Flagyl IV

FLAGYL Infus: contains 500 mg metronidazole/100 ml infusion.

Pharmacology: Trichomoniacide, anaerobicide.
Disposition of metronidazole given orally or by intravenous injection remains constant, with average elimination time of 8 hours in healthy man.
Metronidazole was detected in cerebrospinal fluid, saliva and breast milk in same concentrations as in plasma. Metronidazole was also detected in the pus of hepatic abscess.

Urethritis and vaginitis due to Trichomonas vaginalis; Amoebiasis (intestinal and hepatic amoebiasis); Prevention of post-operative anaerobic infections; Giardiasis due to Giardia lamblia.

Intravenous infusion at the rate of 5 ml per minute has to be replaced soon with oral administration.
Treatment of infections in which bacteria have been identified: In patient whom oral medication is not possible.
Adult and children < 12 years.
Adult: 500 mg by i.v. infusion every 8 hours.
Children: 7.5 mg/kg body-weight every 8 hours.
Prevention of post operative abdominal infections (especially colorectal), gynaecology: Adult: 500 mg by i.v. infusion before operation, followed by 500 mg oral medication every 8 hours as soon as this becomes feasible.
Children: 7.5 mg/kg body-weight (1.5 ml/kg body-weight) every 8 hours.

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.

Hypersensitivity to imidazoles.
During the first trimester of pregnancy.

Used with caution in nursing mothers as metronidazole is excreted in breast milk, during first and second trimesters of pregnancy as metronidazole crosses the placental barrier.
Used with caution in patients with central nervous system diseases. Disturbances of central nervous system have been reported in some cases but disappeared if therapy is discontinued or dose is decreased.
Taking alcohol during metronidazole therapy may cause abdominal cramps, nausea, vomiting, headache, flushing.
In prolonged metronidazole administration, it is recommended to perform hematological tests.
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation, in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Liver functions tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached. If the liver function tests become markedly elevated during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
The use of Flagyl for prolonged treatment duration should be carefully weighed.
Dosage should be reduced and administered with caution in patients with hepatic diseases.
Safety and effectiveness in pediatric patients have not been established, except in the treatment of amoebiasis.
Effects on ability to drive and use machines: Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or eye disorders, and advised not to drive or operate machinery if these symptoms occur.

Used with caution in nursing mothers as metronidazole is excreted in breast milk, during first and second trimesters of pregnancy as metronidazole crosses the placental barrier.

Gastrointestinal disorders: epigastric pain, nausea, vomiting, diarrhea.
Oral mucositis, taste disorders, anorexia.
Reversible cases of pancreatitis.
Tongue discoloration/furry tongue (e.g. due to fungal fungal overgrowth).
Immune system disorders: angioedema, anaphylactic shock.
Nervous system disorders: peripheral sensory neuropathy.
Headache, convulsions, dizziness.
Reports of encephalopathy (e.g. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (e.g. ataxia, dysarthria, gait impairment, nystagmus, and tremor), which may resolve with discontinuation of the drug.
Aseptic meningitis.
Psychiatric disorders: psychotic disorders including confusion, hallucinations.
Depressed mood.
Eye disorders: transient vision disorders such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision.
Optic neuropathy/neuritis.
Blood and lymphatic system disorders: cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Pancytopenia (very rare).
Leucopenia (not known).
Hepatobiliary disorders: increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported.
Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders: rash, pruritus, flushing, urticaria.
Pustular eruptions.
Erythema multiforme.
General disorders and administration site conditions: fever.
Musculoskeletal, connective tissue and bone disorders: Very rare: myalgia, arthralgia.
Renal and urinary disorders: Very rare: darkening of urine (due to metronidazole metabolite).

It is recommended to use metronidazole as single drug. In combination with other antibiotic, both should be given in a full dose for normal therapy.
Concomitant use with warfarin and coumarin anticoagulant: prolonged prothrombin time should be considered and reduce the anticoagulant dose if necessary.
Cimetidine might prolong metronidazole plasma clearance which leads to toxic concentration of metronidazole.
Psychotic reaction has been reported when concomitant metronidazole, disulfiram and alcohol was taken simultaneously.
Metronidazole reduces the clearance of 5-fluorouracil and can therefore result in increased toxicity of 5-fluorouracil.
Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.

Store below 25°C. Protect from light.

Other Antibiotics / Antiamoebics

J01XD01 - metronidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.

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