Neo penotran el. Candles "Neo-Penotran": does the price justify the quality. Interaction with other drugs

Suppositories vaginal

Compound

metronidazole micronized 750 mg

Miconazole nitrate micronized 200 mg

Lidocaine 100 mg

Excipients: Witepsol S55 1436.75 mg.

Pharmacodynamics

Neo-Penotran Forte-L suppositories contain miconazole, which has an antifungal effect, metronidazole, which has an antibacterial and antitrichomonal 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. 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 modifies the permeability of Candida species mycotic cells and inhibits glucose uptake in vitro.

Metronidazole, which is 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 neuronal membrane by inhibiting the ion currents necessary for the generation and conduction of impulses, thereby exerting a local anesthetic effect.

Pharmacokinetics

Miconazole nitrate: The absorption of miconazole nitrate when administered intravaginally is very small (approximately 1.4% of the dose). Miconazole nitrate can be determined in plasma within three days after intravaginal administration of Neo-Penotran Forte-L suppositories.

Metronidazole: The bioavailability of metronidazole when administered intravaginally is 20% compared with oral administration. The equilibrium concentration of metronidazole in plasma is 1.1-5.0 μg / ml after daily intravaginal administration of Neo-Penotran Forte-L suppositories for 3 days. Metronidazole is metabolized in the liver by oxidation. The main metabolites of metronidazole are hydroxy derivatives and acetic acid compounds, which are excreted by the kidneys. The biological activity of hydroxy metabolites is 30% of the biological activity of metronidazole. T1 / 2 of metronidazole is 6-11 hours. After oral or intravenous administration of metronidazole, 60-80% of the dose is excreted by the kidneys (about 20% - unchanged, and in the form of metabolites).

Lidocaine: the action begins in 3-5 minutes. Lidocaine is absorbed when applied superficially to damaged skin and mucous membranes and is rapidly metabolized in the liver. Metabolites and the drug unchanged (10% of the administered dose) are excreted through the kidneys. After daily intravaginal administration of Neo-Penotran Forte-L suppositories for 3 days, lidocaine is absorbed in a minimal amount, and its plasma levels are 0.04-1 μg / ml.

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 vaginal use of metronidazole contained in Neo-Penotran Forte-L vaginal suppositories, the plasma concentration of metronidazole is very low (2-12% compared with 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 the systemic use of metronidazole include hypersensitivity reactions (rarely), leukopenia, ataxia, psycho-emotional disorders, peripheral neuropathy with 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, increased fatigue. These side effects occur in extremely rare cases, since blood levels of metronidazole with intravaginal use are very low.

Selling Features

prescription

Special conditions

It is necessary to avoid alcohol during treatment and at least for 24-48 hours after the end of the course due to possible disulfiram-like reactions. Large doses and prolonged systematic use of the drug can cause peripheral neuropathy and convulsions. 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 renal insufficiency, the dose of metronidazole should be reduced.

In severe hepatic impairment, 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 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 vehicles and control mechanisms

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

Preclinical safety data

Preclinical studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity have not identified a potential risk to humans.

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.

Contraindications

I trimester of pregnancy;

Porfiria;

Epilepsy;

Severe liver dysfunction;

Hypersensitivity to the components of the drug.

drug interaction

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

Alcohol: disulfiram-like reactions.

Oral anticoagulants: increased anticoagulant effect.

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

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

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

Cimetidine: it is possible to increase the level of metronidazole in the blood and, therefore, 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 concentration.

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

Last update of the description by the manufacturer 31.07.2014

Filterable List

Active substance:

Description of the dosage form

Vaginal suppositories in the form of a flat body with a rounded end, white or almost white.

pharmachologic effect

Pharmacodynamics

The drug contains metronidazole, which has an antibacterial and antitrichomonal effect, and miconazole, which has an antifungal effect.

Metronidazole is an antibacterial and antiprotozoal agent and is active against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococcus and Trichomonas vaginalis.

miconazole nitrate has a wide spectrum of activity (especially active against pathogenic fungi, including candida albicans- the causative agent of thrush), effective against gram-positive bacteria.

