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Augmentin contains a combination of amoxicillin and clavulanate potassium. Amoxicillin is an antibiotic belonging to a group of drugs called penicillins. Amoxicillin fights bacteria in the body.
Clavulanate potassium is a beta-lactamase inhibitor that helps prevent certain bacteria from becoming resistant to amoxicillin.
Augmentin 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.
You should not use Augmentin if you have severe kidney disease, if you have had liver problems or jaundice while taking amoxicillin and clavulanate potassium, or if you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, 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. Amoxicillin and clavulanate may not be as effective or could be harmful if you do not use the exact tablet form your doctor has prescribed.
Augmentin 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 Augmentin.
You should not use Augmentin if you are allergic to amoxicillin and clavulanate potassium, or if:
you have severe kidney disease (or if you are on dialysis);
you have had liver problems or jaundice while taking amoxicillin and clavulanate; or
you are allergic to any penicillin or cephalosporin antibiotic, such as Amoxil, Ceftin, Cefzil, Moxatag, Omnicef, and others.
To make sure Augmentin is safe for you, tell your doctor if you have ever had:
liver disease (hepatitis or jaundice);
kidney disease; or
mononucleosis.
Augmentin may cause complications during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.
Amoxicillin and clavulanate potassium can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.
Amoxicillin and clavulanate potassium can pass into breast milk; however, based on a small number of studies, they do not appear to cause harm. Tell your doctor if you are breast-feeding.
Do not give this medicine to a child without medical advice.
The liquid or chewable tablet may contain phenylalanine. Talk to your doctor before using these forms of this medicine if you have phenylketonuria (PKU).
Take Augmentin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take Augmentin every 8-12 hours as prescribed, at the start of a meal to reduce stomach upset.
Do not crush or chew the 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.
The chewable tablet must be chewed before you swallow it.
Shake the liquid medicine well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Use this medicine 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. Augmentin will not treat a viral infection such as the flu or a common cold.
This medicine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Augmentin.
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.
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.
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, hyperactivity, and decreased urination.
Get emergency medical help if you have signs of an allergic reaction to Augmentin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
pale or yellowed skin, dark colored urine, fever, confusion or weakness;
loss of appetite, upper stomach pain, jaundice (yellowing of the skin or eyes);
easy bruising or bleeding;
little or no urination; 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.
Common Augmentin side effects may include:
diarrhea
nausea or vomiting
skin rashes or hives
vaginitis
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.
Tell your doctor about all your current medicines and any you start or stop using, especially:
birth control pills;
allopurinol;
probenecid; or
a blood thinner - warfarin, Coumadin, Jantoven.
This list is not complete. Other drugs may interact with amoxicillin and clavulanate potassium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Augmentin only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Augmentin Es-600 (www.drugs.com/augmentin.html).
Note: This document contains side effect information about amoxicillin / clavulanate. Some of the dosage forms listed on this page may not apply to the brand name Augmentin.
Applies to amoxicillin / clavulanate: oral powder for suspension, oral tablet, oral tablet chewable, oral tablet extended release
Along with its needed effects, amoxicillin/clavulanate 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 while taking amoxicillin / clavulanate:
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking amoxicillin / clavulanate:
Symptoms of overdose
Some side effects of amoxicillin / clavulanate 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
Incidence not known
Applies to amoxicillin / clavulanate: oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release
In general, side effects have been classified as mild and transient. Less than 3% of patients in clinical trials discontinued treatment due to side effects. The most frequent adverse reactions associated with immediate-release formulations have included diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%). Extended-release tablets have been most frequently associated with diarrhea (14.5%), vaginal mycosis (3.3%), nausea (2.1%), and loose stools (1.6%).
Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, indigestion, gastritis, generalized abdominal cramps, stomatitis, glossitis, mucocutaneous candidiasis, enterocolitis, black "hairy" tongue, small intestinal motor disturbances, hemorrhagic colitis, and pseudomembranous colitis. Colitis and Clostridium difficile pseudomembranous colitis have been reported with amoxicillin.
Amoxicillin has been associated with hemorrhagic, sometimes inflammatory colitis, which typically affects the ascending colon. In addition, C difficile pseudomembranous colitis should be considered in patients who develop severe or prolonged diarrhea during or following amoxicillin-clavulanate therapy.
The incidence of diarrhea appears to increase with higher doses, and to decrease with twice daily dosing regimens (of immediate release formulations).
Hypersensitivity reactions to amoxicillin are more likely in patients with a history of allergy, asthma, hay fever, or urticaria.
Hypersensitivity reactions have occurred in up to 10% of patients, and may present as a skin rash, urticaria, pruritus, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome (rarely), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, exfoliative dermatitis, and toxic epidermal necrolysis. Anaphylaxis has been rarely reported (up to 0.2%). Hypersensitivity may play a role in some cases of amoxicillin-clavulanate-induced renal and hepatic toxicity. Urticarial rash, erythematous maculopapular rash, edema, hypotension, fever, eosinophilia, and dyspnea have been associated with hypersensitivity reactions to amoxicillin.
