Usual Adult Dose for Bacterial Infection

Oral (tablets): 250 or 500 mg orally every 12 hours

Parenteral: 750 mg to 1.5 g IV or IM every 8 hours

• Life-threatening infections or infections due to less susceptible organisms: 1.5 g IV every 6 hours may be needed

Comments:

• Dose depends on the nature and severity of the infection.
• The duration of therapy for the parenteral dosage of 750 mg to 1.5 g every 8 hours is usually 5 to 10 days.

Uses:

• Oral: For the treatment of pharyngitis/tonsillitis, sinusitis, bronchitis, uncomplicated skin and skin structure infections, uncomplicated urinary tract infections, and early Lyme disease
• Parenteral: For the treatment of lower respiratory tract infections (including pneumonia), urinary tract infections, skin and skin structure infections, septicemia, meningitis, bone and joint infections, and disseminated gonorrhea

Usual Adult Dose for Bronchitis

Oral (tablets): 250 or 500 mg orally every 12 hours for 10 days
Parenteral: 750 mg to 1.5 g IV or IM every 8 hours

Comments:

• Oral: Safety and efficacy of administration for less than 10 days have not been established.
• Parenteral: The duration of therapy is usually 5 to 10 days.

Uses:

• Oral: For the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase-negative strains), or H parainfluenzae (beta-lactamase-negative strains)
• Parenteral: For the treatment of lower respiratory tract infections due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), Klebsiella species, Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, and Escherichia coli

Usual Adult Dose for Pneumonia

Uncomplicated infections: 750 mg IV or IM every 8 hours
Severe or complicated infections: 1.5 g IV or IM every 8 hours

Use: For the treatment of lower respiratory tract infections (including pneumonia) due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), Klebsiella species, S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, and E coli

Infectious Diseases Society of America (IDSA) and American Thoracic Society (ATS) Recommendations: 500 mg orally twice a day

Comments:

• Recommended as part of a combination regimen for outpatient empiric treatment of community-acquired pneumonia in patients with comorbidities (e.g., chronic heart/lung/liver/renal disease, diabetes mellitus, alcoholism, malignancy, asplenia)
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Urinary Tract Infection

Uncomplicated infections:

• Oral (tablets): 250 mg orally every 12 hours for 7 to 10 days
• Parenteral: 750 mg IV or IM every 8 hours

Severe or complicated infections: 1.5 g IV or IM every 8 hours

Comments:

• Bacteriologic and clinical appraisal recommended frequently during treatment of chronic infections; may be necessary for several months after therapy has ended

Uses:

• Oral: For the treatment of uncomplicated urinary tract infections due to susceptible strains of E coli or Klebsiella pneumoniae
• Parenteral: For the treatment of urinary tract infections due to susceptible strains of E coli and Klebsiella species

Usual Adult Dose for Skin or Soft Tissue Infection

Oral (tablets): 250 or 500 mg orally every 12 hours for 10 days

Parenteral: 750 mg IV or IM every 8 hours

• Severe or complicated infections: 1.5 g IV or IM every 8 hours

Comments:

• Microbiological tests often show growth of susceptible strains of both aerobic and anaerobic organisms in these infections; this drug has been used successfully in such mixed infections.

Uses:

• Oral: For the treatment of uncomplicated skin and skin structure infections due to susceptible strains of S aureus (including beta-lactamase-producing strains) or S pyogenes
• Parenteral: For the treatment of skin and skin structure infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, E coli, Klebsiella species, and Enterobacter species

Usual Adult Dose for Skin and Structure Infection

Oral (tablets): 250 or 500 mg orally every 12 hours for 10 days

Parenteral: 750 mg IV or IM every 8 hours

• Severe or complicated infections: 1.5 g IV or IM every 8 hours

Comments:

• Microbiological tests often show growth of susceptible strains of both aerobic and anaerobic organisms in these infections; this drug has been used successfully in such mixed infections.

