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Amoxicillin

Pronunciation

Pronunciation

(a moks i SIL in)

Index Terms

  • p-Hydroxyampicillin
  • Amoxicillin Trihydrate
  • Amoxil
  • Amoxycillin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 250 mg, 500 mg

Suspension Reconstituted, Oral:

Generic: 125 mg/5 mL (80 mL, 100 mL, 150 mL); 200 mg/5 mL (50 mL, 75 mL, 100 mL); 250 mg/5 mL (80 mL, 100 mL, 150 mL); 400 mg/5 mL (50 mL, 75 mL, 100 mL)

Tablet, Oral:

Generic: 500 mg, 875 mg

Tablet Chewable, Oral:

Generic: 125 mg, 250 mg

Tablet Extended Release 24 Hour, Oral:

Moxatag: 775 mg [contains cremophor el, fd&c blue #2 aluminum lake]

Generic: 775 mg

Brand Names: U.S.

  • Moxatag

Pharmacologic Category

  • Antibiotic, Penicillin

Pharmacology

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption

Oral: Rapid and nearly complete (74% to 92% of a single dose is absorbed); food does not interfere

Extended-release tablet: Rate of absorption is slower compared to immediate-release formulations; food decreases the rate but not extent of absorption

Distribution

Readily into liver, lungs, prostate, muscle, middle ear effusions, maxillary sinus secretions, bone, gallbladder, bile, and into ascitic and synovial fluids; poor CSF penetration (except when meninges are inflamed)

CSF:blood level ratio: Normal meninges: <1%; Inflamed meninges: 8% to 90%

Metabolism

Partially hepatic

Excretion

Urine (60% as unchanged drug); lower in neonates

Time to Peak

Capsule: 2 hours; Extended-release tablet: 3.1 hours; Suspension: Neonates: 3 to 4.5 hours, Children: 1 hour

Half-Life Elimination

Neonates, full-term: 3.7 hours

Infants and Children: 1 to 2 hours

Adults: Normal renal function: 0.7 to 1.4 hours

CrCl <10 mL/minute: 7 to 21 hours

Protein Binding

17% to 20%, lower in neonates

Use: Labeled Indications

Ear, nose, and throat infection (pharyngitis/tonsillitis, otitis media, rhinosinusitis): Immediate-release: Treatment of infections due to beta-lactamase-negative Streptococcus spp (alpha- and beta-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

GU tract infections: Immediate-release: Treatment of infections of the GU tract due to beta-lactamase-negative Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Helicobacter pylori infections (with active or 1 year history of duodenal ulcer disease): Immediate-release: Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence as a component of combination therapy (triple or dual therapy as clinically indicated).

Lower respiratory tract infections (including pneumonia): Immediate-release: Treatment of infections of the lower respiratory tract due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae.

Pharyngitis and tonsillitis: Extended-release tablets: Treatment of tonsillitis and/or pharyngitis due to Streptococcus pyogenes in adults and children 12 years of age and older.

Skin and skin structure infections: Immediate-release: Treatment of infections of the skin and skin structure due to beta-lactamase-negative Streptococcus spp. (alpha- and beta-hemolytic strains only), Staphylococcus spp., or E. coli.

Use: Unlabeled

Postexposure prophylaxis for anthrax exposure with documented susceptible organisms; chronic oral antimicrobial suppression of prosthetic joint infection; prophylaxis of infective endocarditis in patients undergoing surgical or dental procedures

Contraindications

Serious hypersensitivity to amoxicillin (eg, anaphylaxis, Stevens-Johnson syndrome) or to other beta-lactams, or any component of the formulation

Dosing: Adult

Usual dosage range: Oral:

Mild or moderate infection: 250 every 8 hours or 500 mg every 12 hours

Mild or moderate infection (lower respiratory tract): 500 mg every 8 hours or 875 mg every 12 hours

Severe infection (as step-down therapy):

Immediate-release: 500 mg every 8 hours or 875 mg every 12 hours

Extended-release: 775 mg once daily

Indication-specific dosing:

