เอกสารกำกับยา Eng

Neo-Penotran® Forte Vaginal Suppository

COMPOSITION :
Each pessary contains Metronidazole 750 mg and Miconazole nitrate 200 mg.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:
Neo-Penotran
® Forte pessaries contain miconazole nitrate for antifungal and metronidazole for antibacterial and antitrichomonal effects. Miconazole nitrate which is a synthetic imidazolederivative agent has a wide spectrum of activity and is particularly effective against pathogen fungi including Candida albicans .In addition, miconazole nitrate is effective against Gram possitive bacteria. Miconazole shows its effect by ergosterol synthesis in the  cytoplasmic membrane. Miconazole nitrate changes permeability of the mycotic cell and inhibits glucose utilization in vitro. 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 mg/ml. Metronidazole is metabolized in the liver. The hydroxy metabolite is effective. 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:
Neo-Penotran
® Forte should be used in the treatment of vaginal candidiasis due to Candida albicans, in bacterial vaginitis due to anaerobic bacteria and in trichomonal vaginitis due to Trichomonas vaginalis and in mixed vaginal infections

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.

WARNINGS AND 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 pessary formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragmsor 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 clearence may be impaired. Metronidazole may increase encephalopathy symtoms 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. The half life of lidocaine may be prolonged two folds or more in patients with impaired liver function. Impaired renal function does not affect the pharmacokinetics of lidocaine but may increase accumulation of metabolites.

Pregnancy and Lactation:
Pregnancy category is B for metronidazole and C for miconazole.Neo-Penotran
® Forte pessaries may be used in cases considered essential by a physician, but should be used under control. Breastfeeding should be discontinued, since metronidazole appears in milk. Breastfeeding can be started again 24-48 hours after the end of treatment .

SIDE EFFECT AND 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 route). Miconazole nitrate can cause vaginal irritation (burning, itching) as all other imidazole derivative antifungal drugs applied intravaginally (2-6%). These symptoms may be prevented with the local anesthetic action of lidocaine. 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 diarrhoea, constipation, dizziness, headache, lack of appetite, vomiting, nausea, abdominal pain or cramp, seldom taste changes, constipation, dry mouth, metallic or bad taste,  tiredness. These side effects occur very rarely, because of low blood levels of metronidazole after intravaginal application. 

INFORM YOUR 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 below.

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.
Warfarin (Türkçe prospectus değişikliği onaylanınca eklenecek)
Interference with blood levels of liver enzymes, glucose (hexokinase method), theophylline, and procainamide have been observed during the treatment with metronidazole.

DOSAGE AND ADMINISTRATION:
Do not use without consulting a physician. If it is not advised to the contrary by a physician; one pessary 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 pessary  at night for 14 days is recommended.
Pessaries should be applied in lying position. Insert the pessary 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 AND TREATMENT :
There is no human experience with overdosage of intravaginal Metronidazole. There exist no specific antidote; symptomatic therapy can be applied. If accidental ingestion of large quantities of the product occurs an appropriate method of gastric emptying may be used if considered desirable. 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.

STORAGE CONDITIONS:
Store at room  temperature below 25
oC, do not store in a refrigerator.
Keep out of the reach of children and  keep the product in its original package.
Do not use after the expiration date indicated on the package.

PACKAGE:
A package contains 7 pessaries with 7 disposable fingerstalls.

Manufactured by: Interphil Laboratories, Inc., Laguna, Phillipines.

Imported by: Exeltis (Thailand) Co., Ltd., Bangkok., Thailand

www.neopenotranshop.com

Visitors: 71,698