Amoxicillin/Clavulanate potassium

Description

Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is an oral antibacterial combination comprising the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate potassium, the potassium salt of clavulanic acid. Amoxicillin, an analog of ampicillin, is derived from the penicillin nucleus, 6-aminopenicillanic acid, with a molecular formula of C₁₆H₁₉N₃O₅S•3H₂O and a molecular weight of 419.46 g/mol. Its chemical structure is defined as (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.

Clavulanic acid, produced by the fermentation of Streptomyces clavuligerus, is a β-lactam structurally related to penicillins, known for its ability to inactivate a variety of β-lactamases by blocking their active sites. It is particularly effective against clinically significant plasmid-mediated β-lactamases that confer resistance to penicillins and cephalosporins. The molecular formula for clavulanate potassium is C₈H₈KNO₅, with a molecular weight of 237.25 g/mol, and its chemical structure is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo3.2.0-heptane-2-carboxylate.

Each 5 mL of the reconstituted suspension contains 600 mg of amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt, providing 0.248 mEq of potassium. Inactive ingredients include aspartame, colloidal silicon dioxide, hypromellose, orange powder flavor, silicon dioxide, succinic acid, and xanthan gum.

Uses and Indications

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media caused by specific pathogens. This formulation is effective against Streptococcus pneumoniae (penicillin minimum inhibitory concentrations MICs ≤2 mcg/mL), Haemophilus influenzae (including β-lactamase–producing strains), and Moraxella catarrhalis (including β-lactamase–producing strains).

This drug is specifically indicated for pediatric patients who present with risk factors such as antibiotic exposure for acute otitis media within the preceding 3 months, and either an age of 2 years or younger or attendance at daycare. It is important to note that acute otitis media due to S. pneumoniae alone can be treated with amoxicillin.

Amoxicillin and clavulanate potassium for oral suspension is not indicated for the treatment of acute otitis media caused by S. pneumoniae with penicillin MIC ≥4 mcg/mL. Therapy may be initiated prior to obtaining results from bacteriological studies if there is a clinical suspicion of infection involving both S. pneumoniae (penicillin MIC ≤2 mcg/mL) and the aforementioned β-lactamase–producing organisms.

To mitigate the development of drug-resistant bacteria and preserve the efficacy of amoxicillin and clavulanate potassium, it should be utilized solely for the treatment or prevention of infections that are confirmed or strongly suspected to be caused by susceptible bacteria.

Dosage and Administration

For pediatric patients aged 3 months and older, the recommended dosage of amoxicillin and clavulanate potassium is 90 mg/kg/day, divided into two doses every 12 hours, and administered for a duration of 10 days. The specific dosage based on body weight is as follows:

• For a body weight of 8 kg: 3.0 mL twice daily

• For a body weight of 12 kg: 4.5 mL twice daily

• For a body weight of 16 kg: 6.0 mL twice daily

• For a body weight of 20 kg: 7.5 mL twice daily

• For a body weight of 24 kg: 9.0 mL twice daily

• For a body weight of 28 kg: 10.5 mL twice daily

• For a body weight of 32 kg: 12.0 mL twice daily

• For a body weight of 36 kg: 13.5 mL twice daily

There is currently no available experience regarding the dosage for pediatric patients weighing 40 kg and more. Additionally, there is no established dosage for adult patients. It is important to note that adults who have difficulty swallowing should not be administered this oral suspension as a substitute for the 500 mg/125 mg or 875 mg/125 mg tablet formulations.

To minimize gastrointestinal intolerance, it is recommended that amoxicillin and clavulanate potassium 600 mg/42.9 mg per 5 mL be taken at the start of a meal. Administering the medication at this time may enhance absorption.

Contraindications

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, is contraindicated in patients with a history of allergic reactions to any penicillin. Additionally, it is contraindicated in individuals with a previous history of cholestatic jaundice or hepatic dysfunction associated with the use of amoxicillin and clavulanate potassium.

Furthermore, the administration of ampicillin-class antibiotics is contraindicated in patients with mononucleosis due to the risk of severe rash and other complications.

