Amoxicillin

Serious side effects have been reported with Amoxicillin. See the “Drug Precautions” section.

Common side effects of amoxicillin include the following:

• nausea
• vomiting
• diarrhea
• headache

This is not a complete list of amoxicillin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking amoxicillin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to penicillin or any other medications
• develop watery and bloody stools (with or without stomach cramps and fever) 2 or more months after having taken the last dose of the antibiotic. This is not typical, and your doctor should be notified.
• have a history of diarrhea caused by taking antibiotics
• have phenylketonuria
• have kidney disease
• have asthma
• have hay fever
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Keep this and all medications out of the reach of children.
• Store amoxicillin capsules, tablets, and chewable tablets in the original container, tightly closed, away from excess heat (at room temperature) and moisture.
• The liquid suspension and pediatric drops are best kept in the refrigerator, but may be stored at room temperature. Do not freeze. Throw away any unused liquid amoxicillin after 14 days.

Antibacterial; β-lactam antibiotic; an aminopenicillin.6 62

Absorption

Bioavailability

74–92% of an oral dose absorbed from GI tract.4 17 28 44 62

Peak serum concentrations usually attained within 1–2 hours.1 6 23 36 40 47

A 400-mg chewable tablet is bioequivalent to 5 mL of the oral suspension containing 400 mg/5 mL.1

Food

Food has minimal or no effect on bioavailability of oral amoxicillin.4 6 10 22 29 38 40 62

Special Populations

Oral absorption delayed in neonates compared with older children and adults;20 27 peak concentrations attained within 3–4.5 hours in neonates.20 27

Distribution

Extent

Readily distributed into most tissues and fluids1 following oral administration, including lungs,6 48 bronchial secretions,19 maxillary sinus secretions,4 bile,6 48 pleural fluid,6 sputum,4 6 30 and middle ear fluid.4 56 203

Only low concentrations attained in CSF.6 33 37

Crosses the placenta4 6 and is distributed into human milk.4 6 49

Plasma Protein Binding

17–20%.1 6 9 29 45 62

Elimination

Metabolism

Probably metabolized to some extent in the liver.6 28 36 42

Elimination Route

Eliminated principally in urine by both glomerular filtration and tubular secretion.6

Approximately 50–80% of amoxicillin dose excreted unchanged in urine.1 6

Half-life

1–1.4 hours.1 17 21 29 36 43 46 50

Special Populations

Serum concentrations increased and half-life prolonged in patients with renal impairment.17 25 31 41 50 62

Renal clearance may be delayed in neonates and young infants because of incompletely developed renal function.20 27 32 128

Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.

Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, amoxicillin will not work for colds, flu, or other virus infections.

amoxicillin is available only with your doctor's prescription.

General

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy instituted.

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

Prescribing Amoxicillin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory Tests

As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with Amoxicillin should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

Probenecid decreases the renal tubular secretion of Amoxicillin. Concurrent use of Amoxicillin and probenecid may result in increased and prolonged blood levels of Amoxicillin.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

In common with other antibiotics, Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Drug/Laboratory Test Interactions

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with Amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX®) be used.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with Amoxicillin.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of Amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of Amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin and potassium clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).

Pregnancy

Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of Amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Amoxicillin is administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of Amoxicillin may be delayed. Dosing of Amoxicillin should be modified in pediatric patients 12 weeks or younger (≤3 months). (See DOSAGE AND ADMINISTRATION: Neonates and Infants.)

Geriatric Use

An analysis of clinical studies of Amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. Of the 1,811 subjects treated with capsules of Amoxicillin, 85% were <60 years old, 15% were ≥61 years old and 7% were ≥71 years old. This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Information for Patients

Amoxicillin may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed.

Patients should be counseled that antibacterial drugs, including Amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Amoxicillin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Capsules, chewable tablets, and oral suspensions of Amoxicillin may be given without regard to meals. The 400 mg suspension, 400 mg chewable tablet, and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.

Neonates and Infants Aged ≤12 Weeks (≤3 Months)

Due to incompletely developed renal function affecting elimination of Amoxicillin in this age group, the recommended upper dose of Amoxicillin is 30 mg/kg/day divided q12h.

