amoxicillin/clavulanate (Rx)

Brand and Other Names:Augmentin, Augmentin XR, more...Augmentin ES-600
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

amoxicillin/clavulanate

oral suspension

  • (125mg/31.25mg)/5mL
  • (200mg/28.5mg)/5mL
  • (250mg/62.5mg)/5mL
  • (400mg/57mg)/5mL
  • (600mg/42.9mg)/5mL

tablet

  • 250mg/125mg
  • 500mg/125mg
  • 875mg/125mg

tablet, extended release

  • 1000mg/62.5mg

tablet, chewable

  • 200mg/28.5mg
  • 400mg/57mg

Lower Respiratory Tract Infection

β-lactamase−producing strains of Haemophilus influenzae and Moraxella catarrhalis

Mild to moderate: 500/125 mg PO q12hr or 250/125 mg PO q8hr for 10 days

Severe: 875/125 mg PO q12hr or 500/125 mg PO q8hr or 2000 mg (2 extended-release tabs) PO q12hr for 7-10 days

Chronic Obstructive Pulmonary Disease

500 mg PO q8hr

Acute Bacterial Sinusitis

β-lactamase−producing strains of H influenzae and M catarrhalis

2000 mg (2 extended-release tablets) PO q12hr for 10 days

Animal/Human Bite Wounds

875 mg PO q12hr or 500 mg PO q8hr for 3-5 days

Erysipelas

875 mg PO q12hr or 500 mg PO q8hr for 7-10 days

Pyelonephritis

β-lactamase−producing strains of Escherichia coli, Klebsiella spp, and Enterobacter spp

875 mg PO q12hr or 500 mg PO q8hr

Skin Abscess

β-lactamase−producing strains of Staphylococcus aureus, E coli, and Klebsiella spp

875 mg PO q12hr

Diabetic Foot

Mild to moderate, localized cellulitis

2000 mg (2 extended-release tablets) PO q12hr for 7-14 days

Group A Streptococci, Chronic Carrier

40 mg/kg/day PO divided q8hr for 10 days; not to exceed 2000 mg/day

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min: Do not use 875/125 mg tablet or extended-release tablets
  • CrCl 10-30 mL/min: 250-500/125 mg PO q12hr
  • CrCl <10 mL/min: 250-500/125 mg PO q24hr
  • Hemodialysis: 250-500/125 mg PO q24hr; administer additional dose both during and at end of dialysis

Hepatic impairment

  • Dose with caution; monitor hepatic function regularly

Administration

Take with meals to avoid GI upset

Take suspension at start of meal to enhance absorption

Dysphagia: May substitute 250 mg/5 mL suspension for 500/125 mg tablet; may substitute 200 mg/5 mL or 400 mg/5 mL suspension for 875/125 mg tablet

Dosage Forms & Strengths

amoxicillin/clavulanate

oral suspension

  • (125mg/31.25mg)/5mL
  • (200mg/28.5mg)/5mL
  • (250mg/62.5mg)/5mL
  • (400mg/57mg)/5mL
  • (600mg/42.9mg)/5mL

tablet

  • 200mg/28.5mg
  • 250mg/125mg
  • 500mg/125mg
  • 875mg/125mg
  • 1000mg/62.5mg

tablet, chewable

  • 200 mg/28.5mg
  • 400 mg/57mg

General Dosing for Infections for Neonates and Infants <3 months

Indicated for susceptible isolates of lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections

Recommended dosing based on amoxicillin component

Age <3 months: 30 mg/kg/day divided q12hr, based on amoxicillin component; use 125 mg/ 31.25 mg per 5 mL oral suspension

Acute Bacterial Otitis Media

Indicated for acute bacterial otitis media caused by beta-lactamase-producing isolates of H influenzae and M catarrhalis

>3 months and <40 kg

  • 45 mg/kg/day divided q12hr; use 200mg/28.5mg per 5 mL or 400mg/57mg per 5 mL suspension
  • 40 mg/kg/day divided q8hr; use 125mg/31.25mg per 5ml or 250mg/62.5 mg per 5 mL suspension
  • Treatment duration: 10 days