Warnings and Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients undergoing penicillin therapy. These reactions are more prevalent in individuals with a history of penicillin hypersensitivity and/or sensitivity to multiple allergens. Notably, there have been instances of severe reactions in patients with a history of penicillin hypersensitivity who were treated with cephalosporins. Prior to initiating therapy with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, a thorough inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens is essential. Should an allergic reaction occur, the administration of amoxicillin and clavulanate potassium should be discontinued immediately, and appropriate therapeutic measures should be instituted.

In cases of serious anaphylactic reactions, immediate emergency treatment with epinephrine is required. Additional interventions may include the administration of oxygen, intravenous steroids, and airway management, including intubation, as clinically indicated.

Clostridium difficile-associated diarrhea (CDAD) has been documented with the use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium for oral suspension. The severity of CDAD can range from mild diarrhea to fatal colitis, as treatment with antibacterial agents disrupts the normal flora of the colon, leading to C. difficile overgrowth. C. difficile produces toxins A and B, which are implicated in the development of CDAD. Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality, as these infections may be refractory to antimicrobial therapy and could necessitate colectomy. CDAD should be considered in all patients presenting with diarrhea following antibiotic use, and careful medical history is warranted, as CDAD can occur over two months post-administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic therapy not targeting C. difficile may need to be discontinued. Management should include appropriate fluid and electrolyte replacement, protein supplementation, antibiotic treatment for C. difficile, and surgical evaluation as clinically indicated.

Amoxicillin and clavulanate potassium for oral suspension should be used with caution in patients exhibiting signs of hepatic dysfunction. Hepatic toxicity associated with this medication is generally reversible; however, rare cases of fatalities have been reported, typically in patients with serious underlying conditions or those on concomitant medications.

While amoxicillin and clavulanate potassium exhibit the characteristic low toxicity associated with penicillin antibiotics, periodic assessment of organ system functions—including renal, hepatic, and hematopoietic function—is advisable for patients undergoing therapy beyond the approved duration of administration.

It is important to note that a significant percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash; therefore, ampicillin-class antibiotics should not be administered to these patients. Additionally, the potential for superinfections with mycotic or bacterial pathogens should be considered during therapy. If superinfections occur, typically involving Pseudomonas or Candida, the drug should be discontinued, and appropriate therapy should be initiated.

Prescribing amoxicillin and clavulanate potassium for oral suspension in the absence of a proven or strongly suspected bacterial infection, or without a prophylactic indication, is unlikely to benefit the patient and may increase the risk of developing drug-resistant bacteria.

For patients receiving therapy for longer than the approved duration, periodic laboratory assessments of organ system functions, including renal, hepatic, and hematopoietic function, are recommended to ensure patient safety.

Side Effects

The most commonly reported adverse reactions associated with amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL) include contact dermatitis (diaper rash) (3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). Notably, diarrhea (2.5%) and vomiting (1.4%) were the most common adverse experiences leading to withdrawal, indicating a probable or suspected relationship to the medication.

Gastrointestinal adverse reactions may include diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic or pseudomembranous colitis. Symptoms of pseudomembranous colitis may arise during or after antibiotic treatment.

Hypersensitivity reactions have been reported, including skin rashes, pruritus, urticaria, angioedema, and serum sickness-like reactions characterized by urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever. Rarely, erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and exfoliative dermatitis (including toxic epidermal necrolysis) have occurred. Serious and occasionally fatal anaphylactic reactions can occur, particularly in patients with a history of penicillin hypersensitivity or sensitivity to multiple allergens, necessitating immediate emergency treatment with epinephrine.

Liver-related adverse reactions include a moderate rise in AST (SGOT) and/or ALT (SGPT), with the clinical significance of these findings remaining unclear. Infrequent reports of hepatic dysfunction, including hepatitis and cholestatic jaundice, as well as increases in serum transaminases, serum bilirubin, and/or alkaline phosphatase, have been noted. While hepatic dysfunction may be severe, it is typically reversible, with rare instances of fatalities reported (less than 1 death per estimated 4 million prescriptions worldwide).

Renal adverse reactions are rare and include interstitial nephritis and hematuria, with crystalluria also reported. Hematological effects such as anemia (including hemolytic anemia), thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been observed during therapy with penicillins. A slight thrombocytosis was noted in less than 1% of patients treated with amoxicillin and clavulanate potassium. Additionally, increased prothrombin time has been reported in patients receiving this medication alongside anticoagulant therapy.