Pharmacokinetics

The bioavailability of metronidazole with intravaginal use is 20% compared with oral administration. After vaginal administration of the drug Neo-Penotran ® Forte, when the equilibrium state was reached, the plasma concentration of metronidazole was 1.6-7.2 μg / ml. Systemic absorption of miconazole nitrate with this route of administration is very low (approximately 1.4% of the dose), miconazole nitrate in plasma was not detected.

Metronidazole is metabolized in the liver. The hydroxyl metabolite is active. T1 / 2 metronidazole - 6-11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys.

Indications for Neo-Penotran ® Forte

vaginal candidiasis;

bacterial vaginosis;

trichomonas vaginitis;

vaginitis caused by mixed infections.

Contraindications

known hypersensitivity to the active components of the drug or their derivatives;

I trimester of pregnancy;

porphyria;

epilepsy;

severe liver dysfunction;

patients under the age of 18 due to insufficient data on the use in this age category;

virgins.

Use during pregnancy and lactation

Suppositories Neo-Penotran ® Forte can be used after the first trimester of pregnancy under medical supervision, provided that the intended benefit to the mother outweighs the potential risk to the fetus.

At the time of treatment, breastfeeding should be stopped, since metronidazole passes into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment.

Side effects

In rare cases, allergic reactions (skin rash) and side effects may occur, in particular abdominal pain, headache, vaginal irritation (burning, itching).

Local reactions: miconazole nitrate can cause vaginal irritation (burning, itching), as with the intravaginal use of any other antifungal drugs based on imidazole derivatives (2-6%). If irritation is severe, treatment should be discontinued.

Systemic side effects occur very rarely, since the level of metronidazole in plasma is very low during vaginal absorption.

Side effects associated with systemic absorption of metronidazole include: allergic reactions (rarely), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsions; rarely - diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, change in taste (rarely), dry mouth, metallic or unpleasant taste, increased fatigue.

Interaction

Alcohol: the interaction of metronidazole with alcohol can cause disulfiram-like reactions.

Oral anticoagulants: increased anticoagulant action.

Phenytoin: a decrease in the concentration of metronidazole in the blood while increasing the concentration of phenytoin.

Phenobarbital: decrease in the concentration of metronidazole in the blood.

Disulfiram: possible side effects from the central nervous system (psychotic reactions).

Cimetidine: may increase the concentration of metronidazole in the blood and increase the risk of neurological side effects.

Lithium: an increase in lithium toxicity may be observed.

Astemizole and terfenadine: Metronidazole and miconazole inhibit the metabolism of these substances and increase their plasma concentration.

Dosage and administration

intravaginally, 1 vaginal suppository is injected deep into the vagina for 7 days at night.

With recurrent vaginitis or vaginitis resistant to other types of treatment - within 14 days.

Suppositories should be inserted deep into the vagina.

Elderly patients (over 65 years old) - same recommendations as for younger patients.

Overdose

Data on overdose in humans with intravaginal use of metronidazole are not available. However, when administered intravaginally, metronidazole may be absorbed in sufficient amounts to cause systemic effects.

Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, dark urine .

Symptoms of an overdose of miconazole nitrate have not been identified.

Treatment: symptomatic and supportive therapy. In case of accidental ingestion of a large number of suppositories, if necessary, gastric lavage. Improvement in the condition after being achieved in individuals who have taken orally up to 12 g of metronidazole. There is no specific antidote.

special instructions

Preclinical data indicate no specific risk to humans based on standard safety studies, pharmacology, repeated dose toxicity, hepatotoxicity, carcinogenic potential, reproductive system toxicity.

It is necessary to avoid alcohol during treatment and at least for 24-48 hours after the end of the course due to possible disulfiram-like reactions.

Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms due to possible damage to the rubber of the suppository base.

