Usual Adult Dose for Skin and Structure Infection

1500 mg IV once as a single infusion OR 1000 mg IV followed 1 week later by 500 mg IV

Use: For the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) due to susceptible strains of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, S agalactiae, S dysgalactiae, S anginosus group (including S anginosus, S intermedius, S constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates)

Usual Pediatric Dose for Skin and Structure Infection

Birth to less than 6 years: 22.5 mg/kg IV once as a single infusion
6 to less than 18 years: 18 mg/kg IV once as a single infusion
Maximum dose: 1500 mg/dose

Use: For the treatment of patients with ABSSSI due to susceptible strains of the following gram-positive microorganisms: S aureus (including methicillin-susceptible and methicillin-resistant isolates), S pyogenes, S agalactiae, S dysgalactiae, S anginosus group (including S anginosus, S intermedius, S constellatus), and E faecalis (vancomycin-susceptible isolates)

Renal Dose Adjustments

Adult patients:

• CrCl less than 30 mL/min and not receiving regularly scheduled hemodialysis: 1125 mg IV once as a single infusion OR 750 mg IV followed 1 week later by 375 mg IV

• CrCl less than 30 mL/min/1.73 m2: Data not available

• CrCl or GFR should be estimated using an age-appropriate equation accepted for pediatric patients (birth to less than 18 years) to define renal dysfunction.
• Insufficient information is available to recommend dose adjustment for pediatric patients younger than 18 years with CrCl less than 30 mL/min/1.73 m2.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate to severe liver dysfunction (Child-Pugh B or C): Caution recommended.

Comments:

• No data are available to determine appropriate dosing for patients with moderate or severe liver dysfunction.

Precautions

CONTRAINDICATIONS:
Known hypersensitivity to the active component

Consult WARNINGS section for additional precautions.

Dialysis

Regularly scheduled hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available

Comments:

• This drug can be administered without regard to the timing of hemodialysis.

Other Comments

Administration advice:

• Administer by IV infusion over 30 minutes.
• Stopping or slowing the infusion may stop infusion-related reactions.
• Do not co-infuse with other medications or electrolytes.
• If a common IV line is used to administer other drugs in addition to this drug, flush the line with 5% Dextrose Injection, USP before and after each infusion of this drug.

• Lyophilized powder: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Reconstituted and diluted solutions: May store either refrigerated at 2C to 8C (36F to 46F) or at controlled room temperature 20C to 25C (68F to 77F); do not freeze.
• Total time from reconstitution to dilution to administration should not exceed 48 hours.

• This drug must be reconstituted and then further diluted before administration.
• The manufacturer product information should be consulted.

• Compatible: Sterile Water for Injection, USP; 5% Dextrose Injection, USP
• Incompatible: Saline-based infusion solutions may cause precipitation and should not be used.
• The compatibility of the reconstituted solution with IV medications, additives, or substances other than 5% Dextrose Injection, USP has not been established.

• 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, this drug 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.

• Avoid missing doses and complete the entire course of therapy.
• Consult health care provider if severe watery or bloody diarrhea develops.