Neo-Penotran Forte L

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Latin name: Neo-Penotran Forte L

ATX code: G01AF20

Active ingredient: metronidazole (metronidazole), miconazole (miconazole), lidocaine (lidocaine)

Manufacturer: Embil Pharmaceutical, Co. Ltd. (Turkey)

Description and photo update: 2018-22-10

Prices in pharmacies: from 817 rubles.

Buy

Neo-Penotran Forte L vaginal suppositories

Neo-Penotran Forte L is an antimicrobial combined preparation for topical use in gynecology.

Form of release and composition

Dosage form Neo-Penotran Forte L - vaginal suppositories: flat with a rounded end, from yellowish to white (7 pcs. In a plastic blister, 1 blister in a cardboard box, complete with fingertips).

1 suppository contains:

active ingredients: micronized metronidazole - 0.75 g, micronized miconazole nitrate - 0.2 g, lidocaine - 0.1 g;
auxiliary component: witepsol S55.

Pharmacological properties

Pharmacodynamics

Neo-Penotran Forte L is a combined preparation with antifungal, antibacterial and antitrichomonas action and local anesthetic effect.

Miconazole is a synthetic imidazole derivative. Possesses a wide spectrum of antifungal action, is especially active against Candida albicans and other pathogenic fungi. Gram-positive bacteria are also sensitive to miconazole. The mechanism of its action is to change the permeability of the mycotic cell of Candida species and the synthesis of ergosterol in the cytoplasmic membrane. Miconazole inhibits glucose uptake in vitro.

Metronidazole - has antibacterial and antichomonas effect. It is a derivative of 5-nitroimidazole, acts as an antiprotozoal and antibacterial agent. Metronidazole is effective against a number of infections that are caused by protozoa such as Gardnerella vaginalis, Trichomonas vaginalis, and anaerobic bacteria, including anaerobic streptococci.

Synergism or antagonistic action does not occur with the combination of miconazole and metronidazole.

Lidocaine has a local anesthetic effect. Its mechanism of action is based on the stabilization of the neural membrane by inhibiting the ionic fluxes necessary for the occurrence and conduction of impulses.

Pharmacokinetics

With intravaginal use, the absorption of miconazole nitrate is quite low: it can reach approximately 1.4% of a single dose. In the blood plasma of miconazole, nitrate can be determined within three days after the administration of the suppository.

The bioavailability of metronidazole when using suppositories is 20% compared to taking the drug orally. Its equilibrium concentration in blood plasma is 1.1–5.0 μg / ml after three days of regular use of suppositories. Metronidazole metabolism occurs in the liver by oxidation. The main metabolites of metronidazole - acetic acid compounds and hydroxy derivatives - are excreted through the kidneys. The biological activity of hydroxy metabolites does not exceed 30% of the biological activity of metronidazole. The half-life of the active substance is 6-11 hours.

The action of lidocaine begins a few minutes after the administration of the suppository. Lidocaine is metabolized in the liver. Metabolites and 10% of the drug are excreted unchanged by the kidneys. The absorption of lidocaine after three days of intravaginal administration is minimal; its amount in plasma is 0.04–1 μg / ml.

Indications for use

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

Contraindications

epilepsy;
porphyria;
severe liver dysfunction;
childhood;
I trimester of pregnancy;
breast-feeding;
virginity;
individual intolerance to the components of the drug.

Care should be taken to prescribe Neo-Penotran Forte L during the II and III trimester of pregnancy, with hepatic encephalopathy.

Instructions for use of Neo-Penotran Forte L: method and dosage

Suppositories Neo-Penotran Forte L are used by intravaginal administration.

For the procedure, you should take a horizontal position and, lying on your back, with the help of a disposable fingertip (included in the package), deeply insert the drug into the vagina.

Recommended dosage: 1 pc. 1 time per day, in the evening before bedtime. The duration of the usual course is 7 days.

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

Side effects

Against the background of intravaginal use of suppositories, it is possible to develop undesirable phenomena in the form of vaginal itching, burning and irritation of the vagina, abdominal pain, headache; in rare cases - hypersensitivity reactions in the form of skin rashes.

The likelihood of systemic side effects of metronidazole is very low. This is due to the insignificant concentration of metronidazole in the blood plasma during treatment with suppositories. Its content in comparison with oral administration is no more than 12%.

