TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical safety rating: avoid

Other nephrotoxic or ototoxic drugs increase risk of toxicity Monitor peak and trough levels to minimize risk of nephrotoxicity and ototoxicity.

How it works

Tobramycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibiting protein synthesis in susceptible bacteria.

What the body does with it

Metabolism	Tobramycin is primarily eliminated unchanged by the kidneys via glomerular filtration. Minimal hepatic metabolism occurs.
Excretion	Primarily renal (glomerular filtration) with >90% excreted unchanged in urine within 24 hours; minimal biliary/fecal (<1%).
Half-life	2-3 hours in patients with normal renal function; prolonged to 24-60 hours in anuria. Half-life is directly correlated with creatinine clearance.
Protein binding	<30%, primarily to albumin.
Volume of Distribution	0.26 L/kg in adults; higher in critically ill (0.3-0.4 L/kg). Indicates primarily extracellular fluid distribution.
Bioavailability	Intravenous: 100%. Not absorbed orally; inhalation: variable, systemic bioavailability <20%.
Onset of Action	Intravenous: rapid, within 30 minutes of infusion; peak concentrations achieved at end of infusion.
Duration of Action	Concentration-dependent; typically 6-8 hours with conventional dosing, longer with once-daily dosing due to post-antibiotic effect.

Classification & Brands

Dosing & administration

3-5 mg/kg/day IV divided every 8 hours or 5-7 mg/kg IV once daily for adults with normal renal function.

Dosage form	INJECTABLE
Renal impairment	CrCl 30-59 mL/min: extend interval to every 12 hours; CrCl 10-29 mL/min: every 24 hours; CrCl <10 mL/min: every 48-72 hours or per serum concentrations.
Liver impairment	No dose adjustment required for hepatic impairment; monitor for ototoxicity if concurrent hepatotoxicity present.
Pediatric use	Neonates: 4 mg/kg IV every 24-48 hours adjusted for renal function; Infants/Children: 6-7.5 mg/kg/day IV divided every 8 hours or 7.5 mg/kg IV once daily.
Geriatric use	Initial dose based on ideal body weight; adjust interval per renal function; monitor serum concentrations and avoid prolonged courses due to increased nephrotoxicity risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Other nephrotoxic or ototoxic drugs increase risk of toxicity Monitor peak and trough levels to minimize risk of nephrotoxicity and ototoxicity.

FDA category	Positive
Breastfeeding	Very small amounts excreted into breast milk (M/P ratio unknown). Poor oral bioavailability in infants limits systemic absorption. Considered compatible with breastfeeding in standard doses; monitor infant for diarrhea, candidiasis, or rash.
Teratogenic Risk	Aminoglycosides cross the placenta. First trimester: limited human data, no clear structural malformations. Second and third trimesters: risk of fetal ototoxicity (eighth cranial nerve damage) and nephrotoxicity, especially with prolonged or high-dose exposure. Avoid unless essential.

Warnings & precautions

■ FDA Black Box Warning

Aminoglycosides can cause nephrotoxicity, ototoxicity (vestibular and auditory), and neuromuscular blockade. Risk is increased with higher doses, prolonged use, renal impairment, or concurrent use of other nephrotoxic/ototoxic drugs.

Side Effect Profile

Common Effects	Nephrotoxicity
Serious Effects

Absolute Contraindications

["Hypersensitivity to tobramycin or any aminoglycoside","Myasthenia gravis (relative: may exacerbate weakness)"]

Clinical Precautions

Precautions

Monitor renal function (serum creatinine, BUN, urine output) and auditory/vestibular function. Adjust dose based on renal function. Risk of neuromuscular blockade (caution in myasthenia gravis, parkinsonism). Avoid concurrent use of other nephrotoxic/ototoxic drugs. Use in pregnancy only if clearly needed (risk of fetalotoxicity).

Clinical Tips & Counseling

Drug interactions

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TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical safety rating: avoid

Other nephrotoxic or ototoxic drugs increase risk of toxicity Monitor peak and trough levels to minimize risk of nephrotoxicity and ototoxicity.

How it works

Tobramycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibiting protein synthesis in susceptible bacteria.

What the body does with it

Metabolism	Tobramycin is primarily eliminated unchanged by the kidneys via glomerular filtration. Minimal hepatic metabolism occurs.
Excretion	Primarily renal (glomerular filtration) with >90% excreted unchanged in urine within 24 hours; minimal biliary/fecal (<1%).
Half-life	2-3 hours in patients with normal renal function; prolonged to 24-60 hours in anuria. Half-life is directly correlated with creatinine clearance.
Protein binding	<30%, primarily to albumin.
Volume of Distribution	0.26 L/kg in adults; higher in critically ill (0.3-0.4 L/kg). Indicates primarily extracellular fluid distribution.
Bioavailability	Intravenous: 100%. Not absorbed orally; inhalation: variable, systemic bioavailability <20%.
Onset of Action	Intravenous: rapid, within 30 minutes of infusion; peak concentrations achieved at end of infusion.
Duration of Action	Concentration-dependent; typically 6-8 hours with conventional dosing, longer with once-daily dosing due to post-antibiotic effect.

Classification & Brands

Dosing & administration

3-5 mg/kg/day IV divided every 8 hours or 5-7 mg/kg IV once daily for adults with normal renal function.

Dosage form	INJECTABLE
Renal impairment	CrCl 30-59 mL/min: extend interval to every 12 hours; CrCl 10-29 mL/min: every 24 hours; CrCl <10 mL/min: every 48-72 hours or per serum concentrations.
Liver impairment	No dose adjustment required for hepatic impairment; monitor for ototoxicity if concurrent hepatotoxicity present.
Pediatric use	Neonates: 4 mg/kg IV every 24-48 hours adjusted for renal function; Infants/Children: 6-7.5 mg/kg/day IV divided every 8 hours or 7.5 mg/kg IV once daily.
Geriatric use	Initial dose based on ideal body weight; adjust interval per renal function; monitor serum concentrations and avoid prolonged courses due to increased nephrotoxicity risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Other nephrotoxic or ototoxic drugs increase risk of toxicity Monitor peak and trough levels to minimize risk of nephrotoxicity and ototoxicity.

FDA category	Positive
Breastfeeding	Very small amounts excreted into breast milk (M/P ratio unknown). Poor oral bioavailability in infants limits systemic absorption. Considered compatible with breastfeeding in standard doses; monitor infant for diarrhea, candidiasis, or rash.
Teratogenic Risk	Aminoglycosides cross the placenta. First trimester: limited human data, no clear structural malformations. Second and third trimesters: risk of fetal ototoxicity (eighth cranial nerve damage) and nephrotoxicity, especially with prolonged or high-dose exposure. Avoid unless essential.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Common Effects	Nephrotoxicity
Serious Effects

Absolute Contraindications

["Hypersensitivity to tobramycin or any aminoglycoside","Myasthenia gravis (relative: may exacerbate weakness)"]