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

Neo-penotran is a combination product containing two active ingredients: miconazole, the effect of which is aimed at eliminating the fungus, and metronidazole, which has a detrimental effect on some representatives of the bacterial flora.

Working together, these substances destroy a wide range of harmful organisms that cause thrush, microflora disorders and inflammation of the vaginal mucosa.

In this article, we will look at why doctors prescribe Neo-penotran forte, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Neo-penotran forte can be read in the comments.

Composition and form of release

Clinico-pharmacological group: drug with antibacterial, antiprotozoal and antifungal activity for local use in gynecology.

Depending on the amount of active substances, it is customary to distinguish the following types of drugs:

• Candles "Neo-Penotran" contain 500 mg of metronidazole and 100 mg of miconazole nitrate.
• Candles "Neo-Penotran Forte" have a large dose of active substances, namely, 750 mg of metronidazole and 200 mg of miconazole nitrate.

There are also Neo-Penotran Forte-L vaginal suppositories, which also contain metronidazole and miconazole nitrate in amounts of 750 and 200 mg, respectively. In addition, the composition of the drug includes lidocaine (100 mg).

What are neo-penotran forte candles used for?

This drug is prescribed only for women, it is not intended for the male population. "Neo-Penotran Forte", an analogue of the drug, that is, a substitute with similar therapeutic actions, is prescribed for the following diseases:

• bacterial vaginosis;
• trichomonas vaginitis;
• vaginal candidiasis;
• vaginitis caused by mixed infections.

pharmachologic effect

The active substance of Neo Penotran has a local antifungal, antiprotozoal and antibacterial effect. The components included in the preparation are active against:

• Trichomonas vaginalis;
• Pathogenic fungi, including Candida albicans;
• Gardnerella vaginalis;
• Anaerobic bacteria, including anaerobic streptococcus.

According to reviews, Neo Penotran is also effective against some gram-positive bacteria.

Instructions for use

According to the instructions for use, Neo-penotran forte is administered intravaginally, 1 suppository at night for 7 days.

• For recurrent vaginitis or vaginitis resistant to other treatments, Neo-Penotran Forte should be used for 14 days.

Vaginal suppositories should be inserted deep into the vagina using the disposable fingertips contained in the package.

Contraindications

Neo-Penotran Forte contraindications:

• severe liver dysfunction;
• I trimester of pregnancy;
• porphyria;
• epilepsy;
• patients under the age of 18 due to insufficient data on the use in this age category, virgins;
• hypersensitivity to the active components of the drug or their derivatives.

Side effects

Candles "Neo-Penotran Forte" can contribute to the following symptoms:

• Disorders of the nervous system, such as fatigue, dizziness and weakness, convulsions, irascibility and mood changes, false sensations, headache.
• Allergies: itching, hives, rash, swelling, redness of the face and even anaphylactic shock.
• Vaginal discomfort: itching, burning, redness, irritation. In case of severe irritation, it is necessary to stop treatment with this drug.
• Nausea, vomiting, diarrhea, loss of appetite, dry or metallic taste in the mouth, stomatitis, impaired taste buds, constipation, abdominal pain.
• Violation of blood readings, for example, a decrease in the number of leukocytes.

Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, dark urine.

Use during pregnancy

Neo penotran forte can be used to treat pregnant women after the first trimester. This should be done only under the supervision of a doctor, provided that the benefits for the expectant mother are much higher than the harm to the health of the baby. During lactation, this drug is not recommended.

G.01.A.F.20 Combinations of imidazole derivatives

Instructions for use
Neo-Penotran forte L supp. vag. #7

Dosage forms
vaginal suppositories 100mg+750mg+200mg

Synonyms
There are no synonyms.

