"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
(metronidazole) Extended-release Tablets, 750 mg
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FLAGYL ER®, and other antibacterial drugs, FLAGYL ER® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS). Unnecessary use of the drug should be avoided. Its use should be reserved for conditions described in the INDICATIONS AND USAGE section below.
FLAGYL metronidazole extended release tablets is an oral formulation of the synthetic nitroimidazole antimicrobial agent, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:
FLAGYL (metronidazole) extended release tablets, 750 mg (indicated below as FLAGYL ER) contain 750 mg of metronidazole USP. Inactive ingredients include hypromellose, lactose, magnesium stearate, polyethylene glycol, poly (meth) acrylic acid ester copolymers, polysorbate 80, silicon dioxide, simethicone emulsion, talc, titanium dioxide, FD&C Blue No. 2 Aluminum Lake.
What are the possible side effects of metronidazole (Flagyl, Flagyl 375, Flagyl ER)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- numbness or tingling in your hands or feet;
- white patches or sores inside your mouth or on your lips;
- pain or burning when you urinate;
- diarrhea that is watery or bloody;
- vision problems, pain behind your eyes;
- trouble concentrating, slurred speech, mood or behavior changes,...
What are the precautions when taking metronidazole extended release tablets (Flagyl ER)?
Before taking metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazoles such as tinidazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, nervous system disorders (e.g., seizures), blood disorders, Crohn's disease.
Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine because severe stomach upset, nausea, vomiting, headache and flushing may occur.
This drug may make you dizzy. Do not drive, use machinery, or do any activity...
Last reviewed on RxList: 8/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Flagyl ER Information
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