Gordon RC, Regamey C, Kirby WM. Antibacterial; β-lactam antibiotic; aminopenicillin.6 62, Treatment of acute otitis media (AOM).1 140 176 177 190 192 199 200 209 210 211 683 AAP, AAFP, CDC, and others consider amoxicillin the drug of first choice for initial treatment of AOM, unless the infection is suspected of being caused by β-lactamase-producing bacteria resistant to the drug, in which case the fixed combination of amoxicillin and clavulanate is recommended for initial treatment.190 200 202 204 205 210 683 Those who fail to respond to amoxicillin should be retreated with amoxicillin and clavulanate.683, Has been used for management of otitis media with effusion† (OME).193 206 208 219 221 227 Anti-infectives not usually recommended;111 115 206 208 219 221 245 they provide only limited benefit in enhancing resolution of effusion and may promote resistance.115 207 208 219 AAP, AAFP, and others recommend watchful waiting for 3 months from date of effusion onset or diagnosis in those 2 months to 12 years of age who are not at risk for speech, language, or learning problems; some suggest a short course of anti-infectives may be considered for possible short-term benefits when parent and/or caregiver expresses a strong aversion to impending surgery.245 If anti-infectives are used, amoxicillin or the fixed combination of amoxicillin and clavulanate recommended.219 221 227, Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci; GAS) and prevention of initial attacks (primary prevention) of rheumatic fever.1 6 35 39 108 109 110 292 375 580, AAP, IDSA, and AHA recommend a penicillin regimen (i.e., 10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;292 375 580 other anti-infectives (narrow-spectrum oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.292 375 580, If signs and symptoms of pharyngitis recur shortly after initial treatment and presence of S. pyogenes documented, retreatment with original or alternative anti-infective recommended.292 375 580 Alternative regimens recommended for retreatment include a narrow-spectrum oral cephalosporin, oral clindamycin, oral fixed combination of amoxicillin and clavulanate, oral macrolide, or IM penicillin G benzathine.292 375 580, Consider that multiple, recurrent episodes of symptomatic pharyngitis within a period of several months to years may indicate that patient is a long-term pharyngeal carrier of S. pyogenes experiencing repeated episodes of nonstreptococcal (e.g., viral) pharyngitis.292 375 580, Treatment not usually recommended for asymptomatic chronic pharyngeal carriers of S. pyogenes.292 375 580 Eradication of the carrier state may be desirable in certain situations (e.g., community outbreak of acute rheumatic fever, acute poststreptococcal glomerulonephritis, or invasive S. pyogenes infections; outbreak of S. pyogenes pharyngitis in a closed or partially closed community; multiple episodes of documented symptomatic S. pyogenes pharyngitis occurring within a family for many weeks despite appropriate treatment; personal or family history of acute rheumatic fever).292 580 In such situations, recommended regimens include oral clindamycin, oral fixed combination of amoxicillin and clavulanate, or either IM penicillin G benzathine or oral penicillin V used in conjunction with oral rifampin.292 580, Treatment of lower respiratory tract infections caused by susceptible Streptococcus (α- or β-hemolytic strains only), S. pneumoniae, Staphylococcus, or H. influenzae.1 6 57 62 73 81, Treatment of skin and skin structure infections caused by susceptible Streptococcus (α- or β-hemolytic strains only), Staphylococcus, or Escherichia coli.1, Treatment of UTIs caused by susceptible Enterococcus faecalis, Escherichia coli, or Proteus mirabilis.1 3 4 6 75 76 78 81 A drug of choice for treatment of uncomplicated UTIs caused by E. faecalis;81 consider high incidence of amoxicillin-resistant E. coli and other Enterobacteriaceae.6, Previously used for treatment of acute uncomplicated gonorrhea (anogenital and urethral) caused by susceptible Neisseria gonorrhoeae.1 6 184 No longer recommended for gonorrhea by CDC or others (high incidence of penicillin-resistant strains of N. gonorrhoeae).94 189 190, Alternative for treatment of typhoid fever† (enteric fever) caused by susceptible Salmonella typhi.6 57 64 66 68 81 190 Drugs of choice are fluoroquinolones and third generation cephalosporins (e.g., ceftriaxone, cefotaxime);81 190 consider that multidrug-resistant strains of S. typhi (strains resistant to ampicillin, amoxicillin, chloramphenicol, and/or co-trimoxazole) reported with increasing frequency.102 190, Treatment of chronic carriers of S. typhi†; drugs of choice are fluoroquinolones (e.g., ciprofloxacin), ampicillin, or amoxicillin (with probenecid).6 62 63 65 67 81, Alternative for treatment of gastroenteritis caused by nontyphoidal Salmonella†.190 Anti-infectives not indicated in otherwise healthy individuals with uncomplicated (noninvasive) gastroenteritis, but recommended if gastroenteritis is severe and in those at increased risk of invasive disease (e.g., <6 months or >50 years of age; hemoglobinopathies, severe atherosclerosis, valvular heart disease, prostheses, uremia, chronic GI disease, severe colitis; immunocompromised because of malignancy, immunosuppressive therapy, HIV infection).81 120 121 190 Drugs of choice are fluoroquinolones, third generation cephalosporins (cefotaxime, ceftriaxone), ampicillin, amoxicillin, co-trimoxazole, or chloramphenicol, depending on in vitro susceptibility.81 120 121 190, Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer);1 168 172 173 174 eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.1 107 116 119 122 168 172 173, Used in a multidrug regimen that includes amoxicillin, clarithromycin, and either lansoprazole or omeprazole (triple therapy).1 81 107 168 169 172 173 174 175 Used with lansoprazole (dual therapy) in those allergic to or intolerant of clarithromycin or when clarithromycin resistance is suspected.1 168 169, Treatment of early localized or early disseminated Lyme disease† associated with erythema migrans, in the absence of neurologic involvement or third-degree AV heart block.81 95 190 179 181 182 183 184 185 186 188 190 191 238, IDSA, AAP, and others consider amoxicillin a drug of choice for treatment of early localized or early disseminated Lyme disease when oral therapy is appropriate.81 95 179 181 182 185 186 190 232 238 May be used in those with mild Lyme carditis,95 179 181 182 185 186 232 238 Lyme arthritis (without associated neurologic disease),95 181 185 186 190 232 238 or isolated facial nerve palsy (without other neurologic involvement).95 190 238, Amoxicillin is the preferred oral agent for treatment in pregnant women and children <8 years of age who should not receive doxycycline.88 95 179 190 232 238, Treatment of uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis in pregnant women†.81 157 94 189 190 CDC recommends azithromycin as drug of choice and amoxicillin or erythromycin as alternatives for treatment of urogenital chlamydial infections in pregnant women.94, Prevention of α-hemolytic (viridans group) bacterial endocarditis† in patients undergoing certain dental procedures (i.e., procedures that involve manipulation of gingival tissue or periapical region of teeth or perforation of oral mucosa) or certain invasive respiratory tract procedures (i.e., procedures involving incision or biopsy of respiratory mucosa) who have certain cardiac conditions that put them at highest risk of adverse outcomes from endocarditis.69 72 97 99 100 101 451 AHA recommends amoxicillin as drug of choice for such prophylaxis.451, Anti-infective prophylaxis solely for prevention of bacterial endocarditis no longer recommended by AHA for patients undergoing GU or GI procedures.451, Consult most recent AHA recommendations for information on which cardiac conditions are associated with highest risk of adverse outcomes from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.451, Prevention of invasive S. pneumoniae infections in children with anatomic or functional asplenia† (e.g., congenital, resulting from sickle cell disease or surgery)190 or children with malignant neoplasms or thalassemia.190, Oral penicillin V usually drug of choice;74 190 some experts recommend amoxicillin.190, Children at increased risk for pneumococcal infections should receive age-appropriate vaccination with pneumococcal 13-valent conjugate vaccine (PCV13) and pneumococcal 23-valent polysaccharide vaccine (PPSV23).190 243 Long-term anti-infective prophylaxis recommended for children with functional or anatomic asplenia regardless of vaccination status.74 190 243, Alternative for postexposure prophylaxis of anthrax† following exposure to Bacillus anthracis spores (inhalational anthrax).190 228 229 231 233 235 236 239 671 672 Ciprofloxacin or doxycycline are initial drugs of choice for prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores, including exposures that occur in the context of biologic warfare or bioterrorism.190 231 235 671 672 If penicillin susceptibility confirmed, consideration can be given to changing prophylaxis to a penicillin (oral amoxicillin or penicillin V) in infants and children, pregnant or lactating women, or when drugs of choice not tolerated or not available;671 672 673 amoxicillin may be preferred, especially in infants and children.671, Alternative for treatment of inhalational anthrax† when a parenteral regimen not available (e.g., when there are supply or logistic problems in a mass-casualty setting).231, Alternative for treatment of cutaneous anthrax† caused by susceptible B. anthracis.231 671 672 If cutaneous anthrax occurs in the context of biologic warfare or bioterrorism, initial drugs of choice are ciprofloxacin or doxycycline.231 671 672 If penicillin susceptibility confirmed, consideration can be given to changing to a penicillin (oral amoxicillin or penicillin V) in infants and children, pregnant or lactating women, or when drugs of choice not tolerated or not available;671 672 673 amoxicillin may be preferred, especially in infants and children.671, Administer orally without regard to meals.1 4 10 22 29 38 40, Following reconstitution, the required amount of oral suspension should be placed directly on the child’s tongue for swallowing.1 Alternatively, the required amount of suspension can be added to infant formula, milk, fruit juice, water, ginger ale, or cold drinks and these fluids taken immediately and completely consumed.1, For most infections, continue therapy for at least 48–72 hours after patient becomes asymptomatic or evidence that the infection is eradicated is obtained.1 The drug should be given for at least 10 days for treatment of infections caused by S. pyogenes (group A β-hemolytic streptococci).1, Reconstitute oral suspension at the time of dispensing.1 Tap bottle to thoroughly loosen powder and then add the amount of water specified on the bottle in 2 portions; agitate vigorously after each addition.1, Agitate suspension well prior to administration of each dose.1, Available as the trihydrate;1 dosage expressed in terms of anhydrous amoxicillin.1, Neonates and infants ≤12 weeks (3 months) of age: Manufacturer states dosage up to 30 mg/kg daily can be given in divided doses every 12 hours.1, Children ≥3 months of age weighing ≥40 kg: Manufacturer states use usual adult dosage.1, Children beyond neonatal period with mild to moderate infections: AAP recommends 25–50 mg/kg daily given in 3 divided doses.292, Children beyond neonatal period with severe infections: AAP states that 80–100 mg/kg daily given in 3 divided doses can be used for step-down therapy.292 For highly susceptible pathogens, 90 mg/kg daily given in 2 divided doses can be used.292, 80–90 mg/kg daily given in 2 or 3 divided doses† recommended by AAP, AAFP, CDC, and others.190 200 201 205 215 683, Usual duration is 10 days;190 200 201 205 215 optimal duration uncertain.683 AAP recommends 10 days of treatment in those <2 years of age and in those with severe symptoms.683 For mild to moderate AOM in older children, AAP states 7- and 10-day regimens appear equally effective in those 2–5 years of age and a duration of 5–7 days may be adequate in those ≥6 years of age.683, 45 mg/kg daily in 2 divided doses or 40 mg/kg daily in 3 divided doses for 10 days recommended by manufacturer.1, AHA and AAP recommend 50 mg/kg (up to 1 g) once daily for 10 days.292 375, IDSA recommends 50 mg/kg (up to 1 g) once daily for 10 days or 25 mg/kg (up to 500 mg) twice daily for 10 days.580, 25 mg/kg daily in divided doses every 12 hours or 20 mg/kg daily in divided doses every 8 hours for mild to moderate infections.1, 45 mg/kg daily in divided doses every 12 hours or 40 mg/kg in divided doses every 8 hours for severe infections.1, 45 mg/kg daily in divided doses every 12 hours or 40 mg/kg daily in divided doses every 8 hours for mild, moderate, or severe lower respiratory tract infections.1, 45 mg/kg daily in divided doses every 12 hours or 40 mg/kg daily in divided doses every 8 hours for severe infections or those caused by less susceptible bacteria.1, Prepubertal children ≥2 years of age: 50 mg/kg as a single dose given with a single dose of probenecid (25 mg/kg) recommended by manufacturer.1, No longer recommended for gonorrhea by CDC or other experts.94 189, 25–50 mg/kg daily (up to 2 g daily) in 2–3 divided doses for 14–21 days for treatment of early localized or early disseminated Lyme disease†.95 179 181 182 185 190 238, 50 mg/kg daily in 3 divided doses for 14–28 days for mild Lyme carditis95 179 181 182 185 186 or for 28 days for Lyme arthritis (without associated neurologic disease).95 190 181 185 186 232 238, 50 mg/kg given as a single dose 30–60 minutes prior to the procedure.451, 20 mg/kg daily in children with anatomic or functional asplenia.190, In infants with sickle cell anemia, initiate prophylaxis as soon as diagnosis is established (preferably by 2 months of age);74 190 continue until approximately 5 years of age.74 190 243 Appropriate duration in children with asplenia from other causes unknown;190 some experts recommend that asplenic children at high risk receive prophylaxis throughout childhood and into adulthood.190, Full-term neonates ≤4 weeks of age: AAP recommends 75 mg/kg daily given in divided doses every 8 hours.671, Preterm neonates (gestational age 32–37 weeks): AAP recommends 50 mg/kg daily given in divided doses every 12 hours in those ≤1 week of age and 75 mg/kg daily given in divided doses every 8 hours in those 1–4 weeks of age.671, Infants and children ≥1 month of age: AAP recommends 75 mg/kg daily (up to 1 g daily) given in divided doses every 8 hours.671, Children: Some experts recommend 80 mg/kg daily given in divided doses every 8 hours in those weighing <20 kg and 500 mg every 8 hours in those weighing ≥20 kg.231, Use only if penicillin-susceptible B. anthracis involved.671, Total duration of anti-infective prophylaxis should be ≥60 days.190 231 233 239 671, Full-term neonates ≤4 weeks of age for follow-up after initial parenteral regimen: AAP recommends 75 mg/kg daily given in divided doses every 8 hours in conjunction with other anti-infectives.671, Preterm neonates (gestational age 32–37 weeks) for follow-up after initial parenteral regimen: AAP recommends 50 mg/kg daily given in divided doses every 12 hours in those ≤1 week of age and 75 mg/kg daily given in divided doses every 8 hours in those 1–4 weeks of age in conjunction with other anti-infectives.671, Infants and children ≥1 month of age for follow-up after initial parenteral regimen: 75 mg/kg daily (up to 1 g daily) given in divided doses every 8 hours in conjunction with other anti-infectives.671, Children with inhalational anthrax in mass casualty setting when parenteral anti-infectives not available: Some experts recommend 80 mg/kg daily given in divided doses every 8 hours in those weighing <20 kg and 500 mg every 8 hours in those weighing ≥20 kg.231, Recommended dosages are for infections that occur in the context of biologic warfare or bioterrorism231 671 and when meningitis can be ruled out.671, Use only if infection known to be caused by penicillin-susceptible B. anthracis.671, Total duration of anti-infective treatment should be 60 days.231 671, Full-term neonates ≤4 weeks of age with cutaneous anthrax without systemic involvement: AAP recommends 75 mg/kg daily given in divided doses every 8 hours.671, Preterm neonates (gestational age 32–37 weeks) with cutaneous anthrax without systemic involvement: AAP recommends 50 mg/kg daily given in divided doses every 12 hours in those ≤1 week of age and 75 mg/kg daily given in divided doses every 8 hours in those 1–4 weeks of age.671, Infants and children ≥1 month of age with cutaneous anthrax without systemic involvement: AAP recommends 75 mg/kg daily (up to 1 g daily) given in divided doses every 8 hours.671, Children: Some experts recommend 80 mg/kg daily (up to 1.5 g daily) given in divided doses every 8 hours.231, Recommended dosages are for infections that occur in the context of biologic warfare or bioterrorism.231 671, Although 7–10 days may be adequate if cutaneous anthrax occurred as the result of natural or endemic exposure to anthrax,231 234 CDC, AAP, and others recommend 60 days of anti-infective treatment if cutaneous anthrax occurred as the result of exposure to aerosolized anthrax spores (e.g., in context of biologic warfare or bioterrorism).231 234 671, AHA recommends 50 mg/kg (up to 1 g) once daily for 10 days.375, 500 mg every 12 hours or 250 mg every 8 hours for mild to moderate infections.1, 875 mg every 12 hours or 500 mg every 8 hours for severe infections or those caused by less susceptible bacteria.1, 875 mg every 12 hours or 500 mg every 8 hours for mild, moderate, or severe lower respiratory tract infections.1, 3 g as a single dose recommended by manufacturer.1, 100 mg/kg daily or 1–1.5 g every 6 hours for 14 days.6, 1 g 2 