Uses:

• Oral: For the treatment of uncomplicated skin and skin structure infections due to susceptible strains of S aureus (including beta-lactamase-producing strains) or S pyogenes
• Parenteral: For the treatment of skin and skin structure infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, E coli, Klebsiella species, and Enterobacter species

Usual Adult Dose for Septicemia

Life-threatening infections or infections due to less susceptible organisms: 1.5 g IV every 6 hours

Comments:

• In certain cases of confirmed/suspected gram-positive or gram-negative sepsis in which the causative organism has not been identified, this drug may be used concomitantly with an aminoglycoside; the recommended doses of both antibacterials may be given depending on the severity of the infection and the patient's condition.

Use: For the treatment of septicemia due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains), S pneumoniae, E coli, H influenzae (including ampicillin-resistant strains), and Klebsiella species

Usual Adult Dose for Meningitis

Life-threatening infections or infections due to less susceptible organisms: 1.5 g IV every 6 hours

• Maximum dose: 3 g IV every 8 hours

Use: For the treatment of meningitis due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Adult Dose for Joint Infection

1.5 g IV or IM every 8 hours

Comments:

• In clinical trials, adjunctive therapy included surgical intervention when indicated; when appropriate, oral antibiotics were administered after this parenteral therapy was completed.

Uses: For the treatment of bone and joint infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Adult Dose for Osteomyelitis

1.5 g IV or IM every 8 hours

Comments:

• In clinical trials, adjunctive therapy included surgical intervention when indicated; when appropriate, oral antibiotics were administered after this parenteral therapy was completed.

Uses: For the treatment of bone and joint infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Adult Dose for Surgical Prophylaxis

Clean-contaminated or potentially contaminated surgical procedures:

• Preoperative: 1.5 g IV 30 to 60 minutes before the initial incision
• Intraoperative (for prolonged procedures): 750 mg IV or IM every 8 hours

Open heart surgery: 1.5 g IV at induction of anesthesia and every 12 hours thereafter

• Maximum dose: 6 g total

Comments:

• Preoperative prophylactic use of this drug may prevent growth of susceptible pathogenic bacteria; this may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures classified as clean-contaminated or potentially contaminated (e.g., vaginal hysterectomy).
• Prophylactic efficacy depends on timing of administration; the preoperative dose should be administered 30 to 60 minutes before surgery to allow enough time to attain effective antibiotic levels in the wound tissues during surgery; dosing should be repeated during prolonged procedures.
• Prophylaxis usually unnecessary postoperatively and should be stopped within 24 hours; in most surgeries, continued prophylaxis does not reduce incidence of subsequent infections but increases likelihood of side effects and development of bacterial resistance.
• Perioperative use during open heart surgery has been effective in surgical patients for whom infection at the operative site would present serious risk; for such patients, this drug should be continued for at least 48 hours after the end of surgery. If signs of infection observed, specimens for culture and susceptibility testing should be obtained to isolate and identify infecting organisms in order to start appropriate therapy.

Uses: For preventive use (for clean-contaminated/potentially contaminated surgical procedures; during open heart surgery)

American Society of Health-System Pharmacists (ASHP), IDSA, Surgical Infection Society (SIS), and Society for Healthcare Epidemiology of America (SHEA) Recommendations:

• Preoperative dose: 1.5 g IV as a single dose
• Redosing interval (from start of preoperative dose): 4 hours

Comments:

• Recommended for surgical prophylaxis for the following procedures:
• Cardiac: Coronary artery bypass; cardiac device insertion procedures (e.g., pacemaker implantation); ventricular assist devices
• Head and neck: Clean with placement of prosthesis (excludes tympanostomy tubes); clean-contaminated cancer surgery; other clean-contaminated procedures (excluding tonsillectomy, functional endoscopic sinus procedures)
• This drug should be started within 60 minutes before surgical incision.
• A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
• To ensure adequate serum and tissue drug levels, readministration may be needed if the procedure duration exceeds the recommended redosing interval.
• Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
• Coadministration with other agents may be recommended, depending on type of procedure.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Tonsillitis/Pharyngitis

Tablets: 250 mg orally every 12 hours for 10 days

Comments:

• Efficacy in the prevention of rheumatic fever was not established in clinical trials.
• Efficacy in the treatment of penicillin-resistant strains of S pyogenes was not established in clinical trials.

