Amoxicillin/Clavulanate potassium

Uses and Indications

Amoxicillin and Clavulanate Potassium for Oral Suspension 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 medication should be utilized exclusively for the treatment or prevention of infections that are proven or strongly suspected to be caused by bacteria.

There are no teratogenic or nonteratogenic effects associated with the use of Amoxicillin and Clavulanate Potassium for Oral Suspension.

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 to ensure accurate dosing and administration.

Contraindications

Use of Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis or Stevens-Johnson syndrome, to Amoxicillin and Clavulanate Potassium or other beta-lactams, such as penicillins or cephalosporins. Additionally, it is contraindicated in individuals with a history of cholestatic jaundice or hepatic dysfunction associated with the use of Amoxicillin and Clavulanate Potassium.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving Amoxicillin and Clavulanate Potassium for Oral Suspension. In the event of such a reaction, it is imperative to discontinue the medication immediately.

Severe Cutaneous Adverse Reactions (SCAR) may occur during treatment. Healthcare professionals should monitor patients closely for any signs of rash, and if the rash progresses, the medication should be discontinued without delay.

Drug-induced enterocolitis syndrome (DIES) has been associated with the use of amoxicillin, a component of this formulation. Should symptoms indicative of DIES arise, it is essential to discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension and initiate appropriate therapeutic measures.

Patients with hepatic dysfunction are at risk for cholestatic jaundice. If any signs or symptoms of hepatitis develop, the medication must be discontinued. Additionally, liver function tests should be monitored in patients with pre-existing hepatic impairment to ensure safety.

Clostridioides difficile-associated diarrhea (CDAD) is a potential complication of antibiotic therapy. If a patient presents with diarrhea during treatment, a thorough evaluation is warranted to rule out CDAD.

In patients diagnosed with mononucleosis, the use of Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated due to the risk of developing a skin rash.

Finally, clinicians should remain vigilant for the possibility of superinfections with fungal or bacterial pathogens during therapy, as overgrowth may occur. Regular assessment of the patient's clinical status is recommended to address any emerging infections promptly.

Side Effects

Patients receiving Amoxicillin and Clavulanate Potassium for Oral Suspension may experience a range of adverse reactions. Common adverse reactions, occurring in 1% to 9% of patients, include diarrhea or loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%).

Serious adverse reactions have been reported and require immediate attention. These include serious hypersensitivity reactions, which may be fatal; in such cases, Amoxicillin and Clavulanate Potassium should be discontinued. Severe cutaneous adverse reactions (SCAR) necessitate close monitoring, and discontinuation is advised if a rash progresses. Drug-induced enterocolitis syndrome (DIES) has also been observed; if this occurs, the medication should be discontinued, and appropriate therapy should be initiated. Hepatic dysfunction and cholestatic jaundice may arise, and discontinuation is warranted if signs or symptoms of hepatitis develop. Liver function tests should be monitored in patients with pre-existing hepatic impairment. Additionally, Clostridioides difficile-associated diarrhea (CDAD) should be evaluated if diarrhea occurs.

Patients with mononucleosis who are treated with Amoxicillin and Clavulanate Potassium may develop skin rashes, and the use of this medication in such patients is not recommended. The potential for superinfections with fungal or bacterial pathogens should also be considered during therapy.

It is important to note that a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to Amoxicillin and Clavulanate Potassium or other beta-lactams (including penicillins or cephalosporins) may increase the risk of adverse reactions. Furthermore, a history of cholestatic jaundice or hepatic dysfunction associated with this medication should be taken into account.

Other significant adverse reactions include interstitial nephritis, which has resulted in oliguric renal failure following overdosage, and crystalluria, which in some cases has led to renal failure in both adult and pediatric patients after overdosage with Amoxicillin and Clavulanate Potassium.

Drug Interactions

Co-administration of Amoxicillin and Clavulanate Potassium for Oral Suspension with probenecid is not recommended due to potential interactions that may affect therapeutic outcomes.

When used concurrently with oral anticoagulants, Amoxicillin and Clavulanate Potassium for Oral Suspension may lead to an increased prolongation of prothrombin time. Monitoring of prothrombin time is advised in patients receiving this combination to ensure safe and effective anticoagulation management.

The concomitant use of Amoxicillin and Clavulanate Potassium for Oral Suspension with allopurinol has been associated with an increased risk of rash. Caution is advised when these medications are prescribed together.

Additionally, Amoxicillin and Clavulanate Potassium for Oral Suspension may reduce the efficacy of oral contraceptives. Patients should be informed of this potential interaction and advised to consider alternative or additional contraceptive measures during treatment.

Packaging & NDC

The table below lists all NDC Code configurations of 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 of AUGMENTIN Tablets in adults, supplemented by data from a study involving pediatric patients aged 2 months to 12 years with acute otitis media.

