Neo-Penotran® Forte L (Metronidazole + Miconazole + Lidocaine) 7 Vaginal Suppositories

Composition

One suppository contains

active substances:

• metronidazole 750 mg


• miconazole nitrate 200 mg


• lidocaine 100 mg

excipient - witepsol

Pharmachologic effect

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

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

Miconazole works by synthesizing ergosterol in the cytoplasmic membrane. Miconazole alters the permeability of mycotic cells of Candida species and inhibits glucose uptake in vitro.

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

Lidocaine stabilizes the neural membrane by inhibiting the ionic fluxes required for the emergence and conduction of impulses, thereby providing 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.
Application during pregnancy and lactation
Metronidazole and lidocaine are Category B, miconazole is Category C.
After the first trimester of pregnancy, Neo-Penotran Forte-L can be used under medical supervision in cases where the intended benefit outweighs the potential risk to the fetus.

Breastfeeding should be discontinued as metronidazole passes 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. Lidocaine should be used with caution in a nursing woman.

Contraindications

I trimester of pregnancy;
porphyria;
epilepsy;
severe liver dysfunction;
hypersensitivity to the components of the drug Neo-Penotran Forte L.

Side effects

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

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

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 eliminated by the local anesthetic action of lidocaine. In case of severe irritation, treatment should be discontinued.

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

Interaction

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

Alcohol: disulfiram-like reactions.

Oral anticoagulants: enhancement of the anticoagulant effect.

Phenytoin: Increased phenytoin levels and decreased blood levels of metronidazole.

Phenobarbital: a decrease in the level of metronidazole in the blood.

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

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

Lithium: Potentially increased toxicity of lithium.

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

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

How to take, course and dosage

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

Unless otherwise recommended by a doctor, 1 suppository is injected deep into the vagina at night for 7 days.

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

Overdose

Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, paresthesia, convulsions, leukopenia, dark urine. Symptoms of miconazole nitrate overdose are nausea, vomiting, dryness in the larynx and mouth, anorexia, headache, diarrhea.
Treatment: in case of accidental ingestion of a large dose of the drug, if necessary, gastric lavage can be performed. There is no specific antidote; symptomatic treatment is applied. Treatment should be given to individuals who have taken a dose of 12 g of metronidazole.

Special instructions

Not recommended for use in children and virgins.

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. Large 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 suppository base.

In patients with a diagnosis of Trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary.

In renal failure, the dose of metronidazole should be reduced.

With serious violations of liver function, the clearance of metronidazole 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 increase by two or more times.

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

Storage conditions

Store the drug at a temperature not exceeding 25 ° C.
Do not refrigerate.
Store in original packaging.
Shelf life - 2 years