≥40 kg

  • Dose according to adult recommendations
  • Do not use amoxicillin and clavulanate potassium tablet 250 mg/125 mg until child weighs <40 kg, due to different amoxicillin to clavulanic acid ratios in amoxicillin-clavulanate potassium tablet 250 mg/125 mg versus amoxicillin-clavulanate potassium chewable tablet 250 mg/62.5 mg

Sinusitis, Lower Respiratory Tract Infections, and More Severe Infections

Indicated for lower respiratory tract infections and sinusitis caused by beta-lactamase-producing isolates of H influenzae and M catarrhalis

>3 months and <40 kg

  • 45 mg/kg/day PO divided q12hr; use 200mg/28.5mg per 5 mL or 400mg/57mg per 5 mL suspension
  • 40 mg/kg/day PO divided q8hr; use 125mg/31.25mg per 5ml or 250mg/62.5 mg per 5 mL suspension

≥40 kg

  • Dose according to adult recommendations
  • Do not use amoxicillin and clavulanate potassium tablet 250 mg/125 mg until child weighs <40 kg, due to different amoxicillin to clavulanic acid ratios in amoxicillin-clavulanate potassium tablet 250 mg/125 mg versus amoxicillin-clavulanate potassium chewable tablet 250 mg/62.5 mg

Less Severe Infections

>3 months and <40 kg

  • 25 mg/kg/day PO divided q12hr; use 200mg/28.5mg per 5 mL or 400mg/57mg per 5 mL suspension
  • 20 mg/kg/day PO divided q8hr; use 125mg/31.25mg per 5ml or 250mg/62.5 mg per 5 mL suspension

≥40 kg

  • Dose according to adult recommendations
  • Do not use amoxicillin and clavulanate potassium tablet 250 mg/125 mg until child weighs <40 kg, due to different amoxicillin to clavulanic acid ratios in amoxicillin-clavulanate potassium tablet 250 mg/125 mg versus amoxicillin-clavulanate potassium chewable tablet 250 mg/62.5 mg

Dosage Modifications

Renal impairment

  • GFR <30 mL/min: Do not use amoxicillin-clavulanate potassium tablets 875 mg/125 mg dose
  • GFR 10-30 mL/min: Dose amoxicillin-clavulanate potassium to 500 mg/125 mg or 250 mg/125 mg q12hr, depending on the severity of the infection
  • GFR <10 mL/min: Dose amoxicillin-clavulanate potassium to 500 mg/125 mg or 250 mg/125 mg q24hr, depending on severity of infection
  • Hemodialysis: Dose amoxicillin-clavulanate potassium to 500 mg/125 mg or 250 mg/125 mg q24hr, depending on severity of infection; also, requires an additional dose both during and at end of dialysis

Dosing Considerations

Because of the different amoxicillin-to-clavulanate ratios in the 250-mg tablet (amoxicillin 250 mg, clavulanate125 mg) and the 250-mg chewable tablet (amoxicillin 250 mg, clavulanate 62.5 mg), the 250-mg tablet should not be used if the pediatric patient weighs <40 kg (adverse reaction, including severe diarrhea, may occur due to excessive clavulanic acid in 250-mg tablet)

Every 12 hour dosing associated with less diarrhea

Phenylketonuria: Do not use 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspension and chewable tablets 200 mg/28.5 mg and 400 mg/57 mg since these contain aspartame

Safety and efficacy of extended-release tablets in children <16 years old have not been established

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Interactions

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            Adverse Effects

            >10%

            Diarrhea (3-34%; varies upon dose and regimen)

            1-10%

            Diaper rash (3.5%)

            Mycosis (3.3%)

            Nausea (2-3%)

            Rash (1-3%)

            Vomiting (1-2.2%)

            Loose stool (1.6%)

            Candidiasis (1.4%)

            Vaginitis (1%)

