Amoxicillin and Potassium Clavulanate

Augmentin (amoxicillin / clavulanate) is an antibiotic medication. It contains a penicillin and a beta-lactamase inhibitor. This antibiotic treats many types of bacterial infections, like urinary tract infection (UTI), sinus infection, and ear infection, among others. It fights infections by preventing bacteria from protecting themselves from harm. This medication comes as tablets, chewable tablets, and a suspension that are taken by mouth typically two to three times daily. It's approved for use in adults and children. Common side effects include diarrhea, nausea, and rash.

What is Augmentin (amoxicillin / clavulanate) used for?

• Ear infections
• Sinus infections
• Lower respiratory tract infections
• Skin infections (e.g., cellulitis)
• Urinary tract infections (UTIs)

How Augmentin (amoxicillin / clavulanate) works

Augmentin (amoxicillin / clavulanate) is a combination of two medications that work together to treat infections.

• Amoxicillin belongs to a drug class called penicillin antibiotics. It kills bacteria by preventing them from making their protective covering that normally shields them from harm.
• Clavulanate (also known as clavulanic acid) is a beta-lactamase inhibitor. A beta-lactamase is a protein that bacteria use to break down amoxicillin and cause amoxicillin (the antibiotic) to not work. By blocking beta-lactamase from working, clavulanate protects amoxicillin from being broken down. This helps amoxicillin work better at fighting infections.

When does Augmentin (amoxicillin / clavulanate) start working?

Time passed since treatment started:

• Take Augmentin (amoxicillin / clavulanate) exactly as prescribed. Make sure to finish your treatment course, even if you're feeling better. Stopping the antibiotic earlier than prescribed can make your infection come back and become harder to treat.
• In general, it's recommended to take Augmentin (amoxicillin / clavulanate) at the start of a meal to help lessen stomach upset. Be sure to choose a low-fat meal if you're taking the extended-release tablets so the medication gets properly absorbed into the body.
• For Augmentin (amoxicillin / clavulanate) extended-release tablets: You can split the extended-release tablet in half on the score line to help you swallow them easier. Use a pill splitter to help you cut it in half and take both halves right after splitting.
• For the Augmentin (amoxicillin / clavulanate) oral suspension: Shake the bottle well before you measure out your dose using a dose cup or oral syringe from the pharmacy. Don't use household spoons; they aren't accurate and using them might cause you to take the wrong dose. Keep the suspension in the refrigerator for up to 10 days; throw away the bottle after 10 days, even if there's still some medication left.
• Avoid drinking alcohol while you're taking Augmentin (amoxicillin / clavulanate). Alcohol can raise your risk for stomach side effects like nausea, vomiting, and diarrhea.
• Get medical help right away if you develop watery or bloody diarrhea, fever, fatigue, or stomach cramps anytime while you're taking Augmentin (amoxicillin / clavulanate) or after you finish your antibiotic treatment. These could be signs of a type of serious infectious diarrhea that needs to be treated right away.
• Discuss with a healthcare professional (HCP) whether you should take a probiotic to help lessen the risk of infectious diarrhea from your antibiotic. If your HCP recommends taking a probiotic, take it at least 2 hours before or after Augmentin (amoxicillin / clavulanate) to prevent the antibiotic from killing the "good" bacteria in the probiotic.
• Tell your healthcare team and pharmacist about all the medications you're taking or planning to take. Augmentin (amoxicillin / clavulanate) interacts with some medications, such as warfarin (Coumadin) and certain gout medications. Your care team can check for harmful drug interactions and make changes to your medications to keep you safe.

What are the risks and warnings for Augmentin (amoxicillin / clavulanate)?

Augmentin (amoxicillin / clavulanate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Severe allergic reactions and skin reactions

• Risk factors: Allergy to penicillin | Currently have a mononucleosis infection

Severe allergic reactions to Augmentin (amoxicillin / clavulanate) are possible, including life-threatening reactions like facial swelling and anaphylaxis (e.g., closing of the throat). Let your care team know if you have an allergy to any antibiotics so they can check your risk for a reaction to Augmentin (amoxicillin / clavulanate).

