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

<40 kg

Dosages based on amoxicillin

<3 months old

  • 30 mg/kg/day PO (125 mg/5 mL) 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 (adverse reaction, including severe diarrhea, may occur due to excessive clavulonic acid in 250-mg tablet

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

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Interactions

Interaction Checker

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            Contraindicated (0)

              Serious - Use Alternative (13)

              • BCG vaccine live

                amoxicillin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              • cholera vaccine

                amoxicillin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

              • demeclocycline

                demeclocycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • doxycycline

                doxycycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • eravacycline

                eravacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • minocycline

                minocycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • mycophenolate

                amoxicillin will decrease the level or effect of mycophenolate by Other (see comment). Avoid or Use Alternate Drug. Effect may be due to impairment of enterohepatic recirculation

              • omadacycline

                omadacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • pexidartinib

                amoxicillin and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

                clavulanate and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                clavulanate, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

                amoxicillin, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              • sarecycline

                sarecycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • tetracycline

                tetracycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.

              • typhoid vaccine live

                amoxicillin decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.

              Monitor Closely (21)

              • acyclovir

                amoxicillin, acyclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • allopurinol

                allopurinol decreases toxicity of amoxicillin by Other (see comment). Use Caution/Monitor. Comment: Allopurinol may increase potential for allergic or hypersensitivity reactions to amoxicillin.

              • aspirin

                amoxicillin, aspirin. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

                amoxicillin, aspirin. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • aspirin rectal

                amoxicillin, aspirin rectal. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

                amoxicillin, aspirin rectal. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

              • aspirin/citric acid/sodium bicarbonate

                amoxicillin, aspirin/citric acid/sodium bicarbonate. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

                amoxicillin, aspirin/citric acid/sodium bicarbonate. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

              • bazedoxifene/conjugated estrogens

                amoxicillin will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • bendroflumethiazide

                amoxicillin, bendroflumethiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • chlorothiazide

                amoxicillin, chlorothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • choline magnesium trisalicylate

                amoxicillin, choline magnesium trisalicylate. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

                amoxicillin, choline magnesium trisalicylate. Either increases levels of the other by plasma protein binding competition. Use Caution/Monitor.

              • cyclopenthiazide

                amoxicillin, cyclopenthiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • dienogest/estradiol valerate

                amoxicillin will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.

              • estradiol

                amoxicillin will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • ethinylestradiol

                amoxicillin will decrease the level or effect of ethinylestradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

              • hydrochlorothiazide

                amoxicillin, hydrochlorothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate

                amoxicillin will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.

              • mestranol

                amoxicillin will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.

              • methotrexate

                amoxicillin increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. Increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with concurrent administration of high or low doses of methotrexate and penicillins.

              • methyclothiazide

                amoxicillin, methyclothiazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • metolazone

                amoxicillin, metolazone. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • mipomersen

                mipomersen, clavulanate. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.

              • rose hips

                amoxicillin, rose hips. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              Minor (10)

              • amiloride

                amiloride decreases levels of amoxicillin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Administer each drug at least 2 hours apart from each other; monitor for reduced antibiotic efficacy.

              • azithromycin

                azithromycin decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • aztreonam

                aztreonam, amoxicillin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Combination may be used synergistically against Enterobacteriaceae.

              • chloramphenicol

                chloramphenicol decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • clarithromycin

                clarithromycin decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • erythromycin base

                erythromycin base decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • erythromycin lactobionate

                erythromycin lactobionate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • erythromycin stearate

                erythromycin stearate decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • pyridoxine (Antidote)

                amoxicillin will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

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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.

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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
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
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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.