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Carcinogenesis, Mutagenesis, Impairment of Fertility Tumors affecting the liver, lung, mammary, and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters. Pregnancy Teratogenic effects There are no adequate and well-controlled studies of FLAGYL ER in pregnant women.
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. Pediatric use The safety and efficacy of FLAGYL ER 750 mg tablets in the treatment of bacterial vaginosis in post-menarchal females has been established on the extrapolation of clinical trial data from adult women. ADVERSE REACTIONS In two multicenter clinical trials, a total of 270 patients received 750 mg FLAGYL ER tablets orally once daily for 7 days, and 287 were treated with a comparator agent administered intravaginally once daily for 7 days See CLINICAL STUDIES.
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.
Dermatologic: Erythematous rash and pruritus. Renal Impairment Decreased renal function does not alter the single-dose pharmacokinetics of metronidazole. Effect of Dialysis Following a single intravenous infusion or oral dose of metronidazole 500 mg, the clearance of metronidazole was investigated in ESRD subjects undergoing hemodialysis or continuous ambulatory peritoneal dialysis CAPD.
Breaking the pill may cause too much of the drug to be released at one time. This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Flagyl.
See also: Dosage Information in more detail Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.
Do not take extra medicine to make up the missed dose. Overdose symptoms may include nausea, vomiting, dizziness, loss of balance or coordination, numbness and tingling, or seizures convulsions.
Check the labels of any medicines or food products you use to make sure they do not contain alcohol. Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Flagyl and call your doctor.
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There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole during pregnancy. 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.
Pediatric Use Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis. 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. Distribution Metronidazole is the major component appearing in the plasma, with lesser quantities of metabolites also being present.
Renal Impairment Decreased renal function does not alter the singledose-pharmacokinetics of metronidazole.
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Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.
These factors may affect how you should use this medication. Alcohol: A severe set of side effects including nausea, vomiting, and rapid heartbeat may occur if you drink alcohol while taking metronidazole.
If you are taking this medication, wait until at least one day after finishing metronidazole treatment before drinking alcohol.
Blood cell counts: This medication may cause low white blood cell counts, which can mean your immune system is weak. If you develop a fever, talk to your doctor as soon as possible. Your doctor may also perform blood tests regularly to monitor your blood cell counts if you are taking this medication for a long period of time.
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However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries.
The Royal College of Paediatrics and Child Health RCPCHthe Neonatal and Paediatric Pharmacists Group NPPGWellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet. What is metronidazole available as.
Tablets: 200 mg, 400 mgLiquid medicine suspension : 200 mg in 5 mL When should I give metronidazole. If your child is sick more than 30 minutes after having a dose of metronidazole, you do not need to give them another dose.
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Therefore, the use of Flagyl for prolonged treatment duration should be carefully weighed.
Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals weredosed on an intermittent schedule administration during every fourth week only.
Consult your doctor if vomiting occurs while you are taking metronidazole.
You can also report side effects directly via the Yellow Card Scheme at: www.
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.
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Metronidazole can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers.
This medication may cause your urine to turn darker in color.