Neo-Penotran, vaginal suppositories 14 pcs

The Neo-Penotran suppositories contain metronidazole, which has antibacterial and antitrichomonadic 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 activity (especially active against pathogenic fungi, including Candida albicans – the causative agent of thrush), it is effective against Gram-positive bacteria.

Pharmacokinetics

The bioavailability of metronidazole with intravaginal administration is 20% compared to oral administration. After vaginal administration of Neo-Penotran^® at equilibrium plasma concentration of metronidazole was 1.6-7.2 µg/ml. Systemic absorption of miconazole nitrate by this route of administration is very low (approximately 1.4% of the dose); miconazole nitrate was not detected in plasma.

Metronidazole is metabolized in the liver. The hydroxyl metabolite is active. T_1/2 metronidazole is 6-11 h. About 20% of the dose is excreted unchanged by the kidneys.

Indications

Active ingredient

Composition

Active ingredients:

metronidazole (micronized) 500 mg;

Miconazole nitrate (micronized) 100 mg;

Associates:

vitepsol S 55

How to take, the dosage

Intravaginally, 1 vaginal suppository is inserted deep into the vagina for 7 days at night.

In recurrent vaginitis or vaginitis resistant to other treatments, for 14 days.

The suppositories should be inserted deep into the vagina.

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

Interaction

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

Peroral anticoagulants: increase in anticoagulant effect.

Phenytoin: decrease in the concentration of metronidazole in the blood while increasing the concentration of phenytoin.

Phenobarbital: decrease in the blood concentration of metronidazole.

Disulfiram: possible CNS side effects (psychotic reactions).

Cimetidine: may increase the concentration of metronidazole in the blood and increase the risk of neurological side effects.

Lithium: increased toxicity of lithium may be observed.

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

Special Instructions

Preclinical data indicate no specific risk to humans based on the results of standard safety studies, pharmacology, multiple-dose toxicity, hepatotoxicity, carcinogenic potential, and reproductive toxicity.

Alcohol should be avoided during treatment and for at least 24-48 hours after completion of the course because of possible disulfiram-like reactions.

Perhaps caution should be exercised when using the suppositories at the same time as contraceptive diaphragms and condoms because of possible damage to the rubber of the suppository base.

In patients with trichomonas vaginitis, the sexual partner should be treated at the same time.

Do not swallow or use other than intravaginal!

Laboratory tests: there may be a change in results when determining liver enzymes, glucose (hexokinase method), theophylline and procainamide levels in the blood.

Impact on the ability to drive a car or perform work requiring increased speed of physical and mental reactions. Do not affect the ability to drive or operate machinery.

Contraindications

Side effects

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

Local reactions: miconazole nitrate may cause vaginal irritation (burning, itching), as with intravaginal use of any other antifungal drugs based on imidazole derivatives (2-6%). Treatment should be discontinued if there is severe irritation.

Systemic side effects are very rare because during vaginal absorption plasma levels of metronidazole are very low.

The side effects associated with systemic absorption of metronidazole include: Allergic reactions (rare), leukopenia, ataxia, mental changes (anxiety, mood lability), seizures; rarely, diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, change in taste (rare), dry mouth, metallic or unpleasant taste, increased fatigue.

Overdose

Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, motor disorders (ataxia), dizziness, paresthesias, seizures, peripheral neuropathy (including after long-term use in high doses), leukopenia, darkened urine.

The symptoms of overdose of miconazole nitrate have not been identified.

Treatment: symptomatic and supportive therapy. In case of accidental ingestion of a large number of suppositories, if necessary – gastric lavage. Improvement of condition after treatment can be achieved in individuals who have ingested up to 12 g of metronidazole. There is no specific antidote.

Similarities