COMPOSITIONS :
Metronidazole Tablet 500 mg, each tablet contains : Metronidazole 500 mg.
DESCRIPTIONS :
Metronidazole containing Metronidazole is available in tablet 500 mg and infusion 500 mg/100 ml.
INDICATIONS :
Urethritis and vaginitis due to Trichomonas vaginalis.
Amoebiasis (intestinal and hepatic amoebiasis).
Prevention of post-operative anaerobic infection.
Giardiasis due to Giardia lambliasis.
DOSAGE AND ADMINISTRATIONS :
Metronidazole Tablet :
It is recommended to take the tablet during or after meal.
Amoebiasis :
Adults, intestinal amoebiasis : 750 mg, 3 times daily for 5 to 10 days.
Adults, hepatic amoebiasis : 750 mg, 3 times daily for 5 to 10 days.
Children : 35 – 50 mg/kgBW/day, divided into 3 doses, for 10 days.
Trichomoniasis :
To prevent reinfection of Trichomoniasis, spouse of a patient should be given the same dosage regiment.
Adults : 2 g, given either as a single dose in one day; or 500 mg, 2 times daily; or 250 mg, 3 times daily for 7 consecutive days.
Children : 15 mg/kgBW daily, divided into 3 doses, for 7 to 10 days.
Giardiasis :
Adults : 250 mg to 500 mg, 3 times daily, for 5 to 7 days or 2 g daily, as a single dose for 3 days.
Children : 5 mg/kgBW, 3 times daily, for 5 to 7 days.
Anaerobic bacterial infections :
In serious infection, Metronidazole intravenous has to be given as an initial treatment.
Adult : 7.5 mg/kgBW, every 6 hours ( 500 mg for a 70 kg adult), maximum : 4 g daily, for 7 to 10 days.
OVERDOSAGE :
Dose of Metronidazole up to 15 g may cause overdosage symptoms, such as : nausea, vomiting and ataxia.
Treatment for Metronidazole overdosage : Supportive or symptomatic treatment.
CONTRAINDICATIONS :
Hypersensitivity to Metronidazole or to other Nitroimidazoles.
During the 1st trimester of pregnancy.
WARNINGS AND PRECAUTIONS :
Used with caution in nursing mothers as Metronidazole is excreted in breast milk and during first and second trimesters of pregnancy as Metronidazole crosses the placental barrier.
Used with caution in patients with central nervous system diseases. Disturbances of central nervous system has been reported in some cases but disappeared if therapy is discontinued or dose decreased.
Taking alcohol during Metronidazole therapy may cause abdominal cramps, nausea, vomiting, headache, flushing.
In prolonged Metronidazole administration, it is recommended to perform hematological tests.
Dosage should be reduce and administered with caution to patients with hepatic disease.
Safety and effectiveness in pediatric patients have not been established, except in the treatment of amoebiasis.
DRUG INTERACTIONS :
It is recommended to use Metronidazole as single therapy. In combination with other antibiotics, both should be given in a full dose for normal therapy.
Concomitant use with Warfarin and Coumarin anticoagulants : Prolonged prothrombin time should be considered and reduce the anticoagulant dose if necessary.
Cimetidine might prolong Metronidazole plasma clearance which leads to toxic concentration of Metronidazole.
Psychotic reaction has been reported when concomitant Metronidazole, Disulfiram and alcohol was taken simultaneously.
ADVERSE REACTIONS :
Nausea, anorexia and epigastric pain have been reported.
Serious adverse reactions reported : Convulsive seizure and peripheral neuropathy.
Bad taste, furred tongue, nausea, vomiting or gastrointestinal disturbance are frequently reported.
Urticaria, skin rash, pruritus, angioedema and anaphylactic shock (rare).
Rarely : Sleepy, dizziness, headache, ataxia and dark urine (due to metabolite of Metronidazole).
Mild reversible leucopenia in some patients has been reported.
PRESENTATIONS :
Metronidazole Tablet 500 mg Box, 10 strips @ 10 tablets
Reg. No. GKL9402319110A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
