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Amoxicillin/Clavulanate potassium

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Active ingredients
  • Amoxicillin 875 mg
  • Clavulanate Potassium 125 mg
Other brand names
Drug classes
Penicillin-class Antibacterial, beta Lactamase Inhibitor
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
February 6, 2026
FDA Insert
Prescribing information, PDF file
Active ingredients
  • Amoxicillin 875 mg
  • Clavulanate Potassium 125 mg
Other brand names
Drug classes
Penicillin-class Antibacterial, beta Lactamase Inhibitor
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
February 6, 2026
Manufacturer
REMEDYREPACK INC.
Registration number
ANDA204755
NDC root
70518-3967
FDA Insert
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Amoxicillin and clavulanate potassium tablets are a combination of two antibacterial medications: amoxicillin and clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is a type of penicillin antibiotic that helps fight bacteria, while clavulanate potassium works as a beta-lactamase inhibitor, which means it helps prevent certain bacteria from becoming resistant to antibiotics. This combination is effective in treating various bacterial infections by targeting and eliminating the bacteria causing the illness.

These tablets come in different strengths, including 250 mg/125 mg, 500 mg/125 mg, and 875 mg/125 mg, allowing for flexibility in dosing based on your specific needs. By using this combination, healthcare providers can enhance the effectiveness of amoxicillin against infections that might otherwise be resistant.

Uses

Amoxicillin and clavulanate potassium tablets are used to treat various bacterial infections in both adults and children. These include infections of the lower respiratory tract, acute bacterial otitis media (an ear infection), sinusitis (inflammation of the sinuses), skin and skin structure infections, and urinary tract infections.

It's important to note that these tablets should only be used when infections are confirmed or strongly suspected to be caused by bacteria. This helps ensure that the medication is effective and appropriate for your condition.

Dosage and Administration

If you are an adult or a child weighing more than 40 kg, you may be prescribed either 500 mg or 875 mg of the medication every 12 hours, or 250 mg or 500 mg every 8 hours, depending on the specific amoxicillin component in your treatment.

For children aged 12 weeks (3 months) and older, the dosage is based on their weight. You should give them between 25 to 45 mg for each kilogram of their body weight per day, divided into two doses every 12 hours, or 20 to 40 mg per kilogram per day, divided into three doses every 8 hours. However, the total amount should not exceed the adult dose.

If you have a newborn or an infant younger than 12 weeks, the recommended dosage is 30 mg for each kilogram of their body weight per day, divided into two doses every 12 hours. It’s best to use the 125 mg/5 mL oral suspension for this age group to ensure accurate dosing.

What to Avoid

If you have a history of serious allergic reactions, such as anaphylaxis (a severe, potentially life-threatening allergic reaction) or Stevens-Johnson syndrome (a serious skin condition), to amoxicillin and clavulanate potassium or other beta-lactam antibiotics like penicillins or cephalosporins, you should not take this medication. Additionally, if you have experienced cholestatic jaundice or liver problems related to amoxicillin and clavulanate potassium, it is important to avoid using this drug. Always consult your healthcare provider if you have any concerns about your medical history before starting a new medication.

Side Effects

You may experience some common side effects while taking amoxicillin and clavulanate potassium, including diarrhea or loose stools (9%), nausea (3%), skin rashes or hives (3%), vomiting (1%), and vaginitis (1%). It's important to be aware of more serious reactions as well. If you notice any signs of a severe allergic reaction, such as difficulty breathing or swelling, stop taking the medication immediately. Other serious concerns include severe skin reactions, liver problems, and a specific type of diarrhea caused by Clostridioides difficile, which may require further evaluation.

If you have a history of serious allergic reactions to this medication or similar drugs, or if you have liver issues related to its use, you should avoid taking it. Additionally, be cautious of potential superinfections, which can occur during treatment. Always consult your healthcare provider if you experience any unusual symptoms or have concerns about your treatment.

Warnings and Precautions

You should be aware of some important warnings and precautions when using amoxicillin and clavulanate potassium. If you experience any serious allergic reactions, such as difficulty breathing or swelling, stop taking the medication immediately and seek emergency help. Additionally, if you notice a rash that worsens, discontinue use and contact your doctor.

