Amoxicillin and Clavulanate Potassium 562.5 mg; 62.5 mg; 437.5 mg Tablet, Film Coated, Extended Release, 40-count
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🏷️ RxNorm drug class
This medicine belongs to the beta Lactamase Inhibitor class.
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- This antibiotic is used for a range of common bacterial infections — ear infections, sinus infections, lower respiratory tract infections, skin infections, and urinary tract infect...
- What infections does amoxicillin/clavulanate actually treat?
- Taking it at the start of a meal is the best approach. Food doesn't affect amoxicillin much, but it does meaningfully improve how much clavulanate your body absorbs. More important...
- Should I take this with food or on an empty stomach?
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A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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9 inactive ingredients listed in the exact product block matched to this NDC.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $5.834 | $233.36 / 40 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium 562.5 mg/1; 437.5 mg/1; 62.5 mg 00781-1943-39 | Sandoz | 40 tablets | $5.834 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 562.5 mg/1; 62.5 mg/1; 437.5 mgthis 81964-0220-40 | USAntibiotics, | 40 tablets | $5.834 | AB | Availability likely | — |
| Amoxicillin and Clavulanate Potassium 62.5 mg/1; 562.5 mg/1; 437.5 mg 85766-0123-28 | Sportpharm | 28 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 81964-0220-28 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28) | $5.83 / ea | $163.35 | 2025-12-15 | Active |
| 81964-0220-40 You're viewing this | 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40) | $5.83 / ea | $233.36 | 2025-12-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($5.83 NADAC).
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Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/ mL [see Clinical Studies (14) ]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. In patients with community-acquired pneumonia in whom penicillin-resistant S. pneumoniae is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets is prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin-susceptible strain of S. pneumoniae plus a beta-lactamase-producing pathogen can be treated with another amoxicillin and clavulanate potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium Extended Release Tablets is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for treatment of adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL).
(1) Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs greater than or equal to 4 mcg/mL. (1) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria .
(1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients weighing greater than or equal to 40 kg who are able to swallow tablets: The recommended dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets is 4,000 mg/250 mg daily in divided doses at the start of a meal according to the following table. (2) Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg) tablets every 12 hours 7 to 10 days
2.1Important Administration Instructions Amoxicillin and Clavulanate Potassium Extended Release Tablets should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Amoxicillin and Clavulanate Potassium Extended Release Tablets is not recommended to be taken with a high-fat meal because clavulanate absorption is decreased [see Clinical Pharmacology (12.3) ].
2.2Dosage in Adults Patients The recommended dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets is 4,000 mg/250 mg daily in divided doses according to the following table: Table 1: Recommended Dosage of Amoxicillin and Clavulanate Potassium Extended Release Tablets in Adult Patients Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg) tablets every 12 hours 7 to 10 days Amoxicillin and Clavulanate Potassium Extended Release Tablets can be split in half along the score line for patients with difficulty swallowing the tablets whole.
Both halves of the tablet must be taken immediately.
2.3Dosage in Pediatric Patients Pediatric patients who weigh 40 kg or more and can swallow tablets should receive the adult dose [see Dosage and Administration (2.2) and Use in Specific Populations (8.4) ].
2.4Dosage in Patients with Hepatic Impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5.4) ].
2.5Switching Between Dosage Forms and Strengths Amoxicillin and Clavulanate Potassium Extended Release Tablets is NOT substitutable on a mg-to-mg basis with other formulations of Amoxicillin and Clavulanate. In addition, the extended-release tablets provide an extended time course of plasma amoxicillin concentrations compared to immediate-release tablets. Thus, two Amoxicillin and Clavulanate 500 mg tablets are not equivalent to one Amoxicillin and Clavulanate Potassium Extended Release Tablets 1,000 mg tablet.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Amoxicillin and Clavulanate Potassium Extended Release Tablets; 1,000 mg/62.5 mg: Each white, oval film-coated bilayer scored tablet, debossed with "AUGMENTIN XR", contains 1,000 mg of amoxicillin (as amoxicillin sodium and amoxicillin trihydrate) and 62.5 mg clavulanic acid as the potassium salt. Extended-release Tablets: 1,000 mg/62.5 mg. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta‑lactams (e.g., penicillins or cephalosporins). (4.1) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. (4.2) In patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients. (4.3)
4.1Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium Extended Release Tablets 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).
