Amoxicillin
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg
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 of less than 30 mL/min, should NOT receive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2. Table 2.
Dosing in Patients with Severe Renal Impairment [See table below.]
| Patients with Renal Impairment | Dosage Regimen |
| GFR 10 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 To minimize the potential for gastrointestinal intolerance, amoxcillin should be taken at the start of a meal.
Directions for Mixing Oral Suspension Prepare a suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 3). Add approximately 1/3 of the water to powder. Replace cap and shake vigorously to wet powder. Add remaining water. Replace cap and shake vigorously. [See table below.] 150 mL 102 mL For Oral Suspension 200 mg/5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL For Oral Suspension 250 mg/5 mL 80 mL 55 mL 100 mL 68 mL 150 mL 102 mL For Oral Suspension 400 mg/5 mL 50 mL 34 mL 75 mL 51 mL 100 mL 68 mL After reconstitution, the required amount of suspension should be placed directly on the child’s tongue for swallowing.
Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days.
Refrigeration is preferable, but not required.
| Strength | Bottle Size | Total Amount of Water Required for Reconstitution |
|---|---|---|
| For Oral Suspension 125 mg/5 mL | 80 mL | 55 mL |
| 100 mL | 68 mL | |
| 150 mL | 102 mL | |
| For Oral Suspension 200 mg/5 mL | 50 mL | 34 mL |
| 75 mL | 51 mL | |
| 100 mL | 68 mL | |
| For Oral Suspension 250 mg/5 mL | 80 mL | 55 mL |
| 100 mL | 68 mL | |
| 150 mL | 102 mL | |
| For Oral Suspension 400 mg/5 mL | 50 mL | 34 mL |
| 75 mL | 51 mL | |
| 100 mL | 68 mL |
Drug interactions
Check amoxicillin against a medication listLabel text (7 paragraphs)
7 DRUG INTERACTIONS • Co-administration with probenicid is not recommended ( 7.1 ) • Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Coadministration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 )
7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
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. 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 rashes is due to allopurinol or the hyperuricemia present in these patients.
7.4 Oral Contraceptives Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
7.6 Effects on Laboratory Tests High urine concentrations of ampicillin 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, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Contraindications
Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins) ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Highly likely but rare cause of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
Lactation
8.3 Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Breastfeeding (LactMed)
Amoxicillin produces low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, rash and disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, have been reported, but these effects have not been adequately evaluated. Amoxicillin is acceptable in nursing mothers. Amoxicillin powder for suspension reconstituted with breastmilk is absorbed as well as the powder reconstituted with water.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.