Use: For the treatment of mild to moderate pharyngitis/tonsillitis due to susceptible strains of S pyogenes

Usual Adult Dose for Sinusitis

Tablets: 250 mg orally every 12 hours for 10 days

Comments:

• Efficacy for sinus infections due to beta-lactamase-producing H influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in clinical trials.

Use: For the treatment of mild to moderate acute bacterial maxillary sinusitis due to susceptible strains of S pneumoniae or H influenzae (non-beta-lactamase-producing strains only)

Usual Adult Dose for Lyme Disease

Tablets: 500 mg orally every 12 hours for 20 days

Use: For the treatment of early Lyme disease (erythema migrans) due to susceptible strains of Borrelia burgdorferi

IDSA, American Academy of Neurology (AAN), and American College of Rheumatology (ACR) Recommendations: 500 mg orally twice a day

Duration of Therapy:

• Erythema migrans (solitary and multiple): 14 days
• Carditis: 14 to 21 days
• Arthritis:
• Initial treatment: 28 days
• Recurrent or refractory arthritis: 28 days
• Acrodermatitis chronica atrophicans: 21 to 28 days
• Borrelial lymphocytoma: 14 days

Comments:

• Recommended as an oral regimen for the treatment of erythema migrans, Lyme carditis, Lyme arthritis, acrodermatitis chronica atrophicans, and borrelial lymphocytoma
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Gonococcal Infection - Disseminated

750 mg IV or IM every 8 hours

• Severe or complicated infections: 1.5 g IV or IM every 8 hours

Comments:

• The patient's sexual partner(s) should also be evaluated/treated.
• According to the US CDC, the recommended regimen for disseminated gonococcal infection is ceftriaxone.
• Current guidelines should be consulted for additional information.

Use: For the treatment of disseminated gonococcal infections due to susceptible strains of N gonorrhoeae (penicillinase- and non-penicillinase-producing strains)

Usual Adult Dose for Gonococcal Infection - Uncomplicated

Oral (tablets): 1 g orally as a single dose
Parenteral: 1.5 g IM as a single dose

Comments:

• The IM dose should be administered as a single dose at 2 separate sites; 1 g oral probenecid should be coadministered.
• The patient's sexual partner(s) should also be evaluated/treated.
• Due to inferior efficacy and less favorable pharmacodynamics, most oral cephalosporins (including this drug) are not recommended by the US CDC for the treatment of uncomplicated gonococcal infections.
• Current guidelines should be consulted for additional information.

Uses:

• Oral: For the treatment of uncomplicated endocervical and urethral gonorrhea due to susceptible strains of N gonorrhoeae (penicillinase- and non-penicillinase-producing strains); for the treatment of uncomplicated rectal gonorrhea in females due to susceptible strains of N gonorrhoeae (non-penicillinase-producing strains)
• Parenteral: For the treatment of uncomplicated gonococcal infections due to susceptible strains of N gonorrhoeae (penicillinase- and non-penicillinase-producing strains)

Usual Adult Dose for Cholecystitis

SIS and IDSA Recommendations: 1.5 g IV every 8 hours

Comments:

• Recommended as an initial IV regimen for empiric treatment of complicated intraabdominal infection
• With metronidazole, may be used for initial empiric treatment of mild to moderate community-acquired infection (e.g., perforated or abscessed appendicitis)
• May be used for initial empiric treatment of mild to moderate community-acquired acute cholecystitis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Intraabdominal Infection

SIS and IDSA Recommendations: 1.5 g IV every 8 hours

Comments:

• Recommended as an initial IV regimen for empiric treatment of complicated intraabdominal infection
• With metronidazole, may be used for initial empiric treatment of mild to moderate community-acquired infection (e.g., perforated or abscessed appendicitis)
• May be used for initial empiric treatment of mild to moderate community-acquired acute cholecystitis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Appendicitis

SIS and IDSA Recommendations: 1.5 g IV every 8 hours

Comments:

• Recommended as an initial IV regimen for empiric treatment of complicated intraabdominal infection
• With metronidazole, may be used for initial empiric treatment of mild to moderate community-acquired infection (e.g., perforated or abscessed appendicitis)
• May be used for initial empiric treatment of mild to moderate community-acquired acute cholecystitis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Wound Infection

IDSA Recommendations:

• Oral: 500 mg orally twice a day
• Parenteral: 1 g IV every 12 hours

Comments:

• Recommended as an alternative regimen for infected animal bite-related wound
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bacterial Infection

ORAL:
3 months to 12 years:

• Oral suspension: 10 to 15 mg/kg orally twice a day
• Maximum dose: 1 g/day
• Tablets: 250 mg orally every 12 hours

13 years or older:

• Tablets: 250 or 500 mg orally every 12 hours

PARENTERAL:
3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Comments:

• Dose depends on the nature and severity of the infection.

Uses:

• Oral: For the treatment of pharyngitis/tonsillitis, otitis media, sinusitis, bronchitis, uncomplicated skin and skin structure infections, uncomplicated urinary tract infections, early Lyme disease, and impetigo
• Parenteral: For the treatment of lower respiratory tract infections (including pneumonia), urinary tract infections, skin and skin structure infections, septicemia, meningitis, bone and joint infections, and disseminated gonorrhea

American Academy of Pediatrics (AAP) Recommendations:
ORAL:
1 month or older: 20 to 30 mg/kg/day orally in 2 divided doses

• Maximum dose: 1 g/day

PARENTERAL:
Neonates:

• Gestational age less than 32 weeks:
• Postnatal age (PNA) less than 7 days: 50 mg/kg IV or IM every 12 hours
• PNA at least 7 days: 50 mg/kg IV or IM every 8 hours
• Gestational age at least 32 weeks:
• PNA up to 7 days: 50 mg/kg IV or IM every 12 hours
• PNA greater than 7 days: 50 mg/kg IV or IM every 8 hours

1 month or older: 100 to 150 mg/kg/day IV or IM in 3 divided doses

• Maximum dose: 6 g/day

Comments:

• This drug has limited activity against penicillin-resistant pneumococcus.
• Other parenteral agents are preferred for CNS infections.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pneumonia

3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Uses: For the treatment of lower respiratory tract infections (including pneumonia) due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), Klebsiella species, S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, and E coli

US CDC, National Institutes of Health (NIH), HIV Medicine Association of the IDSA (HIVMA/IDSA), Pediatric Infectious Diseases Society (PIDS), and AAP Recommendations for HIV-Exposed And HIV-Infected Children: 35 to 50 mg/kg IV 3 times a day

• Maximum dose: 6 g/day

Comments:

• Recommended as an alternative regimen for bacterial pneumonia due to S pneumoniae (occasionally S aureus, H influenzae)
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bronchitis

Oral (tablets):
13 years or older: 250 or 500 mg orally every 12 hours for 10 days

Parenteral:
3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Comments:

• Oral: Safety and efficacy of administration for less than 10 days have not been established.

Uses:

• Oral: For the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to susceptible strains of S pneumoniae, H influenzae (beta-lactamase-negative strains), or H parainfluenzae (beta-lactamase-negative strains)
• Parenteral: For the treatment of lower respiratory tract infections due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), Klebsiella species, S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, and E coli

Usual Pediatric Dose for Urinary Tract Infection

Oral (tablets):
13 years or older: 250 mg orally every 12 hours for 7 to 10 days

Parenteral:
3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Uses:

• Oral: For the treatment of uncomplicated urinary tract infections due to susceptible strains of E coli or K pneumoniae
• Parenteral: For the treatment of urinary tract infections due to susceptible strains of E coli and Klebsiella species

Usual Pediatric Dose for Skin and Structure Infection

Oral (tablets):
13 years or older: 250 or 500 mg orally every 12 hours for 10 days

Parenteral:
3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Uses:

• Oral: For the treatment of uncomplicated skin and skin structure infections due to susceptible strains of S aureus (including beta-lactamase-producing strains) or S pyogenes
• Parenteral: For the treatment of skin and skin structure infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains), S pyogenes, E coli, Klebsiella species, and Enterobacter species