4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and Clavulanate Potassium Extended Release Tablets is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.
4.3Renal Impairment Amoxicillin and Clavulanate Potassium Extended Release Tablets is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets if a reaction occurs and institute appropriate therapy. (5.1) Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses.
(5.2) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Amoxicillin and Clavulanate Potassium Extended Release Tablets. If this occurs, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets and institute appropriate therapy. (5.3) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.
Monitor liver function tests in patients with hepatic impairment. (5.4) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. (5.5) Patients with mononucleosis who receive Amoxicillin and Clavulanate Potassium Extended Release Tablets develop skin rash.
Avoid Amoxicillin and Clavulanate Potassium Extended Release Tablets use in these patients. (5.6)
5.1Serious Allergic Reactions, including Anaphylaxis Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving Amoxicillin and Clavulanate Potassium Extended Release Tablets. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Amoxicillin and Clavulanate Potassium Extended Release Tablets, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets and institute appropriate therapy.
5.2Severe Cutaneous Adverse Reactions Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Amoxicillin and Clavulanate Potassium Extended Release Tablets discontinued if lesions progress.
5.3Drug-Induced Enterocolitis Syndrome Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Amoxicillin and Clavulanate Potassium Extended Release Tablets [see Adverse Reactions (6.2) ] , with most cases occurring in pediatric patients </=18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia.
If DIES occurs, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets and institute appropriate therapy.
5.4Hepatic Dysfunction Use Amoxicillin and Clavulanate Potassium Extended Release Tablets with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of Amoxicillin and Clavulanate Potassium is usually reversible. Deaths have been reported (fewer than one death reported per estimated four million prescriptions worldwide).
These have generally been cases associated with serious underlying diseases or concomitant medications [see Contraindications (4.2) , and Adverse Reactions (6.2) ].
5.5Clostridioides difficile-Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium Extended Release Tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with anti…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Hepatic Dysfunction [see Warnings and Precautions (5.4) ] Clostridioides difficile -associated diarrhea (CDAD) [see Warnings and Precautions (5.5) ] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions were (incidence >2%) diarrhea, vaginal mycosis, nausea, and loose stools.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 5,643 patients have been treated with Amoxicillin and Clavulanate Potassium Extended Release Tablets. The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%).
Amoxicillin and Clavulanate Potassium Extended Release Tablets had a higher rate of diarrhea which required corrective therapy (4% versus 3% for Amoxicillin and Clavulanate Potassium Extended Release Tablets and all comparators, respectively). Two percent of patients discontinued therapy due to adverse reactions.
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Amoxicillin and Clavulanate products, including Amoxicillin and Clavulanate Potassium Extended Release Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal : Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.3 , 5.5 )] . Immune : Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1) ] . Skin and Appendages : Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis [see Warnings and Precautions ( 5.1 , 5.2 , 5.6 )] .
Liver : A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, [see Contraindications (4.2) ], increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Amoxicillin and Clavulanate. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible.
Deaths have been reported [see Contraindications (4.2) , Warnings and Precautions (5.4) ] . Renal : Interstitial nephritis, hematuria, and crysta…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Co-administration with probenecid is not recommended. (7.1) Concomitant use Amoxicillin and Clavulanate Potassium Extended Release Tablets and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) Co-administration with allopurinol increases the risk of rash. (7.3) Amoxicillin and Clavulanate Potassium Extended Release Tablets may reduce efficacy of oral contraceptives. (7.4)
7.1Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium Extended Release Tablets may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not recommended.
7.2Oral 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.