Adults and Pediatric Patients >3 Months

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.

General

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Amoxicillin/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram Amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Amoxicillin/lansoprazole

The recommended adult oral dose is 1 gram Amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing Recommendations for Adults with Impaired Renal Function

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of  <30 mL/min. should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

Capsules

Amoxicillin Capsules, USP contains 250 mg or 500 mg Amoxicillin as the trihydrate.

                                                   250 mg Capsule

Blue/Pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink.

                  Bottles of 20                                               NDC 65862-016-20
                  Bottles of 100                                             NDC 65862-016-01
                  Bottles of 500                                             NDC 65862-016-05

                                                   500 mg Capsule

Blue/Pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink.

                  Bottles of 20                                               NDC 65862-017-20
                  Bottles of 100                                             NDC 65862-017-01
                  Bottles of 500                                             NDC 65862-017-05

Store at20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Anthrax, inhalational post-exposure prophylaxis (documented susceptible organisms) (adults)

Based on the Centers for Disease Control and Prevention (CDC) recommendations for the post-exposure prophylaxis of inhalational anthrax, amoxicillin is an effective and recommended alternative drug in the management of post-exposure prophylaxis of inhalational anthrax in patients with documented susceptible organisms if first-line agents are not tolerated or are unavailable ([CDC [Hendricks 2014]].

Anthrax, inhalational post-exposure prophylaxis (documented susceptible organisms) (children)

Based on the American Academy of Pediatrics recommendations for the post-exposure prophylaxis of inhalational anthrax, amoxicillin is an effective and recommended drug in the management of post-exposure prophylaxis of inhalational anthrax in patients with documented susceptible organisms [AAP [Bradley 2014]].

Community-acquired pneumonia (children)

Following clinical guideline recommendations on the management of CAP reduces the incidence of morbidity and mortality related to pneumonia. In children older than 3 months of age, amoxicillin is the preferred oral option for empirical treatment of suspected bacterial CAP and for pathogen-directed therapy aimed at S. pneumoniae, GAS, or beta-lactamase-negative H. influenzae.

Erysipeloid

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), amoxicillin is an effective and recommended treatment of erysipeloid [IDSA [Stevens 2014]].

Group A streptococcal pharyngitis (children)

Group A streptococcus is the most common bacterial cause of acute pharyngitis. The safety and efficacy profiles of penicillin and amoxicillin make either agent the drug of choice in non-penicillin-allergic patients. Amoxicillin offers once-daily dosing and is available as a child-friendly palatable suspension, which may help increase compliance and reduce clinical failure in children.

Infective endocarditis (prophylaxis)

Based on the American Heart Association (AHA) guidelines for the prevention of infective endocarditis, amoxicillin is effective and recommended for administration to patients with certain cardiac conditions who are able to take oral medication to provide prophylaxis against infective endocarditis associated with dental or respiratory tract procedures and for patients undergoing genitourinary procedures to eradicate enterococci from the urine unless a known or suspected strain of resistant enterococci exists.

Lyme disease (excluding neurologic disease)

Based on the Infectious Diseases Society of America guidelines for the clinical assessment, treatment and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis, amoxicillin is effective and recommended for the treatment of early localized or early disseminated Lyme disease associated with erythema migrans (in the absence of specific neurologic manifestations or advanced atrioventricular heart block) Lyme arthritis, Lyme carditis (mild), and acrodermatitis chronica atrophicans.

Lyme neuroborreliosis

Parenteral regimens for Lyme disease of the nervous system have a greater potential for morbidity. For severe neurologic disease, class 1 and 2 studies suggested that parenteral treatment was probably safe and effective, but class 2 and 3 studies also indicated that oral therapy (and doxycycline specifically) was comparably safe and effective for patients without parenchymal involvement. The evidence for oral therapy is stronger in adults than in children, but no results indicate that children respond differently than adults. The use of amoxicillin as an alternative oral therapy to doxycycline was supported by inference only.[AAN [Halperin 2007]]

Prophylaxis in patients with prosthetic joint implants undergoing dental procedures which produce bacteremia

