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Amoxicillin/ clavulanate extended-release tablets

Generic Name: amoxicillin/clavulanate (a-MOX-i-SIL-in/KLAV-ue-lan-ate)
Brand Name: Augmentin XR

Amoxicillin/ clavulanate extended-release tablets is used for:

Treating infections caused by certain bacteria.

Amoxicillin/clavulanate extended-release tablets is a penicillin antibiotic. It works by killing sensitive bacteria.

Do NOT use amoxicillin/ clavulanate extended-release tablets if:

  • you are allergic to any ingredient in amoxicillin/clavulanate extended-release tablets or another penicillin antibiotic (eg, ampicillin)
  • you have a history of liver problems or yellowing of the eyes or skin caused by amoxicillin/clavulanate extended-release tablets
  • you have severe kidney problems or are on dialysis
  • you have infectious mononucleosis (mono)
  • you are taking a tetracycline antibiotic (eg, doxycycline)

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using amoxicillin/ clavulanate extended-release tablets:

Some medical conditions may interact with amoxicillin/clavulanate 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 asthma, hay fever, or hives
  • if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)
  • if you have kidney problems or gonorrhea
  • if you have a history of liver problems or yellowing of the eyes or skin
  • if you are on a low-salt (sodium) diet

Some MEDICINES MAY INTERACT with amoxicillin/clavulanate extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Probenecid because it may increase the risk of amoxicillin/clavulanate extended-release tablets's side effects
  • Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease amoxicillin/clavulanate extended-release tablets's effectiveness
  • Methotrexate because the risk of its side effects may be increased by amoxicillin/clavulanate extended-release tablets
  • Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by amoxicillin/clavulanate extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if amoxicillin/clavulanate 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 amoxicillin/ clavulanate extended-release tablets:

Use amoxicillin/clavulanate extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take amoxicillin/clavulanate extended-release tablets by mouth at the start of a meal to decrease the chance of stomach upset.
  • Swallow amoxicillin/clavulanate extended-release tablets whole. Do not break, crush, or chew before swallowing. If you have difficulty swallowing the whole tablet, this tablet may be broken in half.
  • To clear up your infection completely, take amoxicillin/clavulanate 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 amoxicillin/clavulanate 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 amoxicillin/clavulanate extended-release tablets.

Important safety information:

  • Amoxicillin/clavulanate extended-release tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use amoxicillin/clavulanate extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Amoxicillin/clavulanate extended-release tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Be sure to use amoxicillin/clavulanate 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 amoxicillin/clavulanate 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.
  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
  • Do not receive a live vaccine (eg, oral typhoid vaccine) while you are taking amoxicillin/clavulanate extended-release tablets. Talk with your doctor before you receive any vaccine.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using amoxicillin/clavulanate extended-release tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Amoxicillin/clavulanate extended-release tablets has sodium in it. If you are on a low-salt (sodium) diet, include this when you count your daily intake of sodium.
  • Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking amoxicillin/clavulanate extended-release tablets. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.
  • Diabetes patients - Amoxicillin/clavulanate extended-release tablets may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
  • Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use amoxicillin/clavulanate extended-release tablets for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Amoxicillin/clavulanate extended-release tablets should be used with extreme caution in CHILDREN weighing less than 88 lbs (40 kg); safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using amoxicillin/clavulanate extended-release tablets while you are pregnant. Amoxicillin/clavulanate extended-release tablets is found in breast milk. If you are or will be breast-feeding while you use amoxicillin/clavulanate extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of amoxicillin/ clavulanate 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:

Diarrhea; nausea; 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; unusual hoarseness); behavior changes; bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal discharge or irritation; white patches in the mouth or on the tongue; yellowing of the skin or eyes.

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, or emergency room immediately. Symptoms may include decreased urination; severe nausea, vomiting, or diarrhea; stomach pain; unusual drowsiness.

Proper storage of amoxicillin/clavulanate extended-release tablets:

Store at or below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep amoxicillin/clavulanate extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about amoxicillin/clavulanate extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Amoxicillin/clavulanate 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 amoxicillin/clavulanate 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 amoxicillin/clavulanate 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 amoxicillin/clavulanate 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 amoxicillin/clavulanate extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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