KANAFLAGYL 250
Tablets

Urogenital Drugs

  • Chemical Composition

    Metronidazole 250 mg

  • Packing

    20Tablets

  • Medical Id

    T74

  • License Number

    349/2009

  • License date

    21/12/2009

Mechanism Of Action : Metronidazol is selectively taken up by anaerobic bacteria and sensitive protozoal organisms, because of the ability of these organisms to reduce metronidazol to its active form intracellularly. The nitro group of metronidazol is chemically reduced by ferredoxin (or ferredoxin-linked metabolic process) and the products are responsible for disrupting the DNA helical structure, thus inhibiting nucleic acid synthesis.
INDICATIONS Metronidazol is indicated for the treatment of: • Bacterial vaginosis due to Trichomonas vaginalis; and due to Gardnerella or Mycoplasma hominis infection. • Pelvic inflammatory disease in conjunction with other antibiotics such as ofloxacin, levofloxacin, or ceftriaxone. • Amoebic dysentery due to Entamoeba histolytica or Giardia lamblia should be treated alone or in conjunction with iodoquinol or diloxanide furoate. • Hepatic abscess due to Entamoeba histolytica. • Anaerobic bacterial infections such as Bacteroides fragilis, spp, Fusobacterium spp, Clostridium spp, Peptostreptococcus spp, Prevotella spp, or any other anaerobes in intraabdominal abscess, peritonitis, empyema, pneumonia, aspiration pneumonia, lung abscess, diabetic foot ulcer, meningitis and brain abscess, bone and joint infections, septicemia, endometritis, tubo-ovarian abscess, or endocarditis. • Pseudomembranous colitis due to Clostridium difficile . • Helicobacter pylori eradication therapy, as part of a multi-drug regimen in peptic ulcer disease. • Acute gingivitis and other dental infections.
CONTRAINDICATIONS Hypersensitivity to metronidazol or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazol is contraindicated during the first trimester of pregnancy.
Side EFFECTS The most common adverse reactions include disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain, disorder of the peripheral nerves causing weakness and numbness, dizziness, loss of appetite, decrease in the number of white blood cells in the blood (leucopenia), seizures, itchy rash (urticaria), sensation of a furry tongue, unpleasant metallic taste, inflamed and sore mouth, and headache.
WARNINGS : If the treatment course exceeds 10 days it is recommended that haematological tests, especially leucocyte count, should be carried out regularly, and that patients should be monitored for adverse reactions such as peripheral or central neuropathy. This medicine may cause various side effects that could impair the mental or physical ability to safely drive or operate machinary. It is important that the prescribed course of this antibiotic medicine should be finished, because stopping the course early increases the chance that the infection will come back and that the bacteria will grow resistant to the antibiotic. Use with caution in decreased liver function, diseases of the central nervous system (brain and spinal cord), and impairment of brain function caused by liver disease (hepatic encephalopathy). Stop using this medicine and inform your doctor or pharmacist immediately, if you feel you have experienced an allergic reaction.
DRUG INTERACTIONS Metronidazol has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazol is prescribed for patients on this type of anticoagulant therapy. The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazol resulting in reduced plasma levels. The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazol. In patients stabilized on relatively high doses of lithium, short-term metronidazol therapy has been, associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Alcoholic beverages should not be consumed during metronidazolKANAFLAGYL therapy and for at least one day afterward. Psychotic reactions have been reported in alcoholic patients who are using metronidazol and disulfiram concurrently. Metronidazol should not be given to patients who have taken disulfiram within the last two weeks. Drug/Laboratory Test Interactions: Metronidazol may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD+NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazol (322 nm) at pH 7.
Pregnancy And lactations Pregnancy and Breastfeeding: Metronidazol crosses the placental barrier and enters the fetal circulation rapidly, and is secreted in human milk. It should not be used during pregnancy or breastfeeding, unless the physician considers it essential; in these circumstances the short high-dosage regimes are not recommended. Metronidazol has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats.
Dosage And Administration KANAFLAGYL tablets: Trichomoniasis: One-day treatment:2 grams of metronidazol (4 tablets of KANAFLAGYL-500 mg), given either as a single dose or in two divided doses of one gram each given in the same day. Seven-day course of treatment— one tablet of KANAFLAGYL -250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears, signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen. Pregnant patients should not be treated during the first trimester. In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation. When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after retreatment. Amebiasis For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days. For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Storage Conditions Keep out of reach of children, Store below 30 C, Protect from light