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Augmentin ES-600 (amoxicillin-clavulanate)

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Augmentin ES-600 may cause the following symptoms that are related to high fever:

Medical Source Information
Yellow highlights indicate symptoms related to high fever.

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.

Renal side effects have rarely included crystalluria, hematuria, acute renal failure, and acute interstitial nephritis, often associated with fever, rash, and eosinophilia.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects: diarrhea that is watery or has blood in it; pale or yellowed skin, dark colored urine, fever, confusion or weakness; easy bruising or bleeding; skin rash, bruising, severe tingling, numbness, pain, muscle weakness; agitation, confusion, unusual thoughts or behavior, seizure (convulsions); nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or fever, sore throat, and headache with severe blistering, peeling, or red skin rash. Less serious side effects may include: mild diarrhea, gas, stomach pain; nausea or vomiting; headache; skin rash or itching; white patches in your mouth or throat; or vaginal yeast infection (itching or discharge). This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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.

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.

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.

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.

This drug is contraindicated in patients with a previous history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction. Amoxicillin-clavulanate has been associated with hepatic toxicity (usually reversible). Rare fatalities have been reported (less than 1 death per estimated 4 million prescriptions). Caution and liver function monitoring is recommended in patients with hepatic impairment.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

Monitor liver function tests and liver function tests
Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
Monitor blood tests

References

Amoxicillin-induced acute interstitial nephritis. Walker RJ, Bailey RR, Lynn KL, Swainson CP N Z Med J 1985;98:866.
Amoxicillin-clavulanic acid (Augmentin). Anonymous Med Lett Drugs Ther 1984;26:99-100.
Drug allergy to the beta-lactam antibiotics clavulanic acid and amoxicillin. Cahen YD, Wuthrich B Allergy 1997;52:117-8.
Oral clindamycin 300 mg BID compared with oral amoxicillin/clavulanic acid 1 g BID in the outpatient treatment of acute recurrent pharyngotonsillitis caused by group a beta-hemolytic streptococci: an international, multicenter, randomized, investigator-bl Mahakit P, Vicente JG, Butt DI, Angeli G, Bansal S, Zambrano D Clin Ther 2006;28:99-109.
Product Information. Augmentin ES-600 (amoxicillin-clavulanate). Anonymous GlaxoSmithKline, Philadelphia, PA.
Product Information. Augmentin (amoxicillin-clavulanate). Anonymous SmithKline Beecham, Philadelphia, PA. PROD;
Amoxicillin/clavulanic acid: an update of its antibacterial activity, pharmacokinetic properties and therapeutic use. Todd PA, Benfield P Drugs 1990;39:264-307.
Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. Siquier B, Sanchez-Alvarez J, Garcia-Mendez E, et al. J Antimicrob Chemother 2006;57:536-45.
Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. Salvo F, Polimeni G, Moretti U, et al. J Antimicrob Chemother 2007;60:121-6.
Clinical efficacy and tolerance of augmentin in soft tissue infection. Ball AP, Mehtar S, Watson A J Antimicrob Chemother 1982;10:67-74.
Drug hypersensitivity causing granulomatous interstitial nephritis. Singer DR, Simpson JG, Catto GR, Johnston AW Am J Kidney Dis 1988;11:357-9.
Complications involving augmentin. Simon MW Am J Dis Child 1985;139:962.
Augmentin-induced jaundice. Wong FS, Ryan J, Dabkowski P, Dudley FJ, Sewell RB, Smallwood RA Med J Aust 1991;154:698-701.
Product Information. Augmentin XR (amoxicillin-clavulanate). Anonymous GlaxoSmithKline, Philadelphia, PA.
Acute localized exanthematous pustulosis (ALEP) caused by amoxicillin-clavulanic acid. Betto P, Germi L, Bonoldi E, Bertazzoni M Int J Dermatol 2008;47:295-6.

Multum version: 154.0 (Jun 16, 2010)

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