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|Amoxicillin/Clavulanate Extended-Release Tablets

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Amoxicillin/Clavulanate Extended-Release Tablets

Generic Name: Amoxicillin/Clavulanate Extended-Release Tablets (a-MOX-i-SIL-in/KLAV-ue-la-nate)
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 other penicillin antibiotics (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 have recently received or will be receiving live oral typhoid vaccine

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

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 allergies, 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 other 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 amount of Amoxicillin/Clavulanate Extended-Release Tablets in your blood
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
Live oral typhoid vaccine or 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.
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 this medicine.

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.
Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Contact your doctor if you develop diarrhea that lasts for more than 2 or 3 days. Do not treat diarrhea without first checking with your doctor.
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.
Use Amoxicillin/Clavulanate Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.
Amoxicillin/Clavulanate Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 16 years old; 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); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.

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 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.

This information is a summary only. It does not contain all information about Amoxicillin/Clavulanate 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

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