(a mox i sil' in) (klav' yoo lan ic)

Brand Name(s): Augmentin^® (as a combination product containing Amoxicillin, Clavulanate), Augmentin^® XR (as a combination product containing Amoxicillin, Clavulanate)¶; also available generically

WHY is this medicine prescribed?

The combination of amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying amoxicillin.

Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of amoxicillin and clavulanic acid comes as a tablet, a chewable tablet, and a suspension (liquid) to take by mouth. It is usually taken with a meal or snack every 8 hours (three times a day) or every 12 hours (twice a day). To help you remember to take amoxicillin and clavulanate, take it around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amoxicillin and clavulanic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

The chewable tablets should be chewed thoroughly before they are swallowed.

You should begin to feel better during the first few days of treatment with amoxicillin and clavulanic acid. If your symptoms do not improve or get worse, call your doctor.

If you are taking the suspension, do not use a household spoon to measure your dose. Use a properly marked measuring device such as a medicine spoon or oral syringe. Ask your doctor or pharmacist if you need help getting or using a measuring device.

Take amoxicillin and clavulanic acid until you finish the prescription, even if you feel better. If you stop taking amoxicillin and clavulanic too soon, or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What SPECIAL PRECAUTIONS should I follow?

Before taking amoxicillin and clavulanic acid,

• tell your doctor and pharmacist if you are allergic to amoxicillin, clavulanic acid, penicillin, cephalosporins, any other medications, or any of the ingredients in amoxicillin and clavulanic acid tablet, chewable tablet, and oral suspension. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• You should know that amoxicillin and clavulanic acid may decrease the effectiveness of oral contraceptives (birth control pills). You will need to use another method of contraception to prevent pregnancy while taking amoxicillin and clavulanic acid. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

• tell your doctor if you have ever had any liver problems after you have previously taken amoxicillin and clavulanic acid. Your doctor may tell you not to take amoxicillin and clavulanic acid.

• tell your doctor if you have mononucleosis (a virus; also called 'mono') and if you have or have ever had kidney or liver disease, allergies, asthma, hay fever, or hives.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking amoxicillin and clavulanic acid, call your doctor.

• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that amoxicillin and clavulanic acid chewable tablets and oral suspension are sweetened with aspartame that forms phenylalanine.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Amoxicillin and clavulanic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• upset stomach
• vomiting
• vaginal itching and/or discharge

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• watery or bloody stools, stomach cramps, or fever during treatment or for up to two or more months after stopping treatment
• severe vomiting that may occur 1 to 4 hours after you take amoxicillin and clavulanic acid
• rash
• itching
• hives
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, and eyes
• wheezing
• peeling, blistering, or shedding skin
• a return of fever, sore throat, chills, or other signs of infection
• yellowing of the skin or eyes, pain or discomfort in right upper stomach area, fatigue, loss of appetite, bleeding or bruising more easily than normal, or dark urine

Amoxicillin and clavulanic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep liquid medication in the refrigerator, tightly closed, and dispose of any unused medication after 10 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• cloudy or bloody urine
• decreased urination

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to amoxicillin and clavulanic acid.

If you are diabetic, use Clinistix or TesTape (not Clinitest) to test your urine for sugar while taking this medication.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the amoxicillin and clavulanic acid, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 20, 2024.