Metronidazole Extended-Release Tablets

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Metronidazole Extended-Release Tablets


Generic Name: Metronidazole Extended-Release Tablets (me-troe-NIH-duh-zole)
Brand Name: Flagyl ER

Metronidazole Extended-Release Tablets has been shown to cause cancer in animal studies. Do not use Metronidazole Extended-Release Tablets if it is not necessary. Use Metronidazole Extended-Release Tablets only for the condition for which it is prescribed.


Metronidazole Extended-Release Tablets is used for:

Treating certain bacterial infections of the vagina (bacterial vaginosis). It may also be used for other conditions as determined by your doctor.

Metronidazole Extended-Release Tablets is an oral antiprotozoal and antibacterial. It is thought to work by entering the bacterial cell, acting on some components of the cell and destroying the bacteria.

Do NOT use Metronidazole Extended-Release Tablets if:

  • you are allergic to any ingredient in Metronidazole Extended-Release Tablets or to other nitroimidazoles (eg, tinidazole)
  • you are in the first 3 months of pregnancy
  • you are taking busulfan, an ergot alkaloid (eg, ergotamine), or you have taken disulfiram within the past 2 weeks
  • you are taking an HIV protease inhibitor that contains alcohol (eg, amprenavir solution); check with your pharmacist if you are unsure if the medicine contains alcohol
  • you drink alcohol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Metronidazole Extended-Release Tablets:

Some medical conditions may interact with Metronidazole Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have nerve, brain, or blood problems; Crohn disease; or a history of liver problems

Some MEDICINES MAY INTERACT with Metronidazole Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Barbiturates (eg, phenobarbital) or phenytoin because the effectiveness of Metronidazole Extended-Release Tablets may be decreased
  • Anticoagulants (eg, warfarin), busulfan, ergot alkaloids (eg, ergotamine), HIV protease inhibitors containing alcohol (eg, amprenavir solution), lithium, or macrolide immunosuppressants (eg, tacrolimus) because the actions and side effects of these medicines may be increased
  • Disulfiram because side effects, such as mental or mood changes, may occur
  • Oral contraceptives (eg, birth control pills) because their effectiveness may be decreased by Metronidazole Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metronidazole Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Metronidazole Extended-Release Tablets:

Use Metronidazole Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Metronidazole Extended-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
  • Swallow Metronidazole Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
  • To clear up your infection completely, continue using Metronidazole Extended-Release Tablets for the full course of treatment even if you feel better in a few days.
  • If you miss a dose of Metronidazole Extended-Release Tablets take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Metronidazole Extended-Release Tablets.

Important safety information:

  • Metronidazole Extended-Release Tablets may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Metronidazole Extended-Release Tablets. Using Metronidazole Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Do not drink alcohol while you are taking Metronidazole Extended-Release Tablets and for at least 3 days after the last dose.
  • Metronidazole Extended-Release Tablets may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control while using Metronidazole Extended-Release Tablets.
  • If severe diarrhea, stomach cramps/pain, or bloody stools occur, contact your doctor at once. This could be a symptom of a serious side effect that needs immediate medical attention. Do not treat diarrhea without consulting your doctor.
  • Metronidazole Extended-Release Tablets is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).
  • It is important to use Metronidazole Extended-Release Tablets for the full course of treatment. Failure to do so may decrease the effectiveness of Metronidazole Extended-Release Tablets and may increase the risk that the bacteria will no longer be sensitive to Metronidazole Extended-Release Tablets and will not be able to be treated by this or certain other antibiotics in the future.
  • Long-term or repeated use of Metronidazole Extended-Release Tablets may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
  • Metronidazole Extended-Release Tablets may interfere with certain lab test results. Make sure your doctor and laboratory personnel know you are taking Metronidazole Extended-Release Tablets.
  • LAB TESTS, including liver function tests and white blood cell counts, may be performed to monitor your progress and to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Metronidazole Extended-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
  • Use Metronidazole Extended-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Metronidazole Extended-Release Tablets during pregnancy. Do not use Metronidazole Extended-Release Tablets in the first 3 months of pregnancy. Metronidazole Extended-Release Tablets is excreted in breast milk. Do not breast-feed while using Metronidazole Extended-Release Tablets.

Possible side effects of Metronidazole Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; constipation; diarrhea; dizziness; headache; metallic taste; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; increased or decreased urination; numbness, tingling, or burning of your arms, hands, legs, or feet; seizures; severe diarrhea; sore throat, chills, or fever; stomach pain or cramps; vaginal itching, odor, or discharge; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea; seizures; vomiting.

Proper storage of Metronidazole Extended-Release Tablets:

Store Metronidazole Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metronidazole Extended-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Metronidazole Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Metronidazole Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Metronidazole Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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