Usual Adult Dose for Bacterial Infection

IM:
Serious infections: 600 mg IM every 24 hours
More severe infections: 600 mg IM every 12 hours or more often

IV:
Serious infections: 600 to 1000 mg IV every 8 to 12 hours; may need to increase dose for more severe infections
Life-threatening infections: Up to 8 g IV per day, in divided doses
Maximum dose: 8 g/day

Subconjunctival injection: 75 mg subconjunctivally once

Comments:

• Dose should be based on the severity of the infection.
• This drug should be reserved for penicillin-allergic patients or patients for whom a penicillin is considered inappropriate.
• IV doses may be repeated as often as needed up to the maximum dose (8 g/day).
• A dose injected subconjunctivally results in ocular fluid levels that last at least 5 hours with MICs sufficient for most susceptible bacteria.

Usual Pediatric Dose for Bacterial Infection

Over 1 month of age:
IM:
Serious infections: 10 mg/kg IM every 24 hours
More severe infections: 10 mg/kg IM every 12 hours or more often

IV: 10 to 20 mg/kg IV per day, in divided doses (as for adults)

Comments:

• Dose should be based on the severity of the infection.
• This drug should be reserved for penicillin-allergic patients or patients for whom a penicillin is considered inappropriate.

Renal Dose Adjustments

Severe renal dysfunction: 25% to 30% of the usual dose; caution is recommended

Comments: Serum drug levels should be monitored during high-dose therapy in patients with severe renal dysfunction.

Liver Dose Adjustments

Caution is recommended.

Comments: Serum drug levels should be monitored during high-dose therapy in patients with liver dysfunction.

Precautions

US BOXED WARNING:
CLOSTRIDIUM DIFFICILE ASSOCIATED DIARRHEA (CDAD):

• CDAD reported with almost all antibiotics; ranges from mild diarrhea to fatal colitis. Antibacterial therapy alters normal flora of the colon leading to overgrowth of C difficile.
• This drug has been associated with severe colitis which may end fatally; it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. This drug should not be used in patients with nonbacterial infections (e.g., most upper respiratory tract infections).
• C difficile produces toxins that contribute to CDAD development. Hypertoxin-producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial therapy and may require colectomy. CDAD should be considered in all patients who present with diarrhea after antibiotic use; careful medical history needed as CDAD has occurred over 2 months after antibacterial use.
• Antibiotics not directed against C difficile may need to be stopped if CDAD suspected or confirmed; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation recommended as clinically indicated.

Dialysis

Data not available

Comments: Serum drug levels not significantly affected by hemodialysis and peritoneal dialysis

Other Comments

Administration advice:

• Use for lincomycin-sensitive microorganisms only
• Due to the risk of CDAD, consider the nature of the infection and if less toxic alternatives may be appropriate before using this drug.
• Do not administer undiluted as an IV bolus injection; infuse over at least 60 minutes.
• Do not exceed an infusion rate of 1 g per hour; do not exceed a concentration of 10 mg/mL. Severe cardiopulmonary events reported when the recommended concentration and rate were exceeded.
• May coadminister with other antimicrobial agents when indicated
• Do not use in the treatment of meningitis; drug levels in CSF may be inadequate.
• Do not use for the treatment of minor bacterial infections or viral infections.

• Store at controlled room temperature 20C to 25C (68F to 77F)

• The manufacturer product information should be consulted.

• The manufacturer product information should be consulted for physically compatible infusion solutions, vitamins in infusion solutions, and antibacterial agents in infusion solutions.
• Physically incompatible: Novobiocin, kanamycin

• 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.
• Antibacterial therapy plus incision and drainage or other surgical procedures may be required for some infections.

• Gastrointestinal: For change in bowel frequency in severely ill elderly patients
• Hematologic: Blood counts (periodically during prolonged therapy)
• Hepatic: Liver function tests (periodically during prolonged therapy)
• Renal: Kidney function tests (periodically during prolonged therapy)

• Avoid missing doses and complete the entire course of therapy.