Although currently not recommended for routine use prior to dental procedures in patients with prosthetic joint implants to prevent prosthetic joint infection as stated within the American Academy of Orthopaedic Surgeons/American Dental Association Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures guidelines and a subsequent report of the American Dental Association Council on Scientific Affairs, if deemed to be necessary for select patients at risk for prosthetic joint infection (eg, history of complications associated with joint replacement surgery), antibiotic prophylaxis may be considered. Dentists planning invasive oral procedures should therefore consult with the patient's orthopedic surgeon to determine the risk associated with infection and the need for antibiotics. Based on a retired advisory statement from the American Dental Association and American Academy of Orthopaedic Surgeons, the use of amoxicillin (among other antibiotics) was suggested for patients not allergic to penicillin [ADA/AAOS 2003].

Prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of prosthetic joint infection, amoxicillin is an effective and recommended agent for chronic oral antimicrobial suppression of prosthetic joint infection with beta-hemolytic streptococci, Enterococcus spp (penicillin susceptible), and Cutibacterium spp after completion of parenteral therapy.

Note: Unless otherwise specified, all pediatric dosing recommendations based on immediate release product formulations (oral suspension, chewable tablet, tablet, and capsule).

Usual dosage range:

Mild to moderate infection:

Infants ≤3 months: Oral: 25 to 50 mg/kg/day in divided doses every 8 hours (Red Book [AAP 2015]). Note: Manufacturer's labeling recommends a maximum daily dose of 30 mg/kg/day divided into 2 doses per day for this age group.

Infants >3 months, Children, and Adolescents (<40 kg):

AAP recommendations (Red Book [AAP 2015]): Oral: 25 to 50 mg/kg/day in divided doses every 8 hours; maximum dose: 500 mg/dose

Manufacturer's labeling: Oral: 20 to 40 mg/kg/day in divided doses every 8 hours (maximum dose: 500 mg/dose) or 25 to 45 mg/kg/day in divided doses every 12 hours (maximum dose: 875 mg/dose)

Children, and Adolescents (≥40 kg): Refer to adult dosing.

Severe infection (as step-down therapy): Infants, Children, and Adolescents: Oral: 80 to 100 mg/kg/day in divided doses every 8 hours; maximum dose: 500 mg/dose for most indications (Red Book [AAP 2015])

Indication-specific dosing:

Anthrax (off-label use):

Cutaneous, without systemic involvement: Children and Adolescents: Oral: 75 mg/kg/day in 3 divided doses. Maximum dose: 1,000 mg/dose. Duration of therapy: 7 to 10 days for naturally acquired infection, up to 60 days for biological weapon-related exposure (AAP [Bradley 2014]).

Inhalational, postexposure prophylaxis: Children and Adolescents: Oral: 75 mg/kg/day in divided doses every 8 hours for 60 days after exposure; maximum dose: 1,000 mg/dose (AAP [Bradley 2014]).

Catheter (peritoneal dialysis), exit-site or tunnel infection (off-label use): Infants, Children, and Adolescents: Oral: 10 to 20 mg/kg once daily; maximum dose: 1,000 mg/dose (Warady [ISPD 2012])

Endocarditis, prophylaxis (off-label use): Infants, Children, and Adolescents: Oral: 50 mg/kg 1 hour before procedure (maximum dose: 2,000 mg/dose) (Wilson 2007)

Helicobacter pylori eradication: Children and Adolescents: Oral: 50 mg/kg/day in 2 divided doses for 10 to 14 days; maximum daily dose: 2,000 mg/day. Administer in combination with a proton pump inhibitor or bismuth subsalicylate and at least one other antibiotic (clarithromycin and/or metronidazole) (NASPGHAN/ESPGHAN [Koletzko 2011]).

