Flagyl

Flagyl

metronidazole

Manufacturer:

PT Aventis

Distributor:

Distriphil
Concise Prescribing Info
Contents
Metronidazole
Indications/Uses
Tab: Amebiasis; urogenital trichomoniasis; non-specific vaginitis; giardiasis. Curative treatment of medico-surgical infections due to susceptible anaerobic pathogens. Prophylaxis against infections caused by susceptible anaerobic pathogens in high risk surgical contexts. Conversion from prophylactic or curative injectable treatment of infections due to susceptible anaerobic pathogens. Susp: Anaerobic protozoal infections (eg, amoebiasis, giardiasis, trichomoniasis, balantidiasis, blastocystiasis & dientamoebiasis; bacterial infections including Bacteroides fragilis & Clostridium tetanus.
Dosage/Direction for Use
Tab Amebiasis Duration: 7 consecutive days. Adult 1.5 g daily in 3 divided doses. Childn 30-40 mg/kg daily in 3 divided doses. Giardiasis Duration: 5 consecutive days. Adult 0.75-1 g daily. Childn 10-15 yr 500 mg/day, 5-10 yr 375 mg/day, 2-5 yr 250 mg/day. Urethritis & vaginitis due to Trichomonas in women Single 2 g dose or 500 mg daily in 2 divided doses for 10 days. Urethritis due to Trichomonas in men Single 2 g dose or 500 mg/day in 2 divided doses for 10 days. Non-specific vaginitis 500 mg bid for 7 days. Treatment of anaerobic infection Adult 1-1.5 g/day. Childn 20-30 mg/kg/day. Surgical chemoprophylaxis Adult 500 mg every 8 hr beginning 48 hr pre-op. Administer last dose at the latest 12 hr pre-op. Childn 20-30 mg/kg/day. Susp Trichomoniasis Adult Single 2 g, as a 2-day course of 800 mg in morning & 1.2 g in evening or as 7-day course of 600 mg-1g daily in 2 or 3 divided dose. Anaerobic infections Initially 800 mg followed by 400 mg every 8 hr for 7 days. Amoebiasis Adult 400-800 mg tid for 5-10 days. Alternative dose is single 1.5-2.5 g daily for 2-3 days. Childn 7-10 ½ the total adult daily dose; 3-7 yr 1/3 total adult daily dose; 1-3 yr 1 quarter of total adult daily dose. Alternatively 35-50 mg/kg in divided doses. Giardiasis Adult 2 g once daily for 3 successive days or 400 mg tid for 5 days or 500 mg bid for 7-10 days. Childn 15 mg/kg daily in divided doses.
Administration
Tab: Should be taken with food: Swallow whole, do not chew/crush. Oral susp: Should be taken on an empty stomach: Take at least 1 hr before meals.
Contraindications
Hypersensitivity to imidazoles. Susp: Prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. History or evidence of blood dyscrasia. Trichomoniasis. 1st trimester of pregnancy.
Special Precautions
Risk of neurological aggravation in patients w/ active or chronic severe peripheral & CNS diseases. Possibility of disulfiram-like (antabuse effect) reaction. Potential liver injury in patients w/ Cockayne syndrome. Discontinue in case of severe bullous skin reactions eg, SJS, TEN or acute generalized exanthematous pustulosis occur. Perform leukocyte count regularly & monitor for adverse reactions eg, peripheral or central neuropathy (eg, paresthesia, ataxia, dizziness, convulsive seizures). Patients w/ hepatic encephalopathy. May darken urine. May affect ability to drive or operate machinery. Pregnancy & lactation. Susp: Monitor for neurological signs. Overgrowth of candida. Alcohol & warfarin.
Adverse Reactions
Epigastric pain, nausea, vomiting, diarrhea; oral mucositis, taste disorders, anorexia; reversible cases of pancreatitis; tongue discoloration/furry tongue (eg, due to fungal overgrowth). Angioedema, anaphylactic shock. Peripheral sensory neuropathy; headache, convulsions, dizziness; reports on encephalopathy (eg, confusion) & subacute cerebellar syndrome (eg, ataxia, dysarthria, gait impairment, nystagmus & tremor); aseptic meningitis. Psychotic disorders (eg, confusion, hallucinations); depressed mood. Transient vision disorders (eg, diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision); optic neuropathy/neuritis. Impaired hearing/hearing loss (including sensorineural); tinnitus. Cases of agranulocytosis, neutropenia & thrombocytopenia. Increased liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis & hepatocellular liver injury, sometimes w/ jaundice; cases of liver failure requiring liver transplant in patients treated w/ metronidazole in combination w/ other antibiotic drugs. Hearing impairment/hearing loss, tinnitus. Rash, pruritus, flushing, urticarial pustular eruptions, acute generalized exanthematous pustulosis; fixed drug eruption; SJS, TEN. Fever. Susp: GI disturbances, especially nausea & unpleasant metallic taste. Furred tongue, glossitis, & stomatitis. Weakness, drowsiness, insomnia.
Drug Interactions
Reported psychotic reactions w/ disulfiram. Possibility of disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia) w/ alcoholic beverages & drugs containing alcohol. Potentiation of anticoagulant effect & increased hemorrhagic risk caused by decreased hepatic catabolism of oral anticoagulant therapy (warfarin type). May increase plasma levels of lithium; busulfan which may lead to severe busulfan toxicity. Risk of elevation of cyclosporin serum levels. Increased elimination resulting in reduced plasma levels w/ phenytoin or phenobarb. Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil. Susp: Decreased plasma conc by phenobarb. Impair metabolism or excretion of ciclosporin. Increased plasma conc w/ cimetidine which might increase risk of neurological adverse effect.
MIMS Class
Other Antibiotics / Preparations for Vaginal Conditions
ATC Classification
P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
Presentation/Packing
Form
Flagyl Forte FC tab 500 mg
Packing/Price
100's
Form
Flagyl oral susp 125 mg/5 mL
Packing/Price
60 mL x 1's
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