Usual Pediatric Dose for Septicemia

3 months or older: 50 to 100 mg/kg/day IV in equally divided doses every 6 to 8 hours

• Maximum dose: 1.5 g/dose

Use: For the treatment of septicemia due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains), S pneumoniae, E coli, H influenzae (including ampicillin-resistant strains), and Klebsiella species

Usual Pediatric Dose for Meningitis

3 months or older: 200 to 240 mg/kg/day IV in divided doses every 6 to 8 hours

• Maximum dose: 9 g/day

Use: For the treatment of meningitis due to susceptible strains of S pneumoniae, H influenzae (including ampicillin-resistant strains), N meningitidis, and S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Pediatric Dose for Joint Infection

3 months or older: 50 mg/kg IV or IM every 8 hours

• Maximum dose: 1.5 g/dose

Comments:

• In clinical trials, oral antibiotics were administered after this parenteral therapy was completed.

Uses: For the treatment of bone and joint infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Pediatric Dose for Osteomyelitis

3 months or older: 50 mg/kg IV or IM every 8 hours

• Maximum dose: 1.5 g/dose

Comments:

• In clinical trials, oral antibiotics were administered after this parenteral therapy was completed.

Uses: For the treatment of bone and joint infections due to susceptible strains of S aureus (penicillinase- and non-penicillinase-producing strains)

Usual Pediatric Dose for Tonsillitis/Pharyngitis

3 months to 12 years:

• Oral suspension: 10 mg/kg orally twice a day
• Maximum dose: 500 mg/day

13 years or older:

• Tablets: 250 mg orally every 12 hours

Duration of Therapy: 10 days

Comments:

• Efficacy in the prevention of rheumatic fever was not established in clinical trials.
• Efficacy in the treatment of penicillin-resistant strains of S pyogenes was not established in clinical trials.

Use: For the treatment of mild to moderate pharyngitis/tonsillitis due to susceptible strains of S pyogenes

Usual Pediatric Dose for Otitis Media

3 months to 12 years:

• Oral suspension: 15 mg/kg orally twice a day
• Maximum dose: 1000 mg/day
• Tablets: 250 mg orally every 12 hours

Duration of Therapy: 10 days

Use: For the treatment of acute bacterial otitis media due to susceptible strains of S pneumoniae, H influenzae (including beta-lactamase-producing strains), M catarrhalis (including beta-lactamase-producing strains), or S pyogenes

Usual Pediatric Dose for Sinusitis

3 months to 12 years:

• Oral suspension: 15 mg/kg orally twice a day
• Maximum dose: 1000 mg/day
• Tablets: 250 mg orally every 12 hours

13 years or older:

• Tablets: 250 mg orally every 12 hours

Duration of Therapy: 10 days

Comments:

• Efficacy for sinus infections due to beta-lactamase-producing H influenzae or M catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in clinical trials.

Use: For the treatment of mild to moderate acute bacterial maxillary sinusitis due to susceptible strains of S pneumoniae or H influenzae (non-beta-lactamase-producing strains only)

Usual Pediatric Dose for Lyme Disease

13 years or older:

• Tablets: 500 mg orally every 12 hours for 20 days

Use: For the treatment of early Lyme disease (erythema migrans) due to susceptible strains of B burgdorferi

IDSA, AAN, and ACR Recommendations:

• Children: 15 mg/kg orally twice a day
• Maximum dose: 500 mg/dose

Duration of Therapy:

• Erythema migrans (solitary and multiple): 14 days
• Carditis: 14 to 21 days
• Arthritis:
• Initial treatment: 28 days
• Recurrent or refractory arthritis: 28 days
• Acrodermatitis chronica atrophicans: 21 to 28 days
• Borrelial lymphocytoma: 14 days

Comments:

• Recommended as an oral regimen for the treatment of erythema migrans, Lyme carditis, Lyme arthritis, acrodermatitis chronica atrophicans, and borrelial lymphocytoma
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Impetigo

3 months to 12 years:

• Oral suspension: 15 mg/kg orally twice a day for 10 days
• Maximum dose: 1000 mg/day

Uses: For the treatment of impetigo due to susceptible strains of S aureus (including beta-lactamase-producing strains) or S pyogenes

Usual Pediatric Dose for Gonococcal Infection - Uncomplicated

13 years or older:

• Tablets: 1 g orally as a single dose

Comments:

• The patient's sexual partner(s) should also be evaluated/treated.
• Due to inferior efficacy and less favorable pharmacodynamics, most oral cephalosporins (including this drug) are not recommended by the US CDC for the treatment of uncomplicated gonococcal infections.
• Current guidelines should be consulted for additional information.

