Metronidazole
Composition
Each 100 ml contains
Metronidazole 500 mg
Description
Trichomoniacide, anaerobicida
Disposition of Metronidazole in the body is similar for both oral and IV dosage forms, with an average elimination half life in healthy humans of 8 hours. Metronidazole appears in cerebrospinal fluid, saliva and human milk in concentrations similar to those found in plasma. Bactericidal concentrations of Metronidazole have also been detected in pus from hepatic abscesses.
Indications
- Urethritis dan vaginitis (due to trichomonas vaginalis)
- Amoebiasis (intestinal and hepatic amoebiasis)
- Prevention of post operative anaerob infection
- Giardiasis ( due to Giardia lambliasis)
Contra indications
- Patients who hypersensitive to Metronidazole or other derivate of nitroimidazole.
- The first trimester of pregnancy.
Side effects
- Some times vomiting, anorexia, diarrhoea, painful on epigastrium.
- Serious side effect occur have been reported: convulsive seizure and neurophaty perifer.
- Unpleasant taste in the mouth, furred tongue, nausea, vomiting, or gastrointestinal disturbance have been reported.
- Urticaria, pruritus, angiodema and anafilaksis may occur rarely.
- Dizziness, drowsiness, headache, ataxia and darkening of the urine (due to Metronidazole metabolit) have been reported but very rarely.
- Reversible a mild leucopenia has been reported in some patient.
Warning and Precautions
- Use of Metronidazole should be carefully for lactating women because Metronidazole is excreted in human milk, the second and third trimester of pregnancy should be carefully because Metronidazole crosses the placental barrier.
- Metronidazole should be administered with cautions to patient with central nervous system disturbance. (CNS disturbance on several cases have been reported, but it will disappear if the treatment is stop or reduced the dosage).
- Alcoholic beverages should not be consumed during Metronidazole therapy, because abdominal cramps, nausea, vomiting, headaches and flushing may occur.
- For the long term treatment laboratory blood test should be done.
- Patients with severe hepatic (disease metabolize Metronidazole slowly) doses below those usually recommended should be administered cautiously.
- Safety and effectiveness in children have not been established except in the treatment of amoebiasis.
Drug Interaction
- It is best to take Metronidazole alone. If combined with antibiotic, Metronidazole and antibiotic should be given in a full dosage of normal therapy.
- Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anti coagulant, resulting in a prolongation of prothrombine time.
- Cimetidine may prolong the half life and decrease plasma clearance of Metronidazole.
- Psychotic reactions have been reported in alcoholic patients who are using Metronidazole and disulfiram concurrently.
Over dosage
Single oral doses of Metronidazole up to 15 g have been reported: over dosage like nausea, vomiting and ataxia.
Treatment: could be supportive therapy or therapy to eliminate the symptoms.
Dosage
Should be infused intravenously at rate 5 ml/minute. Immediately must be replace to oral dosage form.
- Treatment of infections in which bacteria have been identified: Adult and children ‹ 12 years. In patients who can not treated by oral dosage form. Adult : 500 mg intravenously every 8 hours, Children: 7.5 mg/ kg body weight every 8 hours
- Prevention for post abdomen operative infections, (priority to colorectal ) repeatedly gynecology every 2 hours.
- Adult : 500 mg intravenously before operation, then immediately followed by 500 mg oral dosage every 8 hours. Children: 7.5 mg/kg body weight. (1.5 ml/kg body weight) every 8 hours.
Presentation
Individual box contains 1 bottle@ 100 ml
Reg. No.: DKL03055 11449A1
Storage
Store at room temperature between 25°C- 30°C.
Protect from light
HARUS DENGAN RESEP DOKTER
Manufactured by :
PT Finusolprima Farma Internasional
Bekasi-Indonesia
For
PT Actavis Indonesia,
Jakarta (Actavis Group, Iceland)
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