Metroshin
Metronidazole
Indication
lt is indicated for the treatment of intestinal amoebiasis, acute ulcerative gingivitis, skin and skin structure infections, bacterial septicaemia, bone and joint infections, central nervous system (CNS) infections, endocarditis, symptomatic and asymptomatic Trichomonas vaginal is, Giardiasis, Pse...
Dosage and Administration
Infants and Children:
Amoebiasis: 35 - 50 mg/ kg/ day in divided doses, every 8 hours for 5 - 10 days
Trichomoniasis: 15 - 30 mg/ kg/ day in divided doses, every 8 hours for 7 days
Anaerobic infections: 15 - 35 mg/ kg/ day in divided doses, every 8 hours for 7 days
Clostridium difficile (antibiotic related) colitis: 20 mg/ kg/ day in divided doses, every 6 hours for 10 - 14 days Acute oral infections: 7.5 mg/ kg/ day every 8 hours for 3 days
Adult:
Amoebiasis: 500- 750 mg every 8 hours for 5 - 10 days
Trichomoniasis: 200 mg every 8 hours for 7 days, alternatively 400 - 500 mg every 12 hours for 5 - 7 days, alternatively 2 g for I dose.
Anaerobic infections: 400 mg every 8 hours, alternatively 500 mg every 8 hours usually treated for 7 days
Clostridium difficile (antibiotic related) colitis: 400 mg every 8 hours, alternatively 500 mg every 8 hours usually treated for IO - 14 days
Helicobacter pylori eradication: 400 - 500 mg in combination therapy with at least one other antibiotic and an acid-suppressing agent (proton pump inhibitor or H2 blocker) every 8 hours for 14 days
Acute oral infections: 200 mg every 8 hours for 3 - 7 days.
Composition
Each tablet contains:
Metronidazole BP ... 200 mg.
Description
Metronidazole is an oral formulation of the synthetic nitroimidazole, antimicrobial, 2-(2- methyl-5-nitro-l H-imidazol-1-yl) ethanol which works by killing bacteria or preventing their growth. The molecular formula is C6H9N3O3 and molecular weight is 171.2.
Clinical Pharmacology
Mechanism of Action
Metronidazole is reduced to disrupt energy metabolism of anaerobes by hindering the replication, transcription and repair process of DNA results in cell death. Presence of oxygen prevents reduction of metronidazole and reduces its cytotoxicity.
Antimicrobial Spectrum
Metronidazole is active against T.vaginalis, E. histolytica, Giardia lamblia, Blastocystis hominis, Balantidium coli, Spirochaetes and anaerobic Streptococi.
Aerobic bacteria which are facultative, aerobic and non-sporulating Gram-positive bacilli are mostly resistant. Metronidazole has direct trichomonacidal and amoebicidal activity against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia, Blastocystis hominis, Balantidium coli, Spirochaete...
Pharmacokinetics
Metronidazole is completely and rapidly absorbed after oral administration. The plasma half-life of metronidazole is about 8 hours. Plasma protein binding of metronidazole is more than 20%. Metronidazole is widely distributed throughout the body tissues and fluids. Therapeutic levels can be found in...
Contraindication
Prior history of hypersensitivity to metronidazole, neurological disease, blood dyscrasias, first trimester of pregnancy and chronic alcoholism. In patients with trichomoniasis, metronidazole is contraindicated during the first trimester of pregnancy.
Precaution
Metronidazole should be used with caution in patient with hepatic impairment or hepatic encephalopathy. In this case, total daily dose of metronidazole should be reduced. Metronidazole can cross the placental barrier. Therefore, it should be used with caution in pregnant women because of impaired fe...
Adverse Effects
During treatment with metronidazole, the following adverse effects have been reported: Gastrointestinal disturbances: nausea, vomiting, abdominal cramps, diarrhoea, anorexia, epigastric pain and constipation.
Mouth: a sharp, unpleasant metallic taste, furry tongue, dry mouth, glossitis, a sudden overgrowth of candida which may occur during therapy.
Central nervous system disturbances: headache, dizziness, vertigo, drowsiness, ataxia, convulsive disorders, peripheral neuropathy, seizure, depression, weakness and insomnia.
Hypersensitivity: urticaria, rash, pruritus, fever, arthralgia, myalgia.
Others: darkening of urine, thrombocytopenia, visual disturbances, aseptic meningitis, optic neuropathy, dysuria and polyuria.
Drug Interaction
Alcohol: Disulfiram like intolerance to alcohol occurs in some patients taking metronidazole. Therefore, patient should be warned not to use alcohol 24 hours before starting the metronidazole and for 48 hours after the last dose.
Lithium: Concurrent use of metronidazole with lithium may cause increased risk of lithium toxicity. Cimetidine: Cimetidine inhibits the hepatic metabolism of metronidazole and increased plasma concentration of metronidazole.
Warfarin and other Oral Anticoagulants: Metronidazole enhances warfarin and other oral anticoagulant effect of coumarins. When metronidazole is prescribed with the type of anticoagulant therapy, prothrombin time and TNR should be carefully monitored. Oxidative metabolism of metronidazole is accelera...
Storage
Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.
Presentation
10 x 10's Blisters, I00's Bottle