times daily for 10 or 14 days given in conjunction with clarithromycin and either lansoprazole or omeprazole (triple therapy).1 168 172 173 174, 1 g 3 times daily for 14 days given in conjunction with lansoprazole (dual therapy).1 168, 500 mg 3 times daily for 14–21 days for treatment of early localized or early disseminated Lyme disease.95 238, 500 mg 3 times daily for 14–28 days for mild Lyme carditis95 179 181 182 185 186 or for 28 days for Lyme arthritis (without associated neurologic disease).95 190 181 185 186 232 238, 500 mg 3 times daily for 7 days for treatment of chlamydial infections in pregnant women.94 189 190, 2 g as a single dose given 30–60 minutes prior to the procedure.451, 500 mg every 8 hours has been recommended.231 233 236, 1 g every 8 hours recommended by CDC for adults (including pregnant and postpartum women) if exposure occurred in the context of biologic warfare or bioterrorism.672, Use only if penicillin-susceptible B. anthracis involved.672 673, Total duration of anti-infective prophylaxis should be ≥60 days.190 231 233 239 672, Inhalational anthrax in mass casualty setting when parenteral anti-infectives not available: 500 mg every 8 hours for 60 days.231, 500 mg every 8 hours has been recommended.231, 1 g every 8 hours recommended by CDC for adults (including pregnant and postpartum women) for cutaneous anthrax without systemic involvement if infection occurred in the context of biologic warfare or bioterrorism.672, Use only if infection known to be caused by penicillin-susceptible B. anthracis.672 673, Although 7–10 days may be adequate if cutaneous anthrax occurred as the result of natural or endemic exposure to anthrax,231 234 CDC and others recommend 60 days of anti-infective treatment if cutaneous anthrax occurred as the result of exposure to aerosolized anthrax spores (e.g., in context of biologic warfare or bioterrorism).231 234 672, Maximum 30 mg/kg daily in divided doses every 12 hours.1, Dosage adjustment necessary in severe renal impairment.1 6 41 82 83, Do not use 875-mg tablets in those with severe renal impairment and GFR <30 mL/minute.1, Dosage recommendations not available for pediatric patients with renal impairment.1, 250 or 500 mg every 12 hours depending on infection severity1, 250 or 500 mg every 24 hours depending on infection severity1, 250 or 500 mg every 24 hours depending on infection severity; with an additional dose both during and at the end of dialysis1, Known hypersensitivity to any penicillin.1, Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 21 Discontinue and institute appropriate therapy if superinfection occurs.1, Treatment with anti-infectives may permit overgrowth of clostridia.1 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1 194 195 196 197 198, Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.1 194 195 196 197 198 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.1 194 195 196 197 198, Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with penicillins.1 6 51 53 55, Prior to initiation of therapy, make careful inquiry regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other drugs.1 Partial cross-allergenicity occurs among penicillins and other β-lactam antibiotics including cephalosporins and cephamycins.1 6, If a severe hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1, To reduce development of drug-resistant bacteria and maintain effectiveness of amoxicillin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1, When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1, Moderate increases in serum AST and/or ALT reported.1, Hepatic dysfunction, including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis reported.1, Assess hepatic function periodically during prolonged therapy.1, Assess renal function periodically during prolonged therapy.1, Adverse hematologic effects (e.g., anemia, hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura) reported with penicillins.1 Usually reversible when drug discontinued; may be a hypersensitivity reaction.1, Assess hematologic function periodically during prolonged therapy.1, Possible increased risk of rash in patients with mononucleosis; use in these patients not recommended.4 29 54 60, 200- and 400-mg chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 1.82 or 3.64 mg of phenylalanine, respectively.1 3, Oral suspensions do not contain aspartame and can be used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine.1.

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