When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to Metronidazole or other nitroimidazole derivatives. Psychotic Reaction with Disulfiram Use of oral Metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently.

Interaction with Alcohol Use of oral Metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing.

Cases of encephalopathy and peripheral neuropathy including optic neuropathy have been reported with Metronidazole. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS symptoms are generally reversible within days to weeks upon discontinuation of Metronidazole.

Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity. Convulsive seizures have been reported in patients treated with Metronidazole. Cases of aseptic meningitis have been reported with Metronidazole. Symptoms can occur within hours of dose administration and generally resolve after Metronidazole therapy is discontinued. Precautions General Hepatic Impairment Patients with hepatic impairment metabolize Metronidazole slowly, with resultant accumulation of Metronidazole in the plasma.

For patients with severe hepatic impairment Child-Pugh C , a reduced dose of Metronidazole tablet is recommended. Renal Impairment Patients with end-stage renal disease may excrete Metronidazole and metabolites slowly in the urine, resulting in significant accumulation of Metronidazole metabolites.

Fungal Superinfections Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Metronidazole tablets and requires treatment with a candidacidal agent. Use in Patients with Blood Dyscrasias Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to Metronidazole have been observed in clinical studies.

Total and differential leukocyte counts are recommended before and after therapy. Drug-Resistant Bacteria and Parasites Prescribing Metronidazole tablets in the absence of a proven or strongly suspected bacterial or parasitic infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria and parasites.

Treatment of Bacterial and Parasitic Infections Patients should be counseled that Metronidazole tablets should only be used to treat bacterial and parasitic infections. Metronidazole tablets do not treat viral infections e.

When Metronidazole tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may 1 decrease the effectiveness of the immediate treatment and 2 increase the likelihood that bacteria will develop resistance and will not be treatable by Metronidazole tablets in the future.

Drug Interactions Disulfiram Psychotic reactions have been reported in alcoholic patients who are using Metronidazole and disulfiram concurrently. Warfarin and other Oral Anticoagulants Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When Metronidazole tablets are prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored.

Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative. Metronidazole has shown mutagenic activity in in vitro assay systems including the Ames test.

Studies in mammals in vivo have failed to demonstrate a potential for genetic damage. However, rats treated at the same dose for 6 weeks or longer were infertile and showed severe degeneration of the seminiferous epithelium in the testes as well as marked decreases in testicular spermatid counts and epididymal sperm counts. Fertility was restored in most rats after an eight week, drug-free recovery period. Pregnancy Teratogenic Effects There are no adequate and well controlled studies of Flagyl in pregnant women.

There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than pregnant women who used metronidazole during pregnancy. Many studies included first trimester exposures. One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in-utero; however, these findings were not confirmed. In addition, more than ten randomized placebo-controlled clinical trials enrolled more than pregnant women to assess the use of antibiotic treatment including metronidazole for bacterial vaginosis on the incidence of preterm delivery.

Most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy. Three studies conducted to assess the risk of infant cancer following metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited. Metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known.

Reproduction studies have been performed in rats, rabbits, and mice at doses similar to the maximum recommended human dose based on body surface area comparisons. There was no evidence of harm to the fetus due to metronidazole.

Nursing Mothers Metronidazole is present in human milk at concentrations similar to maternal serum levels, and infant serum levels can be close to or comparable to infant therapeutic levels. Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Alternatively, a nursing mother may choose to pump and discard human milk for the duration of metronidazole therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula.

Pediatric Use Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis. Adverse Reactions The following reactions have been reported during treatment with metronidazole: Central Nervous System The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity.

Treatment Of Overdosage There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy. Psychotic Reaction With Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Interaction With Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing.

Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration. Plasma concentrations of metronidazole are proportional to the administered dose. Studies reveal no significant bioavailability differences between males and females; however, because of weight differences, the resulting plasma levels in males are generally lower.

Distribution Metronidazole is the major component appearing in the plasma, with lesser quantities of metabolites also being present. Metronidazole appears in cerebrospinal fluid , saliva , and breast milk in concentrations similar to those found in plasma.

Bactericidal concentrations of metronidazole have also been detected in pus from hepatic abscesses. Both the parent compound and the hydroxyl metabolite possess in vitro antimicrobial activity. The average elimination halflife of metronidazole in healthy subjects is eight hours. Renal Impairment Decreased renal function does not alter the singledose-pharmacokinetics of metronidazole. Effect Of Dialysis Following a single intravenous infusion or oral dose of metronidazole mg, the clearance of metronidazole was investigated in ESRD subjects undergoing hemodialysis or continuous ambulatory peritoneal dialysis CAPD.

A peritoneal dialysis session lasting for 7. There were no significant changes in the AUC24 of hydroxylmetronidazole in these hepatically impaired patients.

No dosage adjustment is needed for patients with mild to moderate hepatic impairment. Pediatric Patients In one study, newborn infants appeared to demonstrate diminished capacity to eliminate metronidazole. The elimination halflife, measured during the first 3 days of life, was inversely related to gestational age. In infants whose gestational ages were between 28 and 40 weeks, the corresponding elimination halflives ranged from to Microbiology Mechanism Of Action Metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes.

Your liver helps process this drug. If you have severe liver disease , your liver may process this drug more slowly. This would increase the amount of the drug in your body and raise your risk of side effects. Your doctor may lower your dosage of metronidazole or have you take it less often.

For people with kidney disease: Your kidneys help clear this drug from your body. If you have severe kidney disease , your kidneys may process this drug more slowly. This increases the amount of the drug in your body and raises your risk of side effects.

Metronidazole

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Aseptic meningitis Cases of aseptic meningitis have been reported with metronidazole. Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue prospect or to discontinue the drug, taking into account the importance of the drug 250mg the mother. Symptoms reported include nausea, vomiting, flagyl 250mg prospect, and ataxia. Talk flagyl your doctor if you breastfeed your child. Senior dosage ages 65 years and older The kidneys and liver of older adults may not work as well as they used to. Your doctor may lower your dose of metronidazole or have you take it less often. Values of zero may be observed. Psychotic Reaction With Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently, flagyl 250mg prospect. Studies in mammals in vivo have failed to demonstrate a potential for genetic damage.

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