It's also crucial to monitor for signs of liver problems, such as jaundice (yellowing of the skin or eyes), and to have your liver function tested if you have existing liver issues. If you develop diarrhea, especially if it is severe, inform your healthcare provider, as it may be related to a condition called Clostridioides difficile-associated diarrhea (CDAD). Lastly, if you have mononucleosis, avoid using this medication, as it can lead to skin rashes. Always consult your doctor if you have any concerns or experience unusual symptoms while on this medication.

Overdose

If you suspect an overdose of amoxicillin and clavulanate potassium, it’s important to stop taking the medication immediately and seek medical help. While studies suggest that taking less than 250 mg/kg typically doesn’t cause serious symptoms, there are potential risks. Overdosing can lead to conditions like interstitial nephritis (inflammation of the kidneys) and crystalluria (crystals in the urine), which may result in kidney failure.

To help reduce the risk of crystalluria, ensure you maintain adequate fluid intake and urination. If you have kidney problems, be aware that your body may not clear the medication as effectively, increasing the risk of high blood levels. In severe cases, hemodialysis (a procedure to remove waste products from the blood) may be necessary. Always consult a healthcare professional if you experience any concerning symptoms or if you are unsure about your situation.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that amoxicillin and clavulanate potassium are classified as Pregnancy Category B. This means that studies in pregnant animals, such as rats and mice, did not show any harm to the fetus when given high doses of the medication. However, there are no well-controlled studies in pregnant women, so the effects on human pregnancies are not fully understood.

Because animal studies do not always predict how humans will respond, you should only use this medication during pregnancy if it is clearly necessary. Always consult your healthcare provider to discuss the potential risks and benefits before taking any medication while pregnant.

Lactation Use

Amoxicillin can pass into your breast milk, which means that if you are breastfeeding, there are some important considerations to keep in mind. Using amoxicillin and clavulanate potassium while nursing may increase the risk of your baby becoming sensitized (developing an allergic reaction) to these medications.

It's essential to be cautious if you need to take these medications while breastfeeding. Always consult with your healthcare provider to discuss the potential risks and benefits for both you and your baby.

Pediatric Use

Amoxicillin and clavulanate potassium, available as an oral suspension and chewable tablets, are safe and effective for children. Research supports their use in kids, particularly for treating conditions like acute ear infections in children aged 2 months to 12 years. However, if your child is under 12 weeks old (less than 3 months), their dosage may need to be adjusted due to their developing kidneys, which can affect how the medication is processed in their body.

It's important to be aware that newborns and young infants may not eliminate amoxicillin as quickly as older children, although the elimination of clavulanate remains unchanged. Always consult your child's healthcare provider for the appropriate dosage and any specific concerns regarding their age and health.

Geriatric Use

In clinical studies involving amoxicillin and clavulanate potassium, a significant portion of participants were older adults, with 32% aged 65 and older, and 14% aged 75 and older. While no major differences in safety or effectiveness were found between older and younger patients, it's important to note that some older individuals may be more sensitive to the medication.

Since this drug is mainly cleared from the body through the kidneys, older adults, who often have reduced kidney function, should use it with caution. When prescribing this medication, healthcare providers may need to adjust the dosage and monitor kidney function to ensure safety and effectiveness. If you or a loved one is considering this treatment, discussing these factors with a healthcare professional is essential.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be aware of how this may affect your treatment. If you notice any signs or symptoms of hepatitis (inflammation of the liver), such as jaundice (yellowing of the skin or eyes), you should stop taking the medication immediately.

Additionally, your healthcare provider will need to monitor your liver function tests regularly. These tests help assess how well your liver is working and ensure that your treatment is safe for you. Always communicate openly with your doctor about any changes in your health.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, taking amoxicillin and clavulanate potassium tablets alongside oral anticoagulants (medications that help prevent blood clots) may increase the time it takes for your blood to clot, which can be a concern. Additionally, using these tablets with probenecid (a medication that affects how your body processes other drugs) is not recommended.

