Neo-Penotran Forte: instructions for using the medicine, structure, Contraindications
Active material: Metronidazol , Mikonazol
When ATH: G01AF20
CCF: With antibacterial drug, antiprotozoal and antifungal action for local application in gynecology
ICD-10 codes (testimony): A59, B37.3, N76
When CSF: 07.01.03
Manufacturer: JENAPHARM GmbH & Co.KG (Germany)
Neo-Penotran Forte: dosage form, composition and packaging
Vaginal Suppositories in the form of a flat body with a rounded tip, white or nearly white.
| 1 supp. | |
| metronidazol (micronized) | 750 mg |
| miconazole nitrate (micronized) | 200 mg |
Excipients: vitepsol S55.
7 PC. – plastic blisters (1) complete with fingertips – packs cardboard.
Neo-Penotran Forte: pharmachologic effect
With antibacterial drug, antiprotozoal and antifungal action for local application in gynecology.
Preparat soderƶit metronidazol, which has antibacterial and antiprotozoal action, and miconazole, has antifungal effect.
Metronidazol active against Gardnerella vaginalis, Trichomonas vaginalis, Anaerobic bacteria, including anaerobic streptococci.
Miconazole nitrate has a broad spectrum of activity. Especially active against pathogenic fungi, including Candida albicans, It is also active against Gram-positive bacteria.
Neo-Penotran Forte: pharmacokinetics
Absorption
The bioavailability of metronidazole in intravaginal application of 20% compared with oral. After vaginal administration in achieving equilibrium concentration of metronidazole in plasma was 1.6-7.2 ug / ml. Systemic absorption of miconazole nitrate in this method of administration is very low (about 1.4% dose), miconazole nitrate in plasma was not determined.
Metabolism and excretion
Metronidazol metaʙoliziruetsja peceni. The active metabolite is a hydroxyl.
T1/2 Metronidazole is 6-11 no. About 20% the dose is excreted unchanged in the kidneys.
Neo-Penotran Forte: testimony
- vaginal candidiasis;
- bacterial vaginosis;
- trichomonas vaginitis;
- vaginitis, caused by mixed infections.
Neo-Penotran Forte: dosing regimen
The drug is administered vaginally by 1 suppository overnight for 7 days.
At recurrent vaginitis or vaginitis, resistant to other treatments, Neo-Penotran® Forte should be used for 14 days.
Vaginal suppositories should be inserted deep into the vagina using a disposable fingertips, contained in the package.
To elderly patients older 65 years correction dosing regime is not required.
Neo-Penotran Forte: side effects
IN rare may experience hypersensitivity reactions (skin rash) and side effects, like abdominal pain, headache, vaginal itching, burning and irritation of the vagina.
Local reactions: miconazole nitrate, like all other antifungal agents based on imidazole derivatives, which are inserted into the vagina, can irritate the vagina (burning, itch) (2-6%). Due to inflammation of the mucous membrane of the vagina in vaginitis, vaginal irritation (burning, itch) It may be increased after the introduction of the first suppository, or the third day of treatment. These complications are rapidly disappearing with continued treatment. With strong stimulation treatment should be discontinued.
Systemic side effects It is very rare, since at the level of the vaginal absorption of metronidazole in plasma is very low. Side effects, related to systemic absorption of metronidazole, relate: hypersensitivity reactions (rarely), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsions; rarely – diarrhea, dizziness, headache, loss of appetite, nausea, vomiting, pain or cramps, change in taste, constipation, dry mouth, metallic taste, fatigue.
Neo-Penotran Forte: Contraindications
- I trimester of pregnancy;
- porphyria;
- epilepsy;
- severe liver;
- patients under the age 18 years due to insufficient data on the use in this age group, Virgin;
- hypersensitivity to the active components of the drug or their derivatives.
Neo-Penotran Forte: Pregnancy and lactation
The product can be applied after I trimester of pregnancy under medical supervision provided, that the anticipated benefits to the mother outweighs the potential risk to the fetus.
At the time of treatment should stop breastfeeding, as metronidazole passes into breast milk. Breast-feeding can be resumed after 24-48 h after treatment.
Neo-Penotran Forte: Special instructions
Preclinical data indicate that there is no specific risk to humans, based on the results of standard safety studies, Pharmacology, Multiple Dose Toxicity, genotoxicity, carcinogenic potential, toxicity to the reproductive system.
You should avoid drinking alcohol during treatment and, at least, during 24-48 hours after the end of the course due to the development of possible reactions disulfiramopodobnyh.
Caution should be exercised when using suppositories along with contraceptive diaphragms and condoms because of possible damage to the rubber suppository base.
In patients with trichomonas vaginitis should be simultaneous treatment of sexual partner.
The patient should be informed, suppositories that should not be swallowed or used in another way.
You can change the results when determining the level of liver enzymes, Glucose (hexokinase method), theophylline and procainamide blood.
Effects on ability to drive vehicles and management mechanisms
The drug does not affect the ability to drive vehicles and management mechanisms.
Neo-Penotran Forte: overdose
Data on human overdose in intravaginal application of metronidazole absent. But, when administered into the vagina of metronidazole can be absorbed in amounts, sufficient to, to cause systemic effects.
Symptoms overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, perifericheskaya neuropathy (incl. after prolonged use at high doses), leukopenia, dark urine.
Symptoms of overdose of miconazole nitrate not identified.
Treatment: Accidental ingestion of large amounts of suppositories may optionally be produced gastric lavage. Improving upon this can be achieved in patients, ingested up 12 g metronidazole. There is no specific antidote. It is recommended that symptomatic and supportive therapy.
Neo-Penotran Forte: drug interaction
Interaction of Metronidazole with ethanol is capable of causing reaction disulfiramopodobnye.
With simultaneous application of Neo-Penotran® Forte with oral anticoagulants has increased, the anticoagulant action.
With simultaneous application of Neo-Penotran® Forte phenytoin marked decrease in the concentration of metronidazole in the blood while increasing the concentration of phenytoin.
With simultaneous application of Neo-Penotran® Forte phenobarbital marked decrease in the concentration of metronidazole in blood.
With simultaneous application of Neo-Penotran® Forte with disulfiram possible side effects of the central nervous system (psychotic reactions).
With simultaneous application of Neo-Penotran® Forte with cimetidine may increase the concentration of metronidazole in the blood and increase the risk of neurological side effects.
With simultaneous application of Neo-Penotran® Forte with lithium may be an increase of lithium toxicity.
With simultaneous application of Neo-Penotran® Forte with astemizole and terfenadine metronidazole and miconazole inhibit the metabolism of these compounds and increase their concentration in plasma.
Neo-Penotran Forte: terms of dispensing from pharmacies
The drug is released under the prescription.
Neo-Penotran Forte: terms and conditions of storage
The drug should be stored out of reach of children at or above 25 ° C. Do not store in the refrigerator. Shelf life – 2 year.
