Neo-Penotran® Forte (Neo-Penotran® Forte)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMetronidazole + MiconazoleMetronidazole + Miconazole
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  • Neo-Penotran® Forte
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    Exeltys Khelskea S.L.     Spain
    • Dosage form: & nbspVaginal suppositories
    Composition:

    Each vaginal suppository contains:

    - active substances: 750 mg of metronidazole (micronized) and 200 mg of miconazole nitrate (micronized);

    - Excipients: 1550 mg of Witepsol S 55

    Description:Vaginal suppositories in the form of a flat body with a rounded end, white or almost white in color.
    Pharmacotherapeutic group:Antimicrobial combined agent (antimicrobial and antiprotozoal agent + antifungal agent)
    ATX: & nbsp

    G.01.A.F   Imidazole derivatives

    G.01.A.F.20   Combinations of imidazole derivatives

    Pharmacodynamics:
    Neo-Pentotran® Forte suppositories contain metronidazole, which has antibacterial and anti-trichomonoadic effects and miconazole, which has an antifungal effect. Metronidazole is an antibacterial and antiprotozoal agent and is active against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococcus and Trichomonas vaginalis.Miconazole nitrate has a broad spectrum of action (especially active against pathogenic fungi, including Candida albicans - a pathogen of thrush), is effective against gram-positive bacteria.
    Pharmacokinetics:

    Bioavailability of metronidazole for intravaginal application is 20% compared with oral intake. After vaginal administration of Neo-Penotran® Forte, the concentration of metronidazole in plasma reached 1.6-7.2 μg / ml when the equilibrium state was reached. Systemic absorption of miconazole nitrate with this method of administration is very low (approximately 1.4% of the dose), miconazole nitrate in plasma was not detected.

    Metronidazole is metabolized in the liver. The 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:

    - Vaginal candidiasis,

    - bacterial vaginosis,

    - Trichomonas vaginitis,

    - Vaginitis caused by mixed infections.

    Contraindications:Known hypersensitivity to the active components of the drug or their derivatives, the first trimester of pregnancy, porphyria, epilepsy, severe liver dysfunction,patients under the age of 18 years due to the lack of data on the use in this age category, a virgin.
    Pregnancy and lactation:

    Neo-Pentotrans® Forte suppositories can be used after the first trimester of pregnancy under the supervision of a doctor, provided that the intended benefit to the mother exceeds the potential risk to the fetus.

    For the duration of treatment, breastfeeding should be discontinued because metronidazole penetrates into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment.

    Dosing and Administration:

    Intravaginal. One vaginal suppository is injected deep into the vagina for 7 days a night. With recurrent vaginitis or vaginitis, resistant to other types of treatment. Neo-Pentotran® Forte should be used within 14 days. Suppositories should be injected deep into the vagina.

    Elderly patients (over 65 years of age): the same recommendations as for younger patients.

    Side effects:

    In rare cases, allergic reactions (skin rash) and side effects, in particular abdominal pain, headache, vaginal irritation (burning, itching) can be observed.

    Local reactions: miconazole nitrate can cause vaginal irritation (burning, itching), as with intravaginal application of any other antifungal agents based on imidazole derivatives (2-6%). If irritation is severe, treatment should be discontinued.

    Systemic side effects occur very rarely, because with vaginal absorption the level of metronidazole in the plasma is very low. Side effects associated with systemic absorption of metronidazole include: allergic reactions (rarely), leukopenia, ataxia, changes in the psyche (anxiety, lability of mood), convulsions, rarely: diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, pain or cramps in the abdomen, a change in taste (rarely), dry mouth, metallic or unpleasant aftertaste, increased fatigue.

    Overdose:Data on overdose in humans with intravaginal administration of metronidazole are not available. However, when inserted into the vagina metronidazole can be absorbed in amounts sufficient to induce systemic effects. With the occasional ingestion of a large number of suppositories, if necessary,gastric lavage. Improvement of the condition after this can be achieved in those who have taken inwards up to 12 g of metronidazole. There is no special antidote. Symptomatic and supportive therapy is recommended. Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, motor disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, darkening of urine. Symptoms of an overdose of miconazole nitrate are not revealed.
    Interaction:

    Alcohol: The interaction of metronidazole with alcohol can cause disulfiram-like reactions.

    Peroral anticoagulants: strengthening of anticoagulant action.

    Phenytoin: decrease in the concentration of metronidazole in the blood with simultaneous

    increasing the concentration of phenytoin.

    Phenobarbital: decrease in the concentration of metronidazole in the blood.

    Disulfiram: side effects from the central nervous system (psychotic reactions) are possible. Cimetidine: can increase the concentration of metronidazole in the blood and increase the risk of developing neurological side effects.

    Lithium: an increase in lithium toxicity may be observed.

    Astemizole and terfenadine: metronidazole and miconazole suppress the metabolism of these substances and increase their concentrations in the plasma.

    Special instructions:

    Preclinical data indicate the absence of a specific risk for a person, based on the results of standard safety studies, pharmacology, multiple dose toxicity, genotoxicity, carcinogenic potential, toxicity for the reproductive system.

    It is necessary to avoid drinking alcohol during treatment and at least 24-48 hours after the end of the course due to possible disulfiram-like reactions.

    Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms because of possible damage to the rubber by the suppository base.

    Patients with a diagnosis of "trichomonas vaginitis" need simultaneous treatment of the sexual partner.

    Do not swallow and do not use it in any other way!

    Laboratory Tests

    It is possible to change the results when determining the level of hepatic enzymes, glucose (hexokinase), theophylline and procainamide in the blood.

    Effect on the ability to drive transp. cf. and fur:Neo-Pentotran® Forte suppositories do not affect the ability to drive and operate machinery.
    Form release / dosage:Vaginal suppositories, 750 mg + 200 mg.
    Packaging:For 7 suppositories in a blister of PVC / PE. 1 blister together with instructions for use are placed in a cardboard box.
    Storage conditions:At a temperature of no higher than 25 ° C. Suppositories can be stored in the refrigerator (2-8 ° C). Do not freeze. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiry date printed on the package!
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006559/09
    Date of registration:17.08.2009/12.05.2016
    The owner of the registration certificate:Exeltys Khelskea S.L.Exeltys Khelskea S.L. Spain
    Manufacturer: & nbsp
    Representation: & nbspExeltys Khelskea S.L.Exeltys Khelskea S.L.Spain
    Information update date: & nbsp19.06.2018
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