Usual Adult Dose for Intraabdominal Infection

1 g IV or IM once a day for 5 to 14 days

Use: For the treatment of complicated intraabdominal infections due to Escherichia coli, Clostridium clostridioforme, Eggerthella lenta (previously Eubacterium lentum), Peptostreptococcus species, Bacteroides fragilis, B distasonis, B ovatus, B thetaiotaomicron, or B uniformis

Usual Adult Dose for Pelvic Infections

1 g IV or IM once a day for 3 to 10 days

Use: For the treatment of acute pelvic infections (including postpartum endomyometritis, septic abortion, postsurgical gynecological infections) due to Streptococcus agalactiae, E coli, B fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia

Usual Adult Dose for Pneumonia

1 g IV or IM once a day
Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or Klebsiella pneumoniae

Usual Adult Dose for Pyelonephritis

1 g IV or IM once a day
Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or Klebsiella pneumoniae

Usual Adult Dose for Urinary Tract Infection

1 g IV or IM once a day
Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or Klebsiella pneumoniae

Usual Adult Dose for Skin or Soft Tissue Infection

1 g IV or IM once a day for 7 to 14 days

Comments:

• Not studied in diabetic foot infections with concurrent osteomyelitis
• Patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral conversion therapy).

Use: For the treatment of complicated skin and skin structure infections (including diabetic foot infections without osteomyelitis) due to Staphylococcus aureus (methicillin-susceptible isolates only), S agalactiae, S pyogenes, E coli, K pneumoniae, Proteus mirabilis, B fragilis, Peptostreptococcus species, P asaccharolytica, or P bivia

Usual Adult Dose for Infection Prophylaxis

1 g IV once as a single dose, 1 hour before surgical incision

Use: For the prevention of surgical site infection after elective colorectal surgery

Usual Pediatric Dose for Intraabdominal Infection

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Duration of therapy: 5 to 14 days

Use: For the treatment of complicated intraabdominal infections due to E coli, C clostridioforme, E lenta (previously E lentum), Peptostreptococcus species, B fragilis, B distasonis, B ovatus, B thetaiotaomicron, or B uniformis

Usual Pediatric Dose for Pelvic Infections

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Duration of therapy: 3 to 10 days

Use: For the treatment of acute pelvic infections (including postpartum endomyometritis, septic abortion, postsurgical gynecological infections) due to S agalactiae, E coli, B fragilis, P asaccharolytica, Peptostreptococcus species, or P bivia

Usual Pediatric Dose for Pneumonia

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, H influenzae (beta-lactamase negative isolates only), or M catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or K pneumoniae

Usual Pediatric Dose for Pyelonephritis

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, H influenzae (beta-lactamase negative isolates only), or M catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or K pneumoniae

Usual Pediatric Dose for Urinary Tract Infection

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Total duration of therapy: 10 to 14 days

Comments:

• Duration includes a possible conversion to appropriate oral therapy (after at least 3 days of parenteral therapy) once clinical improvement established.

Uses:

• For the treatment of community-acquired pneumonia due to S pneumoniae (penicillin-susceptible isolates only) including cases with concomitant bacteremia, H influenzae (beta-lactamase negative isolates only), or M catarrhalis
• For the treatment of complicated urinary tract infections (including pyelonephritis) due to E coli, including cases with concomitant bacteremia, or K pneumoniae

Usual Pediatric Dose for Skin or Soft Tissue Infection

3 months to 12 years: 15 mg/kg IV or IM twice a day

• Maximum dose: 1 g/day

13 years or older: 1 g IV or IM once a day

Duration of therapy: 7 to 14 days

Comments:

• Not studied in diabetic foot infections with concurrent osteomyelitis
• Adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral conversion therapy).

Use: For the treatment of complicated skin and skin structure infections (including diabetic foot infections without osteomyelitis) due to S aureus (methicillin-susceptible isolates only), S agalactiae, S pyogenes, E coli, K pneumoniae, P mirabilis, B fragilis, Peptostreptococcus species, P asaccharolytica, or P bivia

Renal Dose Adjustments

Adult patients:

• CrCl greater than 30 mL/min/1.73 m2: No adjustment recommended.
• Severe renal dysfunction (CrCl up to 30 mL/min/1.73 m2) and ESRD (CrCl up to 10 mL/min/1.73 m2): 500 mg IV or IM once a day

Pediatric patients:

• Renal dysfunction: Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component, any of the ingredients, or other drugs in the same class
• Demonstrated anaphylactic reactions to beta-lactams
• IM: Known hypersensitivity to amide-type local anesthetics

Safety and efficacy have not been established in patients younger than 3 months; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Adult patients:

• Hemodialysis: 500 mg IV or IM once a day
• If administered at least 6 hours before hemodialysis: No supplemental dose is needed.
• If administered within 6 hours before hemodialysis: A supplemental dose of 150 mg is recommended after the hemodialysis session.
• Peritoneal dialysis or hemofiltration: Data not available

Pediatric patients: Data not available

Other Comments

Administration advice:

• For IV or IM use
• IV: Infuse over 30 minutes; do not use with a needleless IV system.
• IV: Complete the infusion within 6 hours of reconstitution.
• IM: May use as an alternative to IV administration for infections where IM therapy is appropriate; administer by deep IM injection into a large muscle mass (e.g., gluteal muscles, lateral part of the thigh); use caution to avoid inadvertent injection into a blood vessel.
• IM: Use the IM solution within 1 hour after reconstitution.
• May administer by IV infusion for up to 14 days or by IM injection for up to 7 days
• Do not administer the reconstituted solution IV.
• Do not co-infuse with other drugs.

Storage requirements:

• Before reconstitution: Do not store above 25C (77F).
• Reconstituted and infusion solutions: Reconstituted solution (immediately diluted) may be stored at room temperature (25C) and used within 6 hours or stored for 24 hours refrigerated and used within 4 hours after removal from refrigerator; do not freeze solutions.

Reconstitution/preparation techniques:

• This drug must be reconstituted and then diluted before IV administration.
• This drug must be reconstituted with lidocaine (without epinephrine) before IM administration.
• Diluents containing dextrose (alfa-D-Glucose) should not be used.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Water for Injection, 0.9% Sodium Chloride Injection, Bacteriostatic Water for Injection
• Do not mix with other drugs.

General:

• This drug is for the specified moderate to severe infections due to susceptible isolates of the designated microorganisms.
• 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.

Monitoring:

• General: Organ system functions, including renal, hepatic, and hematopoietic (periodically during prolonged therapy)
• Hematologic: Hematopoietic function (periodically during prolonged therapy)
• Hepatic: Hepatic function (periodically during prolonged therapy)
• Renal: Renal function (periodically during prolonged therapy)

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.