You should also know that combining amoxicillin and clavulanate with allopurinol (a medication used to treat gout) can raise the risk of developing a rash. Furthermore, if you are using oral contraceptives, these tablets may make them less effective. Always discuss any medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider to ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20° to 25°C (68° to 77°F), which is considered a controlled room temperature. Always keep the product in its original container and make sure it is closed tightly when not in use. This helps protect it from contamination and maintains its quality.

It's also important to keep the product out of the reach of children to prevent any accidental ingestion or misuse. By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Amoxicillin and clavulanate potassium?

Amoxicillin and clavulanate potassium tablets are an oral antibacterial combination consisting of amoxicillin and clavulanate potassium, a beta-lactamase inhibitor.

What infections are treated with Amoxicillin and clavulanate potassium?

This medication is indicated for lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections.

What are the common side effects of Amoxicillin and clavulanate potassium?

Common side effects include diarrhea, nausea, skin rashes, vomiting, and vaginitis.

What should I do if I experience a serious allergic reaction?

If you experience a serious hypersensitivity reaction, such as anaphylaxis or severe skin rash, discontinue use immediately and seek medical attention.

Can I take Amoxicillin and clavulanate potassium during pregnancy?

Amoxicillin and clavulanate potassium is classified as Pregnancy Category B, indicating no evidence of harm in animal studies, but it should be used during pregnancy only if clearly needed.

Is it safe to use Amoxicillin and clavulanate potassium while breastfeeding?

Amoxicillin is excreted in human milk, and caution should be exercised when administering this medication to nursing mothers.

What are the dosage recommendations for adults?

Adults and pediatric patients over 40 kg may take 500 or 875 mg every 12 hours, or 250 or 500 mg every 8 hours, based on the amoxicillin component.

What should I do if I have a history of hypersensitivity to beta-lactams?

You should not take Amoxicillin and clavulanate potassium if you have a history of serious hypersensitivity reactions to this medication or other beta-lactams.

How should Amoxicillin and clavulanate potassium be stored?

Store the tablets at 20° to 25°C (68° to 77°F) and keep them in the original container, out of reach of children.

What are the inactive ingredients in Amoxicillin and clavulanate potassium tablets?

Inactive ingredients include colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, talc, and titanium dioxide.

Packaging Info

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.

Packaging configurations for Amoxicillin and Clavulanate Potassium.
Details

FDA Insert (PDF)

This is the full prescribing document for Amoxicillin and Clavulanate Potassium, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Amoxicillin and clavulanate potassium tablets, 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 molecular formula of amoxicillin is C16H19N3O5S•3H2O, with a molecular weight of 419.46 g/mol. Chemically, amoxicillin is (2S,5R,6R)-6-R-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo3.2.0heptane-2-carboxylic acid trihydrate. The molecular formula of clavulanate potassium is C8H8KNO5, and its molecular weight is 237.25 g/mol. Clavulanate potassium is chemically defined as potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo3.2.0-heptane-2-carboxylate.

Amoxicillin and clavulanate potassium tablets are available in three strengths: 250 mg/125 mg, 500 mg/125 mg, and 875 mg/125 mg. Each tablet of the 250 mg/125 mg formulation contains 250 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). The 500 mg/125 mg formulation contains 500 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). The 875 mg/125 mg formulation contains 875 mg of amoxicillin, USP as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium, USP). Each tablet contains 0.63 mEq potassium.

Inactive ingredients include colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, talc, and titanium dioxide.

Uses and Indications

Amoxicillin and clavulanate potassium tablets are 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.

These tablets 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 this medication.

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 formulation and dosing schedule are selected based on the patient's age, weight, and clinical condition.

Contraindications

Use of this product is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis or Stevens-Johnson syndrome, to amoxicillin and clavulanate potassium or to 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 amoxicillin and clavulanate potassium.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving amoxicillin and clavulanate potassium. 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, discontinuation of amoxicillin and clavulanate potassium is warranted.

