Amoxicillin and Clavulanate Potassium

💊 What is Amoxicillin and Clavulanate Potassium used for?

• •The label says this form is used to treat recurrent or persistent acute otitis media (middle ear infection) in children aged 3 months to 12 years who weigh 40 kg (about 88 pounds) or less. The infection must be caused by certain named bacteria (S. pneumoniae, H. influenzae, or M. catarrhalis). The label says it is used when there are risk factors, such as recent antibiotic use for an ear infection within the past 3 months, plus either age 2 years or younger or day care attendance. The label also says it should be used only for infections proven or strongly suspected to be caused by susceptible bacteria. It is not for viral infections such as the common cold.

How it works

The label describes amoxicillin as a penicillin-class antibacterial and clavulanate potassium as a beta-lactamase inhibitor. The label text provided does not explain in more detail how these work together.

How it is usually taken

• •The label says to take it with a meal or snack to reduce stomach upset. It also says to take it at the start of a meal, because this may help the clavulanate absorb. The label describes a schedule of two doses a day, about 12 hours apart. Shake the bottle well before each use. Measure each dose with a dosing spoon or medicine dropper, and rinse the spoon or dropper after each use. The label says to follow the amount and number of days your doctor or pharmacist gives you. Take it exactly as directed, even if you feel better early.

Comes as

• •Oral suspension (dry powder mixed with water to make an orange-flavored liquid), 600 mg amoxicillin and 42.9 mg clavulanic acid per 5 mL
• •Bottles of 75 mL, 125 mL, and 200 mL

⚠️ Amoxicillin and Clavulanate Potassium side effects

🛑 Who should not take Amoxicillin and Clavulanate Potassium, and who should be careful

The label says not to take it if

• 🚨You have had a serious allergic reaction (such as anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate, or other beta-lactam antibiotics such as penicillins or cephalosporins. The label says this medicine is contraindicated in this case.
• 🚨You have had cholestatic jaundice or liver dysfunction linked to this medicine in the past. The label says this medicine is contraindicated in this case.

Tell your doctor before taking it if

• •Tell your doctor or pharmacist about any past allergic reaction to penicillins, cephalosporins, or other drugs or allergens. The label says careful questioning about past hypersensitivity is needed before starting.
• •Tell your doctor about any liver problems. The label says it should be used with caution in people with liver dysfunction, and liver function may be monitored.
• •Tell your doctor if you or your child has mononucleosis. The label says patients with mononucleosis who receive this medicine can develop a skin rash, and the label advises avoiding use in these patients.
• •Tell your doctor if you have phenylketonuria. The label says each 5 mL contains 1.4 mg of phenylalanine.
• •The label says this form is for children and that experience in adults is not available. Adults who have trouble swallowing should not be given this liquid in place of the tablets.
• •The label says that the bottle may contain more liquid than needed, so follow your doctor's instructions about the amount to use.

🔀 Amoxicillin and Clavulanate Potassium with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •Probenecid: The label says coadministration is not recommended, because it can increase and prolong amoxicillin blood levels.
• •Oral anticoagulants (blood thinners): The label says these may increase prolongation of prothrombin time. Appropriate monitoring is advised, and anticoagulant doses may need adjusting.
• •Allopurinol: The label says taking it together increases the risk of rash.
• •Oral contraceptives (birth control pills): The label says this medicine may reduce their effectiveness, because it may affect intestinal bacteria and estrogen reabsorption.
• •Urine glucose tests: High urine amoxicillin can cause false-positive results with some glucose tests (CLINITEST, Benedict's, or Fehling's). The label recommends enzymatic glucose oxidase tests instead.

Alcohol and food

The label says to take this medicine with a meal or snack, and at the start of a meal, to reduce stomach upset and help absorption. The label text provided does not mention alcohol.

🤰 Amoxicillin and Clavulanate Potassium in pregnancy and breastfeeding

Pregnancy

The label says available data have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. It notes that one study in women with preterm premature rupture of membranes found that prophylactic treatment with amoxicillin and clavulanate may be linked to an increased risk of necrotizing enterocolitis in newborns. Animal studies at certain doses showed no evidence of harm to the fetus. The label notes that all pregnancies carry a background risk of birth defects and loss.

Breastfeeding

The label does not say.

🗓️ Storage, missed doses and taking too much

Storage

The label says to keep the reconstituted suspension refrigerated, and to shake well before use. It says to discard unused suspension after 10 days. The dry powder is stored at 20 to 25 C (68 to 77 F), kept in its original container and tightly closed. Keep this and all medicines out of the reach of children.

If a dose is missed

The label does not say.

If too much is taken

The label says overdose has mainly caused stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness were seen in a small number of patients. The label text provided does not give further instructions for what a person should do after an overdose.

🗒️ Questions to ask about Amoxicillin and Clavulanate Potassium

• Is this liquid the right form for my child's age and weight, based on the label?
• Which infection is this medicine treating, and how do you know it is caused by bacteria?
• What should I do if my child has diarrhea, and when should I call you?
• How should I mix, measure, and store the liquid, and when should I throw away leftover medicine?
• Does my child have any allergy history to penicillin or cephalosporin antibiotics?
• Could this medicine affect any other medicines my child or I take, such as blood thinners, allopurinol, or birth control pills?
• What signs of a serious allergic or skin reaction should I watch for?

❓ Amoxicillin and Clavulanate Potassium: frequently asked questions