Amoxicillin/Clav Pot Oral Susp 400 mg/5mL; 57 mg/5mL Powder, For Suspension, 5 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta Lactamase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by stopping bacteria from breaking down amoxicillin. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists a...
Read the full MedlinePlus article ↗- 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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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
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Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
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Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
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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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 · Q2 2026 | $0.0932 | $0.47 / 5 ml |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0367-32 You're viewing this | 5 mL in 1 BOTTLE (72189-367-32) | 2022-08-08 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| FDA label (SPL via DailyMed) | ✓ Available |
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| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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.
Amoxicillin and clavulanate potassium for oral suspension, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1Lower Respiratory Tract Infections caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2Acute Bacterial Otitis Media caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.
1.3Sinusitis caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis.
1.4Skin and Skin Structure Infections caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5Urinary Tract Infections caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension, USP should not be used.
⏱️ Dosage and Administration ▾
Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
2.1Adults The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet.
The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should not be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet. Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
2.2Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium for oral suspension should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months): The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older: See dosing regimens provided in Table 1.
The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see CLINICAL STUDIES (14.2)]. However, the every 12 hour suspension (200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL) and chewable tablets (200 mg/28.5 mg and 400 mg/57 mg) contain aspartame and should not be used by phenylketonurics [see WARNINGS AND PRECAUTIONS (5.6)]. Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older a Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. b Duration of therapy studied and recommended for acute otitis media is 10 days.
INFECTION DOSING REGIMEN Every 12 hours Every 8 hours 200 mg/28.5 mg per 5 mL or 400 mg/57 mg per 5 mL oral suspensiona 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL oral suspensiona Otitis mediab, sinusitis, lower respiratory tract infections, and more severe infections 45 mg/kg/day every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours Patients Weighing 40 kg or More: Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet should not be used until the child weighs…
💊 Dosage Forms and Strengths ▾
200 mg/28.5 mg per 5 mL: White to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. 400 mg/57 mg per 5 mL: White to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg/125 mg tablet should not be used in children weighing less than 40 kg.
The amoxicillin and clavulanate potassium 250 mg/125 mg tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The amoxicillin and clavulanate potassium 250 mg/125 mg tablet contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid. Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets should NOT be substituted for one amoxicillin and clavulanate potassium 500 mg/125 mg tablet.
Since both the amoxicillin and clavulanate potassium 250 mg/125 mg and 500 mg/125 mg tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are not equivalent to one amoxicillin and clavulanate potassium 500 mg/125 mg tablet
⛔ Contraindications ▾
4.1Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium for oral 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).
4.2Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension.
⚠️ Warnings and Cautions ▾
5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium for oral suspension. 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 for oral suspension, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, amoxicillin and clavulanate potassium for oral suspension should be discontinued and appropriate therapy instituted.
5.2Hepatic Dysfunction Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin and clavulanate potassium for oral suspension. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
5.3Clostridium difficile-Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium for oral suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
5.4Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin and clavulanate potassium for oral suspension should not be administered to patients with mononucleosis.
5.5Potential for Microbial Overgrowth The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin and clavulanate potassium should be discontinued and appropriate therapy instituted.
5.6Phenylketonurics Each 5 mL of the 200 mg/28.5 mg per 5 mL oral suspension contains 4.42 mg phenylalanine and each 5 mL of the 400 mg/57 mg per 5 mL oral suspension contains 6.35 mg phenylalanine.
5.7Development of Drug-Resistant Bacteria Prescribing amoxicillin and clavulanate potassium for oral suspension in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug-resistant bacteria.
🤒 Adverse Reactions ▾
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see WARNINGS AND PRECAUTIONS (5.1)] Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS (5.2)] CDAD [see WARNINGS AND PRECAUTIONS (5.3)]
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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions.
The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days in the treatment of acute otitis media.
A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see CLINICAL STUDIES (14.2)].
6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium for oral suspension. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium for oral suspension.
Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment [see WARNINGS AND PRECAUTIONS (5.3)]. Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see WARNINGS AND PRECAUTIONS (5.1)].
Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium for oral suspension. 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 (5.2)].
Renal: Interstitial nephritis, hematuria, and crystalluria have been reported [see OVERDOSAGE (10)]. Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have b…
🔄 Drug Interactions ▾
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see WARNINGS AND PRECAUTIONS (5.1)] Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS (5.2)] CDAD [see WARNINGS AND PRECAUTIONS (5.3)]
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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions.
The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for oral suspension for 10 days in the treatment of acute otitis media.
A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see CLINICAL STUDIES (14.2)].
6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium for oral suspension. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium for oral suspension.
Gastrointestinal: Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment [see WARNINGS AND PRECAUTIONS (5.3)]. Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see WARNINGS AND PRECAUTIONS (5.1)].
Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium for oral suspension. 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 (5.2)].
Renal: Interstitial nephritis, hematuria, and crystalluria have been reported [see OVERDOSAGE (10)]. Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have b…
👥 Use in Specific Populations ▾
8.1Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium for oral suspension (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 for oral suspension. 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.
8.2Labor and Delivery Oral ampicillin-class antibiotics are poorly absorbed during labor. It is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
8.3Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin and 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.
8.4Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium powder for oral suspension and chewable tablets have been established in pediatric patients. Use of amoxicillin and clavulanate potassium for oral suspension in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium powder for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see CLINICAL STUDIES (14.2)].