Drug-induced enterocolitis syndrome (DIES) has been associated with the use of amoxicillin, a component of this combination therapy. Should symptoms indicative of DIES arise, it is essential to discontinue the medication and initiate appropriate therapeutic measures.

Patients with hepatic impairment require careful monitoring of liver function tests. If any signs or symptoms of hepatic dysfunction or cholestatic jaundice, such as hepatitis, are observed, amoxicillin and clavulanate potassium should be discontinued.

Clostridioides difficile-associated diarrhea (CDAD) is a potential complication of antibiotic therapy. Patients presenting with diarrhea should be evaluated for this condition, and appropriate management should be initiated if CDAD is confirmed.

In patients with mononucleosis, the use of amoxicillin and clavulanate potassium is contraindicated due to the risk of developing a skin rash. Therefore, this medication should be avoided in such cases.

Additionally, healthcare professionals should remain vigilant for the possibility of superinfections with fungal or bacterial pathogens during therapy, as overgrowth may occur.

Side Effects

Patients receiving amoxicillin and clavulanate potassium may experience a range of adverse reactions. Common adverse reactions observed in clinical trials include diarrhea or loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%).

Serious adverse reactions have also been reported. These include serious hypersensitivity reactions, which may be fatal; therefore, amoxicillin and clavulanate potassium should be discontinued immediately if such a reaction occurs. Severe cutaneous adverse reactions (SCAR) require close monitoring, and discontinuation is advised if any rash progresses. Drug-induced enterocolitis syndrome (DIES) necessitates discontinuation of the medication and appropriate therapeutic intervention if it occurs. Hepatic dysfunction and cholestatic jaundice have been noted, with recommendations to discontinue the drug if signs or symptoms of hepatitis arise, and to monitor liver function tests in patients with pre-existing hepatic impairment. Clostridioides difficile-associated diarrhea (CDAD) should be evaluated if diarrhea develops during treatment.

Additionally, patients with mononucleosis who are treated with amoxicillin and clavulanate potassium may develop skin rashes, and its use is contraindicated in these individuals. The potential for superinfections with fungal or bacterial pathogens should also be considered during therapy.

Important considerations include a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to amoxicillin and clavulanate potassium or other beta-lactams, including penicillins and cephalosporins. A history of cholestatic jaundice or hepatic dysfunction associated with amoxicillin and clavulanate potassium is also significant. Furthermore, interstitial nephritis resulting in oliguric renal failure has been reported following overdosage, as has crystalluria, which in some cases has led to renal failure in both adult and pediatric patients.

Drug Interactions

Co-administration of amoxicillin and clavulanate potassium tablets with certain medications may lead to significant interactions that require careful consideration.

Pharmacodynamic Interactions

The concomitant use of amoxicillin and clavulanate potassium tablets with oral anticoagulants may result in an increased prolongation of prothrombin time. Clinicians should monitor prothrombin time closely in patients receiving this combination to ensure appropriate anticoagulation levels are maintained.

Pharmacokinetic Interactions

Co-administration with probenecid is not recommended due to potential pharmacokinetic interactions that may affect the efficacy and safety of amoxicillin and clavulanate potassium tablets.

Additionally, the use of allopurinol alongside amoxicillin and clavulanate potassium tablets has been associated with an increased risk of rash. Patients should be monitored for dermatological reactions when these medications are used together.

Other Considerations

Amoxicillin and clavulanate potassium tablets may reduce the efficacy of oral contraceptives. Patients using hormonal contraceptives should be advised to consider alternative or additional contraceptive methods during treatment with amoxicillin and clavulanate potassium tablets to prevent unintended pregnancy.

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.

Packaging configurations for Amoxicillin and Clavulanate Potassium.
Details

Pediatric Use

The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. Evidence supporting the use of these formulations in children is derived from studies involving amoxicillin and clavulanate potassium tablets in adults, along with data from a study specifically examining the oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media.

In neonates and young infants, renal function is not fully developed, which may lead to delayed elimination of amoxicillin; however, the elimination of clavulanate remains unaffected in this age group. Therefore, dosing of amoxicillin and clavulanate potassium should be adjusted for pediatric patients aged less than 12 weeks (less than 3 months) to ensure safety and efficacy.

