amoxicillin/clavulanate (Rx)

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

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
more...

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
more...

<40 kg

Dosages based on amoxicillin

<3 months old

  • 30 mg/kg/day PO (125 mg/5 mL or chewable tablets) divided q12hr

>3 months old

  • Less severe infections: 20 mg/kg/day PO (125 mg/5 mL or 250 mg/5 mL) divided q8hr or 25 mg/kg/day PO (200 mg or 400 mg chewable tablets; 200 mg/5 mL or 400 mg/5 mL) divided q12hr
  • Severe infections, lower respiratory tract infections, sinusitis, otitis media: 40 mg/kg/day PO (125 mg/5 mL or 250 mg/5 mL) divided q8hr or 45 mg/kg/day PO (200 mg or 400 mg chewable tablets; 200 mg/5 mL or 400 mg/5 mL) divided q12hr

Acute otitis media

  • S pneumoniae, nontypeable H influenzae, M catarrhalis
  • 80-90 mg/kg/day PO divided q12hr for 10 days (may be 5-7 days for children >6 years old with mild-to-moderate disease)

Community-acquired Pneumonia

Mild to moderate infection

  • 90 mg/kg/day PO divided q12hr; not to exceed 4000 mg/day

H. influenzae

  • 45 mg/kg/day PO divided q8hr or 90 mg/kg/day PO divided q12hr

>40 kg

Dose according to adult recommendations

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

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

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Interactions

Interaction Checker

and amoxicillin/clavulanate

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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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

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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

            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

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Drug excreted in breast milk; use caution

            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.

            more...
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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

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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