7.3Allopurinol The concurrent administration of allopurinol and amoxicillin substantially 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. In controlled clinical trials of Amoxicillin and Clavulanate Potassium Extended Release Tablets, 25 patients received concomitant allopurinol and Amoxicillin and Clavulanate Potassium Extended Release Tablets.
No rashes were reported in these patients. However, this sample size is too small to allow for any conclusions to be drawn regarding the risk of rashes with concomitant Amoxicillin and Clavulanate Potassium Extended Release Tablets and allopurinol use.
7.4Oral Contraceptives Amoxicillin and Clavulanate Potassium Extended Release Tablets may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
7.5Effects 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 Extended Release Tablets, 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal Impairment:Amoxicillin and Clavulanate Potassium Extended Release Tablets has not been studied in patients with renal impairment. ( 8.6 )
8.1Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data) .
Reproduction studies performed in pregnant rodents, given oral doses up to approximately 1.6 times the amount of amoxicillin and 13 times the amount of clavulanate in the Maximum Human Recommended Dose (MHRD) of Amoxicillin and Clavulanate Potassium Extended Release Tablets, revealed no evidence of harm to the fetus (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanic acid (amoxicillin and clavulanate, n=1,212), amoxicillin and clavulanate and erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery.
Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n = 24) in the amoxicillin and clavulanate only group versus 0.5% (n = 6) in the placebo group (p = 0.001), and 1.8% (n = 44) in the any amoxicillin and clavulanate group versus 0.7% (n =17) in the no amoxicillin and clavulanate group (p = 0.0005). Animal Data Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate (2:1 ratio formulation) at oral doses up to 1,200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate.
In terms of body surface area, the doses in rats were 1.6 times the Maximum Human Recommended Dose (MHRD) of amoxicillin and 13 times the MHRD for clavulanate in Amoxicillin and Clavulanate Potassium Extended Release Tablets. For mice, these doses were 0.9 and 7.4 times the MHRD of amoxicillin and clavulanate, respectively.
8.2Lactation Risk Summary Data from a published clinical lactation study report that amoxicillin is present in human milk . There are reports of diarrhea, irritability, and rash in infants exposed to amoxicillin and clavulanate through breast milk; therefore, infants exposed to Amoxicillin and Clavulanate Potassium Extended Release Tablets should be monitored for these symptoms. There are no data on the effects of amoxicillin and clavulanate on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Amoxicillin and Clavulanate Potassium Extended Release Tablets and any potential adverse effects on the breastfed child from Amoxicillin and Clavulanate Potassium Extended Release Tablets or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets have been established for pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets. Use of Amoxicillin and Clavulanate Potassium Extended Release Tablets in these pediatric patients is supported by evidence from adequate and well-controlled trials of adults with acute bacterial sinusitis…
🆘 Overdosage ▾
10 OVERDOSAGE Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets, treat symptomatically, and institute supportive measures as required.
If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying. 1 Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In the case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration.
High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amoxicillin and Clavulanate Potassium Extended Release Tablets is an antibacterial drug [see Clinical Pharmacology (12.4) ] .
12.3Pharmacokinetics Amoxicillin and Clavulanate Potassium Extended Release Tablets is an extended-release formulation which provides sustained plasma concentrations of amoxicillin. Amoxicillin systemic exposure achieved with Amoxicillin and Clavulanate Potassium Extended Release Tablets is similar to that produced by the oral administration of equivalent doses of amoxicillin alone. Absorption Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration of Amoxicillin and Clavulanate Potassium Extended Release Tablets.
In a study of healthy adult volunteers, the pharmacokinetics of Amoxicillin and Clavulanate Potassium Extended Release Tablets were compared when administered in a fasted state, at the start of a standardized meal (612 kcal, 89.3 g carb, 24.9 g fat, and 14 g protein), or 30 minutes after a high‑fat meal. When the systemic exposure to both amoxicillin and clavulanate is taken into consideration, Amoxicillin and Clavulanate Potassium Extended Release Tablets is optimally administered at the start of a standardized meal.
