Metronidazole tablets








Indications


Metronidazole is active against a wide range of pathogenic micro-organisms, notably species of Bacteroids, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.


It is also active against Trichomonas vaginalis, Entamoeba histolytica, Gardia lamblia, Balantidium coli and Helicobacter pylori.


Metronidazole is indicated in adults and children for the following indications:


1) Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroids and anaerobic streptococci.


2) The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.


3) Urogenital trichomoniasis in the female (Trichomonas vaginalis), and in man.


4) Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginalis).


5) All forms of amoebiasis (intestinal and extra-intestinal disease and asymptomatic cyst passers).


6) Giardiasis.


7) Acute ulcerative gingivitis.


8) Acute dental infections (eg acute pericoronitis and acute apical infections)


9) Anaerobically-infected leg ulcers and pressure sores.


10) Treatment of Helicobacter pylori infection associated with peptic ulcer as part of triple therapy.


Consideration should be given to official guidance on the appropriate use of antibacterial agents.


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Posology and method of administration


Posology


Metronidazole Tablets should be taken during or after meals, swallowed with water and NOT CHEWED.


Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage.


Hepatic impairment: Caution is advised in patients with hepatic encephalopathy. One third of the daily dose given once a day should be considered.


1) Anaerobic infections:


Treatment for 7 days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician may decide to prolong treatment, eg for eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.


Children > 8 weeks to 12 years of age: The usual daily dose is 20-30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. Duration of treatment is usually 7 days.


Children < 8 weeks of age: 15 mg/kg as a single dose daily or divided into 7.5 mg/kg every 12 hours.


In newborns with a gestation age <40 weeks, accumulation of metronidazole can occur during the first week of life, why the concentrations of metronidazole in serum should preferable be monitored after a few days therapy.


Children under 10 years: A more suitable dosage form should be used for this age group.


Prophylaxis against anaerobic infection - chiefly in the context of abdominal (especially colorectal) and gynaecological surgery.


Adults: 1g stat dose 24 hours pre-operatively, followed by 400mg at 8 hourly intervals during the 24 hours preceding operation followed by post-operative iv or rectal administration until the patient is able to take tablets.


Children < 12 years: 20-30 mg/kg as a single dose given 1-2 hours before surgery.


Newborns with a gestation age <40 weeks: 10 mg/kg body weight as a single dose before operation.


Children under 10 years: A more suitable dosage form should be used for this age group.


2) Treatment of established infections:


Adults and children over 10 years: 800mg followed by 400mg 8 hourly.


Children under 10 years: A more suitable dosage form should be used for this age group.


3) Urogenital trichomoniasis:


Where reinfection is likely, sexual partners should be treated concomitantly.


Adults and adolescents: 2000 mg as a single dose or 200 mg 3 times daily for 7 days or 400 mg twice daily for 5-7 days.


Children < 10 years: 40 mg/kg orally as a single dose or 15 – 30 mg/kg/day divided in 2-3 doses for 7 days; not to exceed 2000 mg/dose.


Children under 10 years: A more suitable dosage form should be used for this age group.


4) Bacterial vaginosis


Adults: 400mg twice daily for 7 days, or 2g as a single dose for one day only.


Adolescents: 400 mg twice daily for 5-7 days or 2000 mg as a single dose.


5) Amoebiasis


Adults> 10 years: 400 to 800 mg 3 times daily for 5-10 days.


Children 7 to 10 years: 200 to 400 mg 3 times daily for 5-10 days.


Children 3 to 7 years: 100 to 200 mg 4 times daily for 5-10 days.


Children 1 to 3 years: 100 to 200 mg 3 times daily for 5-10 days.


Alternatively, doses may be expressed by body weight:


35 to 50 mg/kg daily in 3 divided doses for 5 to 10 days, not to exceed 2400 mg/day.


Children under 7 years: A more suitable dosage form should be used for this age group.


6) Giardiasis:


Adults > 10 years: 2000 mg once daily for 3 days, or 400 mg. three times daily for 5 days, or 500 mg twice daily for 7 to 10 days.


Children 7 to 10 years: 1000 mg once daily for 3 days.


Children 3 to 7 years: 600 to 800 mg once daily for 3 days.


Children 1 to 3 years: 500 mg once daily for 3 days.


Alternatively, as expressed in mg per kg of body weight:


15-40 mg/kg/day divided in 2-3 doses.


Children under 7 years: A more suitable dosage form should be used for this age group.


7) Acute ulcerative gingivitis (for 3 day duration):


Adults and children over 10 years: 200mg three times daily.


Children under 10 years: A more suitable dosage form should be used for this age.


8) Acute dental infections (for 3-7 day duration):


Adults and children over 10 years: 200mg three times daily.


9) Leg ulcers and pressure sores (for 7 day duration):


Adults and children over 10 years: 400mg three times daily.