Anthrax, inhalational prophylaxis (ACIP recommendations): Oral: 500 mg every 8 hours. Note: Use only if isolates of the specific B. anthracis are sensitive to amoxicillin (MIC ≤0.125 mcg/mL); may be administered to pregnant and breast-feeding women. Duration of antibiotic postexposure prophylaxis (PEP) is ≥60 days in a previously unvaccinated exposed person. Antimicrobial therapy should continue for 14 days after the third dose of PEP vaccine. Those who are partially or fully vaccinated should receive at least a 30-day course of antimicrobial PEP and continue with licensed vaccination regimen. Unvaccinated workers, even those wearing personal protective equipment with adequate respiratory protection, should receive antimicrobial PEP. Antimicrobial PEP is not required for fully vaccinated people (five-dose IM vaccination series with a yearly booster) who enter an anthrax area clothed in personal protective equipment. If respiratory protection is disrupted, a 30-day course of antimicrobial therapy is recommended (ACIP 2010).

Ear, nose, throat, genitourinary tract, or skin/skin structure infections: Note: IDSA guidelines recommend amoxicillin-clavulanate as preferred first-line treatment of acute bacterial rhinosinusitis (ABRS)(IDSA [Chow 2012]); AAO-HNS guidelines for adult sinusitis recommend either amoxicillin or amoxicillin-clavulanate as initial first-line therapy of ABRS, with consideration given for amoxicillin-clavulanate instead of amoxicillin in certain patients (eg, moderate to severe ABRS symptoms, antibiotic use in past month, high prevalence of resistant bacteria in community, history of recurrent ABRS, presence of comorbidities) (AAO-HNS [Rosenfeld 2015]).

Mild-to-moderate: Oral: 500 mg every 12 hours or 250 mg every 8 hours

Severe: Oral: 875 mg every 12 hours or 500 mg every 8 hours

Tonsillitis and/or pharyngitis: Oral: Extended release tablet: 775 mg once daily

Endocarditis, prophylaxis (off-label use): Oral: 2 g 30 to 60 minutes before procedure. Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Erysipeloid (off-label use): 500 mg 3 times daily for 7 to 10 days (IDSA [Stevens 2014])

Helicobacter pylori eradication (with active or 1 year history of duodenal ulcer disease): 1,000 mg twice daily in combination therapy with clarithromycin and lansoprazole for 14 days; or 1,000 mg 3 times daily in combination with lansoprazole for 14 days (patients allergic/intolerant or suspected resistance to clarithromycin)

Lower respiratory tract infections: Oral: 875 mg every 12 hours or 500 mg every 8 hours

Lyme neuroborreliosis (off-label use): Oral: 500 mg every 6 to 8 hours (depending on size of patient) for 21 to 30 days

Periodontitis (aggressive) (in combination with metronidazole) associated with presence of Actinobacillus actinomycetemcomitans (AA): Oral: 500 mg every 8 hours for 10 days used in addition to scaling and root planing (Varela 2011)

Pharyngitis, group A streptococci (IDSA guidelines): 1,000 mg once daily or 500 mg twice daily (maximum daily dose: 1,000 mg) for 10 days (Shulman 2012)

Prophylaxis in total joint replacement patients undergoing dental procedures which produce bacteremia: Oral: 2 g 1 hour prior to procedure (ADA/AAOS 2003). Note: In general, patients with prosthetic joint implants do not require prophylactic antibiotics prior to dental procedures. In planning an invasive oral procedure, dental consultation with the patient's orthopedic surgeon may be advised to review the risks of infection (Sollecito 2015).

Prosthetic joint infection, chronic antimicrobial suppression of prosthetic joint infection associated with beta-hemolytic streptococci, penicillin-susceptible Enterococcus spp, or Propionibacterium spp (off-label use): Oral: 500 mg 3 times daily (Osmon 2013)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Usual dosage range:

Mild to moderate infection: Oral: Immediate-release:

Infants ≤3 months:

Manufacturer’s labeling: Up to 30 mg/kg/day divided every 12 hours (maximum dose: 30 mg/kg/day).

Alternate dosing (Red Book [AAP 2012]): 25 to 50 mg/kg/day divided every 8 hours.

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

Manufacturer’s labeling: 20 to 40 mg/kg/day in divided doses every 8 hours or 25 to 45 mg/kg/day in divided doses every 12 hours.

Alternate dosing (Red Book [AAP 2012]): 25 to 50 mg/kg/day in divided doses every 8 hours (maximum dose: 500 mg/dose).

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

Severe infection (as step-down therapy):

Infants, Children, and Adolescents (Red Book [AAP 2012]): Oral: Immediate-release: 80 to 100 mg/kg/day in divided doses every 8 hours (maximum dose for most indications: 500 mg/dose).

Children ≥12 years and Adolescents: Oral: Extended-release: Refer to adult dosing.

Indication-specific dosing:

Infants, Children, and Adolescents: Note: In general, infants, children, and adolescents >3 months and ≥40 kg should be dosed according to the adult recommendations except where indicated.

Anthrax (off-label use): Oral: Immediate-release:

Cutaneous, community-acquired or bioterrorism-related (Stevens 2005):

Children <20 kg: 40 mg/kg/day in divided doses every 8 hours for 5 to 9 days.

Children ≥20 kg: 500 mg every 8 hours for 5 to 9 days.

Inhalational, postexposure prophylaxis (ACIP recommendations): Note: Use only if B. anthracis isolate is susceptible to amoxicillin (MIC ≤0.125 mcg/mL). Continue therapy for 30 to ≥60 days depending on vaccination status and for 14 days after the third vaccine dose (CDC 2010); see "Note" below.

Children <40 kg:

CDC recommendations: 45 mg/kg/day in divided doses every 8 hours (maximum dose: 500 mg/dose).(CDC 2010).

AAP recommendations: 80 mg/kg/day in divided doses every 8 hours (maximum dose: 500 mg/dose). The higher dose is recommended due to the lack of data on lower amoxicillin dosages for treating anthrax and the high mortality rate (Red Book [AAP 2012]).

Children ≥40 kg: 500 mg every 8 hours.

Note: Duration of antibiotic postexposure prophylaxis (PEP) is ≥60 days in a previously unvaccinated exposed person. Those who are partially or fully vaccinated should receive at least a 30-day course of antimicrobial PEP and continue with licensed vaccination regimen. Unvaccinated workers, even those wearing personal protective equipment with adequate respiratory protection, should receive antimicrobial PEP. Antimicrobial PEP is not required for fully vaccinated people (5-dose IM vaccination series with a yearly booster) who enter an anthrax area clothed in personal protective equipment. If respiratory protection is disrupted, a 30-day course of antimicrobial therapy is recommended (CDC 2010).

Endocarditis, prophylaxis (off-label use): Oral: Immediate-release: 50 mg/kg 1 hour before procedure (maximum dose: 2,000 mg/dose) (Wilson 2007). Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.

Lyme neuroborreliosis (off-label use): Infants, Children, and Adolescents: Oral: Immediate-release: 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: Immediate-release: 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 2012]); 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: Immediate-release: 50 mg/kg administered 30 to 60 minutes before dental procedure (maximum dose: 2000 mg/dose) (Warady 2012).

Pharyngitis (tonsillopharyngitis), group A streptococcal infection, treatment and primary prevention of rheumatic fever (off-label use): Oral:

Immediate release: Children and Adolescents 3 to 18 years: 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.

Pneumococcal infection prophylaxis for anatomic or functional asplenia (eg, sickle cell disease ([SCD]) (off-label use) (Price 2007, Red Book [AAP 2012]): Oral: Immediate-release:

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

Children ≥6 years and Adolescents: 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 2011): Infants ≥3 months, Children, and Adolescents: Oral: Immediate-release: 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: 90 mg/kg/day in divided doses every 12 hours (maximum daily dose: 4,000 mg/day).

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

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

S. pneumoniae (MICs to penicillin ≤2.0 mcg/mL), mild infection or step-down therapy: 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: Oral: Immediate-release:

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

High dose (use reserved for select patients; see "Note"): 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.

Dosing: Renal Impairment

Use of certain dosage forms (eg, extended-release 775 mg tablet and immediate-release 875 mg tablet) should be avoided in pediatric or adult patients with CrCl <30 mL/minute or patients requiring hemodialysis

Adults: Oral: Immediate-release:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 10 to 30 mL/minute: 250 to 500 mg every 12 hours.

CrCl <10 mL/minute: 250 to 500 mg every 24 hours.

