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amoxicillin and clavulanate potassium

Pronunciation

Generic Name: amoxicillin and clavulanate potassium (am OKS i sil in KLAV yoo la nate po TAS ee um)
Brand Name: Augmentin, Augmentin ES-600, Augmentin XR

What is amoxicillin and clavulanate potassium?

Amoxicillin is an antibiotic in a group of drugs called penicillins. Amoxicillin fights bacteria in the body.

Clavulanate potassium is a form of clavulanic acid. It is used to overcome resistance in bacteria that secrete beta-lactamase, thereby counteracting possible bacterial resistance to the amoxicillin.

The combination of amoxicillin and clavulanate potassium is used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.

Amoxicillin and clavulanate potassium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about amoxicillin and clavulanate potassium?

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 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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. This medicine 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.

What should I discuss with my healthcare provider before taking amoxicillin and clavulanate potassium?

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 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 this medicine, 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.

FDA pregnancy category B. This medication 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).

How should I take amoxicillin and clavulanate potassium?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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. The strength of clavulanate potassium is not the same among the different tablet forms, even though the amount of amoxicillin may be the same as in the tablet you were using before. This medicine may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.

Take this medicine with a full glass of water.

Take the medicine at the start of a meal to reduce stomach upset.

Take the medicine at the same time each day.

The Augmentin tablet should be swallowed whole.

The Augmentin Chewable tablet must be chewed before swallowing. Do not swallow a chewable tablet whole.

Do not crush or chew the Augmentin XR (extended-release) tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. If you have trouble swallowing a whole or half pill, talk with your doctor about using another form of amoxicillin and clavulanate potassium.

Shake the liquid form of this medicine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Amoxicillin and clavulanate potassium will not treat a viral infection such as the common cold or flu.

This medication can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using amoxicillin and clavulanate potassium.

Store the tablets at room temperature away from moisture and heat.

Store the liquid in the refrigerator. Throw away any unused liquid after 10 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, and hyperactivity.

What should I avoid while taking amoxicillin and clavulanate potassium?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Amoxicillin and clavulanate potassium side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Amoxicillin and clavulanate potassium dosing information

Usual Adult Dose for Aspiration Pneumonia:

500 mg orally every 8 hours or 875 mg orally every 12 hours

Therapy should be continued until the infiltrate is cleared or a residual scar forms, sometimes for as long as 2 to 4 months, depending on the nature and severity of the infection.

Usual Adult Dose for Bronchitis:

500 mg orally every 8 hours or 875 mg orally every 12 hours for 7 to 10 days

Usual Adult Dose for Febrile Neutropenia:

Low-risk: 500 mg orally every 8 hours in combination with ciprofloxacin until the patient has been afebrile for at least 24 hours and the absolute neutrophil count is more than 500 cells/mm3

Usual Adult Dose for Otitis Media:

250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 to 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Pneumonia:

Immediate release tablets: 500 mg orally every 8 hours or 875 mg orally every 12 hours

The duration of therapy for pneumococcal pneumonia is 7 to 10 days. Pneumonia caused by other organisms may require up to 21 days of therapy.

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 7 to 10 days for community-acquired pneumonia

Usual Adult Dose for Pyelonephritis:

250 mg orally every 8 hours or 500 mg orally every 12 hours for 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Sinusitis:

Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 to 14 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered. Longer courses of therapy, sometimes 3 or 4 weeks, may be required for refractory or recurrent cases.

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection:

250 mg orally every 8 hours or 500 mg orally every 12 hours for 7 days, or for 3 days following resolution of acute inflammation

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered. For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

Usual Adult Dose for Upper Respiratory Tract Infection:

250 mg orally every 8 hours or 500 mg orally every 12 hours for 10 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Adult Dose for Urinary Tract Infection:

250 mg orally every 8 hours or 500 mg orally every 12 hours for 3 to 7 days

For more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered.

Usual Pediatric Dose for Otitis Media:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours for 10 days

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours for 10 days
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours for 10 days

40 kg or more:
Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Recurrent or persistent acute otitis media:
600 mg/5 mL oral suspension:
3 months or older:
Less than 40 kg: 45 mg/kg orally every 12 hours for 10 days
40 kg or more: Data not available; other formulations are recommended

Usual Pediatric Dose for Pneumonia:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:
Immediate release tablets: 500 mg orally every 8 hours or 875 mg orally every 12 hours
Extended release tablets: 2 g (2 tablets) orally every 12 hours for 7 to 10 days for community-acquired pneumonia

Usual Pediatric Dose for Sinusitis:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours
600 mg/5 mL oral suspension: 45 mg/kg orally every 12 hours

40 kg or more:
Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Extended release tablets: 2 g (2 tablets) orally every 12 hours for 10 days

Usual Pediatric Dose for Bacterial Infection:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:
Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Urinary Tract Infection:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:
Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Skin and Structure Infection:

Less than 12 weeks:
125 mg/5 mL oral suspension: 15 mg/kg orally every 12 hours

3 months (12 weeks) or older:
Less than 40 kg:
125 mg/5 mL or 250 mg/5 mL oral suspension: 6.67 to 13.33 mg/kg orally every 8 hours
200 mg/5 mL or 400 mg/5 mL oral suspension or chewable tablets: 12.5 to 22.5 mg/kg orally every 12 hours

40 kg or more:
Immediate release tablets: 250 mg orally every 8 hours or 500 mg orally every 12 hours; for more severe infections, 500 mg orally every 8 hours or 875 mg orally every 12 hours may be administered

Usual Pediatric Dose for Melioidosis:

8 years or younger: Amoxicillin-clavulanate 30 mg/kg-15 mg/kg per day plus amoxicillin 30 mg/kg/day are recommended after an initial 10 days of parenteral antibiotic therapy

Duration: 20 weeks

What other drugs will affect 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.

Where can I get more information?

  • Your pharmacist can provide more information about amoxicillin and clavulanate potassium.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2011-02-01, 1:37:34 PM.

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