Three out of four patients with infectious mononucleosis and an amoxicillin-associated rash displayed hypersensitivity to amoxicillin and ampicillin by skin tests and lymphocyte transformation tests. Two of these patients had side-chain-specific sensitization.
Dermatologic side effects have included rash, fixed drug eruption, bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis. Amoxicillin rashes occur more frequently in patients with unrecognized infectious mononucleosis. This rash is not necessarily indicative of a lifelong amoxicillin hypersensitivity.
Hepatic side effects have included moderate elevations in serum transaminases (ALT and/or AST). Hepatic dysfunction (including cholestatic jaundice and hepatitis, increases in ALT and/or AST, serum bilirubin, and/or alkaline phosphatase) has been reported infrequently. Rare cases of jaundice, ductopenia, cholestatic hepatitis, granulomatous hepatitis, hepatic necrosis, and hepatocellular damage have also been reported. Less than 1 death per approximately 4 million prescriptions has been reported worldwide. Hepatic cholestasis and acute cytolytic hepatitis have been reported with amoxicillin use.
In cases of amoxicillin-clavulanate-induced hepatotoxicity, biopsy findings have typically revealed evidence of cholestatic injury. However, hepatocellular and mixed-type (cholestatic and hepatocellular) injury have also been documented. In many instances, hepatotoxicity may be due to a hypersensitivity. Onset of symptoms has been delayed in some patients, with presentation occurring after therapy has been discontinued. Prolonged treatment may increase the risk of hepatotoxicity. Elderly patients may be at increased risk of developing amoxicillin-clavulanate-induced jaundice. Fatalities are rare, but have been reported.
Rechallenge with amoxicillin alone has not been followed by a recurrence of hepatitis. However, rechallenge with amoxicillin-clavulanate has resulted in a relapse of liver injury. Therefore, the clavulanic acid may be the hepatotoxic part of the drug.
In patients with liver disease, frequent monitoring of liver function tests during amoxicillin-clavulanate therapy is recommended.
Renal side effects have rarely included crystalluria, hematuria, acute renal failure, and acute interstitial nephritis, often associated with fever, rash, and eosinophilia.
A 45-year-old female developed massive crystalluria, gross hematuria, and acute anuric renal failure after 12 days of intravenous amoxicillin-clavulanate at a dose of 2 g amoxicillin 3 times daily (not available in the United States). The crystals were composed of amoxicillin trihydrate. The renal failure and hematuria resolved over 6 days after discontinuation of the antibiotic.
Amoxicillin has been shown to induce hemolytic anemia in rare cases. A case of bone marrow "maturation arrest" resulting in neutropenia and of Henoch-Schonlein purpura syndrome has been associated with amoxicillin-clavulanate.
A patient undergoing dental extraction and receiving warfarin anticoagulation therapy had prolonged bleeding times (PT and INR), and decreased hemoglobin and hematocrit. The bleeding was felt due to vitamin K deficiency as a result of depletion of intrinsic vitamin K-producing gut flora from use of amoxicillin for prophylaxis of subacute bacterial endocarditis.
Hematologic side effects associated with penicillins have included thrombocytopenia, anemia, hemolytic anemia, thrombocytopenic purpura, eosinophilia, agranulocytosis, and leukopenia. These are believed to be due to hypersensitivity and are usually reversible when the drug is discontinued. Mild to moderate thrombocytosis has been reported in less than 1% of patients treated with amoxicillin-clavulanate and 3.6% of patients treated with the extended-release tablets. Purpura, pancytopenia, granulocytopenia, medullary aplasia, prolongation of prothrombin time, and transient neutropenia have also been reported.
Immunologic side effects associated with amoxicillin have included mucocutaneous candidiasis and vulvovaginal mycotic infection.
Nervous system side effects have rarely included agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity. Rare cases of psychosis associated with amoxicillin therapy have been reported, but may have been due to underlying infection or concomitant medication. Rarely, somnolence and aseptic meningitis have been reported with amoxicillin.
Genitourinary side effects have included genital moniliasis (2.1%).
Amoxicillin-clavulanate may cause false-positive urine glucose tests in patients using Clinitest(R) tablets. Enzymatic glucose oxidase tests should be used during amoxicillin-clavulanate therapy.
Other side effects have rarely included brown, yellow, or gray tooth discoloration, primarily in pediatric patients. Brushing or dental cleaning reduced or eliminated the discoloration in most cases.
Respiratory side effects associated with amoxicillin have included cough and rhinorrhea.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Augmentin Es-600 (www.drugs.com/augmentin.html).
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