Product Details

Amoxicillin/Clavulanate Potassium

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Amoxicillin/Clavulanate Potassium

Action
Indications
Contraindications
Route/Dosage
Interactions
Lab Test Interferences
Adverse Reactions
Precautions

(uh-MOX-ih-sil-in/CLAV-you-lah-nate poe-TASS-ee-uhm)AugmentinTablets: 250 mg amoxicillin/125 mg clavulanic acid, 500 mg amoxicillin/125 mg clavulanic acid, 875 mg amoxicillin/125 mg clavulanic acidChewable tablets: 125 mg amoxicillin/31.25 mg clavulanic acid, 200 mg amoxicillin/28.5 mg clavulanic acid, 250 mg amoxicillin/62.5 mg clavulanic acid, 400 mg amoxicillin/57 mg clavulanic acidPowder for oral suspension: 125 mg amoxicillin/31.25 mg clavulanic acid/5 mL, 200 mg amoxicillin/28.5 mg clavulanic acid/5 mL, 250 mg amoxicillin/62.5 mg clavulanic acid/5 mL, 400 mg amoxicillin/57 mg clavulanic acid/5 mLAugmentin ES-600Powder for oral suspension: 600 mg amoxicillin (as trihydrate) and 42.9 mg clavulanic acid/5 mL (as the potassium salt).Class: Aminopenicillin

 Action Amoxicillin inhibits bacterial cell wall mucopeptide synthesis. Clavulanic acid inactivates a wide range of beta-lactam enzymes found in bacteria resistant to penicillins and cephalosporins.

 Indications Treatment of infections caused by susceptible strains of microorganisms.

 Contraindications History of amoxicillin/clavulanate-associated cholestatic jaundice or liver disease.

 Route/Dosage

Augmentin

Strength listed below is based on amoxicillin content.

ADULTS AND CHILDREN OVER 12 YR: PO One 500 mg tablet q 12 hr or one 250 mg tablet q 8 hr (500 and 250 mg tablets contain the same amount of clavulanate. Thus two 250 mg tablets are not equivalent to one 500 mg tablet.)

Severe Infections

PO 500 mg q 8 hr; 875 mg q 12 hr.

CHILDREN UNDER 3 MO: PO Elimination impaired in children under 3 mo. 30 mg/kg/day divided q 12 hr. CHILDREN OVER 3 YR: PO For otitis media, sinusitis, lower respiratory tract infections, severe infections, 45 mg/kg/day if given q 12 hr; 40 mg/kg/day if given q 8 hr. LESS SEVERE INFECTIONS FOR CHILDREN: PO 25 mg/kg/day if given q 12 hr; 20 mg/kg/day if given q 8 hr.

Augmentin ES-600

Augmentin ES-600 (5 mL) does not contain the same amount of clavulanic acid as any of the other Augmentin suspensions (5 mL). Therefore, Augmentin ES-600 and Augmentin are not interchangeable. The dose listed below is based on the amoxicillin component. CHILDREN 3 MO AND OLDER: PO 90 mg/kg/day divided q 12 hr for 10 days.

 Interactions

Allopurinol: May increase incidence of rash. Contraceptives, oral: May reduce effectiveness of oral contraceptives. Probenecid: May increase and prolong blood levels of amoxicillin. Tetracyclines: May reduce antibacterial effectiveness of amoxicillin.

 Lab Test Interferences May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets (enzyme-based tests [eg, Clinistix, Tes-Tape] are recommended); false-positive direct Coombs test result in certain patient groups; false-positive protein reactions with sulfosalicylic acid and boiling test, acetic acid test, biuret reaction, and nitric acid test (Bromphenol Blue Test, Multi-Stix is recommended).

 Adverse Reactions

CNS: Dizziness; fatigue; insomnia; reversible hyperactivity. DERM: Erythema multiforme; maculopapular to exfoliative dermatitis; skin rashes; vesicular eruptions; urticaria. EENT: Abnormal taste sensation; black “hairy” tongue; glossitis; itchy eyes; laryngeal edema; laryngospasm; sore or dry mouth or tongue; stomatitis. GI: Abdominal pain or cramps; anorexia; diarrhea or bloody diarrhea; enterocolitis; epigastric distress; flatulence; gastritis; nausea; pseudomembranous colitis; rectal bleeding; vomiting. GU: Interstitial nephritis (eg, oliguria, proteinuria, hematuria, hyaline casts, pyuria); nephropathy; vaginitis. HEMA: Agranulocytosis; anemia; basophils; bone marrow depression; eosinophilia; granulocytopenia; hemolytic anemia; increased monocytes; increased or decreased lymphocyte count; leukopenia; neutropenia; platelets; prolonged bleeding and prothrombin time; reduced hemoglobin or hematocrit; thrombocytopenia; thrombocytopenic purpura. HEPA: Cholestatic jaundice; transient hepatitis. META: Albumin; elevated serum alkaline phosphatase and hypernatremia; reduced serum potassium; total proteins and uric acid. OTHER: Hyperthermia; superinfection.

 Precautions

Pregnancy: Category B. Children: Safety and efficacy of Augmentin ES-600 in children weighing 40 kg or more not established. Adults: Safety and efficacy of Augmentin ES-600 not established. Lactation: Secreted into breast milk. Mononucleosis patients: Increased risk of skin rash. Use not recommended. Phenylalanine: Contains phenylalanine. 200 and 400 mg chewable tablets, 200 mg/5 mL and 400 mg/5 mL only. Renal: Dose reduction or q 12 hr recommended with severe impairment. Hepatic: Use with caution.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts