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

vaginal candidiasis;
trichomonas vulvovaginitis;
bacterial vaginosis;
mixed vaginal infection.

Pharmacological effect

Neo-Penotran suppositories contain metronidazole, which has antibacterial and antitrichomoniacal 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 wide spectrum of action (especially active against pathogenic fungi, including Candida albicans, the causative agent of thrush), and is effective against gram-positive bacteria.

Pharmacokinetics

The bioavailability of metronidazole when administered intravaginally is 20% compared to oral administration. After vaginal administration of the drug Neo-Penotran®, when equilibrium was reached, the concentration of metronidazole in plasma was 1.6–7.2 μg/ml. Systemic absorption of miconazole nitrate with 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. T1/2 of metronidazole is 6–11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys.

Special instructions

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

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

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

In patients with trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary.

Do not swallow or use in any other way than intravaginally!

Laboratory tests: results may change when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood.

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

Active ingredient

Metronidazole, Miconazole

Composition

Active ingredients:

metronidazole (micronized) 500 mg;

miconazole nitrate (micronized) 100 mg;

Excipients:

vitepsol S 55

Contraindications

hypersensitivity to the active components of the drug or their derivatives;
porphyria;
epilepsy;
severe liver dysfunction;
pregnancy (first trimester);
age under 18 years (insufficient data on use in this age category);
in virgins.

Side Effects

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

Local reactions: miconazole nitrate can cause vaginal irritation (burning, itching), as with intravaginal use of any other antifungal drugs based on imidazole derivatives (2–6%). In case of severe irritation, treatment should be discontinued.

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

Side effects associated with systemic absorption of metronidazole include: allergic reactions (rare), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsions; 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.

Interaction

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

Oral anticoagulants: enhanced anticoagulant effect.

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

Phenobarbital: decreased concentration of metronidazole in the blood.

Disulfiram: possible side effects from the central nervous system (psychotic reactions).

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

Lithium: Increased lithium toxicity may occur.

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

Overdose

Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, darkening of urine.

No symptoms of miconazole nitrate overdose have been identified.

Treatment: symptomatic and supportive therapy. In case of accidental ingestion of a large number of suppositories, gastric lavage is necessary. Improvement in the condition was achieved in individuals who took up to 12 g of metronidazole orally. There is no special antidote.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Exeltis Ilach San. Ve Tik. A.S., Türkiye