Augmentin

Uses and Indications

AUGMENTIN is indicated for the treatment of the following infections in adults and pediatric patients: lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections. This drug should be utilized only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Limitations of use include the recommendation that AUGMENTIN should not be used when susceptibility test results indicate susceptibility to amoxicillin, which suggests the absence of beta-lactamase production.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and pediatric patients weighing greater than 40 kg, the recommended dosage is either 500 mg or 875 mg administered every 12 hours, or 250 mg or 500 mg every 8 hours, depending on the amoxicillin component.

Pediatric patients aged 12 weeks (3 months) and older should receive a dosage of 25 to 45 mg/kg/day divided into two doses every 12 hours, or 20 to 40 mg/kg/day divided into three doses every 8 hours, not exceeding the adult dose.

For neonates and infants less than 12 weeks of age, the recommended dosage is 30 mg/kg/day, divided into two doses every 12 hours. It is advised to use the 125 mg/5 mL oral suspension for this age group.

Healthcare professionals should ensure that the appropriate dosing regimen is selected based on the patient's weight and age, and monitor for efficacy and tolerability throughout the treatment course.

Contraindications

Use of this product is contraindicated in patients with a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to AUGMENTIN or other beta-lactams, including penicillins or cephalosporins. Additionally, it is contraindicated in individuals with a history of cholestatic jaundice or hepatic dysfunction associated with AUGMENTIN.

Warnings and Precautions

Serious hypersensitivity reactions, including fatal outcomes, have been associated with the use of AUGMENTIN. In the event of such a reaction, it is imperative to discontinue AUGMENTIN immediately.

Severe Cutaneous Adverse Reactions (SCAR) may occur; therefore, patients should be monitored closely for any signs of rash. If the rash progresses, AUGMENTIN should be discontinued without delay.

Drug-induced enterocolitis syndrome (DIES) has been reported in patients receiving Amoxicillin, a component of AUGMENTIN. Should this syndrome manifest, it is essential to discontinue AUGMENTIN and initiate appropriate therapeutic measures.

Patients with hepatic dysfunction or cholestatic jaundice require careful monitoring. If any signs or symptoms of hepatitis arise, AUGMENTIN should be discontinued. Additionally, liver function tests should be conducted in patients with pre-existing hepatic impairment to ensure safety.

Clostridioides difficile-associated diarrhea (CDAD) is a potential complication; thus, healthcare professionals should evaluate patients who present with diarrhea during treatment.

AUGMENTIN is contraindicated in patients with mononucleosis, as these individuals are at risk of developing a skin rash upon administration.

The possibility of superinfections due to overgrowth of fungal or bacterial pathogens should be considered during the course of therapy with AUGMENTIN.

It is important to note that high urine concentrations of amoxicillin may lead to false-positive results when testing for glucose in urine using CLINITEST®, Benedict's Solution, or Fehling's Solution. Therefore, it is recommended to utilize glucose tests based on enzymatic glucose oxidase reactions for accurate results.

Lastly, following the administration of amoxicillin to pregnant women, a transient decrease in plasma concentrations of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been observed. This should be taken into consideration when prescribing AUGMENTIN to pregnant patients.

Side Effects

The most frequently reported adverse reactions observed in clinical trials included diarrhea or loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%). Less frequently reported adverse reactions, occurring in less than 1% of participants, included abdominal discomfort, flatulence, and headache.

Serious adverse reactions have been documented, including hypersensitivity reactions that may be fatal; AUGMENTIN should be discontinued if such a reaction occurs. Severe cutaneous adverse reactions (SCAR) require close monitoring, and discontinuation is advised if a rash progresses. Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of AUGMENTIN; in such cases, AUGMENTIN should be discontinued, and appropriate therapy should be initiated. Hepatic dysfunction and cholestatic jaundice have also been noted; discontinuation of AUGMENTIN is necessary if signs or symptoms of hepatitis arise, and liver function tests should be monitored in patients with hepatic impairment. Clostridioides difficile-associated diarrhea (CDAD) should be evaluated in patients who experience diarrhea during treatment. Additionally, patients with mononucleosis who receive AUGMENTIN may develop skin rashes, and the use of AUGMENTIN in these patients is not recommended. The potential for superinfections with fungal or bacterial pathogens should be considered during therapy.

Additional adverse reactions include interstitial nephritis, which has resulted in oliguric renal failure following overdosage with amoxicillin and clavulanate potassium. Crystalluria, which in some cases has led to renal failure, has also been reported after overdosage in both adult and pediatric patients.

