Neo-Penotran forte, vaginal suppositories 750mg+200mg 7pcs

Composition

Active ingredients:

metronidazole (micronized) 750 mg;

miconazole nitrate (micronized) 200 mg;

Auxiliary substances:  

vitepsol S 55.

Pharmacological action

Neo-Penotran forte suppositories contain metronidazole, which has an antibacterial and antitrichomonasic effect, 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-the causative agent of thrush), is effective against gram-positive bacteria.

Pharmacokinetics

The bioavailability of metronidazole with intravaginal use is 20% compared to oral use. After vaginal use of Neo-Penotran®, when the equilibrium state was reached, the plasma concentration of metronidazole was 1.6–7.2 mcg / ml. The systemic absorption of miconazole nitrate with this method of use 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. T1 / 2 of metronidazole is 6-11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys.

Indications

• : vaginal candidiasis;
• Trichomonas vulvovaginitis;
• bacterial vaginosis;
• mixed vaginal infection.

Contraindications

• hypersensitivity to the active components of the drug or their derivatives;
• porphyria;
• epilepsy;
• severe liver function disorders;
• pregnancy (I trimester);
• age up to 18 years (insufficient data on use in this age category);
• in virgins.

Side effects

In rare cases, there may be allergic reactions (skin rash) and side effects, 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%). If severe irritation occurs, treatment should be discontinued.

Systemic side effects are very rare, as the plasma level of metronidazole is very low during vaginal absorption.

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, taste changes (rare), dry mouth, metallic or unpleasant taste, increased fatigue.

Interaction

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

Oral anticoagulants:  increased anticoagulant action.

Phenytoin:  a decrease in the concentration of metronidazole in the blood with a simultaneous increase in the concentration of phenytoin.

Phenobarbital:  decrease in the 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 concentration in plasma.

How to take, course of use and dosage

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

For recurrent vaginitis or vaginitis that is resistant to other types of treatment — within 14 days.

Suppositories should be inserted deep into the vagina.

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

Overdose

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 the urine.

No symptoms of miconazole nitrate overdose were detected.

Treatment:  symptomatic and supportive care. In case of accidental ingestion of a large number of suppositories, if necessary, gastric lavage. Improvement can be achieved in individuals who have taken up to 12 g of metronidazole orally. There is no special antidote.

Special instructions

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

It is necessary to avoid alcohol intake during treatment and at least for 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, due to possible damage to the rubber base of the suppositories.

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

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

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

Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. They do not affect the ability to drive a car or work with mechanisms.

Form of production

Vaginal suppositories

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Metronidazole, Miconazole

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Description

For women, For adults as prescribed by a doctor

Indications

Vaginitis, Inflammation of the female genital organs, Thrush