Lyme disease (off-label use): Infants, Children, and Adolescents: Oral: 50 mg/kg/day divided every 8 hours (maximum dose: 500 mg/dose) (Halperin 2007; Wormser 2006)

Otitis media, acute: Infants ≥2 months and Children: Oral: 80 to 90 mg/kg/day divided every 12 hours; variable duration of therapy, if <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to moderate symptoms: 7-day course; ≥6 years of age with mild to moderate symptoms: 5- to 7-day course; some experts recommend initiating with 90 mg/kg/day (AAP [Lieberthal 2013]; Red Book [AAP 2015]); a maximum dose is not provided in the Guidelines for The Diagnosis and Management of Acute Otitis Media (AAP [Lieberthal 2013]); however, some experts suggest a maximum daily dose of 4,000 mg/day for high-dose amoxicillin therapy (Bradley 2015).

Peritonitis, prophylaxis (for patients receiving peritoneal dialysis who require dental procedures) (off-label use): Infants, Children, and Adolescents: Oral: 50 mg/kg administered 30 to 60 minutes before dental procedure (maximum dose: 2000 mg/dose) (Warady [ISPD 2012])

Pneumococcal infection prophylaxis for anatomic or functional asplenia (eg, sickle cell disease ([SCD]) (off-label use) (Price 2007; Red Book [AAP 2015]):

Infants (<2 months to 1 year, or as soon as SCD is diagnosed or asplenia occurs) and Children ≤5 years: Oral: 20 mg/kg/day in divided doses every 12 hours (maximum dose: 250 mg/dose)

Children ≥6 years and Adolescents: Oral: 250 mg every 12 hours. Note: The decision to discontinue penicillin prophylaxis after 5 years of age in children who have not experienced invasive pneumococcal infection and have received recommended pneumococcal immunizations is patient and clinician dependent.

Pneumonia, community-acquired (CAP) (Bradley [IDSA 2011]): Infants ≥3 months, Children, and Adolescents: Note: In pediatric patients 5 to 15 years of age, a macrolide antibiotic may be a more reasonable first choice as M. pneumoniae is the chief cause of pneumonia in this age group.

Empiric treatment: Oral: 90 mg/kg/day in divided doses every 12 hours (maximum daily dose: 4,000 mg/day)

Group A Streptococcus: Oral: 50 to 75 mg/kg/day in divided doses every 12 hours (maximum daily dose: 4,000 mg/day)

H. influenzae: Oral: 75 to 100 mg/kg/day in divided doses every 8 hours (maximum daily dose: 4,000 mg/day)

S. pneumoniae (MICs to penicillin ≤2 mcg/mL), mild infection or step-down therapy: Oral: 90 mg/kg/day in divided doses every 12 hours or 45 mg/kg/day in divided doses every 8 hours (maximum daily dose: 4,000 mg/day)

Rhinosinusitis, acute bacterial; uncomplicated: Note: AAP guidelines recommend amoxicillin as first-line empiric therapy for pediatric patients 1 to 18 years with uncomplicated cases and where resistance is not suspected; however, the IDSA guidelines consider amoxicillin/clavulanate as the preferred therapy (Chow 2012, Wald 2013):

Children and Adolescents:

Low dose: Oral: 45 mg/kg/day in divided doses every 12 hours

High dose (use reserved for select patients; see Note): Oral: 80 to 90 mg/kg/day in divided doses every 12 hours (maximum dose: 1,000 mg/dose). Note: Should only be used in the following: Mild to moderate infections in communities with a high prevalence of nonsusceptible S. pneumoniae resistance.

Tonsillopharyngitis; Group A streptococcal infection, treatment and primary prevention of rheumatic fever:

Immediate release: Children ≥3 years and Adolescents: Oral: 50 mg/kg once daily or 25 mg/kg twice daily for 10 days; maximum daily dose: 1,000 mg/day (Gerber 2009; Shulman 2012)

Extended release: Children ≥12 years and Adolescents: Oral: 775 mg once daily for 10 days. Note: Patient must be able to swallow tablet whole.

Urinary tract infection, prophylaxis (hydronephrosis, vesicoureteral reflux): Infants ≤2 months: Oral: 10 to 15 mg/kg once daily; some suggest administration in the evening (drug resides in bladder longer); Note: Due to resistance, amoxicillin should not be used for prophylaxis after 2 months of age (Belarmino 2006; Greenbaum 2006; Mattoo 2007).

There are no dosage adjustments provided in the manufacturer’s labeling.