Miconazole nitrate can cause a local irritant effect in the form of burning and itching, which is neutralized by the anesthetic effect of lidocaine. With significant irritation, therapy must be discontinued.

With systemic use of metronidazole, the following side effects may develop: rarely - diarrhea, impaired taste, hypersensitivity reactions; loss of appetite, ataxia, leukopenia, psychoemotional disorders, convulsions; against the background of long-term use - peripheral neuropathy. In addition, you may experience increased fatigue, constipation, dizziness, headache, pain or cramps in the abdominal cavity, nausea, vomiting, dry mouth, and an unpleasant or metallic taste. The listed side effects during the treatment with Neo-Penotran Forte L are very rare.

Overdose

Symptoms: abdominal pain, nausea, vomiting, diarrhea, metal taste in the mouth, itching, headache, ataxia, convulsions, paresthesia, leukopenia, dark urine, dry mouth and larynx, anorexia.

Treatment: no specific antidote. In case of accidental ingestion of a high dose of the drug (12 g of metronidazole), immediate gastric lavage and the appointment of symptomatic therapy are required.

special instructions

Neo-Penotran Forte L should not be used to treat virgins and children.

The use of alcohol is contraindicated during the period of treatment and within two days after the end of its course.

During the period of treatment, it is recommended to be careful while using barrier methods of contraception (condoms) and contraceptive diaphragms, since the interaction of the suppository base with latex is possible.

When treating trichomonas vaginitis, simultaneous treatment of the sexual partner is required.

Neo-Penotran Forte L may affect the blood levels of liver enzymes and glucose.

Preclinical studies of the drug did not reveal a potential risk (genotoxicity, carcinogenic potential, toxicity for reproduction) to human health during its use, including repeated use.

Influence on the ability to drive vehicles and complex mechanisms

According to the instructions, Neo-Penotran Forte-L does not affect the ability to drive vehicles and mechanisms.

Application during pregnancy and lactation

The use of Neo-Penotran Forte-L during the II and III trimesters of pregnancy is possible in exceptional cases, if the intended effect of therapy for the mother outweighs the potential threat to the fetus. Treatment should be carried out under medical supervision.

Use during lactation is contraindicated, since metronidazole passes into breast milk. If it is necessary to use the drug during lactation, breastfeeding should be temporarily stopped. Breastfeeding can be resumed two days after drug withdrawal.

Pediatric use

It is not recommended to use Neo-Penotran Forte L for the treatment of children.

With impaired renal function

In renal failure, it is recommended to reduce the dose of metronidazole.

Impairment of renal function does not affect the pharmacokinetics of lidocaine, but it can cause the accumulation of its metabolites.

If liver function is impaired

The appointment of Neo-Penotran Forte L is contraindicated in patients with severe hepatic insufficiency.

Severe liver dysfunctions contribute to a deterioration in the clearance of metronidazole.

In hepatic encephalopathy, metronidazole can increase its plasma concentration and cause the development of symptoms of encephalopathy. Therefore, in this category of patients, the daily dose of metronidazole should be reduced by 3 times.

It should be borne in mind that the half-life of lidocaine with reduced liver function may exceed the normal period by 2 or more times.

Drug interactions

With simultaneous use with Neo-Penotran Forte-L:

oral anticoagulants enhance their effect;
phenobarbital helps to lower the level of metronidazole in blood plasma;
phenytoin causes a decrease in the level of metronidazole and increases its level in the blood;
disulfiram can cause central nervous system disorders, including mental disorders;
lithium can increase its toxicity;
cimetidine increases the level of metronidazole in the blood and the risk of developing side effects of neurological etiology;
astemizole and terfenadine increase their plasma concentration;
ethanol causes disulfiram-like reactions.
theophylline and procainamide can alter their blood levels.

Analogs

Analogs of Neo-Penotran Forte L are Metromicon-Neo, Ginalgin, Klion-D 100, Klomezol, Pulsitex, Ginofort, Klevazol, Kandibene, Candisan, Ketonazole, Livarol, Gravagin, Clotrimazole, Metronidazole, Metrogil, Vaginal, Mikogalazol, Trichopol.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, not refrigerated.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Neo-Penotran Forte L

Reviews of Neo-Penotran Forte L are mostly positive. Patients confirm the effectiveness of the drug in the treatment of thrush, including in its chronic form.

Price for Neo-Penotran Forte L in pharmacies

The price for Neo-Penotran Forte L for a package containing 7 suppositories can be 858-1099 rubles.