Central nervous system effects, although rare, may include agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity. Miscellaneous adverse reactions include tooth discoloration (brown, yellow, or gray staining), which has been reported primarily in pediatric patients and is often reduced or eliminated with brushing or dental cleaning.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including amoxicillin and clavulanate potassium. The severity of CDAD can range from mild diarrhea to fatal colitis, and it should be considered in all patients presenting with diarrhea following antibiotic use.

Drug Interactions

Probenecid is known to decrease the renal tubular secretion of amoxicillin. When amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL) is administered concurrently with probenecid, there may be increased and prolonged blood levels of amoxicillin. Therefore, co-administration of probenecid with this formulation is not recommended.

The concurrent use of allopurinol and ampicillin has been associated with a significantly higher incidence of rashes in patients compared to those receiving ampicillin alone. It remains unclear whether this increased incidence is attributable to allopurinol or the hyperuricemia present in these patients. There is no available data regarding the concurrent administration of allopurinol with amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL).

Amoxicillin/clavulanate, like other broad-spectrum antibiotics, may reduce the efficacy of oral contraceptives. Patients using oral contraceptives should be advised to consider alternative or additional contraceptive measures during treatment.

Oral administration of amoxicillin and clavulanate potassium results in high urine concentrations of amoxicillin. These elevated concentrations may lead to false-positive results when testing for glucose in urine using CLINITEST®, Benedict's Solution, or Fehling's Solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions, such as CLINISTIX®, be utilized to avoid this issue.

In pregnant women, administration of ampicillin has been associated with a transient decrease in plasma concentrations of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol. This effect may also be observed with amoxicillin and, consequently, with amoxicillin and clavulanate potassium for oral suspension (600 mg/42.9 mg per 5 mL). Monitoring of hormone levels may be warranted in pregnant patients receiving this 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 efficacy of amoxicillin and clavulanate potassium 600 mg/42.9 mg per 5 mL have not been established in infants younger than 3 months. For pediatric patients aged 3 months to 12 years, this formulation has demonstrated safety and efficacy in the treatment of acute otitis media. Additionally, it has been established as safe and effective for treating acute bacterial sinusitis in the same age group.

Geriatric Use

Elderly patients should be treated with amoxicillin and clavulanate potassium for oral suspension with caution, particularly those with evidence of hepatic dysfunction, which is more prevalent in this population. Hepatic dysfunction, including conditions such as hepatitis and cholestatic jaundice, has been reported more frequently among elderly patients, especially in males or those undergoing prolonged treatment.

For geriatric patients receiving therapy for durations exceeding the approved administration period, periodic assessment of organ system functions—including renal, hepatic, and hematopoietic functions—is advisable to monitor for potential adverse effects.

Additionally, the risk of superinfections with mycotic or bacterial pathogens should be considered during treatment, particularly in elderly patients who may have other underlying health issues that could complicate their clinical status.

It is important to note that the safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in adults have not been well established, and this formulation is not recommended for adults who experience difficulty swallowing.

Elderly patients may also exhibit a higher incidence of hepatic dysfunction, which is generally reversible upon discontinuation of the medication. Furthermore, renal impairment associated with the use of this drug appears to be reversible with cessation of administration; however, elderly patients with impaired renal function may experience elevated blood levels of both amoxicillin and clavulanate due to decreased renal clearance. Therefore, careful monitoring and potential dose adjustments may be necessary in this demographic.

Pregnancy

The use of amoxicillin and clavulanate potassium during pregnancy should be approached with caution. Currently, there is insufficient data to determine whether administration during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of requiring obstetrical interventions such as forceps delivery or resuscitation of the newborn.

A single study involving women with premature rupture of fetal membranes indicated that prophylactic treatment with amoxicillin and clavulanate potassium may be associated with an increased risk of necrotizing enterocolitis in neonates. Given these findings, healthcare professionals should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients.

Lactation

Ampicillin-class antibiotics, including amoxicillin and clavulanate potassium, are excreted in human milk. Therefore, caution should be exercised when administering this medication to lactating mothers. The potential effects on breastfed infants have not been fully established, and healthcare professionals should consider the benefits of breastfeeding alongside the potential risks associated with the use of this antibiotic in nursing women.

