Neo-Penotran Forte

Neo-Penotran Forte

Manufacturer:

Exeltis

Distributor:

DKLL
Full Prescribing Info
Contents
Metronidazole, miconazole nitrate.
Description
Each suppository contains Metronidazole 750 mg and Miconazole nitrate 200 mg.
Action
Pharmacology: Pharmacodynamics: Neo-Penotran Forte suppositories contain miconazole nitrate for antifungal and metronidazole for antibacterial and antitrichomonal effects. Miconazole nitrate which is a synthetic imidazole derivative antifungal has a wide spectrum of activity and is particularly effective against pathogen fungi including Candida albicans. In addition, miconazole nitrate is effective against Gram positive bacteria. Miconazole shows its effect by interfering ergosterol synthesis in the cytoplasmic membrane. Miconazole nitrate changes permeability of the mycotic cell of Candida species. Metronidazole, a 5-nitroimidazole derivative is an antiprotozoal and an antibacterial agent and is 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 have not synergic or antagonistic when administered concomitantly.
Pharmacokinetics: Absorption of miconazole nitrate through the intravaginal route is very low (approximately 1.4% of dose). Bioavailability of metronidazole by this route is 20% compared to the oral route. Miconazole nitrate could not be detected in plasma after vaginal application of Neo-Penotran Forte, steady state levels of metronidazole in plasma ranged 1.1-5.0 μg/ml. Metronidazole is metabolized in the liver by oxidation. Major metabolites of metronidazole, hydroxyl and acetic acid metabolites, are excreted in urine. The hydroxyl metabolite has a 30% of biologic activity of metronidazole. The half-life of metronidazole is 6-11 hours. After oral or intravenous application of metronidazole, 60-80% of the dose is excreted renally (unchanged (20%) and as metabolites).
Indications/Uses
Neo-Penotran Forte should be used in the treatment of vaginal candidiasis due to Candida albicans, in bacterial vaginitis due to anaerobic bacteria and Gardnerella vaginalis, in trichomonal vaginitis due to Trichomonas vaginalis and in mixed vaginal infections.
Dosage/Direction for Use
Do not use without consulting a physician. If it not advised to the contrary by a physician; one suppository should be inserted high into the vagina at night for 7 days.
In recurrent cases, or when the vaginitis has been resistant to other treatments, application of one suppository at night for 14 days is recommended.
Suppositories should be applied in lying position. Insert the suppository high into the vagina using disposable finger stalls provided in the package.
Elderly (over 65 years): As for younger adults.
Children: Not recommended for children.
Not recommended for virgins.
Not to be swallowed or applied by other routes.
Overdosage
If accidental ingestion of large quantities of the product occurs an appropriate method of gastric emptying may be used if considered desirable. There exist no specific antidote; symptomatic therapy can be applied. Cure can be provided in persons who ingested a dose of 12 g of metronidazole. Symptoms of metronidazole overdose are nausea, vomiting, abdominal pain, diarrhea, pruritus, metallic taste, ataxia, vertigo, paresthesias, convulsion, leukopenia, darkening of urine. Symptoms of miconazole nitrate overdose are nausea, vomiting, sore throat and mouth, anorexia, headache, diarrhea.
Contraindications
Neo-Penotran Forte should not be used in patients known to be hypersensitive to the active ingredients or their derivatives, during the first trimester of pregnancy, in cases of porphyria, epilepsy and serious liver function disorders.
Special Precautions
Patients should be warned not to take alcohol during the therapy and for at 2 days after the end of a course of treatment, because of the possibility of disulfiram-like reactions. High doses and long term systemic usage may cause peripheric neuropathy and convulsion. The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms or condoms, therefore concurrent use is not recommended. Sexual partners of patients with Trichomonas vaginalis should be treated at the same time. Metronidazole dose must be reduced in renal failure. In serious liver function failures metronidazole clearance may be impaired. Metronidazole may increase encephalopathy symptoms due to increased plasma levels and therefore should be used carefully in hepatic encephalopathy patients. The daily dose of metronidazole must be reduced to 1/3 in patients with hepatic encephalopathy.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy category is B for metronidazole and C for miconazole, Neo-Penotran Forte suppositories may be used after the first trimester of pregnancy in cases considered essential by a physician but should be used under control.
Use in Lactation: Breastfeeding should be discontinued, since metronidazole appears in milk. Breastfeeding can be started again 24-28 hours after the end of treatment.
Adverse Reactions
Hypersensitivity reactions (skin rash) and side effects like abdominal pain, headache, vaginal itching, burning and irritation may be observed rarely. The incidence of systemic side effects is very rare since after intravaginal administration of metronidazole, very low plasma levels are observed (2-12% compared to oral routed). Miconazole nitrate can cause vaginal irritation (burning, itching) as all other imidazole derivative antifungal drugs applied intravaginally (2-6%). If there is severe irritation, treatment should be discontinued. Side effects due to systemic use of metronidazole are; hypersensitivity reactions (rare), leukopenia, ataxia, mental changes, peripheral neuropathy at overdose and after long period of usage, convulsion, seldom diarrhea, constipation, dizziness, headache, lack of appetite, vomiting, nausea, abdominal pain or cramp, seldom taste changes, dry mouth, metallic or bad taste, tiredness. These side effects occur very rarely, because of low blood levels of metronidazole after intravaginal application.
THE PATIENT MUST INFORM HIS/HER PHYSICIAN WHENEVER AN UNEXPECTED EFFECT IS OBSERVED.
Drug Interactions
Due to Metronidazole absorption, the following interactions can be seen if used concomitantly with the drugs as follows: Alcohol: Alcohol intolerance (disulfiram-like reaction);
Oral anticoagulants: Increase in anticoagulant effect.
Phenytoin: Increase in blood levels of phenytoin, decrease in blood levels of metronidazole.
Phenobarbital: Decrease in blood levels of metronidazole.
Disulfiram: Central nervous system related effects (e.g. psychotic reactions) may occur.
Cimetidine: The blood level of metronidazole and the risk of neurologic side effects may increase.
Lithium: Increase in lithium toxicity can be observed.
Astemizole and terfenadine: Metronidazole and miconazole inhibit the metabolism of these drugs and increase their plasma concentrations. Interference with blood levels of liver enzymes, glucose (hexokinase method), theophylline and procainamide have been observed during the treatment with metronidazole.
Storage
Do not store above 30°C.
ATC Classification
G01AF20 - combinations of imidazole derivatives ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vag supp 7's.
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