Amoxicillin 1000 mg Clavulanate Potassium 200 mg Injection

Do not use this medication if you are allergic to amoxicillin or clavulanate potassium, or if you have ever had liver problems caused by this medication.

Do not use amoxicillin and clavulanate if you are allergic to any other penicillin antibiotic, such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen)), and others.

To make sure you can safely take amoxicillin and clavulanate, tell your doctor if you have any of these other conditions:

• liver disease (or a history of hepatitis or jaundice);

• kidney disease;

• mononucleosis; or

• if you are allergic to a cephalosporin antibiotic, such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

Amoxicillin and clavulanate potassium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking amoxicillin and clavulanate potassium.

Amoxicillin and clavulanate potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The liquid and chewable tablet forms of this medication may contain phenylalanine. Talk to your doctor before using these forms of amoxicillin and clavulanate potassium if you have phenylketonuria (PKU).

Get emergency medical help if you have any of these signs of an allergic reaction to amoxicillin and clavulanate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• diarrhea that is watery or has blood in it;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• easy bruising or bleeding;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• agitation, confusion, unusual thoughts or behavior, seizure (convulsions);

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious amoxicillin and clavulanate side effects may include:

• mild diarrhea, gas, stomach pain;

• nausea or vomiting;

• headache;

• skin rash or itching;

• white patches in your mouth or throat; or

• vaginal yeast infection (itching or discharge).

Lower Respiratory Tract Infections

– caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.

Acute Bacterial Otitis Media

– caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Sinusitis

– caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections

– caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.

Urinary Tract Infections

– caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Do not use this medication if you are allergic to amoxicillin or clavulanate potassium, or if you have ever had liver problems caused by this medication.

Do not use amoxicillin and clavulanate potassium if you are allergic to any other penicillin antibiotic, such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others.

Before taking amoxicillin and clavulanate potassium, tell your doctor if you have liver disease (or a history of hepatitis or jaundice), kidney disease, or mononucleosis, or if you are allergic to a cephalosporin antibiotic, such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

If you switch from one tablet form to another (regular, chewable, or extended-release tablet), take only the new tablet form and strength prescribed for you. Amoxicillin and clavulanate may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.

Amoxicillin and clavulanate potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking amoxicillin and clavulanate potassium.

Tell your doctor about all other medications you use, especially:

• allopurinol (Zyloprim);

• probenecid (Benemid);

• a blood thinner such as warfarin (Coumadin, Jantoven); or

• another antibiotic (for the same or for a different infection).

This list is not complete and other drugs may interact with amoxicillin and clavulanate potassium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Bacteriologic Efficacy Rates for Amoxicillin and Clavulanate Potassium Tablets