Absorption of amoxicillin is decreased in the fasted state. Amoxicillin and Clavulanate Potassium Extended Release Tablets is not recommended to be taken with a high‑fat meal, because clavulanate absorption is decreased. The pharmacokinetics of the components of Amoxicillin and Clavulanate Potassium Extended Release Tablets following administration of two Amoxicillin and Clavulanate Potassium Extended Release Tablets tablets at the start of a standardized meal are presented in Table 2.
Table 2: Mean (SD) Pharmacokinetic Parmameters for Amoxicillin and Clavulanate Following Oral Administration of Two Amoxicillin and Clavulanate Potassium Extended Release Tablets (2,000 mg/125 mg) to Healthy Adult Volunteers (n=55) Fed a Standardized Meal Parameter (units) Amoxicillin Clavulanate AUC (0‑inf) (mcg•hr/mL) 71.6 (16.5) 5.29 (1.55) C max (mcg/mL) 17.0 (4.0) 2.05 (0.80) T max (hours) a 1.50 (1.00 to 6.00) 1.03 (0.75 to 3.00) T 1/2 (hours) 1.27 (0.20) 1.03 (0.17) a Median (range) The half-life of amoxicillin after the oral administration of Amoxicillin and Clavulanate Potassium Extended Release Tablets is approximately 1.3 hours, and that of clavulanate is approximately 1.0 hour.
Distribution Neither component in Amoxicillin and Clavulanate Potassium Extended Release Tablets is highly protein‑bound; clavulanate has been found to be approximately 25% bound to human serum and amoxicillin approximately 18% bound. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.
Excretion Clearance of amoxicillin is predominantly renal, with approximately 60% to 80% of the dose being excreted unchanged in urine, whereas clearance of clavulanate has both a renal (30% to 50%) and a non‑renal component. Specific Populations Pediatric Patients In a study of pediatric patients with acute bacterial sinusitis, 7 to 15 years of age, and weighing at least 40 kg, the pharmacokinetics of amoxicillin and clavulanate were assessed following administration of Amoxicillin and Clavulanate Potassium Extended Release Tablets 2,000 mg/125 mg (as two 1,000 mg/62.5 mg tablets) every 12 hours with food (Table 3).
Table 3: Mean (SD) Pharmacokinetic Parameters for Amoxicillin and Clavulanate Following Oral Administration of Two Amoxicillin and Clavulanate Extended Release Tablets (2,000 mg/125 mg) Every 12 Hours with Food in Pediatric Patients (7 to 15 Years of Age and Weighing greater than or equal to 40 kg) With Acute Bacterial Sinusitis Parameter (units) Amoxicillin (n = 24) Clavulanate (n = 2…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Amoxicillin and Clavulanate Potassium Extended Release Tablets are white, oval film-coated bilayer scored tablets debossed with "AUGMENTIN XR". Each tablet contains 1,000 mg of amoxicillin (as amoxicillin sodium and amoxicillin trihydrate) and 62.5 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Extended Release Tablets are supplied as follows: NDC 81964‑220‑28 Bottles of 28 (7-day XR pack) NDC 81964‑220‑40 Bottles of 40 (10-day XR pack) Storage Store tablets at or below 25°C (77°F).
Dispense in original container.
📋 Description ▾
11 DESCRIPTION Amoxicillin and Clavulanate Potassium Extended Release Tablets is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin sodium and amoxicillin trihydrate) and the beta-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.45.
Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino (4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid monosodium salt and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus.
It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25.
Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as: Each tablet of Amoxicillin and Clavulanate Potassium Extended Release Tablets contains 1,000 mg of amoxicillin (437.5 mg of amoxicillin equivalent to 463.8 mg of amoxicillin sodium and 562.5 mg of amoxicillin in the form of amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum.
Each tablet of Amoxicillin and Clavulanate Potassium Extended Release Tablets contains approximately 13 mg of potassium and 30 mg of sodium. Amoxicillin Trihydrate Amoxicillin Sodium clavulanate potassium