In neonates and young infants, renal function is incompletely developed, which may lead to delayed elimination of amoxicillin; however, the elimination of clavulanate remains unaltered in this age group. Therefore, dosing of amoxicillin and clavulanate potassium should be modified for pediatric patients aged less than 12 weeks (less than 3 months).

Geriatric Use

In an analysis of clinical studies involving AUGMENTIN, 32% of the 3,119 patients evaluated 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, it is important to note that greater sensitivity to the drug in some older individuals cannot be ruled out.

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

Pregnancy Category B. Reproduction studies conducted in pregnant rats and mice administered AUGMENTIN (a 2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day demonstrated no evidence of fetal harm attributable to AUGMENTIN. The amoxicillin doses in these studies were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours) based on body surface area. For clavulanate, the corresponding multiples 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 the 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored for liver function tests. In the event of hepatic dysfunction or the development of cholestatic jaundice, it is recommended to discontinue treatment if signs or symptoms of hepatitis occur. Regular assessment of liver function is essential to ensure patient safety and to guide any necessary adjustments in therapy.

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 amoxicillin below 250 mg/kg typically do not result in significant clinical symptoms.

However, serious complications can arise from higher doses. Interstitial nephritis leading to oliguric renal failure has been documented in patients following an overdosage of amoxicillin and clavulanate potassium. Additionally, crystalluria, which may progress to renal failure, has been reported in both adult and pediatric populations after overdosage with these agents.

To mitigate the risk of crystalluria associated with amoxicillin and clavulanate potassium overdosage, 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 elevated 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

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) demonstrated non-mutagenic properties in both the Ames bacterial mutation assay and the yeast gene conversion assay. However, it exhibited weakly positive results in the mouse lymphoma assay, where the observed trend toward increased mutation frequencies coincided with doses that also resulted in decreased cell survival. AUGMENTIN was found to be negative in the mouse micronucleus test and in the dominant lethal assay in mice.

Potassium clavulanate, when tested independently in the Ames bacterial mutation assay and the mouse micronucleus test, yielded negative results in both assays.

In terms of reproductive toxicity, AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) administered at oral doses of up to 1,200 mg/kg/day did not affect fertility or reproductive performance in rats. This dosage corresponds to approximately four times the maximum recommended adult human oral dose of amoxicillin (875 mg every 12 hours) and approximately nine times the maximum recommended adult human oral dose of clavulanate (125 mg every 8 hours), when adjusted for body surface area.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should inform patients that Amoxicillin and clavulanate potassium may be administered every 8 hours or every 12 hours, depending on the prescribed dosage. Each dose should be taken with a meal or snack to minimize the risk of gastrointestinal upset.

It is essential to counsel patients that Amoxicillin and clavulanate potassium 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 the medication immediately and report any initial signs or symptoms of skin rash, mucosal lesions, or other indications of hypersensitivity.

Patients should also be informed that diarrhea is a common side effect associated with antibacterial medications, typically resolving upon discontinuation of the drug. However, they should be vigilant for the development of watery and bloody stools, which may occur even weeks after completing the treatment. If diarrhea is severe or persists for more than 2 or 3 days, patients should contact their physician promptly.

Counsel patients that antibacterial drugs, including Amoxicillin and clavulanate potassium, are effective only against bacterial infections and do not treat viral infections, such as the common cold. When prescribed Amoxicillin and clavulanate potassium for oral suspension, patients should be advised that it is common to feel improvement early in the treatment. However, it is crucial to take the medication 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 store the suspension in the refrigerator 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 a temperature range of 20º to 25ºC (68º to 77ºF), in accordance with USP Controlled Room Temperature guidelines. Once reconstituted, the suspension must be stored under refrigeration. Any unused suspension should be discarded after 10 days to ensure safety and efficacy.

The product should be dispensed in its original container to maintain integrity. Additionally, it is essential to keep the product out of the reach of children to prevent accidental ingestion.

Additional Clinical Information

Amoxicillin and clavulanate potassium may be administered every 8 or 12 hours, depending on the prescribed dosage, and should be taken with a meal or snack to minimize gastrointestinal upset. Clinicians should counsel patients that this medication contains a penicillin-class drug, which can lead to allergic reactions in some individuals. Patients should be informed about the signs of serious skin reactions and instructed to discontinue use and report any symptoms such as skin rash or mucosal lesions immediately.

Additionally, patients should be made aware that diarrhea is a common side effect of antibacterial medications, typically resolving after discontinuation of the drug. If diarrhea is severe or persists for more than 2 to 3 days, patients should contact their physician. It is crucial to emphasize that antibacterial drugs, including Amoxicillin and clavulanate potassium, are effective only against bacterial infections and not viral infections. Patients should adhere strictly to the prescribed regimen, as skipping doses or failing to complete the full course may reduce treatment effectiveness and contribute to antibiotic resistance. For those using the suspension form, it should be refrigerated, shaken well before use, and administered with a calibrated oral syringe, with any unused medicine discarded appropriately.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Amoxicillin and Clavulanate Potassium as submitted by Devatis, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)