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium for oral suspension should be modified in pediatric patients aged <12 weeks (<3 months) [see DOSAGE AND ADMINISTRATION (2.2)].
8.5Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium for oral suspension, 32% were ≥65 years old, and 14% were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
8.6Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See PATIENTS WITH RENAL IMPAIRMENT (2.3) for specific recommendations in patients with renal impairment.
🆘 Overdosage ▾
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. 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 symptoms1. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium 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 amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see DOSAGE AND ADMINISTRATION (2.3)].
🧬 Clinical Pharmacology ▾
12.1Mechanism of Action Amoxicillin and clavulanate potassium is an antibacterial drug [see MICROBIOLOGY (12.4)].
12.3Pharmacokinetics Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of amoxicillin and clavulanate potassium tablets are shown in Table 3 and following administration of amoxicillin and clavulanate potassium powder for oral suspension and chewable tablets are shown in Table 4. Table 3: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parametersa,b with Amoxicillin and Clavulanate Potassium Tablets a Mean (± standard deviation) values of 14 normal adults (N=15 for clavulanate potassium in the low-dose regimens).
Peak concentrations occurred approximately 1.5 hours after the dose. b Amoxicillin and clavulanate potassium administered at the start of a light meal. Dose and Regimen Cmax (mcg/mL) AUC0-24 (mcg*h/mL) Amoxicillin and Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 250 mg/125 mg every 8 hours 3.3 ± 1.12 1.5 ± 0.7 26.7 ± 4.56 12.6 ± 3.25 500 mg/125 mg every 12 hours 6.5 ± 1.41 1.8 ± 0.61 33.4 ± 6.76 8.6 ± 1.95 500 mg/125 mg every 8 hours 7.2 ± 2.26 2.4 ± 0.83 53.4 ± 8.87 15.7 ± 3.86 875 mg/125 mg every 12 hours 11.6 ± 2.78 2.2 ± 0.99 53.5 ± 12.31 10.2 ±
3.04Table 4: Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parametersa,b with Amoxicillin and Clavulanate Potassium Powder for Oral Suspension and Chewable Tablets a Mean (± standard deviation) values of 28 normal adults. Peak concentrations occurred approximately 1 hour after the dose. b Amoxicillin and clavulanate potassium administered at the start of a light meal. Dose Cmax (mcg/mL) AUC0-24 (mcg*h/mL) Amoxicillin and Clavulanate Potassium Amoxicillin Clavulanate Potassium Amoxicillin Clavulanate Potassium 400 mg/57 mg (5 mL of suspension) 6.94 ± 1.24 1.1 ± 0.42 17.29 ± 2.28 2.34 ± 0.94 400 mg/57 mg (1 chewable tablet) 6.67 ± 1.37 1.03 ± 0.33 17.24 ± 2.64 2.17 ±
0.73Oral administration of 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension or the equivalent dose of 10 mL of amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL suspension provides average peak serum concentrations approximately 1 hour after dosing of 6.9 mcg/mL for amoxicillin and 1.6 mcg/mL for clavulanic acid. The areas under the serum concentration curves obtained during the first 4 hours after dosing were 12.6 mcg*hr/mL for amoxicillin and 2.9 mcg•hr/mL for clavulanic acid when 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension or equivalent dose of 10 mL of amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL suspension were administered to normal adults.
One amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet or two amoxicillin and clavulanate potassium 125 mg/31.25 mg chewable tablets are equivalent to 5 mL of amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension and provide similar serum concentrations of amoxicillin and clavulanic acid. Amoxicillin serum concentrations achieved with amoxicillin and clavulanate potassium are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. Time above the minimum inhibitory concentration of 1 mcg/mL for amoxicillin has been shown to be similar after corresponding every 12 hour and every 8 hour dosing regimens of amoxicillin and clavulanate potassium in adults and children.
Absorption: Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. While amoxicillin and clavulanate potassium can be given without regard to meals, absorption of clavulanate potassium when taken with food is greater relative to the fasted state. In one study, the relative bioavailability of clavulanate was reduced when amoxicillin and clavulanate potassium was dosed at 30 and 150 minutes after the start of a high-fat breakfast.
Distribution…
📦 How Supplied / Storage and Handling ▾
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. Bottles of 50 mL NDC 65862-533-50 Bottles of 75 mL NDC 65862-533-75 Bottles of 100 mL NDC 65862-533-01 Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 400 mg/57 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.
Bottles of 50 mL NDC 65862-534-50 Bottles of 75 mL NDC 65862-534-75 Bottles of 100 mL NDC 65862-534-01 Dispense in original container. Store dry powder at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
Keep out of the reach of children.
📋 Description ▾
Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.46.
Chemically, amoxicillin 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: [Amoxicillin chemical Structure] 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 some beta-lactamases by blocking the active sites of these enzymes. 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: [Clavulanic acid chemical structure] After reconstitution each teaspoonful (5 mL) of suspension will contain 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt or 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 200 mg/28.5 mg per 5 mL contains 0.14 mEq potassium.
Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 400 mg/57 mg per 5 mL contains 0.29 mEq of potassium. Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow with orange flavored suspension after reconstitution. Inactive Ingredients: Colloidal silicon dioxide, hypromellose, orange flavour, silicon dioxide, succinic acid, xanthan gum and aspartame [see WARNINGS AND PRECAUTIONS (5.6)].