazole. There is no special antidote. Symptomatic and supportive therapy is recommended.
Interaction with other drugs
The interaction of metronidazole with ethanol is capable of causing disulfiram-like reactions. When Neo-Penotran Forte is used simultaneously with oral anticoagulants, there is an increase in anticoagulant action. When Neo-Penotran Forte is used with phenytoin, there is a decrease in the concentration of metronidazole in the same time as it appears. Penotran Forte with phenobarbital decreases in the concentration of metronidazole in the blood. When used simultaneously Neo-Penotran Forte with disulfiram may have side effects from the central nervous system (psychotic reactions). If you use Neo-Penotran Forte with cimetidine at the same time, the concentration of metronidazole in the blood and the risk of neurological side effects may increase. If you use Neo-Penotran Forte with lithium at the same time An increase in lithium toxicity can be observed. When Neo-Penotran Forte is used simultaneously with astemizole and terfenadine, metronidazole and miconazole inhibit the metabolism of these substances and increase their plasma concentrations.
special instructions
Preclinical data indicate the absence of a specific risk to humans, based on the results of standard safety studies, pharmacology, multiple dose toxicity, genotoxicity, carcinogenic potential, and reproductive system toxicity. Care should be taken when using suppositories simultaneously with contraceptive diaphragms and condoms due to possible damage rubber suppository base. Patients with trichomonas vaginitis need simultaneous treatment by A new partner. The patient should be informed that suppositories should not be swallowed or used in another way. The results can be altered when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood. Effect on the ability to drive vehicles and control mechanisms. does not affect the ability to drive vehicles and management mechanisms.