|AMOXICILLIN AND CLAVULANATE POTASSIUM
Augmentin, Augmentin-ES600, Augmentin XR, Clavulin
Classifications: beta-lactam antibiotic; aminopenicillin; Therapeutic: antibiotic
Pregnancy Category: B
250 mg, 500 mg, 875 mg tablets; 125 mg, 200 mg, 400 mg chewable tablets; 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL, 600 mg/5 mL oral suspension; 1000 mg amoxicillin/62.5 mg clavulanate sustained-release tablets
As a beta-lactam antibiotic, amoxicillin is bactericidal. It inhibits the final stage of bacterial cell wall synthesis by
binding with specific penicillin-binding proteins (PBPs) that are located inside the bacterial cell wall that leads to bacterial
cell lysis and death.
Effectivenes of ampicillin is synergistic in combination with clavulanic acid. Clavulanic acid in combination with ampicillin
inhibits enzyme (beta-lactamase) degradation of amoxicillin and by synergism extends both spectrum of activity and bactericidal
effect of amoxicillin against many strains of beta-lactamase-producing bacteria resistant to amoxicillin alone.
Infections caused by susceptible beta-lactamase-producing organisms: lower respiratory tract infections, acute bacterial
sinusitis, community acquired pneumonia, otitis media, sinusitis, skin and skin structure infections, and UTI.
Hypersensitivity to penicillins; infectious mononucleosis; patient with previous history of drug-induced cholestasis, jaundice,
or other hepatic dysfunction.
Allergic disorders; cephalosporin hypersensitivity; GI disorders; hepatic or renal disease; elderly; pregnancy (category
Route & Dosage
|Mild to Moderate Infections
Adult: PO 250 or 500 mg tablet (each with 125 mg clavulanic acid) q812h; Sustained-release tabs: 2 tablets (2000 mg amoxicillin/125
mg clavulanate) q12h x 710 d
Child: PO <40 kg, 2040 mg/kg/d (based on amoxicillin component) divided q812h; >3 mo, 90 mg/kg/d of 600 ES divided q12h x 10 d
Neonate/Infant (<3 mo): PO 30 mg/kg/d (amoxicillin) divided q12h
- Give at the start of a meal to minimize GI upset and enhance absorption.
- Note that both 250- and 500-mg tablets contain the exact amount of clavulanic acid (125 mg and potassium salt); therefore,
two 250-mg tablets are not equivalent to one 500-mg tablet.
- Reconstitute oral suspension by adding amount of water specified on container to provide a 5 mL suspension. Tap bottle before
adding water to loosen powder, then add water in 2 portions, agitating suspension well before each addition.
- Agitate suspension well just before administration of each dose.
- Give dialysis patient an additional 2 doses on the day of dialysis; one dose before and another dose after dialysis.
- Store tablets in tight containers at <24° C (71° F). Reconstituted oral suspension should be refrigerated at 2°8°
C (36°46° F), then discarded after 10 d.
Adverse Effects (≥1%) GI: Diarrhea,
nausea, vomiting. Skin:
Rash, urticaria. Other:
Candidal vaginitis; moderate increases in serum ALT, AST; glomerulonephritis; agranulocytosis
Diagnostic Test Interference
May interfere with urinary glucose determinations using cupric sulfate, Benedict's solution, Clinitest; does not affect glucose oxidase methods (e.g., Clinistix, TesTape). Positive direct antiglobulin (Coombs') test results may be reported, a reaction that could interfere with hematologic studies or with transfusion cross-matching procedures.
Interactions Drug: tetracyclines
may inhibit activity of amoxicillin; probenecid
prolongs the activity of amoxicillin
Nearly complete absorption. Peak:
12 h. Distribution:
Diffuses into most tissues and body fluids, except synovial fluid and CSF (unless meninges are inflamed); crosses placenta;
distributed into breast milk in very small amounts. Metabolism:
In liver. Elimination:
5073% of the amoxicillin
and 2545% of the clavulanate dose excreted in urine in 2 h. Half-Life:
Amoxicillin 11.3 h, clavulanate 0.781.2 h.
Assessment & Drug Effects
- Determine previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens prior to therapy.
- Lab tests: Baseline C&S tests prior to initiation of therapy; start drug pending results.
- Monitor for S&S of an urticarial rash (usually occurring within a few days after start of drug) suggestive of a hypersensitivity
reaction. If it occurs, look for other signs of hypersensitivity (fever, wheezing, generalized itching, dyspnea), and report
to physician immediately.
- Note: Generalized, erythematous, maculopapular rash (ampicillin rash) is not due to hypersensitivity. It is usually mild, but can
be severe. Report onset of rash to physician, since hypersensitivity should be ruled out.
Patient & Family Education
- Female patients should report onset of symptoms of Candidal vaginitis (e.g., moderate amount of white, cheesy, nonodorous vaginal discharge; vaginal inflammation and itching; vulvar excoriation,
inflammation, burning, itching). Therapy may have to be discontinued.
- Note: Use Clinistix or TesTape when monitoring urinary glucose to avoid false readings with diabetes mellitus.