Group
Combined antimicrobials

International non-proprietary name
Lidocaine + Metronidazole + Miconazole

Manufacturers
Embil Pharmaceutical Co. Ltd (Turkey)

Pharmachologic effect:
The drug contains metronidazole, which has an antibacterial and antitrichomonal effect, and miconazole, which has an antifungal effect. Metronidazole is an antibacterial and antiprotozoal agent and is active against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococcus and Trichomonas vaginalis. Miconazole nitrate has a wide spectrum of activity (especially active against pathogenic fungi, including Candida albicans, the causative agent of thrush), effective against gram-positive bacteria.
Indications for use:
Neo-Penotran® Fortevaginal candidiasis; bacterial vaginosis; trichomonas vaginitis; vaginitis caused by mixed infections.
Contraindications:
known hypersensitivity to the active components of the drug or their derivatives; I trimester of pregnancy; porphyria; epilepsy; severe liver dysfunction; patients under the age of 18 due to insufficient data on the use in this age category; virgins.
Use during pregnancy and lactation:
Neo-Penotran® Forte suppositories can be used after the first trimester of pregnancy under medical supervision, provided that the intended benefit to the mother outweighs the potential risk to the fetus. At the time of treatment, breastfeeding should be stopped, since metronidazole passes into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment.
Dosage and administration:
In rare cases, allergic reactions (skin rash) and side effects may occur, in particular abdominal pain, headache, vaginal irritation (burning, itching). Local reactions: miconazole nitrate can cause vaginal irritation (burning, itching), as with the intravaginal use of any other antifungal drugs based on imidazole derivatives (2-6%). If irritation is severe, treatment should be discontinued. Systemic side effects are very rare, since plasma levels of metronidazole are very low during vaginal absorption. Side effects associated with systemic absorption of metronidazole include: allergic reactions (rarely), leukopenia, ataxia, mental changes (anxiety, mood lability), convulsions; rarely - diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, change in taste (rarely), dry mouth, metallic or unpleasant taste, increased fatigue.
Side effects:
Alcohol: The interaction of metronidazole with alcohol can cause disulfiram-like reactions. Oral anticoagulants: increased anticoagulant action. Phenytoin: a decrease in the concentration of metronidazole in the blood while increasing the concentration of phenytoin. Phenobarbital: decrease in the concentration of metronidazole in the blood. Disulfiram: possible side effects from the central nervous system (psychotic reactions). Cimetidine: The concentration of metronidazole in the blood may increase and the risk of developing neurological side effects may increase. Lithium: There may be an increase in lithium toxicity. Astemizole and terfenadine: metronidazole and miconazole inhibit the metabolism of these substances and increase their plasma concentration.
Special instructions:
Intravaginally, 1 vaginal suppository is injected deep into the vagina for 7 days at night. With recurrent vaginitis or vaginitis resistant to other types of treatment - within 14 days. Suppositories should be inserted deep into the vagina. Elderly patients (over 65 years old) - the same recommendations as for younger patients.
Drug interaction:
Data on overdose in humans with intravaginal use of metronidazole are not available. However, when administered intravaginally, metronidazole may be absorbed in sufficient amounts to cause systemic effects. Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, dark urine. Symptoms of an overdose of miconazole nitrate have not been identified. Treatment: symptomatic and supportive therapy. In case of accidental ingestion of a large number of suppositories, if necessary, gastric lavage. Improvement in the condition after being achieved in individuals who have taken orally up to 12 g of metronidazole. There is no specific antidote.
Overdose:
Preclinical data indicate no specific risk to humans based on standard safety studies, pharmacology, repeated dose toxicity, hepatotoxicity, carcinogenic potential, reproductive system toxicity. It is necessary to avoid alcohol during treatment and at least for 24-48 hours after the end of the course due to possible disulfiram-like reactions. Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms due to possible damage to the rubber of the suppository base. In patients with trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary. Do not swallow or use in any other way than intravaginal! Laboratory tests: changes in the results are possible when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood. Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. Do not affect the ability to drive a car and work with mechanisms.

Storage conditions:
Neo-Penotran® Forte At a temperature not exceeding 25 °C. Suppositories can be stored in the refrigerator (2-8 °C). Do not freeze. Keep out of the reach of children.
Best before date:
Neo-Penotran® Forte 2 years.