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

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

Pharmacological effect

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

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

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

Metronidazole, 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. Miconazole and metronidazole do not have a synergistic or antagonistic effect when taken together.

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic currents necessary for the initiation and conduction of impulses, thereby exerting a local anesthetic effect.

Special instructions

Use in children and virgins is not recommended.

It is necessary to avoid drinking alcohol during treatment and for at least 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 diagnosed with trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary.

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

In cases of severe liver dysfunction, 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 suffering from 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 twofold or more.

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

Impact on the ability to drive vehicles and operate machinery

Neo-Penotran Forte-L suppositories do not affect the ability to drive a car or operate machinery.

Preclinical safety data

Preclinical studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and reproductive toxicity have shown no potential risk to humans.

Active ingredient

Lidocaine, Metronidazole, Miconazole

Composition

Active ingredients:

metronidazole micronized 750 mg,

miconazole nitrate micronized 200 mg,

lidocaine 100 mg;

Excipients:

vitepsol – 1436.75 mg.

Pregnancy

Metronidazole and lidocaine are classified as category B, miconazole is classified as category C.

After the first trimester of pregnancy, Neo-Penotran Forte-L can be used under medical supervision in cases where the expected benefit outweighs the potential risk to the fetus.

Breastfeeding should be stopped because… 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. A nursing woman should take lidocaine with caution.

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 have been observed.

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

Miconazole nitrate, like all other antifungal agents based on imidazole derivatives that are introduced into the vagina, can 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.

Side effects caused by systemic use of metronidazole include hypersensitivity reactions (rarely), leukopenia, ataxia, psycho-emotional disorders, peripheral neuropathy in overdose and long-term use, convulsions; 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 in extremely rare cases, since blood levels of metronidazole when used intravaginally are very low.

Interaction

The following interactions may occur as a result of metronidazole absorption.

Alcohol: disulfiram-like reactions.

Oral anticoagulants: enhanced anticoagulation effect.

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

Phenobarbital: decreased levels of metronidazole in the blood.

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

Cimetidine: There may be an increase in metronidazole blood levels and therefore an increased risk of neurological side effects.

Lithium: Possible increased toxicity of lithium.

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

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

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 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, gastric lavage can be done if necessary. There is no special antidote; symptomatic treatment is used. Treatment should be prescribed to persons who have taken a dose of 12 g of metronidazole.

Storage conditions

Store the drug at a temperature not exceeding 25°C.

Shelf life

2 years

Manufacturer

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