Trazol Forte

Trazol Forte
17 May

Trazol Forte

Amoebicidal & Antiprotozoals
  • Metronidazole is a 5-nitroimidazole derivative with activity against:
    • Anaerobic bacteria (Bacteroides, Clostridium Spp., Gardnerellavaginalis, and Helicobacter pylori)
    • Protozoa (including Balantidium coli, Blastocystishominis, Entamoebahistolytica, Giardia Lamblia and Trichomonasvaginalis).
  • 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.

Indecation

  • TRAZOL®is used in the prophylaxis and treatment of  susceptible protozoal infections such as:
    • Amoebiasis, Balantidiasis, Blastocystishominis 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.

Dosage & Administration

  • 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:.500-1000 mg 4 times daily for 7 days.
    • 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 :
    • Invasive intestinal amoebiasis:
      •  (1-3 years): 5ml / 8 hrs
      • (3- 7 years): 5ml / 6 hrs
      • (7-10 years): 10ml / 8 hrs
    • Extra intestinal amoebiasis:
      • (1-3 years): 2.5-5 ml/ 8 hrs
      • (3-7 years): 2.5-5 ml / 6 hrs
      • (7-10 years): 5-10 ml / 8 hrs
    • AAA:
      • (1-3 years): 12.5ml daily for 3 days.
      • (3-7 years): 15-20 ml daily.
      • (7-10 years): 25ml  daily.
    • Anaerobic infections: 7.5 mg/kg every 8 hrs.
  • TRAZOL®should be taken with or after food.
  • Each tablet of  TRAZOL® Forte contains: Metronidazole 500 mg
  • Each tablet of  TRAZOL®250 contains: Metronidazole 250 mg
  • Each 5 ml of  TRAZOL®oral suspension contains: Metronidazole 200 mg (as Metronidazole benzoate)

TRAZOL®is contra-indicated in Patients with hypersensitivity to metronidazole or one of  its derivatives.

  • Concomitant use of TRAZOL®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 TRAZOL®by increasing its metabolism, and may require higher doses of TRAZOL®.
  • Concomitant use with Cimetidine may decrease the clearance of TRAZOL®thereby increasing its potential for causing adverse effects.
  • TRAZOL®should be avoided during pregnancy (especially during the first trimester)
  • Women taking TRAZOL®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.
  • TRAZOL® should be used with cautions in :
    • Patients with a history of blood dyscrasias, because the drug can cause leukopenia.
    • Patients with severe hepatic or severe renal impairment (use at lower than recommended dose).
    • Patients with peripheral neuropathy and seizure disorders, as they can be exacerbated in some patients.
    • If therapy exceeds 10 days, regular clinical and laboratory monitoring is advised.
  • TRAZOL®Forte: (Blisters of 10 tablets, Pack of 2 blisters)
  • TRAZOL®250 : (Blisters of 10 tablets, Pack of 2 blisters)
  • TRAZOL® oral suspension: (Bottle of 100 ml oral suspension)

Store in a dry place at a temperature not exceeding 25oC, and protected from light.