Renal Impairment

Patients with renal impairment should use amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL with caution. While specific dosing adjustments for patients with reduced kidney function are not detailed, it is important to monitor these patients closely due to the potential for altered pharmacokinetics. Additionally, caution is advised in patients with evidence of hepatic dysfunction, as this may further complicate the management of therapy. Regular assessment of renal function is recommended to ensure safe and effective use of the medication in this population.

Hepatic Impairment

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used with caution in patients with evidence of hepatic dysfunction. While hepatic toxicity associated with the use of amoxicillin/clavulanate potassium is usually reversible, it is important to monitor liver function in these patients.

On rare occasions, deaths have been reported in patients receiving this medication, with less than 1 death reported per estimated 4 million prescriptions worldwide. These fatalities have generally occurred in patients with serious underlying diseases or those taking concomitant medications. Therefore, careful consideration and monitoring are advised for patients with compromised liver function when prescribing this medication.

Overdosage

Following an overdosage of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, patients have primarily exhibited gastrointestinal symptoms. These symptoms include stomach and abdominal pain, vomiting, and diarrhea. Additionally, a small number of patients have reported experiencing rash, hyperactivity, or drowsiness.

In the event of an overdosage, it is recommended to discontinue the administration of the medication and to treat the patient symptomatically while instituting supportive measures as necessary. If the overdosage has occurred very recently and there are no contraindications, healthcare professionals may consider inducing emesis or employing other methods to remove the drug from the stomach. 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 and do not necessitate gastric emptying.

It is important to note that interstitial nephritis resulting in oliguric renal failure has been reported in a small subset of patients following overdosage with amoxicillin. Furthermore, crystalluria, which in some instances has led to renal failure, has also been documented in both adult and pediatric patients after amoxicillin overdosage. To mitigate the risk of crystalluria, maintaining adequate fluid intake and diuresis is essential.

Renal impairment observed in these cases appears to be reversible upon cessation of the drug. It is crucial to recognize that patients with impaired renal function may experience higher blood levels of the drug due to decreased renal clearance of both amoxicillin and clavulanate. Both compounds can be effectively removed from the circulation through hemodialysis, which may be necessary in cases of significant overdosage.

Nonclinical Toxicology

Reproduction studies conducted in pregnant rats and mice administered amoxicillin and clavulanate potassium at oral dosages up to 1,200 mg/kg/day, which corresponds to 4.9 and 2.8 times the maximum adult human oral dose based on body surface area, demonstrated no evidence of teratogenic effects on the fetus. However, there are no adequate and well-controlled studies in pregnant women. Due to the limitations of animal reproduction studies in predicting human outcomes, the use of this drug during pregnancy should be considered only when clearly necessary.

In terms of non-teratogenic effects, amoxicillin and clavulanate potassium, when given at oral doses of up to 1,200 mg/kg/day (5.7 times the maximum adult human dose based on body surface area), did not adversely affect fertility or reproductive performance in rats treated with a 2:1 ratio formulation of amoxicillin to clavulanate.

Long-term studies assessing the carcinogenic potential of amoxicillin and clavulanate potassium have not been conducted. The mutagenic potential of this drug was evaluated through various in vitro assays, including the Ames test, a human lymphocyte cytogenetic assay, a yeast test, and a mouse lymphoma forward mutation assay, as well as in vivo assessments using mouse micronucleus tests and a dominant lethal test. All tests returned negative results, except for the in vitro mouse lymphoma assay, which indicated weak activity at very high, cytotoxic concentrations.

No additional specific details regarding animal pharmacology and toxicology are available beyond those mentioned in the non-teratogenic effects and nonclinical toxicology sections.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, as reported voluntarily or through surveillance programs.

Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including this formulation. The severity of CDAD can range from mild diarrhea to fatal colitis, as treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. Hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality, and CDAD must be considered in all patients presenting with diarrhea following antibiotic use. It is noteworthy that CDAD has been reported to occur over two months after the administration of antibacterial agents.

In cases where CDAD is suspected or confirmed, it may be necessary to discontinue ongoing antibiotic use not directed against C. difficile. Management should include appropriate fluid and electrolyte support, protein supplementation, antibiotic treatment for C. difficile, and surgical evaluation as clinically indicated.

