Dosing & Uses
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 if 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 if 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 if 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (14)
- 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.
- microbiota oral
amoxicillin decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- 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 (11)
- 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.
- patiromer
patiromer, amoxicillin. cation binding in GI tract. Minor/Significance Unknown. No observed clinically important interaction. No separation of dosing required.
- 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.
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
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
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.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
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