Although rare, Augmentin (amoxicillin / clavulanate) can also cause serious skin reactions, such as Stevens-Johnson syndrome (SJS). Because a higher number of people with a mononucleosis infection who took amoxicillin developed a skin rash, this medication isn't recommended if you currently have a mononucleosis infection.

Stop taking Augmentin (amoxicillin / clavulanate) and get medical help right away if you have an allergic reaction to the antibiotic. Look out for any swelling of the lips or tongue, trouble breathing, severe vomiting or diarrhea, or pale skin after you take Augmentin (amoxicillin / clavulanate). Also call for medical help if you notice unusual changes in your skin, such as hives, rash, blisters, skin reddening, or skin peeling.

Liver problems

• Risk factors: History of liver problems

Although rare, Augmentin (amoxicillin / clavulanate) might cause serious liver problems. These liver problems are typically reversible, but can also sometimes be life-threatening. Make sure your care team knows whether you have a history of liver problems. You might need to get blood tests done to check your liver health.

Get medical attention right away if you notice signs of liver problems, such as swelling of your stomach; stomach pain; yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); or dark or brown urine. You might need to stop taking Augmentin (amoxicillin / clavulanate) to prevent further liver damage.

Diarrhea from Clostridioides difficile infection

Augmentin (amoxicillin / clavulanate) can raise your risk of getting infected with bacteria called Clostridioides difficile (C. diff). This is because antibiotics change the amount of normal bacteria in your stomach and intestines. This can allow C. diff to overgrow in your gut, lead to an infection, and cause severe diarrhea.

It's important to recognize the difference between diarrhea as a side effect of Augmentin (amoxicillin / clavulanate) and this type of infectious diarrhea. C. diff-related diarrhea can cause rapid heart rate, foul-smelling diarrhea, fever, nausea, frequent bowel movements (even up to 15 times per day). It's a medical emergency so get medical help right away if you have any of these symptoms while you're taking this antibiotic. You'll get tested for a C. diff infection and get appropriate treatment, if needed.

Caution use in people with phenylketonuria (PKU) - for chewable tablets and suspension

Some chewable tablets and oral suspensions of the medication contain phenylalanine, a component of the artificial sweetener aspartame. If you have a genetic condition called phenylketonuria (PKU), taking these forms of Augmentin (amoxicillin / clavulanate) can be dangerous for you.

Bottle of oral suspension

• 50ml of 200mg/28.5mg/5ml
• 75ml of 200mg/28.5mg/5ml
• 100ml of 200mg/28.5mg/5ml
• 75ml of 600mg/42.9mg/5ml
• 125ml of 600mg/42.9mg/5ml
• 200ml of 600mg/42.9mg/5ml
• 50ml of 400mg/57mg/5ml
• 75ml of 400mg/57mg/5ml
• 100ml of 400mg/57mg/5ml
• 75ml of 250mg/62.5mg/5ml
• 100ml of 250mg/62.5mg/5ml
• 150ml of 250mg/62.5mg/5ml

Chewable tablet

• 200mg/28.5mg
• 400mg/57mg

Tablet

• 250mg/125mg
• 500mg/125mg
• 875mg/125mg

The dosage for Augmentin (amoxicillin / clavulanate) is given based on the milligrams of the amoxicillin. Your dose might differ if you have kidney problems.

Augmentin (amoxicillin / clavulanate) immediate-release tablets, chewable tablets, and liquid suspensions:

• Adults and children who weigh 88 lbs or more
  • Serious infections or respiratory tract infections: The typical dose is 875 mg of amoxicillin by mouth every 12 hours, or 500 mg of amoxicillin by mouth every 8 hours.
  • Less severe infections: The typical dose is 500 mg of amoxicillin by mouth every 12 hours, or 250 mg of amoxicillin by mouth every 8 hours.
• Children who weigh less than 88 lbs
  • Your child's pediatrician will calculate the dosage based on your child's body weight and age. Doses are typically swallowed (for the liquid suspension) or chewed (for the chewable tablets) every 8 to 12 hours.