Oral suspension: Refer to manufacturer’s product labeling for reconstitution instructions. Shake vigorously.

Store at room temperature. Reconstituted oral suspension remains stable for 14 days at room temperature or refrigerated (refrigeration preferred). Unit-dose antibiotic oral syringes are stable at room temperature for at least 72 hours (Tu 1988).

Frequency not defined.

Cardiovascular: Hypersensitivity angiitis

Central nervous system: Agitation, anxiety, behavioral changes, confusion, dizziness, headache, hyperactivity (reversible), insomnia, seizure

Dermatologic: Acute generalized exanthematous pustulosis, erythematous maculopapular rash, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Gastrointestinal: Dental discoloration (brown, yellow, or gray; rare), diarrhea, hemorrhagic colitis, melanoglossia, mucocutaneous candidiasis, nausea, pseudomembranous colitis, vomiting

Genitourinary: Crystalluria

Hematologic & oncologic: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia,thrombocytopenia, thrombocytopenia purpura

Hepatic: Cholestatic hepatitis, cholestatic jaundice, hepatitis (acute cytolytic), increased serum ALT, increased serum AST

Hypersensitivity: Anaphylaxis

Immunologic: Serum sickness-like reaction

Amoxicillin is a penicillin antibiotic that fights bacteria.

Amoxicillin is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, gonorrhea, and infections of the ear, nose, throat, skin, or urinary tract.

Amoxicillin is also sometimes used together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole (Prevacid).

There are many brands and forms of amoxicillin available and not all brands are listed on this leaflet.

Applies to amoxicillin: oral capsule, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet dispersible, oral tablet extended release

General

The most frequently reported side effects were diarrhea, nausea, and skin rash.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Hemorrhagic/pseudomembranous colitis, tooth discolored, black hairy tongue, glossitis, stomatitis
Postmarketing reports: Sore mouth/tongue[Ref]

Dermatologic

Common (1% to 10%): Erythema, exanthema, rash
Uncommon (0.1% to 1%): Urticaria, pruritus
Very rare (less than 0.01%): Angioedema, hypersensitivity vasculitis
Frequency not reported: Erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, bullous dermatitis, exfoliative dermatitis, toxic epidermal necrolysis/Lyell's syndrome, acute generalized exanthematous pustulosis, maculopapular rash, erythema nodosum, pemphigoid reactions[Ref]

Genitourinary

Common (1% to 10%): Vulvovaginal mycotic infection[Ref]

Nervous system

Common (1% to 10%): Headache, taste perversion
Very rare (less than 0.01%): Convulsion, dizziness, hyperkinesia
Frequency not reported: Reversible hyperactivity, central nervous system toxicity, encephalopathy[Ref]

Immunologic

Very rare (less than 0.01%): Anaphylaxis, serum sickness-like reaction
Frequency not reported: Jarisch-Herxheimer reaction[Ref]

Renal

Very rare (less than 0.01%): Crystalluria, interstitial nephritis
Frequency not reported: Nephropathy[Ref]

Hematologic

Very rare (less than 0.01%): Leucopenia, severe neutropenia, agranulocytosis, hemolytic anemia, thrombocytopenia, bleeding time prolonged, prothrombin time prolonged
Frequency not reported: Anemia, thrombocytopenic purpura, eosinophilia, platelet function defective, lymphadenopathy[Ref]

Other

Common (1% to 10%): Candidiasis, fungal/mycotic infection
Very rare (less than 0.01%): Mucocutaneous candidiasis
Frequency not reported: Intestinal candidiasis, oral moniliasis, vaginal moniliasis, fever, chills[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, cholestatic jaundice, AST increased, ALT increased
Frequency not reported: Hepatic dysfunction, hepatic cholestasis, acute cytolytic hepatitis[Ref]

Respiratory

Frequency not reported: Bronchospasm, acute severe dyspnea, pneumonitis allergic[Ref]

Local

Frequency not reported: Phlebitis, injection site pain[Ref]

Metabolic

Frequency not reported: Electrolyte disturbance, hypokalemia[Ref]

Musculoskeletal

Frequency not reported: Joint pain, arthralgia[Ref]

Psychiatric

Frequency not reported: Agitation, anxiety, insomnia, confusion, behavior changed, hallucination[Ref]

Some side effects of amoxicillin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

US CDC recommendations: 500 mg orally 3 times a day for 7 days in pregnant patients as an alternative to azithromycin

Comments:
-Women less than 25 years and those at an increased risk for chlamydia should be re-screened during the third trimester of pregnancy to prevent maternal postnatal complications and chlamydial infection in the infant.
-Current guidelines should be consulted for additional information.

