Neo-Penotran®

Brand Embil Pharmaceutical

In stock 1082 Items

Available since: 2019-09-19

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Clinical Pharmacology

Suppositories Neo-Penotran^® Forte L contains miconazole, which has antifungal effects, metronidazole, which has antibacterial and antitrihomonadny effects, as well as lidocaine, which gives a local anesthetic effect.

Miconazole which is a synthetic imidazole derivative, has antifungal activity and has a wide spectrum of action. Especially effective against pathogenic fungi, includingCandida albicans. In addition, miconazole is effective against gram-positive bacteria. The action of miconazole is the synthesis of ergosterol in the cytoplasmic membrane. Miconazole changes the permeability of mycotic cellsCandida species and inhibits glucose uptakein vitro.

Metronidazole, which is a 5-nitroimidazole derivative, is an antiprotozoan and antibacterial agent effective against several infections caused by anaerobic bacteria and protozoa, such asTrichomonas vaginalis, Gardnerella vaginalis and anaerobic bacteria, incl. anaerobic streptococci. Miconazole and metronidazole do not have a synergistic or antagonistic effect while taking.

Lidocaine stabilizes the neural membrane, inhibiting the ion fluxes necessary for the occurrence 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.

Composition

1 suppository contains:

Active substances: metronidazole micronized 750 mg, miconazole micronized nitrate 200 mg, lidocaine 100 mg;

Excipients: Witepsol - 1436.75 mg.

Neo-Penotran® is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Neo-Penotran Forte L	Embil Pharmaceutical	Turkey	suppositories
Neo-Penotran	Embil Pharmaceutical	Turkey	suppositories

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Dosage and Administration

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

Unless otherwise recommended by the doctor, 1 suppository is administered deep into the vagina overnight for 7 days.

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

Adverse reactions

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 frequency of systemic side effects is very low, because with vaginal use of metronidazole contained in vaginal suppositories Neo-Penotran Forte-L, plasma concentrations of metronidazole are very low (2-12% compared with oral administration).
Miconazole nitrate, like all other antifungal agents based on imidazole derivatives that are inserted into the vagina, can cause vaginal irritation (burning, itching) (2-6%). Such symptoms can be eliminated 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, psychoemotional disturbances, peripheral neuropathy during overdose and prolonged use, convulsions; diarrhea (rarely), constipation, dizziness, headache, loss of appetite, nausea, vomiting, pain or cramps in the abdomen, change in taste (rarely), 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.

Contraindications

I trimester of pregnancy;
porphyria;
epilepsy;
severe abnormal liver function;
Hypersensitivity to the components of the drug Neo-Penotran Forte L.

Drug interactions

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

Alcohol: disulfiram-like reactions.

Oral anticoagulants: increased anticoagulant effect.

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

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

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

Cimetidine: possible increase in the level of metronidazole in the blood and, consequently, increased risk of neurological side effects.

Lithium: may increase the toxicity of lithium.

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

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

Pregnancy and Lactation

Metronidazole and lidocaine belong to category B, miconazole - to 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 stop because metronidazole passes into breast milk. Feeding can be resumed within 24-48 hours after the end of treatment. It is not known whether lidocaine penetrates into breast milk. A nursing woman should take lidocaine with caution.

Special instructions

Not recommended for use in children and virgins.
Alcohol intake should be avoided during treatment and, at least, within 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.Care should be taken 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 insufficiency, the dose of metronidazole should be reduced.
In severe hepatic impairment, clearance of metronidazole may be impaired.
Metronidazole can 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 impaired liver function, the half-life of lidocaine may increase by two or more times.
Reduced renal function does not affect the pharmacokinetics of lidocaine, but may cause accumulation of metabolites.
Influence on ability to drive motor transport and control mechanisms
Suppositories Neo-Penotran Forte-L do not affect the ability to drive and work with mechanisms.
Preclinical safety data
Preclinical studies of safety, pharmacology, toxicity at repeated use, genotoxicity, carcinogenic potential, toxicity for reproduction, revealed no potential risk to humans.

Overdosage

Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, paresthesia, convulsions, leukopenia, dark urine. Symptoms in 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, if necessary, gastric lavage can be done No special antidote; applied symptomatic treatment. Treatment should be prescribed to individuals taking a dose of 12 g of metronidazole.