Augmentin (amoxicillin / clavulanate) extended-release tablets

• Adults and children who weigh 88 lbs or more
  • Sinus infection and pneumonia: The typical dose is 2,000 mg of amoxicillin by mouth every 12 hours for 7 to 10 days.

Augmentin (amoxicillin / clavulanate) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Augmentin (amoxicillin / clavulanate). Please note that only the generic name of each medication is listed below.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chlortetracycline
• Cholera Vaccine, Live
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Eravacycline
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Lymecycline
• Meclocycline
• Mestranol
• Methacycline
• Methotrexate
• Minocycline
• Mycophenolate Mofetil
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Omadacycline
• Oxytetracycline
• Rolitetracycline
• Sarecycline
• Sulfasalazine
• Tetracycline
• Tigecycline
• Venlafaxine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Khat
• Probenecid

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Immediate-release tablets, chewable tablets, and suspension

• Diarrhea or loose stools (9%)
• Nausea (3%)
• Skin rash (3%)

Extended-release tablets

• Diarrhea (15%)
• Vaginal yeast infection (3%)

Augmentin ES-600 (amoxicillin / clavulanate) suspension

• Vomiting (7%)
• Fever (6%)
• Rash (6%)
• Upper respiratory tract infection (e.g., common cold; 4%)
• Diarrhea (4%)

Other Side Effects

• Allergic reactions
• Itching

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reactions and skin reactions: hives, rash, blisters, skin reddening or peeling, swelling of the lips or tongue, trouble breathing, severe vomiting
• Infectious diarrhea (C. difficile-related diarrhea): rapid heart rate, foul-smelling diarrhea, fever, nausea, frequent bowel movements (even up to 15 times per day)
• Liver damage: swelling of your stomach, yellowing of your skin or the whites of your eyes, dark or brown urine, confusion

When do Augmentin (amoxicillin / clavulanate) possible side effects begin and end?

Time passed since treatment started:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Hives or welts
• Itching
• Itching of the vagina or genital area
• Pain during sexual intercourse
• Redness of the skin
• Skin rash
• Thick, white vaginal discharge with no odor or with a mild odor

Rare

• Bloody or cloudy urine
• Fever
• Greatly decreased frequency of urination or amount of urine
• Seizures
• Swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach cramps or tenderness
• Back, leg, or stomach pains
• Black, hairy tongue
• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Bloating
• Blood in the stools
• Bloody nose
• Chest pain
• Chills
• Clay-colored stools
• Cough or hoarseness
• Cracks in the skin
• Dark urine
• Diarrhea
• Diarrhea, watery and severe, which may also be bloody
• Difficulty with breathing
• Difficulty with moving
• Difficulty with swallowing
• Dizziness
• Fast heartbeat
• Fever with or without chills
• General body swelling
• General feeling of tiredness or weakness
• Headache
• Heavier menstrual periods
• Increased thirst
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Light-colored stools
• Loss of appetite
• Loss of heat from the body
• Lower back or side pain
• Muscle stiffness
• Nausea or vomiting
• Pain
• Pain, swelling, or redness in the joints
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rash
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Red, swollen skin
• Scaly skin
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Tightness in the chest
• Troubled breathing with exertion
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight loss
• Upper right abdominal or stomach pain
• Vomiting of blood
• White patches in the mouth or throat or on the tongue
• White patches with diaper rash
• Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain
• Cloudy urine
• Diarrhea
• Greatly decreased frequency of urination or amount of urine
• Sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Anxiety
• Dry mouth
• Hyperventilation
• Irregular heartbeats
• Irritability
• Restlessness
• Shaking
• Sleeplessness
• Tooth discoloration
• Trouble sitting still
• Trouble with sleeping

Incidence not known

• Burning feeling in the chest or stomach
• Indigestion
• Redness, swelling, or soreness of the tongue
• Stomach upset
• Swelling or inflammation of the mouth