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Metronidazole extended-release tablets

Pronunciation

Generic Name: metronidazole (MET-roe-NID-a-zole)
Brand Name: Flagyl ER

Long-term use of metronidazole extended-release tablets has caused cancer in mice and rats. Discuss any questions or concerns with your doctor. Do not use metronidazole extended-release tablets for a condition other than the one for which it was prescribed.


Metronidazole extended-release tablets is used for:

Treating certain bacterial infections of the vagina (bacterial vaginosis) in women who are not pregnant. 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 another nitroimidazole (eg, tinidazole)
  • you are taking busulfan or you have taken disulfiram within the past 2 weeks
  • you drink alcohol or take any products containing alcohol or propylene glycol. Check with your doctor or pharmacist if you are unsure if any of your medicines contain alcohol or propylene glycol

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, planning 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 a history of nerve, brain, or blood problems; Crohn disease; liver or kidney problems; or seizures

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:

  • Disulfiram because side effects, such as mental or mood changes, may occur
  • Barbiturates (eg, phenobarbital) or phenytoin because they may decrease metronidazole extended-release tablets's effectiveness
  • Cimetidine because it may increase the risk of metronidazole extended-release tablets's side effects
  • Anticoagulants (eg, warfarin), busulfan, or lithium because the risk of their side effects may be increased 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 by mouth 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, take metronidazole extended-release tablets for the full course of treatment. Keep taking it 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. This effect may be worse if you take it with alcohol or certain medicines. Use metronidazole extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take any products containing alcohol or propylene glycol while you are taking metronidazole extended-release tablets and for at least 3 days after the last dose. Drinking alcohol or taking products with alcohol or propylene glycol may cause stomach cramps, nausea, vomiting, headaches, and flushing.
  • Metronidazole extended-release tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Be sure to use metronidazole extended-release tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of metronidazole extended-release tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Some patients have developed persistent nerve problems (peripheral neuropathy) after taking metronidazole extended-release tablets for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Metronidazole extended-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking metronidazole extended-release tablets.
  • Lab tests, including liver function and white blood cell counts, may be performed while you use metronidazole extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use metronidazole extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects.
  • Metronidazole extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you are pregnant, contact your doctor. You will need to discuss the benefits and risks of using metronidazole extended-release tablets while you are pregnant. Metronidazole extended-release tablets is found in breast milk. Do not breast-feed while taking 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 or cramping; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased coordination; depression; fainting; increased or decreased urination; irritability; numbness, tingling, or burning of the arms, hands, legs, or feet; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe or persistent dizziness or headache; severe or persistent stomach pain or cramping; sore throat, chills, or fever; speech problems; stiff neck; vaginal itching, odor, or discharge; vision loss or other vision changes; weakness; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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), or emergency room immediately.

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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take metronidazole extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about metronidazole extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to metronidazole extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using metronidazole extended-release tablets.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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