Uses: For the treatment of uncomplicated endocervical and urethral gonorrhea due to susceptible strains of N gonorrhoeae (penicillinase- and non-penicillinase-producing strains); for the treatment of uncomplicated rectal gonorrhea in females due to susceptible strains of N gonorrhoeae (non-penicillinase-producing strains)

Usual Pediatric Dose for Surgical Prophylaxis

ASHP, IDSA, SIS, and SHEA Recommendations:

• Preoperative dose: 50 mg/kg IV as a single dose
• Maximum dose: 1.5 g/dose
• Redosing interval (from start of preoperative dose): 4 hours

Comments:

• Recommended for surgical prophylaxis for the following procedures:
• Cardiac: Coronary artery bypass; cardiac device insertion procedures (e.g., pacemaker implantation); ventricular assist devices
• Head and neck: Clean with placement of prosthesis (excludes tympanostomy tubes); clean-contaminated cancer surgery; other clean-contaminated procedures (excluding tonsillectomy, functional endoscopic sinus procedures)
• This drug should be started within 60 minutes before surgical incision.
• A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
• To ensure adequate serum and tissue drug levels, readministration may be needed if the procedure duration exceeds the recommended redosing interval.
• Redosing may be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
• Coadministration with other agents may be recommended, depending on type of procedure.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Intraabdominal Infection

SIS and IDSA Recommendations: 150 mg/kg/day IV in divided doses every 6 to 8 hours

Comments:

• Recommended as an initial IV regimen for treatment of complicated intraabdominal infection
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

ADULT PATIENTS:
Oral:

• CrCl 10 to less than 30 mL/min: Standard dose orally every 24 hours
• CrCl less than 10 mL/min (without hemodialysis): Standard dose orally every 48 hours

Parenteral:

• CrCl greater than 20 mL/min: 750 mg to 1.5 g IV or IM every 8 hours
• CrCl 10 to 20 mL/min: 750 mg IV or IM every 12 hours
• CrCl less than 10 mL/min: 750 mg IV or IM every 24 hours

PEDIATRIC PATIENTS:
Oral: Data not available

Parenteral:

• CrCl greater than 20 mL/min: Standard dose IV or IM every 8 hours
• CrCl 10 to 20 mL/min: Standard dose IV or IM every 12 hours
• CrCl less than 10 mL/min: Standard dose IV or IM every 24 hours

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Oral formulations: Known hypersensitivity (e.g., anaphylaxis) to the active component or to other beta-lactam antibacterial agents (e.g., penicillins, cephalosporins)
• Parenteral formulations: Known allergy to cephalosporin antibacterials
• Dextrose (glucose)-containing IV solutions: Hypersensitivity to corn products

Safety and efficacy have not been established in patients younger than 3 months.

Consult WARNINGS section for additional precautions.

Dialysis

ADULTS:
Hemodialysis:

• Oral: A single additional standard dose should be administered at the end of each dialysis.
• Parenteral: A supplemental 750 mg dose should be administered at the end of dialysis.

Peritoneal dialysis: Data not available

PEDIATRIC PATIENTS: Data not available

Comments:

• This drug is dialyzable.

Other Comments

Administration advice:
ORAL:

• Tablets and oral suspension are not bioequivalent; do not substitute on a mg/mg basis.
• Administer tablets with or without food; swallow whole, without crushing.
• Use the oral suspension in pediatric patients who cannot swallow the tablets whole; the tablet has a strong, persistent bitter taste when crushed.
• After reconstitution, wait 1 hour before administering the oral suspension to a patient.
• Shake the oral suspension well before each use and administer with food; discard any remaining oral suspension after 10 days.

