Amoxicillin and clavulanic acid
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beta Lactamase Inhibitor
Dosing in kidney impairment
Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate (GFR) of less than 30 mL/min should NOT receive the 875 mg dose (based on the amoxicillin component) of Amoxicillin and clavulanate potassium.
See dosing regimens in patients with severe renal impairment provided in Table 4. Table 4. Dosing Regimens of Amoxicillin and clavulanate potassium in Patients with Severe Renal Impairment Patients with Renal Impairment Dosing Regimen GFR 10 mL/min to 30 mL/min 500 mg or 250 mg every 12 hours, depending on the severity of the infection GFR less than 10 mL/min 500 mg or 250 mg every 24 hours, depending on severity of the infection Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis
| Patients with Renal Impairment | Dosing Regimen |
| GFR 10 mL/min to 30 mL/min | 500 mg or 250 mg every 12 hours, depending on the severity of the infection |
| GFR less than 10 mL/min | 500 mg or 250 mg every 24 hours, depending on severity of the infection |
| Hemodialysis | 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis |
Preparation and administration
Important Administration Instructions Amoxicillin and clavulanate potassium suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and clavulanate potassium suspension should be taken at the start of a meal.
Directions for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension Prepare Amoxicillin and clavulanate potassium for oral suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure a total (see Table 5 below for total amount of water for reconstitution) OF WATER. Add approximately 2/3 of the water to the powder.
Replace cap and shake VIGOROUSLY. Add remaining water. Replace cap and shake VIGOROUSLY. Table 5: Amount of Water for Mixing Amoxicillin and Clavulanate Potassium for Oral Suspension [See table below.] 400 mg/57 mg per 5 mL 50 mL 75 mL 100 mL 45 mL 68 mL 90 mL 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt Shake oral suspension well before using.
Reconstituted suspension must be stored under refrigeration and discarded after 10 days. Some color change is normal during dosing period.
| Strength of Amoxicillin and clavulanate potassium for Oral Suspension | Bottle Size | Amount of Water for Reconstitution | Contents of Each Teaspoonful (5 mL) |
| 200 mg/28.5 mg per 5 mL | 50 mL75 mL100 mL | 48 mL71 mL95 mL | 200 mg of amoxicillin and 28.5 mg of clavulanic acid as the potassium salt |
| 400 mg/57 mg per 5 mL | 50 mL75 mL100 mL | 45 mL68 mL90 mL | 400 mg of amoxicillin and 57 mg of clavulanic acid as the potassium salt |
Drug interactions
Check amoxicillin and clavulanic acid against a medication listLabel text (6 paragraphs)
7 DRUG INTERACTIONS • Co-administration with probenecid is not recommended. ( 7.1 ) • Concomitant use of amoxicillin and clavulanate potassium for oral suspension and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Coadministration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin and clavulanate potassium for oral suspension may reduce efficacy of oral contraceptives. ( 7.4 )
7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.
7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin and clavulanate potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
7.4 Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Contraindications
4 CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4.1 ) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension. ( 4.2 )
4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium suspension.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for amoxicillin and clavulanic acid. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation
8.3 Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.
Breastfeeding (LactMed)
Limited information indicates that adverse reactions in infants are uncommon during the use of amoxicillin-clavulanic acid during nursing. Amoxicillin-clavulanic acid is acceptable in nursing mothers. Monitor the infant for restlessness, diarrhea and rash.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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