Neo-Penotran forte L, vaginal suppositories 750mg+200mg+100mg 7pcs

Composition

Active ingredients:

metronidazole micronized 750 mg,

miconazole nitrate micronized 200 mg,

lidocaine 100 mg;

Auxiliary substances:

vitepsol — 1436.75 mg

Pharmacological action

Neo-Penotran ® Forte L suppositories contain miconazole, which has an antifungal effect, metronidazole, which has an antibacterial and antitrichomonas effect, and lidocaine, which gives a local anesthetic effect.

Miconazole, which is a synthetic derivative of imidazole, has antifungal activity and has a wide spectrum of action. Especially effective against pathogenic fungi, including Candida albicans. In addition, miconazole is effective against gram-positive bacteria.

The action of miconazole is to synthesize ergosterol in the cytoplasmic membrane. Miconazole alters the permeability of mycotic Candida species cells and inhibits glucose uptake in vitro.

Metronidazole, which is a derivative of 5-nitroimidazole, is an antiprotozoal and antibacterial agent that is effective against several infections caused by anaerobic bacteria and protozoa, such as Trichomonas vaginalis, Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococci. Miconazole and metronidazole do not have a synergistic or antagonistic effect when taken simultaneously.

Lidocaine stabilizes the neural membrane by inhibiting ion fluxes necessary for the generation and conduction of impulses, thereby exerting a local anesthetic effect.

Indications

• vaginal candidiasis caused by Candida albicans;
• bacterial vaginitis caused by anaerobic bacteria and Gardnerella vaginalis, Trichomonas vaginitis caused by Trichomonas vaginalis;
• mixed vaginal infections.

Use during pregnancy and lactation

Metronidazole and lidocaine belong to category B, miconazole-to category C.

After the first trimester of pregnancy, Neo-Penotran Forte-L can be used under the supervision of a doctor in cases where the intended benefit exceeds the potential risk to the fetus.

Breast-feeding should be discontinued, as metronidazole penetrates into breast milk. Feeding can be resumed 24-48 hours after the end of treatment. It is not known whether lidocaine passes into breast milk. A nursing woman should take lidocaine with caution.

Contraindications

• I trimester of pregnancy;
• porphyria;
• epilepsy;
• severe liver function disorders;
• hypersensitivity to the components of Neo-Penotran Forte L.

Side effects

In rare cases, there are hypersensitivity reactions (skin rashes) and side effects such as abdominal pain, headache, vaginal itching, burning and vaginal irritation.

The incidence of systemic side effects is very low, since the vaginal use of metronidazole, contained in the vaginal suppositories Neo-Penotran Forte-L, the concentration of metronidazole in plasma is very low (2-12% compared to oral use).

Miconazole nitrate, like all other antifungal agents based on imidazole derivatives that are injected into the vagina, can cause vaginal irritation (burning, itching) (2-6%). Such symptoms can be relieved by the local anesthetic action of lidocaine. In case of serious irritation, treatment should be discontinued.

Side effects associated with systemic use of metronidazole include hypersensitivity reactions (rare), leukopenia, ataxia, psychoemotional disorders, peripheral neuropathy with overdose and prolonged use, convulsions; diarrhea (rare), constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, changes in taste sensations (rare), dry mouth, metallic or unpleasant taste, increased blood pressure fatigue. These side effects occur in extremely rare cases, since blood levels of metronidazole are very low when intravaginal use is performed.

Interaction

As a result of metronidazole absorption, the following interactions may occur.

Alcohol:  disulfiram-like reactions.

Oral anticoagulants:  increased anticoagulation effect.

Phenytoin:  increased levels of phenytoin and decreased levels of metronidazole in the blood.

Phenobarbital:  reduced blood levels of metronidazole.

Disulfiram:  there may be changes in the central nervous system (for example, mental reactions).

Cimetidine:  it is possible to increase the level of metronidazole in the blood and, consequently, increase the risk of neurological side effects.

Lithium:  lithium toxicity may increase.

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

There is an effect on the blood level of liver enzymes, glucose (when determined by the hexokinase method), theophylline and procainamide.

How to take, course of use and dosage

Intravaginally. Suppositories should be administered in the supine position, deep into the vagina.

If the doctor does not recommend otherwise,1 suppository is inserted deep into the vagina at night for 7 days.

In case of recurrent disease or vaginitis that is resistant to another treatment, it is recommended to extend the course of treatment to 14 days.

Overdose

Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, paresthesia, convulsions, leukopenia, dark urine. Symptoms of an overdose of miconazole nitrate include nausea, vomiting, dry throat and mouth, anorexia, headache, and diarrhea.

Treatment: in case of accidental ingestion of a large dose of the drug, gastric lavage can be performed if necessary. There is no special antidote; symptomatic treatment is used. Treatment should be given to individuals who have taken a dose of 12 g of metronidazole.

Special instructions

It is not recommended for use in children and virgins.

Alcohol intake should be avoided during treatment and at least for 24-48 hours after the end of the course due to possible disulfiram-like reactions. High doses and long-term systematic use of the drug can cause peripheral neuropathy and seizures. Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms due to the possible interaction of rubber with the base of the suppositories.

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

In patients with renal insufficiency, the dose of metronidazole should be reduced.

In severe hepatic impairment, metronidazole clearance may be impaired.

Metronidazole may cause symptoms of encephalopathy due to elevated plasma levels and should therefore be used with caution in patients with hepatic encephalopathy.

In patients with hepatic encephalopathy, the daily dose of metronidazole should be reduced to 1/3.

In patients with reduced liver function, the half-life of lidocaine may be increased by two or more times.

Decreased renal function does not affect the pharmacokinetics of lidocaine, but may cause accumulation of metabolites.

Influence on the ability to drive motor vehicles and manage mechanisms

Neo-Penotran Forte-L suppositories do not affect the ability to drive a car and work with mechanisms.

Preclinical safety data sheet

Preclinical studies of safety, pharmacology, re-use toxicity, genotoxicity, carcinogenic potential, and reproductive toxicity have not revealed a potential risk to humans.

Product form

vaginal suppositories

Storage conditions

Store the product at a temperature not exceeding 25°C. Do not store in the refrigerator. Store in the original packaging.

Shelf life

2 years

Active ingredient

Metronidazole, Miconazole, Lidocaine

Conditions of release from pharmacies

By prescription

Dosage form

vaginal suppositories

Description

For adults as prescribed by a doctor, For pregnant women in the second and third trimester as prescribed by a doctor, For women

Indications

Female genital inflammation, Trichomoniasis, Thrush, Vaginitis