Amoxicillin

Description

Formulation of Amoxicillin for Oral Suspension, USP contains amoxicillin, a semisynthetic antibacterial and an analog of ampicillin, exhibiting a broad spectrum of bactericidal activity against various Gram-positive and Gram-negative microorganisms. Chemically, amoxicillin is described 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. The molecular formula of amoxicillin is C16H19N3O5S·3H2O, with a molecular weight of 419.45. Each 5 mL of the reconstituted suspension for oral administration contains 400 mg of amoxicillin as the trihydrate. Additionally, each 5 mL of the 400-mg reconstituted suspension contains 0.09 mEQ (2.18 mg) of sodium. Inactive ingredients include bubble gum flavor, FD&C Red No. 40, silicon dioxide, sodium benzoate, sodium citrate anhydrous, sucrose, and xanthan gum.

Uses and Indications

Amoxicillin for oral suspension is indicated for the treatment of infections caused by susceptible strains of designated microorganisms. This medication is appropriate for use in both adults and pediatric patients for the following conditions:

• Upper respiratory tract infections of the ear, nose, and throat

• Infections of the genitourinary tract

• Infections of the skin and skin structure

• Infections of the lower respiratory tract

In adult patients specifically, amoxicillin for oral suspension is also indicated for the treatment of Helicobacter pylori infection and duodenal ulcer disease.

Amoxicillin for oral suspension should be utilized only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. This approach is essential to reduce the development of drug-resistant bacteria and to maintain the effectiveness of amoxicillin and other antibacterial agents.

Dosage and Administration

In adults, the recommended dosage ranges from 750 mg to 1750 mg per day, administered in divided doses every 8 to 12 hours. For pediatric patients over 3 months of age, the dosage is 20 mg to 45 mg per kilogram of body weight per day, also given in divided doses every 8 to 12 hours. Healthcare professionals should refer to the full prescribing information for specific dosing regimens tailored to individual patient needs.

For neonates and infants aged 3 months or younger, the upper limit of dosing is 30 mg per kilogram of body weight per day, divided and administered every 12 hours.

In the treatment of Helicobacter pylori infection in adults, two therapeutic regimens are recommended. The triple therapy consists of 1 gram of amoxicillin for oral suspension, 500 mg of clarithromycin, and 30 mg of lansoprazole, all administered twice daily (every 12 hours) for a duration of 14 days. Alternatively, the dual therapy involves 1 gram of amoxicillin for oral suspension and 30 mg of lansoprazole, each given three times daily (every 8 hours) for 14 days.

It is essential to reduce the dosage in patients with severe renal impairment, specifically those with a glomerular filtration rate (GFR) greater than 30 mL/min.

Contraindications

Use is contraindicated in patients with a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to amoxicillin or other beta-lactams, including penicillins and cephalosporins.

Warnings and Precautions

Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving penicillin therapy, including amoxicillin. In the event of an anaphylactic reaction, amoxicillin for oral suspension should be discontinued immediately.

Severe cutaneous adverse reactions (SCAR) may occur in some patients. It is essential to monitor patients closely for any signs of rash, and if the rash progresses, amoxicillin should be discontinued.

Drug-induced enterocolitis syndrome (DIES) has also been associated with the use of amoxicillin. Should this condition arise, it is imperative to discontinue amoxicillin for oral suspension and initiate appropriate therapeutic measures.

Clostridioides difficile-associated diarrhea (CDAD) can manifest in a spectrum ranging from mild diarrhea to severe, potentially fatal colitis. If a patient experiences diarrhea during treatment, a thorough evaluation is warranted to determine the appropriate course of action.

Side Effects

Patients receiving amoxicillin for oral suspension may experience a range of adverse reactions. Common adverse reactions include diarrhea, rash, vomiting, and nausea.

Serious adverse reactions have also been reported. Anaphylactic reactions, which can be serious and occasionally fatal, have occurred in patients undergoing penicillin therapy, including those treated with amoxicillin. It is imperative to discontinue amoxicillin for oral suspension if such a reaction occurs. Additionally, severe cutaneous adverse reactions (SCAR) have been noted; patients should be monitored closely, and the medication should be discontinued if the rash progresses. Drug-induced enterocolitis syndrome (DIES) has been associated with amoxicillin use, necessitating discontinuation of the drug and appropriate therapeutic intervention if this condition arises. Clostridioides difficile-associated diarrhea (CDAD) can manifest, ranging from mild diarrhea to potentially fatal colitis, warranting evaluation if diarrhea occurs.

Patients with a history of serious hypersensitivity reactions, such as anaphylaxis or Stevens-Johnson syndrome, to amoxicillin or other beta-lactams (including penicillins or cephalosporins) should be closely monitored or may require alternative therapies.

Overdosage of amoxicillin has been linked to interstitial nephritis, which can result in oliguric renal failure, as reported in a small number of patients. Crystalluria has also been documented, with some cases leading to renal failure in both adult and pediatric patients following overdosage.

Drug Interactions

Co-administration of amoxicillin for oral suspension with probenicid is not recommended due to potential interactions that may affect the pharmacokinetics of amoxicillin.

When used concurrently with oral anticoagulants, amoxicillin for oral suspension may lead to an increased prolongation of prothrombin time. It is advisable to monitor prothrombin time closely in patients receiving both medications to ensure appropriate anticoagulation levels.

The concomitant use of amoxicillin for oral suspension and allopurinol has been associated with an increased risk of rash. Patients should be monitored for dermatological reactions when these medications are prescribed together.

Additionally, amoxicillin for oral suspension may reduce the efficacy of oral contraceptives. Patients using both amoxicillin and oral contraceptives should be advised to consider alternative or additional contraceptive methods during treatment.

