This combination product containing amoxicillin and clavulanic acid belongs to the group of medications known as antibiotics. It is used to treat infections caused by certain bacteria. Amoxicillin works by killing the bacteria that is causing the infection. Clavulanic acid helps make the amoxicillin more effective. This medication is most commonly used to treat infections of the sinus, ear, lung, skin, and bladder.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended adult dose of amoxicillin–clavulanic acid depends on the infection being treated. The usual recommended adult doses include 500 mg every 8 or 12 hours or 875 mg every 12 hours.

The children's dose of amoxicillin–clavulanic acid is based on body weight, as prescribed by the doctor. Depending on the infection being treated, the dose will range between 20 mg and 45 mg per kilogram of body weight per day, taken in divided doses.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The medication may be taken with or without food, but taking it with food may reduce side effects such as upset stomach, nausea, diarrhea, and abdominal cramps. Amoxicillin–clavulanic acid is usually taken for a period of 7 to 10 days. In some cases, it may be necessary to take this medication for a longer period.

If using the suspension form, use an oral syringe to measure each dose to get a more accurate measurement than household teaspoons.

It is very important to take this medication exactly as prescribed by the doctor for the full duration of treatment, even though you may feel better before the medication is finished. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the tablets at room temperature, protect them from light and moisture, and keep them out of the reach of children.

Store the suspension in the refrigerator and keep it out of the reach of children.

250 mg/125 mg
Each debossed, white-to-off-white, oval, film-coated tablet contains 250 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 2:1). Nonmedicinal ingredients:  microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, hypromellose, propylene glycol, SDA 3A Alcohol 27 CFR, titanium dioxide and hydroxypropyl cellulose.

500 mg/125 mg
Each scored, debossed, white-to-off-white, oval, film-coated tablet contains 500 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 4:1). Non-medicinal ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, hypromellose, propylene glycol, SDA 3A Alcohol 27 CFR, titanium dioxide, and hydroxypropyl cellulose.

875 mg/125 mg
Each scored, debossed, white-to-off-white, capsule-shaped tablet contains 875 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (in a ratio of 7:1). Non-medicinal ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, hypromellose, propylene glycol, SDA 3A Alcohol 27 CFR, titanium dioxide, and hydroxypropyl cellulose.

Do not take this medication if you:

• are allergic to amoxicillin, penicillin, cephalosporins (e.g., cephalexin, ceftriaxone), clavulanic acid, or any ingredients of the medication
• have had jaundice or liver problems with previous use of this medication
• have or are suspected to have mononucleosis

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diaper rash (infant)
• diarrhea (mild)
• headache
• heartburn
• nausea
• tongue discolouration or "hairy" tongue
• tooth discolouration
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• itchy or bumpy rash
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• vaginal itching and discharge
• white patches in the mouth or on the tongue

Stop taking the medication and seek immediate medical attention if any of the following occur:

• blood vessel inflammation (red patches or raised spots on the skin, fever, numbness, weakness, fatigue)
• diarrhea (watery and severe; may also be bloody)
• fever that appears after starting the antibiotic
• flu-like symptoms (e.g., fever, rash, swollen glands)
• seizures
• signs of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
• signs of a severe skin reaction (such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
• symptoms of a severe allergic reaction (severe skin rash; itching; hives; difficulty breathing; swelling of the mouth, throat, or tongue)
• wheezing, difficulty breathing, or shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Amoxicillin, one of the ingredients in this medication, is a penicillin. If you have previously had an allergic reaction to antibiotics such as penicillin or cephalosporins (e.g., cephalexin, ceftriaxone), you should not take this medication. Before you take amoxicillin–clavulanic acid, inform your doctor about any previous adverse reactions you have had to medications, especially cephalosporins and penicillins. Other forms of allergic reactions can include skin reactions, decreased liver function and, rarely, heart attack.

Get immediate medical attention if you experience symptoms of a severe allergic reaction (e.g., hives; swelling of the face, tongue, or throat; trouble breathing), liver problems, blistered skin, or chest pain.

Antibiotic-associated colitis: This medication, like other antibiotics, may cause a potentially dangerous condition called antibiotic-associated, or pseudomembranous, colitis. Symptoms include severe, watery diarrhea that may be bloody. If you notice these symptoms, stop taking amoxicillin–clavulanic acid and contact your doctor as soon as possible.

Aspartame: The suspension forms of this medication contain aspartame. If you have phenylketonuria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bacterial resistance: Misuse of an antibiotic such as amoxicillin–clavulanic acid may lead to the growth of resistant bacteria that will not be killed by the antibiotic. If this happens, the antibiotic may not work for you in the future. Although you may begin to feel better early in your course of treatment with this medication, you need to take the full course exactly as directed to finish ridding your body of the infection and to prevent resistant bacteria from taking hold. Do not take amoxicillin–clavulanic acid or other antibiotics to treat a viral infection such as the common cold; antibiotics do not kill viruses, and using them to treat viral infections can lead to the growth of resistant bacteria.

Birth control: This medication may decrease the effectiveness of birth control pills. Some doctors recommend adding another method of birth control for the rest of the cycle when amoxicillin–clavulanate is taken.

Kidney function: This medication is removed from the body mostly by the kidneys. If you have kidney disease or reduced kidney function, this medication may build up in your body and cause unwanted effects.

If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Clavulanic acid may cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mononucleosis: When amoxicillin–clavulanic acid is used by a person who has mononucleosis, a widespread rash may occur. If you have or suspect you have mononucleosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication should not be used by anyone who has or is suspected to have mononucleosis.

Overgrowth of organisms (super-infection): Prolonged or repeated use of this antibiotic may allow normal fungus or certain types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections such as yeast infections. Contact your doctor if you notice white patches in the mouth (thrush), abnormal vaginal discharge, or itching.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Amoxicillin passes into breast milk. It is not known if clavulanic acid passes into breast milk. If you are a breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

There may be an interaction between amoxicillin–clavulanic acid and any of the following:

• allopurinol
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• BCG
• birth control pills
• cholera vaccine
• certain monoclonal antibodies (e.g., atezolizumab, durvalumab, ipilimumab)
• methotrexate
• mycophenolate
• nivolumab
• probenecid
• sodium picosulfate
• tetracyclines (e.g., tetracycline, minocycline, doxycycline)
• typhoid vaccine
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.