Immediate-release:
-Mild to moderate infection: 250 mg orally every 8 hours or 500 mg every 12 hours
-Severe infection: 500 mg orally every 8 hours or 875 mg every 12 hours

Comments: Dosing for infections caused by bacteria that are intermediate in their susceptibility should follow recommendations for severe infections.

Uses: For the treatment of infections of the ear, nose and throat due to susceptible (only beta lactamase negative) isolates of Streptococcus species (alpha and beta-hemolytic isolates only) Streptococcus pneumoniae, Staphylococcus species, or Haemophilus influenzae; for the treatment of infections of the genitourinary tract due to susceptible (only beta lactamase negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis; and for the treatment of infections of the skin and structure due to susceptible (only beta lactamase negative) isolates of Streptococcus species (alpha and beta-hemolytic isolates only) S pneumoniae, Staphylococcus species, and H influenzae

Immediate-Release Formulations:
Mild, Moderate, or Severe Infection:
3 months or younger: Up to 30 mg/kg/day orally in divided doses every 12 hours

Comments:
-Treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication occurs.
-At least 10 days of treatment for any infection caused by Streptococcus pyogenes is recommended to prevent the occurrence of acute rheumatic fever.

Immediate-Release Formulations:
Mild to Moderate Infection:
4 months or older:
-Less than 40 kg: 20 mg/kg/day orally in divided doses every 8 hours or 25 mg/kg/day in divided doses every 12 hours
-At least 40 kg: 250 mg orally every 8 hours or 500 mg every 12 hours

Severe Infection:
4 months or older:
-Less than 40 kg: 40 mg/kg/day orally in divided doses every 8 hours or 45 mg/kg/day in divided doses every 12 hours
-At least 40 kg: 500 mg orally every 8 hours or 875 mg every 12 hours

Comments: Dosing for infections caused by bacteria that are intermediate in their susceptibility should follow recommendations for severe infections.

Uses: For the treatment of infections of the ear, nose and throat due to susceptible (only beta lactamase negative) isolates of Streptococcus species (alpha and beta-hemolytic isolates only) Streptococcus pneumoniae, Staphylococcus species, or Haemophilus influenzae; for the treatment of infections of the genitourinary tract due to susceptible (only beta lactamase negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis; and for the treatment of infections of the skin and structure due to susceptible (only beta lactamase negative) isolates of Streptococcus species (alpha and beta-hemolytic isolates only) S pneumoniae, Staphylococcus species, and H influenzae

AAP Recommendations:
Up to 1 week of age:
-Gestational age 32 to 37 weeks: 50 mg/kg orally in divided doses every 12 hours
-Term neonate: 75 mg/kg orally in divided doses every 8 hours

1 to 4 weeks:
-Gestational age 32 to 37 weeks: 75 mg/kg orally in divided doses every 8 hours
-Term neonate: 75 mg/kg/day orally in divided doses every 8 hours

1 month or older: 75 mg/kg/day orally in divided doses every 8 hours; not to exceed 1 g/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax:
-To complete a regimen of 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)
-Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:
-Recommended as an alternative regimen for postexposure prophylaxis, the treatment of cutaneous anthrax without systemic involvement, and oral follow-up therapy for severe anthrax
-Recommended as an alternative for penicillin-susceptible strains
-Recommended for use with a protein synthesis inhibitor when used for follow-up therapy for severe anthrax (includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck).
-Current guidelines should be consulted for additional information.