PARENTERAL:

• Duplex Container: Administer IV; do not use plastic containers in series connections.
• Powder in vials: May administer IV or IM
• IM: By deep IM injection into a large muscle mass (such as the gluteus or lateral part of the thigh); aspirate before injecting to avoid inadvertent injection into a blood vessel.
• IV: May administer via direct intermittent injection (inject slowly over 3 to 5 minutes directly into vein or through the tubing by which the patient is also receiving other IV solutions), intermittent infusion with a Y-type administration set (through the tubing system by which the patient may be receiving other IV solutions), or continuous infusion
• If a Y-type administration set is used for IV infusion: During infusion of the solution containing this drug, temporarily discontinue administration of any other solutions at the same site.
• IV route may be preferred for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks due to lowered resistance, especially if shock is present/impending.
• In general, continue antibiotic therapy for at least 48 to 72 hours after the patient becomes asymptomatic or after obtaining evidence of bacterial eradication; treat infections due to S pyogenes for at least 10 days to reduce the risk of rheumatic fever or glomerulonephritis. The duration of therapy for the parenteral dosage of 750 mg to 1.5 g every 8 hours is usually 5 to 10 days.
• Do not use parenteral doses smaller than those indicated above for adults.
• Use the higher pediatric parenteral dose (100 mg/kg/day) for more severe or serious infections.
• If concomitant IV therapy with an aminoglycoside is indicated, administer each drug separately.

Storage requirements:
ORAL:

• Oral suspension:
• Before reconstitution: Store between 2C and 30C (36F and 86F).
• After reconstitution: Immediately store refrigerated between 2C and 8C (36F and 46F); discard after 10 days.
• Tablets: Store between 15C and 30C (59F and 86F).
• Replace cap securely after each opening.

PARENTERAL:

• Duplex Container:
• Unactivated: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• After reconstitution (activation): May store up to 24 hours at room temperature or 7 days under refrigeration
• Powder in Vials:
• Before constitution: Store between 15C and 30C (59F and 86F); protect from light.
• After constitution/dilution: The manufacturer product information should be consulted regarding stability periods of reconstituted and/or further diluted solutions at room temperature, under refrigeration (5C [41F]), or frozen (-20C [-4F]).
• Frozen solutions: Thaw frozen solution at room temperature; do not force thaw by immersion in water baths or by microwave irradiation; once thawed, do not refreeze.

Reconstitution/preparation techniques:

• Oral suspension, Duplex Container, and powder in vials: The manufacturer product information should be consulted.

IV compatibility:

• Compatible (powder in vials): Sterile Water for Injection; 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose And 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 10% Invert Sugar in Water for Injection; heparin (10 and 50 units/mL) in 0.9% Sodium Chloride Injection; potassium chloride (10 and 40 mEq/L) in 0.9% Sodium Chloride Injection
• Incompatible: Sodium Bicarbonate Injection, USP
• Solutions of this drug should not be added to solutions of aminoglycosides due to potential interaction; if concomitant therapy is indicated, each drug can be administered separately.
• Duplex Container: Do not introduce additives into container.

General:

• This drug is for the treatment of infections due to susceptible strains of the designated bacteria.
• To reduce the development of drug-resistant organisms and maintain effective therapy, antibiotics should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
• Persistent infections may require several week of treatment.
• Surgical drainage may be indicated for infections with abscess formation.
• In certain cases of confirmed/suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, this drug may be used concomitantly with an aminoglycoside; the recommended doses of both antibacterials may be given depending on the severity of the infection and the patient's condition.
• The oral suspension contains phenylalanine (a component of aspartame).

Monitoring:

• Hematologic: Prothrombin time in at-risk patients, including those with renal or liver dysfunction, with poor nutritional state, receiving prolonged antimicrobial therapy, or previously stabilized on anticoagulant therapy (during parenteral therapy)
• Renal: Renal status, especially in seriously ill patients receiving maximum doses (during therapy); renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Contact physician as soon as possible if watery and bloody stools (with or without stomach cramps and fever) develop.