Drug Interactions

Co-administration of AUGMENTIN with probenecid is not recommended due to potential interactions that may affect the pharmacokinetics of AUGMENTIN.

When AUGMENTIN is used concurrently with oral anticoagulants, there is an increased risk of prolonged prothrombin time. Monitoring of prothrombin time is advised to ensure patient safety and appropriate anticoagulation management.

The concomitant use of AUGMENTIN and allopurinol has been associated with an increased risk of rash. Caution is advised when these medications are prescribed together, and patients should be monitored for dermatological reactions.

Additionally, AUGMENTIN may reduce the efficacy of oral contraceptives. Patients using oral contraceptives should be informed of this potential interaction and advised to consider alternative or additional contraceptive methods during treatment with AUGMENTIN.

Packaging & NDC

The table below lists all NDC Code configurations of Augmentin (amoxicillin and clavulanate potassium), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of AUGMENTIN for Oral Suspension and Chewable Tablets have been established in pediatric patients. Evidence supporting the use of AUGMENTIN in this population includes studies conducted with AUGMENTIN Tablets in adults, supplemented by data from a study involving pediatric patients aged 2 months to 12 years with acute otitis media.

Dosing of Amoxicillin and Clavulanate Potassium should be adjusted for pediatric patients aged less than 12 weeks (less than 3 months) due to the incompletely developed renal function in neonates and young infants, which may result in delayed elimination of amoxicillin. It is important to note that the elimination of clavulanate is not affected in this age group.

Geriatric Use

In clinical studies of AUGMENTIN, 32% of the 3,119 patients analyzed were aged 65 years or older, and 14% were aged 75 years or older. No overall differences in safety or effectiveness were observed between these elderly patients and their younger counterparts. However, while clinical experience has not identified significant differences in responses between elderly and younger patients, it is important to note that greater sensitivity to the drug may be present in some older individuals.

AUGMENTIN is substantially excreted by the kidneys, which raises concerns regarding the risk of adverse reactions in patients with impaired renal function. Given that elderly patients are more likely to experience decreased renal function, careful consideration should be given to dose selection in this population. It may be beneficial to monitor renal function to ensure appropriate dosing and minimize the risk of adverse effects.

Pregnancy

Pregnant patients should be aware that AUGMENTIN is classified as Pregnancy Category B. Reproductive studies conducted in pregnant rats and mice, which received oral doses of AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) up to 1200 mg/kg/day, demonstrated no evidence of harm to the fetus. The amoxicillin doses administered in these studies were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours), while the doses for clavulanate were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours).

Despite these findings, there are no adequate and well-controlled studies in pregnant women. Therefore, due to the limitations of animal reproduction studies in predicting human response, AUGMENTIN should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering AUGMENTIN for pregnant patients.

Lactation

Amoxicillin has been shown to be excreted in human milk. The use of amoxicillin and clavulanate potassium by nursing mothers may lead to sensitization of breastfed infants. Therefore, caution should be exercised when administering amoxicillin and clavulanate potassium to a lactating mother.

Renal Impairment

Amoxicillin is primarily eliminated by the kidney, and dosage adjustment is usually required in patients with severe renal impairment, specifically those with a glomerular filtration rate (GFR) of less than 30 mL/min. Healthcare professionals should refer to the specific recommendations for patients with renal impairment to ensure appropriate dosing and monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored for liver function tests. In the event that signs or symptoms of hepatitis occur, it is recommended to discontinue treatment. Careful assessment of liver function is essential to ensure patient safety and to guide therapeutic decisions.

Overdosage

In the event of an overdosage, it is imperative to discontinue the medication immediately and provide symptomatic treatment along with supportive measures as necessary. A prospective study involving 51 pediatric patients at a poison-control center indicated that overdosages of less than 250 mg/kg of amoxicillin are generally not associated with significant clinical symptoms.

Potential Symptoms and Complications Overdosage of amoxicillin and clavulanate potassium has been associated with interstitial nephritis, which can lead to oliguric renal failure. Additionally, crystalluria has been reported, which in some cases may progress to renal failure in both adult and pediatric patients.

Management Recommendations To mitigate the risk of crystalluria following an overdosage of amoxicillin and clavulanate potassium, it is essential to maintain adequate fluid intake and promote diuresis. This approach helps to reduce the likelihood of crystallization in the renal system.