Geriatric Use

In clinical studies involving amoxicillin and clavulanate potassium, 32% of the 3,119 patients analyzed were aged 65 years or older, and 14% were aged 75 years or older. Overall, no significant differences in safety or effectiveness were observed between elderly patients and their younger counterparts. However, it is important to note that greater sensitivity to the drug may be present in some older individuals, which cannot be entirely ruled out based on current data.

Amoxicillin and clavulanate potassium is primarily excreted through the kidneys, and the risk of adverse reactions may be heightened in patients with impaired renal function. Given that geriatric patients are more likely to experience decreased renal function, careful consideration should be given to dose selection in this population. It is advisable to monitor renal function in elderly patients to ensure appropriate dosing and minimize the risk of adverse effects.

Pregnancy

Pregnancy Category B. Reproduction studies conducted in pregnant rats and mice administered amoxicillin and clavulanate potassium (2:1 ratio formulation) at oral doses up to 1200 mg/kg/day demonstrated no evidence of harm to 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 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, amoxicillin and clavulanate potassium should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against the risks when considering this medication 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 immediately. Careful 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. Symptomatic treatment should be initiated, and supportive measures should be implemented as necessary to manage the patient's condition effectively.

A prospective study indicates that overdosages of amoxicillin below 250 mg/kg are generally not associated with significant clinical symptoms. However, it is important to note that more severe outcomes can occur with higher doses. Notably, interstitial nephritis leading to oliguric renal failure has been documented in patients who have experienced an overdosage of amoxicillin and clavulanate potassium. Additionally, crystalluria has been reported, which in some instances has resulted in renal failure among both adult and pediatric patients.

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 ensure proper renal function and reduces the likelihood of complications.

Patients with impaired renal function are at an increased risk for elevated blood levels of amoxicillin and clavulanate potassium due to decreased renal clearance. In such cases, hemodialysis may be considered as a method to remove the drug from circulation effectively.

Healthcare professionals should remain vigilant in monitoring patients for any signs of overdosage and respond promptly to any adverse effects that may arise.

Nonclinical Toxicology

Long-term studies in animals have not been conducted to assess the carcinogenic potential of amoxicillin and clavulanate potassium. In mutagenicity testing, the combination of amoxicillin and clavulanate potassium (4:1 ratio formulation) 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. The compound was found to be negative in the mouse micronucleus test and in the dominant lethal assay in mice.

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

In terms of reproductive toxicity, amoxicillin and clavulanate potassium (2:1 ratio formulation) administered at oral doses of up to 1,200 mg/kg/day did not adversely 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 about nine times the maximum recommended adult human oral dose of clavulanate (125 mg every 8 hours), when adjusted for body surface area.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of amoxicillin and clavulanate potassium tablets. Notably, severe cutaneous adverse reactions (SCAR) have been reported, which include signs and symptoms indicative of serious skin manifestations.

Patients are advised to discontinue the use of the medication immediately upon the first appearance of any skin rash, mucosal lesions, or other signs suggestive of hypersensitivity.

Patient Counseling

Patients should be informed that amoxicillin and clavulanate potassium tablets 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 regarding the potential for allergic reactions, as amoxicillin and clavulanate potassium tablets contain a penicillin class drug. 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 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 accompanying stomach cramps and fever, even up to two 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 amoxicillin and clavulanate potassium tablets, are effective only against bacterial infections and do not treat viral infections, such as the common cold. When prescribed for a bacterial infection, patients should be reminded that it is common to feel better early in the treatment. However, they must 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 more difficult to treat with amoxicillin and clavulanate potassium tablets or other antibacterial agents.

Storage and Handling

The product is supplied in its original container to ensure integrity and stability. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Patients are advised to keep the product in a closed container to maintain its efficacy and prevent contamination. Additionally, it is crucial to keep the product out of the reach of children to ensure safety.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Amoxicillin and Clavulanate Potassium, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA204755) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.