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Antibiotics

Metronidazole STADA® 250 mg

 

Pack size:

Box of 2 blisters x 10 film-coated tablets.


Composition:

Each film-coated tablet contains metronidazole 250 mg.


Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from light.

Do not store above 30oC.


 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of susceptible protozoal infections such as trichomoniasis, amoebiasis, balantidiasis, Blastocystis hominis infections, giardiasis, dracunculiasis.
  • Treatment and prophylaxis of anaerobic bacterial infections. Specific bacterial infections include bacterial vaginosis, acute necrotising ulcerative gingivitis, pelvic inflammatory disease and antibiotic-associated colitis.
  • Eradicate Helicobacter pylori in peptic ulcer disease (in combination with other drugs).
     
  • Administered orally with or after food.
     
  • Trichomoniasis:
    A single 2 g dose or a 7-day course of 250 mg, 3 times daily.
    Sexual partners should also be treated.
  • Amoebiasis
    Acute intestinal amoebiasis caused by E. histolytica.:
    Adult: 750 mg, 3 times daily for 5 - 10 days.
    Children: 35 - 50 mg/kg daily in 3 divided doses for 5 - 10 days.
    Amoebic liver abscess:
    Adult: 500 - 750 mg, 3 times daily for 5 - 10 days or 1.5 - 2.5 g as a single daily dose for 2 or 3 days.
    Children: 35 - 50 mg/kg daily in 3 divided doses for 5 - 10 days.
  • Balantidiasis and Blastocystis hominis infection:
    750 mg, 3 times daily for 5 - 10 days, respectively.
  • Giardiasis:
    Adult: 2 g once daily for 3 successive days or 250 mg three times daily for 5 - 7 days.
    Children: 15 mg/kg daily in 3 divided doses for 5 - 7 days.
  • Dracunculiasis:
    Adult: 250 mg, 3 times daily or 25 mg/kg daily for 10 days.
    Children: 25 mg/kg daily for 10 days, not be exceeded 750 mg daily (include children over 30 kg)
  • Anaerobic bacterial infections:
    7.5 mg/kg to maximum of 1 g every 6 hours for 7 days or more.
  • Bacterial vaginosis:
    A single 2 g dose or as a 5 to 7-day course of 500 mg twice daily.
  • Acute necrotising ulcerative gingivitis:
    250 mg three times daily is given orally for 3 days; similar doses are used in acute oral infections.
  • Antibiotic-associated colitis:
    500 mg, 3 - 4 times daily.
  • Pelvic inflammatory:
    500 mg twice daily in conjunction with ofloxacin given orally in a dosage of 400 mg twice daily; therapy should be continued for 14 days.
  • Prevention of postoperative anaerobic bacterial infections:
    20 - 30 mg/kg daily in 3 divided doses.
  • H. pylori associate peptic ulcer disease:
    500 mg, 3 times daily in combination with at least one other agent that has activity against H. pylori (e.g. bismuth subsalicylate, amoxicillin...) for 1 - 2 weeks.
  • Hepatic impairment:
    Since metronidazole is mainly metabolised by hepatic oxidation, accumulation of metronidazole and its metabolites is likely in patients with severely impaired hepatic function. Metronidazole should therefore be given with caution and at reduced doses to patients with severe hepatic impairment, and especially hepatic encephalopathy when adverse effects of metronidazole can add to the symptoms of the disease. One-third of the usual daily dose may be given once daily in these patients. For patients with lesser degrees of hepatic impairment, pharmacokinetic studies have not produced consistent results and no recommendations about dosage reduction.
  • Renal impairment:
    The elimination of metronidazole is largely unchanged in patients with renal impairment, although metabolites may accumulate in patients with end-stage renal disease on dialysis. Dosage reductions are therefore not usually recommended for patients with renal impairment although, since both metronidazole and its metabolites are removed by haemodialysis, doses need to be given immediately after haemodialysis.


Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to metronidazole or other nitroimidazole derivatives or to any ingredient of the drug.
  • The first trimester of pregnancy.

     

  • The adverse effects of metronidazole are generally dose - related.

Most common:

  • Nausea, vomiting, anorexia, abdominal pain, diarrhoea and unpleasant metallic taste.

Less common:

  • Leucopenia.

Rare:

  • Agranulocytosis; epileptiform seizures, peripheral neuropathy, headache; erythema multiforme, skin rash, pruritus; darkening of the urine.

     

  • Metronidazole appears to inhibit alcohol dehydrogenase and other alcohol oxidizing enzymes. Mild disulfiram - like reactions including flushing, headache, nausea, vomiting, abdominal cramps, and sweating.
  • Clinical and laboratory monitoring is advised if treatment exceeds 10 days.
  • Metronidazole should be used with caution and in reduced dosage in patients with severe hepatic impairment. Plasma concentration metronidazole be monitored in patients with severe hepatic impairment.
  • Pregnancy: Metronidazole crosses the placental barrier and enters the fetal circulation rapidly.
    There are no adequate or well - control studies to date using metronidazole in pregnant women, and the drug should be used during pregnancy only when clearly needed.
    Pregnant patients should not be treated during the first trimester.
  • Lactation: Metronidazole is secreted in human milk in concentrations similar to those found in plasma.
  • Because of the potential for tumorigenicity, shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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