Indication
METAZOL® is used in the
¤ prophylaxis and treatment of susceptible protozoal infections such as:
- Amoebiasis, Balantidiasis, Blastocystis hominis infections, Giardiasis, and Trichomoniasis
¤ It has also been tried in leishmaniasis and microsporidiosis.
¤ Treatment and prophylaxis of anaerobic bacterial infections such as:
- Bacterial vaginosis, acute necrotising ulcerative gingivitis, pelvic inflammatory disease, tetanus, and antibiotic associated colitis.
- Eradicate Helicobacter pylori in peptic ulcer, duodenal ulcer disease in combination with other antimicrobials.
¤ Treatment of guinea-worm infection, perianal crohn’s disease.
Composition
Each tablet of METAZOL® Forte contains:
- Metronidazole 500 mg
Each tablet of METAZOL® 250 contains:
- Metronidazole 250 mg
Each 5 ml of METAZOL® oral suspension contains:
- Metronidazole 125 mg (as Metronidazole benzoate)
Dosage
Adults:
¤ Antiprotozoal:
- Amoebiasis: 500- 750 mg three times daily for 5 to 10 days.
- Giardiasis: 250 mg three times daily for 5 days. Or 2 g once a day for 3 days.
- Trichomoniasis: 250 mg three times daily for 7 days. Or 2 g as a single dose.
¤ Antibacterial:
- Anaerobic infections:500 mg every 8 hours .
- Vaginitis: 500 mg twice daily for 7 days.
- Colitis & diarrhea: 500 mg three or four times daily for 7 days.
¤ Peptic ulcer disease:
- 500 mg three times daily with Randin® (Ranitidine) Moxalin® (Amoxicillin) for 2 weeks.
Children :
¤ Intestinal and hepatic amoebiasis:
- 35- 50mg/kg divided into 3 doses for 10 days.
¤ Trichomniasis:
- 5mg/kg divided into 3 doses for 7 days.
¤ Giardiasis:
- 15mg/kg divided into 3 doses for 5 -7 days.
¤ Anaerobic infections:
- 20- 30mg/kg body weight/day , divided into 3- 4 doses .
METAZOL® should be taken with or after food.
Metronidazole is a 5-nitroimidazole derivative with activity against:
- anaerobic bacteria (Bacteroides, Clostridium Spp., Gardnerella vaginalis, and Helicobacter pylori)
- protozoa (including Balantidium coli, Blastocystis hominis, Entamoeba histolytica, Giardia Lamblia and Trichomonas vaginalis).
- Metronidazole is readily absorbed following administration by mouth and bioavailability approaches 100%. Peak plasma concentrations of approximately 5 and 10 μg /ml are achieved usually within 1 to 2 hours after single dose of 250 and 500 mg respectively.
- Absorption may be delayed, but is not reduced overall by administration with food.
- Metronidazole is widely distributed. It appears in most body tissues and fluids including bile, bones, breast milk, cerebral abscesses, cerebrospinal fluid, liver abscesses, saliva, seminal fluid and vaginal secretion. It also crosses the placenta and enters the fetal circulation.
- Metronidazole is metabolized in the liver by side chain oxidation and glucuronide formation.
- The elimination half life of metronidazole is about 8 hours.
- The majority of the dose of metronidazole is excreted in urine, mainly as metabolites, a small amount appears in the faeces.
Each tablet of METAZOL® Forte contains:
- Metronidazole 500 mg
Each tablet of METAZOL® 250 contains:
- Metronidazole 250 mg
Each 5 ml of METAZOL® oral suspension contains:
- Metronidazole 125 mg (as Metronidazole benzoate)
METAZOL® is used in the
¤ prophylaxis and treatment of susceptible protozoal infections such as:
- Amoebiasis, Balantidiasis, Blastocystis hominis infections, Giardiasis, and Trichomoniasis
¤ It has also been tried in leishmaniasis and microsporidiosis.
¤ Treatment and prophylaxis of anaerobic bacterial infections such as:
- Bacterial vaginosis, acute necrotising ulcerative gingivitis, pelvic inflammatory disease, tetanus, and antibiotic associated colitis.
- Eradicate Helicobacter pylori in peptic ulcer, duodenal ulcer disease in combination with other antimicrobials.
¤ Treatment of guinea-worm infection, perianal crohn’s disease.
- METAZOL® be used in patients with hypersensitivity to metronidazole or any of its derivatives.
- Concomitant use of METAZOL® with oral anticoagulants (e.g. Warfarin) prolongs prothrombine time, which should be monitored in such a case.
- Concomitant use with Barbiturates and Phenytoin may diminish the antimicrobial effectiveness of METAZOL® by increasing its metabolism, and may require higher doses of METAZOL®.
- Concomitant use with Cimetidine may decrease the clearance of METAZOL® thereby increasing its potential for causing adverse effects.
- METAZOL ® should be avoided during pregnancy (especially during the first trimester)
- Women taking METAZOL ® should not breast feed their babies during treatment.
The most common side effects are:
- Gastrointestinal disturbances especially: nausea, unpleasant metallic taste, vomiting, diarrhoea or constipation.
- Weakness, dizziness, ataxia, headache, drowsiness, skin rash and darkening of the urine.
Adults:
¤ Antiprotozoal:
- Amoebiasis: 500- 750 mg three times daily for 5 to 10 days.
- Giardiasis: 250 mg three times daily for 5 days. Or 2 g once a day for 3 days.
- Trichomoniasis: 250 mg three times daily for 7 days. Or 2 g as a single dose.
¤ Antibacterial:
- Anaerobic infections:500 mg every 8 hours .
- Vaginitis: 500 mg twice daily for 7 days.
- Colitis & diarrhea: 500 mg three or four times daily for 7 days.
¤ Peptic ulcer disease:
- 500 mg three times daily with Randin® (Ranitidine) Moxalin® (Amoxicillin) for 2 weeks.
Children :
¤ Intestinal and hepatic amoebiasis:
- 35- 50mg/kg divided into 3 doses for 10 days.
¤ Trichomniasis:
- 5mg/kg divided into 3 doses for 7 days.
¤ Giardiasis:
- 15mg/kg divided into 3 doses for 5 -7 days.
¤ Anaerobic infections:
- 20- 30mg/kg body weight/day , divided into 3- 4 doses .
METAZOL® should be taken with or after food.
Metazole should be used with caution in:
- Patients with severe hepatic or renal insufficiency (it is advised to reduce the dose).
- In the event of further infection, treatment should be stopped immediately.
- METAZOL ® Forte: (Blisters of 10 tablets, Pack of 2 blisters).
- METAZOL ® 250: (Blisters of 10 tablets, Pack of 2 blisters).
- METAZOL ® oral suspension: (Bottle of 100 ml oral suspension).
- Store in a dry place at a temperature not exceeding 30ºC, and protected from light.