Tobramycin (Systemic)

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Feeling tired or weak.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Generic: 10 mg/mL (2 mL); 80 mg/2 mL (2 mL); 1.2 g/30 mL (30 mL); 2 g/50 mL (50 mL)

Solution, Intravenous:

Generic: 80 mg (100 mL [DSC])

Solution Reconstituted, Injection:

Generic: 1.2 g (1 ea)

Solution Reconstituted, Injection [preservative free]:

Generic: 1.2 g (1 ea)

Treatment of documented or suspected infections caused by susceptible gram-negative bacilli, including Pseudomonas aeruginosa.

Additional Off-Label Uses

Synergy (for gram-positive infections)

Dosage should be based on an estimate of ideal body weight.

IM, IV: 1.5 to 5 mg/kg/day in 1 to 2 divided doses

IV: Once daily or extended interval: 5 to 7 mg/kg/dose given every 24, 36, or 48 hours based on creatinine clearance

IM, IV:

Conventional dosing:

CrCl >60 mL/minute: Administer every 8 hours.

CrCl 40 to 60 mL/minute: Administer every 12 hours.

CrCl 20 to 39 mL/minute: Administer every 24 hours.

CrCl <20 mL/minute: Loading dose, then monitor levels.

High-dose therapy: Interval may be extended (eg, every 48 hours) in patients with moderate renal impairment (CrCl 30 to 59 mL/minute) and/or adjusted based on serum level determinations.

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days) (Heintz 2009): Dialyzable (25% to 70%; variable; dependent on filter, duration, and type of HD): IV:

Loading dose of 2 to 3 mg/kg, followed by:

Mild UTI or synergy: 1 mg/kg/dose every 48 to 72 hours; consider redosing for pre-HD or post-HD serum concentrations <1 mg/L

Moderate to severe UTI: 1 to 1.5 mg/kg/dose every 48 to 72 hours; consider redosing for pre-HD serum concentrations <1.5 to 2 mg/L or post-HD concentrations <1 mg/L

Systemic gram-negative infection: 1.5 to 2 mg/kg/dose every 48 to 72 hours; consider redosing for pre-HD serum concentrations <3 to 5 mg/L or post-HD serum concentrations <2 mg/L

Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions.

Peritoneal dialysis (PD):

Administration via peritoneal dialysis (PD) fluid:

Gram-negative infection: 4 to 8 mg/L (4 to 8 mcg/mL) of PD fluid

Gram-positive infection (ie, synergy): 3 to 4 mg/L (3 to 4 mcg/mL) of PD fluid

Administration IVPB/IM: Dose as for CrCl <10 mL/minute and follow levels

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as target drug concentrations (if appropriate). Note: The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH/CVVHD/CVVHDF: IV:

Mild UTI or synergy: Loading dose of 2 to 3 mg/kg, followed by 1 mg/kg/dose every 24 to 36 hours (redose when serum concentration <1 mg/L [Heintz 2009])

Moderate-severe UTI: Loading dose of 2 to 3 mg/kg, followed by 1 to 1.5 mg/kg/dose every 24 to 36 hours (redose when serum concentration <1.5 to 2 mg/L [Heintz 2009])

Systemic gram-negative infection: Loading dose of 2 to 3 mg/kg, followed by 1.5 to 2.5 mg/kg/dose every 24 to 48 hours (generally accepted to redose when serum concentration <2 mg/L; one reference suggests redosing when <3 mg/L [Heintz 2009])

Solution for injection: Dilute in 50-100 mL NS or D5W for IV infusion.

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.

Urinalysis, urine output, BUN, serum creatinine, peak and trough plasma tobramycin levels. Levels are typically obtained after the third dose in conventional dosing. Be alert to ototoxicity; hearing should be tested before and during treatment

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro. This may be clinically-significant for certain penicillin (ticarcillin, piperacillin, carbenicillin) and aminoglycoside (gentamicin, tobramycin) combination therapy in patients with significant renal impairment. Close monitoring of aminoglycoside levels is warranted.