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

The Neo-Penotran® Forte L suppositories contain miconazole with antifungal activity, metronidazole with antibacterial and antitrichomonas activity, and lidocaine with local anesthetic effect.

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

The action of miconazole is in the synthesis of ergosterol in the cytoplasmic membrane. Myconazole changes permeability of Candida species mycotic cell and inhibits glucose uptake in vitro.

Metronidazole, which is a 5-nitroimidazole derivative, 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 including anaerobic streptococci. Myconazole and metronidazole have no synergistic or antagonistic effect when taken simultaneously.

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes necessary for impulse generation and conduction, thereby providing a local anesthetic effect.

Indications

Composition

Active ingredients:

metronidazole micronized 750 mg,

myconazole nitrate micronized 200 mg,

Lidocaine 100 mg;

Excipients:

Vitepsol – 1436.75 mg.

How to take, the dosage

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

If not otherwise advised by the physician, 1 suppository is inserted deep into the vagina at night for 7 days.

In cases of recurrent disease or vaginitis that is resistant to other treatment, it is recommended that the course of treatment be extended to 14 days.

Interaction

The following interactions may be observed as a result of absorption of metronidazole.

Alcohol: disulfiram-like reactions.

Peroral anticoagulants: increase in anticoagulant effect.

Phenytoin: increase in phenytoin levels and decrease in metronidazole blood levels.

Phenobarbital: decrease in blood levels of metronidazole.

Disulfiram: possible CNS changes (e.g., psychiatric reactions).

Cimetidine: possible increase in metronidazole blood levels and, therefore, an increased risk of neurological side effects.

Lithium: increased toxicity of lithium is possible.

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

There have been observed effects on blood levels of hepatic enzymes, glucose (when determined by hexokinase method), theophylline and procainamide.

Special Instructions

The use in children and virgins is not recommended.

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

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

The dose of metronidazole should be reduced if there is renal impairment.

In severe hepatic dysfunction, metronidazole clearance may be impaired.

Metronidazole may cause symptoms of encephalopathy due to elevated plasma levels and therefore should 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 decreased hepatic function, the half-life of lidocaine may be doubled or more.

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

Impact on driving and operating machinery

The Neo-Penotran Forte-L suppositories do not affect the ability to drive and operate machinery.

Preclinical safety data

Preclinical studies of safety, pharmacology, toxicity on repeated administration, genotoxicity, carcinogenic potential, and toxicity to reproduction have not identified potential risks to humans.

Contraindications

Side effects

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

The incidence of systemic side effects is very low because when metronidazole in Neo-Penotran Forte-L vaginal suppositories is used vaginally, plasma concentrations of metronidazole are very low (2-12% compared to oral administration).

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

The side effects due to systemic use of metronidazole include hypersensitivity reactions (rare), leukopenia, ataxia, psychoemotional disturbances, peripheral neuropathy in overdose and long-term use, seizures; diarrhea (rare), constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, changes in taste (rare), dry mouth, metallic or unpleasant taste, increased fatigue. These side effects occur very rarely because the blood levels of metronidazole when used intravaginally are very low.

Overdose

Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, paresthesia, seizures, leukopenia, darkened urine. Symptoms of myconazole nitrate overdose are nausea, vomiting, dryness in the throat and mouth, anorexia, headache, diarrhea.

Treatment: if an accidental ingestion of a large dose of the drug, gastric lavage may be performed if necessary. There is no specific antidote; symptomatic treatment is used. Treatment should be given to those who have taken a dose of 12 g of metronidazole.

Pregnancy use

Metronidazole and lidocaine are category B and miconazole is category C.

After the first trimester of pregnancy Neo-Penotran Forte-L may be used under medical supervision in cases where the expected benefits exceed the potential risk to the fetus.

Breastfeeding should be stopped because metronidazole passes into breast milk. Breastfeeding can be resumed 24-48 h after the end of treatment. It is not known whether lidocaine penetrates into breast milk. A breastfeeding woman should take lidocaine with caution.