Usual Adult Dose for Skin and Structure Infection

500 mg IV every 8 hours

• Complicated infections due to Pseudomonas aeruginosa: 1 g IV every 8 hours

Uses: As a single agent therapy for the treatment of complicated skin and skin structure infections due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, S agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), P aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species

Usual Adult Dose for Intraabdominal Infection

1 g IV every 8 hours

Uses: As a single agent therapy for the treatment of complicated intraabdominal infections (including appendicitis and peritonitis) due to viridans group streptococci, E coli, Klebsiella pneumoniae, P aeruginosa, B fragilis, B thetaiotaomicron, Peptostreptococcus species

Usual Adult Dose for Meningitis

Infectious Diseases Society of America (IDSA) recommendations: 2 g IV every 8 hours for 7 to 21 days

Comments:

• Recommended as an alternative therapy

Usual Adult Dose for Nosocomial Pneumonia

American Thoracic Society, IDSA recommendations: 1 g IV every 8 hours
Duration of therapy: As short as 7 days recommended (reducing from traditional 14 to 21 days) if causative organism is not P aeruginosa and patient has good clinical response

Comments:

• Recommended as empiric therapy of hospital-acquired pneumonia (including ventilator-associated pneumonia) and healthcare-associated pneumonia
• If multidrug-resistant organisms suspected, initial empiric treatment with broad-spectrum coverage (according to the hospital's and/or ICU's antibiogram) is recommended.
• Shortening the duration of therapy may reduce the risk of superinfections with resistant organisms.

Usual Pediatric Dose for Skin and Structure Infection

3 months or older: 10 mg/kg IV every 8 hours
Maximum dose: 500 mg/dose

• Complicated infections due to P aeruginosa: 20 mg/kg IV every 8 hours

Maximum dose: 1 g/dose

Uses: As a single agent therapy for the treatment of complicated skin and skin structure infections due to S aureus (methicillin-susceptible isolates only), S pyogenes, S agalactiae, viridans group streptococci, E faecalis (vancomycin-susceptible isolates only), P aeruginosa, E coli, P mirabilis, B fragilis, Peptostreptococcus species

Usual Pediatric Dose for Intraabdominal Infection

Less than 3 months:

• Infants less than 32 weeks gestational age (GA) and postnatal age (PNA) less than 2 weeks: 20 mg/kg IV every 12 hours
• Infants less than 32 weeks GA and PNA 2 weeks or older: 20 mg/kg IV every 8 hours
• Infants 32 weeks or older GA and PNA less than 2 weeks: 20 mg/kg IV every 8 hours
• Infants 32 weeks or older GA and PNA 2 weeks or older: 30 mg/kg IV every 8 hours

3 months or older: 20 mg/kg IV every 8 hours
Maximum dose: 1 g/dose

Uses: As a single agent therapy for the treatment of complicated intraabdominal infections (including appendicitis and peritonitis) due to viridans group streptococci, E coli, K pneumoniae, P aeruginosa, B fragilis, B thetaiotaomicron, Peptostreptococcus species

Usual Pediatric Dose for Meningitis

3 months or older: 40 mg/kg IV every 8 hours
Maximum dose: 2 g/dose

Comments:

• Effective in eliminating concurrent bacteremia associated with bacterial meningitis.
• Efficacy as monotherapy in the treatment of meningitis due to penicillin nonsusceptible isolates of S pneumoniae has not been established.

Uses: As a single agent therapy for the treatment of bacterial meningitis due to S pneumoniae, Haemophilus influenzae, Neisseria meningitidis

IDSA recommendations:
Infants and children: 40 mg/kg IV every 8 hours
Maximum dose: 2 g/dose

Comments:

• Recommended as an alternative therapy

Renal Dose Adjustments

Adults:
Greater than 50 mL/min: Recommended dose every 8 hours
CrCl greater than 25 to 50 mL/min: Recommended dose every 12 hours
CrCl 10 to 25 mL/min: One-half recommended dose every 12 hours
CrCl less than 10 mL/min: One-half recommended dose every 24 hours

Pediatric patients: Data not available

Liver Dose Adjustments

No adjustment recommended.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Hemodialysis, peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Adults: Administer by IV infusion over about 15 to 30 minutes; alternatively, doses of 1 g may be administered as an IV bolus injection over about 3 to 5 minutes.
• Pediatric patients 3 months or older: Administer as IV infusion over about 15 to 30 minutes or as an IV bolus injection over about 3 to 5 minutes; limited safety data available to support use of a 40 mg/kg (maximum of 2 g) bolus dose.
• Pediatric patients younger than 3 months: Administer as IV infusion over 30 minutes.
• Do not use flexible container in series connections.

Storage requirements:

• Dry powder: Store at controlled room temperature 20C to 25C (68F to 77F)
• Constituted solution for IV bolus: If unable to use freshly prepared solution immediately, may store up to 3 hours at up to 25C (77F) or for 13 hours at up to 5C (41F)
• Solution for IV infusion when constituted with Sodium Chloride Injection 0.9%: If unable to use freshly prepared solution immediately, may store for 1 hour at up to 25C (77F) or 15 hours at up to 5C (41F)
• Solution for IV infusion when constituted with Dextrose Injection 5%: Freshly prepared solution should be used immediately.
• Do not freeze IV solutions.

Reconstitution/preparation techniques:

• For IV bolus: Constitute injection vials with sterile Water for Injection; shake to dissolve then let stand until clear.
• For IV infusion: May constitute infusion vials directly with compatible infusion fluid; alternatively, may constitute an injection vial, add the resulting solution to an IV container, then further dilute with an appropriate infusion fluid

IV compatibility:

• Compatible for IV bolus: Sterile Water for Injection
• Compatible for IV infusion: Sodium Chloride Injection 0.9%, Dextrose Injection 5%
• Compatibility with other drugs not established; this drug should not be mixed with or physically added to solutions containing other drugs.

General:

• Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
• This drug is useful as presumptive therapy in the indicated condition before causative organism is identified due to broad spectrum of bactericidal activity.
• Concentration of solution for IV bolus: Up to 50 mg/mL
• Concentration of solution for IV infusion: Ranges from 1 to 20 mg/mL

Monitoring:

• General: Organ system functions (periodically during prolonged therapy)
• Hematologic: Hematopoietic organ system functions (periodically during prolonged therapy)
• Hepatic: Hepatic organ system functions (periodically during prolonged therapy)
• Renal: Renal organ system functions (periodically during prolonged therapy); renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Do not operate machinery or motorized vehicles until it is reasonable well established that this drug is well tolerated.