AMOXICILLIN AND CLAVULANATE POTASSIUM (a-mox-i-sill'in) Augmentin, Augmentin-ES600, Augmentin XR, Clavulin Classifications: antiinfective; beta-lactam antibiotic; aminopenicillin Prototype: Ampicillin Pregnancy Category: B
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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
Used alone, clavulanic acid antibacterial activity is weak. In combination, it 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.
Semisynthetic broad-spectrum antibiotic with fixed combination of amoxicillin, an aminopenicillin, and the potassium salt
to clavulanic acid, a competitive beta-lactamase inhibitor. Active against gram-positive bacteria including Staphylococcus aureus, Streptococcus pneumoniae, Clostridium, Peptococcus, Bacteroides fragilis group, and many gram-negative organisms including Branhamella catarrhalis (formerly Neisseria catarrhalis), Haemophilus influenzae, Proteus mirabilis; Salmonella, Shigella, and Klebsiella sp. Generally inactive against Pseudomonas.
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.
Combination shares toxic potential of ampicillin. Hypersensitivity to penicillins; infectious mononucleosis.
Pregnancy (category B), lactation.
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: PO <3 mo, 30 mg/kg/d (amoxicillin) divided q12h
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Oral
- 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.
GI:
Diarrhea, nausea, vomiting. Skin: Rash, urticaria. Other: Candidal vaginitis; moderate increases in serum ALT, AST; glomerulonephritis; agranulocytosis (rare).
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.
Drug:
tetracyclines may inhibit activity of amoxicillin; probenecid prolongs the activity of amoxicillin.
Absorption: Rapid and 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: Metabolized 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.
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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.
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Note: Use Clinistix or TesTape when monitoring urinary glucose to avoid false readings with diabetes mellitus.
- Do not breast feed while taking this drug without consulting physician.