10) Treatment of Helicobacter pylori in infected patients


As a part of a combination therapy, 20 mg/kg/day not to exceed 500 mg twice daily for 7-14 days. Official guidelines should be consulted before initiating therapy.


Method of Administration


For oral administration.


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Contraindications


? Known hypersensitivity to metronidazole or any of the ingredients in the tablets.


? Pregnancy - metronidazole should not be used in the first trimester in patients with trichomoniasis or bacterial vaginosis .


? Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used.


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Special warnings and precautions for use


? Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take metronidazole as this product contains lactose.


? Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred.


? Caution is advised in patients with porphyria.


? Metronidazole tablets should not be used in patients with blood dyscrasias or with active non-infectious disease of the central nervous system. High doses of metronidazole may mask the presence of syphilis.


? Caution in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures.


? Use with caution in the second and third trimester when used to treat trichomoniais or bacterial vaginosis.


? Regular clinical and laboratory surveillance are advised if treatment continues for more than 10 days.


? Consideration of the therapeutic benefit against the risk of peripheral neuropathy is advised with continuous therapy for chronic conditions.


? There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist.


? The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole, therefore, needs no reduction. Such patients, however, retain the metabolites of metronidazole. The clinical significance of this is not known at present.


? In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight-hour period of dialysis. Metronidazole should, therefore, be readministered immediately after haemodialysis.


? No routine adjustment in the dosage of metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IPD) or continuous ambulatory peritoneal dialysis (CAPD).


Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Signficant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to symptoms of the encephalopathy. Therefore, metronidazole should be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.


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Interaction with other medicinal products and other forms of interaction


? Interactions to be used with caution:


? Lithium: Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentration of lithium, creatinine, and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.


? Anticoagulants: Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the latter may require reducing. Prothrombin times should be monitored. No interactions have been reported with anticoagulants of the heparin type. However, anticoagulant activity should be routinely monitored with these products.


? Alcohol: Patients should be advised not to take alcohol during metronidazole therapy and for at least 48 hours after because of the possibility of a disulfiram-like reaction.


? Disulfiram: Psychotic reactions have been reported.


? Immunosuppressants: Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.


? Pharmacokinetic interactions:


? Antiepileptics: Patients receiving phenobarbital metabolise metronidazole at a much greater rate than normally, reducing the half-life to approximately 3 hours. Metronidazole inhibits metabolism of phenytoin (increases plasma-phenytoin concentration). Primidone accelerates the metabolism of Metronidazole causing reduced plasma concentrations.


? Cytotoxics: Metronidazole inhibits metabolism of fluorouracil. Therefore, increased toxicity of fluorouracil can result.


? Ulcer-healing drugs: Cimetidine inhibits the metabolism of metronidazole (increases plasma-metronidazole concentration).


? Oestrogens: broad spectrum antibiotics possibly reduce the contraceptive effect.


? Drug-lab modifications: Aspartate amino transferase assays may give spuriously low values in patients taking metronidazole, depending on the method used.


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Undesirable effects


Serious adverse reactions occur very rarely with standard recommended regimens. Frequency, type and severity of adverse reactions in children are the same as in adults.


? Hypersensitivity reactions: Urticaria, fever and angioedema occur occasionally. Anaphylaxis may occur rarely.


? Blood and lymphatic system disorders: There have been reports of bone marrow depression disorders such as aplastic anaemia, agranulocytosis, neutropenia, leucopenia, thrombocytopenia and pancytopenia which may be reversed on drug withdrawal, although fatalities have been reported.


? Nervous system disorders: Drowsiness, dizziness, headache, ataxia, depression, paraesthesia, incoordination of movement has been reported very rarely. Transient visual disorders, such as diplopia and myopia, have been reported very rarely. Psychotic disorders, including confusion and hallucinations, have been reported very rarely. During intensive and/or prolonged metronidazole therapy, a few instances of peripheral neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.


? Gastrointestinal disorders: Unpleasant taste in the mouth, furred tongue, taste disorders, oral mucositis, nausea, vomiting, diarrhoea, abdominal pain, anorexia and gastro-intestinal disturbances occur occasionally.


? Hepatobiliary disorders: Metronidazole may result in hepatotoxicity and reactions such as abnormal liver function tests, cholestatic hepatitis, pancreatitis and jaundice have been reported very rarely which may be reversed upon drug withdrawal.


? Skin and subcutaneous tissue disorders: pruritus, skin rashes and pustular eruptions have been reported very rarely and metronidazole treatment has been documented to be associated with erythema multiforme which may be reversed on drug withdrawal.


? Musculoskeletal, connective tissue and bone disorders: myalgia and arthralgia has been reported very rarely.


? Renal and urinary disorders: darkening of the urine (due to metronidazole metabolite) have been reported but very rarely.





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