AAP Recommendations:
Up to 1 week of age:
-Gestational age 32 to 37 weeks: 50 mg/kg orally in divided doses every 12 hours
-Term neonate: 75 mg/kg orally in divided doses every 8 hours

1 to 4 weeks:
-Gestational age 32 to 37 weeks: 75 mg/kg orally in divided doses every 8 hours
-Term neonate: 75 mg/kg/day orally in divided doses every 8 hours

1 month or older: 75 mg/kg/day orally in divided doses every 8 hours; not to exceed 1 g/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax:
-To complete a regimen of 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)
-Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:
-Recommended as an alternative regimen for postexposure prophylaxis, the treatment of cutaneous anthrax without systemic involvement, and oral follow-up therapy for severe anthrax
-Recommended as an alternative for penicillin-susceptible strains
-Recommended for use with a protein synthesis inhibitor when used for follow-up therapy for severe anthrax (includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck).
-Current guidelines should be consulted for additional information.

AAP Recommendations:
Up to 1 week of age:
-Gestational age 32 to 37 weeks: 50 mg/kg orally in divided doses every 12 hours
-Term neonate: 75 mg/kg orally in divided doses every 8 hours

1 to 4 weeks:
-Gestational age 32 to 37 weeks: 75 mg/kg orally in divided doses every 8 hours
-Term neonate: 75 mg/kg/day orally in divided doses every 8 hours

1 month or older: 75 mg/kg/day orally in divided doses every 8 hours; not to exceed 1 g/dose

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax:
-To complete a regimen of 10 to 14 days or longer (up to 4 weeks of age) or to complete a regimen of 14 days or longer (1 month or older)
-Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:
-Recommended as an alternative regimen for postexposure prophylaxis, the treatment of cutaneous anthrax without systemic involvement, and oral follow-up therapy for severe anthrax
-Recommended as an alternative for penicillin-susceptible strains
-Recommended for use with a protein synthesis inhibitor when used for follow-up therapy for severe anthrax (includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck).
-Current guidelines should be consulted for additional information.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea, diarrhea, abdominal pain, headache, taste perversion and skin rash are the most common side effects (occurring in less than 10% of people who take amoxicillin).
• May cause an allergic reaction in those allergic to penicillin. The overall incidence of anaphylaxis is rare (less than 0.01%).
• Not active against beta-lactamase producing strains of bacteria.
• Staphylococci bacteria that are resistant to methicillin/oxacillin should be considered resistant to amoxicillin as well.
• Severe diarrhea associated with Clostridium difficile is a potential side effect of almost all antibacterial agents, including amoxicillin.
• The risk of a rash is high in people with mononucleosis administered ampicillin-like antibiotics such as amoxicillin, and amoxicillin should be avoided in these people.
• May cause false-positive results for glucose in some urine tests.
• Avoid in people with a history of penicillin allergy.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

• Take exactly as directed. Amoxicillin is usually administered every eight to twelve hours, depending on the infection being treated. Complete the course of amoxicillin as prescribed by your doctor.
• May be taken with or without food.
• Available as chewable tablets and an oral suspension if you have difficulty swallowing capsules.
• Dial 911 if you experience any trouble breathing, swelling or tightness of the throat.
• See your doctor if you develop prolonged or significant diarrhea or a rash.
• If you are taking amoxicillin long-term your doctor may need to periodically order blood tests and check your kidney and liver function.
• If you are taking amoxicillin for gonorrhea, you may need a follow-up test for STDs (such as syphilis) after three months.

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: A US FDA pregnancy category: B Comments: May reduce efficacy of oral contraceptives.

Animal studies have failed to reveal evidence of teratogenicity, impaired fertility, or fetal harm. The effects during labor and delivery are unknown. There are no controlled data in human pregnancy. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

LactMed Record Number

13

Last Revision Date

20140708

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Amoxicillin is a penicillin antibiotic that fights bacteria.

Amoxicillin is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, gonorrhea, and infections of the ear, nose, throat, skin, or urinary tract.

Amoxicillin is also sometimes used together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole (Prevacid).

There are many brands and forms of amoxicillin available and not all brands are listed on this leaflet.

Amoxicillin may also be used for purposes not listed in this medication guide.