Renal impairment resulting from overdosage appears to be reversible upon cessation of the drug. It is important to note that patients with pre-existing renal impairment may experience higher blood levels of amoxicillin and clavulanate potassium due to decreased renal clearance. In cases of severe overdosage, hemodialysis may be employed to facilitate the removal of the drug from circulation.

Nonclinical Toxicology

Pregnancy Category B. Reproduction studies conducted in pregnant rats and mice administered AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day demonstrated no evidence of teratogenic effects on the fetus. The amoxicillin doses in these studies were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours) for rats and mice, respectively. For clavulanate, the corresponding dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). However, there are no adequate and well-controlled studies in pregnant women, and since animal reproduction studies may not always predict human response, this drug should be used during pregnancy only if clearly needed.

Long-term studies in animals have not been conducted to assess the carcinogenic potential of AUGMENTIN. In mutagenicity testing, AUGMENTIN (4:1 ratio formulation of amoxicillin:clavulanate) was found to be non-mutagenic in the Ames bacterial mutation assay and the yeast gene conversion assay. It exhibited weak positivity in the mouse lymphoma assay; however, the observed trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and the mouse micronucleus test, yielding negative results in both assays.

AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) administered at oral doses up to 1,200 mg/kg/day did not affect fertility or reproductive performance in rats. Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours), while for clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be informed that AUGMENTIN may be taken every 8 hours or every 12 hours, depending on the prescribed dosage. It is important that each dose is taken with a meal or snack to minimize the risk of gastrointestinal upset.

Healthcare providers should counsel patients that AUGMENTIN contains a penicillin-class drug, which can lead to allergic reactions in some individuals. Patients should be made aware of the signs and symptoms of serious skin reactions. They should be instructed to discontinue AUGMENTIN immediately and report any initial signs or symptoms of skin rash, mucosal lesions, or other indications of hypersensitivity.

Patients should also be advised that diarrhea is a common side effect associated with antibacterial medications, typically resolving upon discontinuation of the drug. However, it is crucial to inform patients that they may experience watery and bloody stools (with or without stomach cramps and fever) even up to 2 months after completing the course of treatment. If diarrhea is severe or persists for more than 2 to 3 days, patients should contact their physician promptly.

It is essential to counsel patients that antibacterial drugs, including AUGMENTIN, are intended solely for the treatment of bacterial infections and are ineffective against viral infections, such as the common cold. When AUGMENTIN is prescribed for a bacterial infection, patients should be reminded that while it is common to feel better early in the treatment, the medication must be taken exactly as directed. Skipping doses or failing to complete the full course of therapy may reduce the effectiveness of the treatment and increase the risk of bacterial resistance, making future infections harder to treat.

Patients should be advised to keep the suspension refrigerated and to shake it well before use. When administering the suspension to a child, a calibrated oral syringe should be used, and it is important to rinse the syringe after each use. Patients should follow their healthcare provider's instructions regarding the appropriate dosage and duration of treatment for their child, and any unused medication should be discarded.

Storage and Handling

The dry powder should be stored at or below 25°C (77°F) to maintain its stability. Once reconstituted, the suspension must be kept under refrigeration. Any unused suspension should be discarded after 10 days to ensure safety and efficacy. It is essential to dispense the product in its original container to protect it from environmental factors. Additionally, the product should be kept out of the reach of children to prevent accidental ingestion.

Additional Clinical Information

High urine concentrations of amoxicillin may lead to false-positive results for glucose in urine when using CLINITEST®, Benedict's Solution, or Fehling's Solution. Clinicians are advised to utilize glucose tests based on enzymatic glucose oxidase reactions for accurate results. Additionally, following amoxicillin administration in pregnant women, a transient decrease in plasma concentrations of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been observed.

Patients should be informed that AUGMENTIN can be taken every 8 or 12 hours, depending on the prescribed dosage, and should be taken with food to minimize gastrointestinal upset. It is important to counsel patients about the potential for allergic reactions due to the penicillin component, as well as the signs of severe cutaneous adverse reactions (SCAR). Patients should be instructed to discontinue AUGMENTIN and report any skin rash, mucosal lesions, or other hypersensitivity signs immediately. Diarrhea is a common side effect of antibacterial therapy, typically resolving after discontinuation of the medication; however, patients should seek medical advice if diarrhea is severe or persists beyond 2 to 3 days. Furthermore, patients should be reminded that AUGMENTIN is effective only against bacterial infections and that incomplete courses of therapy may lead to reduced effectiveness and increased risk of antibacterial resistance.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Augmentin as submitted by Allegis Holdings, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)