ESRD on dialysis: Moderately dialyzable (20% to 50%); ~30% removed by 3-hour hemodialysis (Aronoff 2007): 250 to 500 mg every 24 hours; patients should receive an additional dose both during and after dialysis sessions.

Infants, Children, and Adolescents: Oral: Immediate-release:

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

Alternate dosing (Aronoff 2007):

Mild to moderate infection: Dosing based on 25 to 50 mg/kg/day divided every 8 hours in patients with normal renal function:

GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 10 to 29 mL/minute/1.73 m2: 8 to 20 mg/kg/dose every 12 hours.

GFR <10 mL/minute/1.73 m2: 8 to 20 mg/kg/dose every 24 hours.

End-stage renal disease (ESRD) on hemodialysis: Moderately dialyzable (20% to 50%); ~30% removed by 3-hour hemodialysis: 8 to 20 mg/kg/dose every 24 hours; give after dialysis.

Peritoneal dialysis: 8 to 20 mg/kg/dose every 24 hours.

Severe infection: Dosing based on 80 to 90 mg/kg/day divided every 12 hours in patients with normal renal function:

GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 10 to 29 mL/minute/1.73 m2: 20 mg/kg/dose every 12 hours; do not use the 875 mg tablet.

GFR <10 mL/minute/1.73 m2: 20 mg/kg/dose every 24 hours; do not use the 875 mg tablet.

ESRD on hemodialysis: Moderately dialyzable (20% to 50%); ~30% removed by 3-hour hemodialysis: 20 mg/kg/dose every 24 hours; give after dialysis.

Peritoneal dialysis: 20 mg/kg/dose every 24 hours.

Dosing: Hepatic Impairment

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

Administration

Administer around-the-clock to promote less variation in peak and trough serum levels. The appropriate amount of suspension may be mixed with formula, milk, fruit juice, water, ginger ale, or cold drinks; administer dose immediately after mixing.

Moxatag extended release tablet: Administer within 1 hour of finishing a meal.

Dietary Considerations

May be taken with food. Some products may contain phenylalanine.

Moxatag: Take within 1 hour of finishing a meal.

Storage

Amoxicillin 250 mg and 500 mg capsules, and 125 mg/5 mL and 250 mg/5 mL unreconstituted powder: Store at or below 20°C (68°F).

Amoxicillin 500 mg and 875 mg tablets, and 200 mg/5 mL and 400 mg/5mL unreconstituted powder: Store at or below 25°C (77°F).

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

Moxatag: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Amoxicillin. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Methotrexate: Penicillins may increase the serum concentration of Methotrexate. Monitor therapy

Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Monitor therapy

Probenecid: May increase the serum concentration of Penicillins. Management: Avoid the routine use of penicillins and probenecid, but this combination may be used advantageously in select cases with careful monitoring. Monitor for toxic effects of penicillins if probenecid is initiated or the dose is increased. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

May interfere with urinary glucose tests using cupric sulfate (Benedict's solution, Clinitest)

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.

Adverse Reactions

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

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, including amoxicillin, especially with a history of beta-lactam hypersensitivity (including severe reactions with cephalosporins) and/or a history of sensitivity to multiple allergens.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis develop an erythematous rash during amoxicillin therapy; avoid use in these patients.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended. In addition, use of certain dosage forms (eg, extended release 775 mg tablet and immediate release 875 mg tablet) should be avoided in patients with CrCl <30 mL/minute or patients requiring hemodialysis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Chewable tablets may contain phenylalanine; see manufacturer’s labeling.

Monitoring Parameters

With prolonged therapy, monitor renal, hepatic, and hematologic function periodically; assess patient at beginning and throughout therapy for infection; monitor for signs of anaphylaxis during first dose

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Maternal use of amoxicillin has generally not resulted in an increased risk of adverse fetal effects; however, an increased risk of cleft lip with cleft palate has been observed in some studies. It is the drug of choice for anthrax prophylaxis when penicillin susceptibility is documented. Amoxicillin may be used in certain situations prior to vaginal delivery in women at high risk for endocarditis.

Due to pregnancy-induced physiologic changes, oral amoxicillin clearance is increased during pregnancy resulting in lower concentrations and smaller AUCs. Oral ampicillin-class antibiotics are poorly absorbed during labor.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), bruising, bleeding, or redness or white patches in mouth or throat (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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