Packaging & NDC

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

Pediatric Use

The safety and effectiveness of amoxicillin for oral suspension have been established in pediatric patients for the treatment of upper respiratory tract infections, as well as infections of the genitourinary tract, skin and skin structure, and lower respiratory tract. However, the safety and effectiveness of amoxicillin for the treatment of H. pylori infection have not been established in this population.

In neonates and young infants, renal function is incompletely developed, which may lead to delayed elimination of amoxicillin. Therefore, dosing of amoxicillin for oral suspension should be modified in pediatric patients who are 12 weeks or younger (3 months or younger) see Dosage and Administration (2.3).

Geriatric Use

Clinical studies of amoxicillin for oral suspension have been analyzed to assess whether elderly patients, specifically those aged 65 and over, exhibit different responses compared to younger subjects. The findings from these analyses did not identify significant differences in responses between these age groups; however, it is important to note that a greater sensitivity to the drug in some older individuals cannot be entirely excluded.

Amoxicillin is primarily excreted by the kidneys, which raises concerns regarding the potential for toxic reactions, particularly 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 mitigate the risk of adverse effects associated with renal impairment.

Pregnancy

Pregnancy Category B indicates that reproduction studies conducted in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area) have shown no evidence of harm to the fetus due to amoxicillin. However, there are no adequate and well-controlled studies in pregnant women. Therefore, while animal studies suggest a lack of teratogenic effects, the absence of human data necessitates caution. Amoxicillin should be used during pregnancy only if clearly needed, as animal reproduction studies are not always predictive of human response. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of amoxicillin in pregnant patients.

Lactation

Nursing mothers should be aware of the potential for excretion of amoxicillin in breast milk. There is a risk of infant exposure to amoxicillin through breast milk. Caution is advised when administering amoxicillin to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage of amoxicillin for oral suspension, 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.

Clinical observations from a prospective study indicate that overdosages of amoxicillin below 250 mg/kg typically do not result in significant clinical symptoms. However, it is important to remain vigilant, as there have been reports of interstitial nephritis leading to oliguric renal failure in a small number of patients following overdosage. Additionally, crystalluria has been documented, which in some instances has progressed to renal failure in both adult and pediatric populations.

To mitigate the risk of crystalluria associated with amoxicillin overdosage, it is crucial to ensure adequate fluid intake and maintain diuresis. This approach helps to promote renal function and reduce the likelihood of complications.

It is also noteworthy that patients with impaired renal function may experience elevated blood levels of amoxicillin due to decreased renal clearance. In such cases, hemodialysis may be considered as a method to remove amoxicillin from circulation effectively.

Healthcare professionals should remain alert to these potential complications and manage overdosage cases with appropriate clinical interventions.

Nonclinical Toxicology

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of the compound. While specific studies to detect the mutagenic potential of amoxicillin alone have not been conducted, relevant data is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate, known as AUGMENTIN.

AUGMENTIN was found to be non-mutagenic 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 occurred at doses that were also associated with decreased cell survival. In contrast, AUGMENTIN yielded negative results in the mouse micronucleus test and the dominant lethal assay in mice.

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

In a multi-generation reproduction study conducted in rats, no impairment of fertility or other adverse reproductive effects were observed at doses up to 500 mg/kg, which is approximately two times the 3 g human dose based on body surface area.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe allergic reactions, such as anaphylaxis, and serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Additionally, cases of Clostridium difficile-associated diarrhea have been documented. Hepatic dysfunction has also been reported, characterized by elevated liver enzymes and jaundice. Renal impairment, specifically interstitial nephritis, has been noted among patients. Furthermore, hematologic reactions, including thrombocytopenia, leukopenia, and hemolytic anemia, have been observed.

Patient Counseling

Patients should be advised that amoxicillin for oral suspension may be taken every 8 hours or every 12 hours, depending on the prescribed dosage. It is important to counsel patients that this medication contains a penicillin class drug, which can cause allergic reactions in some individuals.

Healthcare providers should inform patients about the signs and symptoms of serious skin manifestations. Patients must be instructed to stop taking amoxicillin for oral suspension immediately and to promptly report any signs or symptoms of skin rash, mucosal lesions, or other indications of hypersensitivity.

Patients should also be made aware that diarrhea is a common side effect associated with antibacterial drugs, typically resolving upon discontinuation of the medication. However, it is crucial to inform patients that they may experience watery and bloody stools (with or without stomach cramps and fever) even as late as two months after their last dose. If such symptoms occur, patients should contact their physician as soon as possible.

Counsel patients that antibacterial drugs, including amoxicillin for oral suspension, are intended solely for the treatment or prevention of bacterial infections and do not address viral infections, such as the common cold. When prescribed amoxicillin for a bacterial infection, patients should be reminded that it is common to feel better early in the treatment course, but 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.

It is preferable to refrigerate amoxicillin suspensions, although this is not mandatory. Patients should be instructed to shake the oral suspension well before each use and to keep the bottle tightly closed. When dosing a child with the suspension, a calibrated oral syringe should be used, and it is important to rinse the syringe after each use. Patients should follow their doctor’s instructions regarding the appropriate amount to use and the duration of treatment required for their child. Any unused portion of the suspension should be discarded after 14 days.

Additionally, patients with phenylketonuria should be counseled that each 200 mg chewable tablet contains 1.82 mg of phenylalanine, while each 400 mg chewable tablet contains 3.64 mg of phenylalanine.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for ordering and inventory purposes. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To ensure the integrity of the product, it must be protected from light during storage. Any unused portion of the product should be discarded after 14 days to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)