A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibiotics, although the clinical significance of these findings remains unclear. Hepatic dysfunction, including hepatitis and cholestatic jaundice, as well as increases in serum transaminases, serum bilirubin, and/or alkaline phosphatase, has been infrequently reported with AUGMENTIN. These events have been more commonly observed in elderly patients, males, or those undergoing prolonged treatment. The onset of hepatic dysfunction may occur during therapy or several weeks after discontinuation, and while the dysfunction is usually reversible, rare cases of death have been reported, typically in patients with serious underlying conditions or concomitant medications.

Rare reports of interstitial nephritis and hematuria have also been documented, along with crystalluria. Hematological reactions, including anemia (hemolytic anemia), thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis, have been observed during therapy with penicillins. These reactions are generally reversible upon discontinuation of therapy and are believed to be hypersensitivity phenomena. A slight thrombocytosis was noted in less than 1% of patients treated with this formulation, and increased prothrombin time has been reported in patients receiving concomitant anticoagulant therapy.

Neuropsychiatric events such as agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported rarely. Additionally, tooth discoloration (brown, yellow, or gray staining) has been noted, primarily in pediatric patients, with most cases showing improvement or resolution through dental cleaning.

The most commonly reported side effects with a probable or suspected relationship to amoxicillin and clavulanate potassium for oral suspension include contact dermatitis (diaper rash, 3.5%), diarrhea (2.9%), vomiting (2.2%), moniliasis (1.4%), and rash (1.1%). The adverse experiences leading to withdrawal that were of probable or suspected relationship to this formulation were primarily diarrhea (2.5%) and vomiting (1.4%).

Patient Counseling

Healthcare providers should advise patients to take amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, every 12 hours with a meal or snack to minimize the risk of gastrointestinal upset. Patients should be informed that diarrhea is a common side effect associated with antibiotics, which typically resolves upon discontinuation of the medication. However, if patients experience severe diarrhea or if it persists for more than 2 or 3 days, they should contact their physician.

It is important to counsel patients that they may develop watery and bloody stools, with or without stomach cramps and fever, even as late as 2 months after completing the antibiotic course. In such cases, patients should seek medical attention promptly.

Patients should be instructed to keep the suspension refrigerated and to shake the bottle well before each use. When administering the suspension to children, healthcare providers should recommend using a dosing spoon or medicine dropper, ensuring that the spoon or dropper is rinsed after each use. Providers should clarify that the bottles may contain more liquid than necessary and emphasize the importance of following the physician's instructions regarding the dosage and duration of treatment, as any unused medicine should be discarded.

Healthcare providers should explain that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, are effective only against bacterial infections and do not treat viral infections, such as the common cold. Patients should be reminded that even if they feel better early in the treatment, it is crucial to take the medication exactly as prescribed. 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.

Lastly, patients should be made aware that each 5 mL dose of the suspension contains 7 mg of phenylalanine, which may be relevant for those with phenylketonuria or other related conditions.

Storage and Handling

The dry powder for oral suspension is supplied in its original container, ensuring the integrity of the product. It should be stored at a controlled room temperature of 20-25°C (68-77°F) as per USP guidelines. Once reconstituted, the suspension must be stored under refrigeration and should be discarded if not used within 10 days to maintain safety and efficacy.

Additional Clinical Information

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, should be administered every 12 hours with a meal or snack to minimize gastrointestinal upset. Patients are advised to keep the suspension refrigerated and to shake well before use. When dosing children, a dosing spoon or medicine dropper should be utilized, and any unused medicine should be discarded according to the physician's instructions.

Patients should be informed that this antibiotic is effective only against bacterial infections and does not treat viral infections, such as the common cold. It is crucial to complete the full course of therapy as prescribed, even if symptoms improve early, to prevent decreased effectiveness and the potential development of antibiotic resistance. Additionally, patients should be aware that severe diarrhea lasting more than 2 or 3 days, or the occurrence of watery and bloody stools, warrants immediate medical attention. Each 5 mL dose contains 7 mg of phenylalanine, which is relevant for phenylketonurics.

FDA Insert (PDF)

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

View full prescribing information (PDF)