            <1%

            Hypersensitivity reactions

            Anaphylaxis

            Anemia

            Thrombocytopenia

            Leukopenia

            Agranulocytosis

            Hepatoxicity

            AST/ALT elevation

            Pseudomembranous colitis

            Serum sickness

            Abdominal discomfort

            Cholestatic jaundice

            Flatulence

            Postmarketing Reports

            Gastrointestinal: Stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis

            Immune: Anaphylactic/ anaphylactoid reactions (including shock), angioedema, (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis

            Skin and appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis

            Renal: Interstitial nephritis, crystalluria

            Central nervous system: Agitation, anxiety, behavioral changes, aseptic meningitis, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely

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            Warnings

            Contraindications

            Allergy to penicillins

            Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate

            Extended release: Hemodialysis patients and severe renal impairment (CrCl <30 mL/min)

            Cautions

            Allergy to cephalosporins, carbapenems

            Different tablets are not interchangeable, because ratios of amoxicillin to clavulanate are different

            Extended release tablets not for use in renal impairment (CrCl <30 mL/min)

            Incidence of diarrhea is higher than with amoxicillin alone

            Unknown safety and efficacy of extended-release tablets in patients <16 years old

            Risk of Clostridium difficile-associated diarrhea (CDAD); consider in patients who present with diarrhea after antibiotic use; CDAD has been known to occur over 2 months after antibiotic therapy; if suspected, discontinue drug immediately and administer appropriate fluid/electrolyte therapy, protein supplementation, and C difficile antibiotic treatment

            Prescribing treatment in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria; risk of bacterial or fungal superinfections; if suspected, discontinue drug immediately and administer appropriate therapy

            High percentage of patients with mononucleosis reported to develop rash during therapy; ampicillin-class antibiotics not recommended in these patients

            Use caution in hepatic impairment; hypatic dysfunction (rare) is more common in elderly and/or males and prolonged therapy may increase risk; may occur after completing therapy

            Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported; these reactions are more likely to occur in individuals with history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens; before initiating therapy, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens; if allergic reaction occurs, discontinue treatment and institute appropriate therapy

            Therapy may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP); if patients develop a skin rash, they should be monitored closely, and discontinued if lesions progress

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            Pregnancy & Lactation

            Pregnancy

            Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parenterally administered drugs have shown no teratogenic effects; in a single study in women with preterm, premature rupture of the fetal membrane (pPROM), it was reported that prophylactic treatment with this drug may be associated with an increased risk of necrotizing enterocolitis in neonates; as with all medications, use should be avoided in pregnancy, unless considered essential by the physician

            Lactation

            Ampicillin-class antibiotics are excreted in human milk; therefore caution should be exercised when the drug is administered to a nursing mother; however, the drug may be administered during the period of lactation; with the exception of risk of sensitization, associated with excretion of trace quantities in breast milk, there are no known detrimental effects for the breastfed infant

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Amoxicillin binds to penicillin-binding proteins, thus inhibiting final transpeptidation step of peptidoglycan synthesis in bacterial cell walls; addition of clavulanate inhibits beta-lactamase-producing bacteria, allowing amoxicillin extended spectrum of action

            It is a semisynthetic antibiotic with a broad spectrum of bactericidal activity, covering both gram-negative and gram-positive microorganisms

            Not effective against Mycoplasma and Legionella spp

            Absorption

            Peak plasma time: 2 hr (amoxicillin); 1.1 hr (clavulanic acid)

            Peak concentration: 8-22 mcg/mL (amoxicillin); 0.8-2.6 mcg/mL (clavulanic acid)

            AUC: 40-80 mcg•hr/mL (amoxicillin); 2-6 mcg•hr/mL (clavulanic acid)

            Distribution

            Protein bound: 18% (amoxicillin); 25% (clavulanic acid)

            Widely distributed (except CNS)

            Metabolism

            Partially metabolized by liver

            Elimination

            Half-life

            • Amoxicillin: 3.7 hr (full-term neonates); 1-2 hr (infants and children); 0.7-1.4 hr (adults)
            • Clavulanic acid: 0.8-1.4 hr

            Excretion: Urine, unchanged; 50-70% (amoxicillin), 25-40% (clavulanic acid)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.