U-GENCIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for U-GENCIN (U-GENCIN).

How it works

Aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis.

What the body does with it

Metabolism	Not metabolized; excreted unchanged primarily by glomerular filtration.
Excretion	Primarily renal (glomerular filtration) with 40-70% excreted unchanged in urine within 24 hours; minor biliary/fecal (<5%)
Half-life	Terminal elimination half-life is 2-3 hours in patients with normal renal function; may prolong to 20-40 hours in end-stage renal disease
Protein binding	10-20% bound to serum albumin
Volume of Distribution	0.2-0.4 L/kg, indicating limited distribution primarily to extracellular fluid
Bioavailability	Intramuscular: approximately 100%; Topical: negligible systemic absorption; Ophthalmic: negligible systemic absorption
Onset of Action	Intramuscular: 30-60 minutes; Topical: local effect within 24-48 hours; Ophthalmic: 15-30 minutes
Duration of Action	Intramuscular: 6-8 hours; Topical: varies with formulation; Ophthalmic: 6-8 hours

Classification & Brands

Dosing & administration

1-2 mg/kg IV every 8 hours for 7-10 days, targeting peak serum concentration of 6-10 mcg/mL and trough <2 mcg/mL.

Dosage form	INJECTABLE
Renal impairment	For CrCl 30-60 mL/min: administer every 12-18 hours; CrCl 15-29 mL/min: every 24 hours; CrCl <15 mL/min: every 48-72 hours or based on serum levels. Hemodialysis: administer 1-2 mg/kg post-dialysis.
Liver impairment	No dose adjustment required for hepatic impairment; monitor serum levels as changes in volume of distribution may occur.
Pediatric use	Neonates (0-4 weeks): 2.5 mg/kg IV every 12 hours; Infants and children: 1-2.5 mg/kg IV every 8 hours; adjust based on renal function and therapeutic drug monitoring.
Geriatric use	Initial dose of 1 mg/kg IV, then adjust based on renal function (CrCl calculated using Cockcroft-Gault) and serum concentrations; monitor nephrotoxicity and ototoxicity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for U-GENCIN (U-GENCIN).

Breastfeeding	Gentamicin is excreted into breast milk in low concentrations (M/P ratio approximately 0.3-0.5). The absolute infant dose is less than 1% of the maternal therapeutic dose, which is considered negligible. However, caution is advised due to potential gut flora alterations and theoretical ototoxicity. Use with monitoring for infant diarrhea or candidiasis.
Teratogenic Risk	U-GENCIN (gentamicin) is an aminoglycoside antibiotic. There is no evidence of major teratogenicity in human studies, but it carries a risk of fetal nephrotoxicity and ototoxicity, especially in the second and third trimesters. Prolonged exposure may lead to sensorineural hearing loss. Use only if clearly needed and monitor fetal well-being.

Warnings & precautions

■ FDA Black Box Warning

WARNING: Nephrotoxicity and ototoxicity (auditory and vestibular) may occur, especially in patients with renal impairment, pre-existing hearing loss, or those receiving high doses or prolonged therapy. Neurotoxicity (neuromuscular blockade) may occur. Risk is increased with concurrent use of other nephrotoxic, ototoxic, or neurotoxic drugs.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to gentamicin or other aminoglycosides. Avoid in pregnancy due to risk of fetal harm (categorization not defined in standard sources; use only if clearly needed).

Clinical Precautions

Precautions

Monitor renal function, auditory and vestibular function, and serum drug levels. Avoid prolonged use. Use caution in patients with renal impairment, myasthenia gravis, or hypocalcemia. Hydration should be maintained.

Clinical Tips & Counseling

Drug interactions

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U-GENCIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for U-GENCIN (U-GENCIN).

How it works

Aminoglycoside antibiotic that binds to the 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis.

What the body does with it

Metabolism	Not metabolized; excreted unchanged primarily by glomerular filtration.
Excretion	Primarily renal (glomerular filtration) with 40-70% excreted unchanged in urine within 24 hours; minor biliary/fecal (<5%)
Half-life	Terminal elimination half-life is 2-3 hours in patients with normal renal function; may prolong to 20-40 hours in end-stage renal disease
Protein binding	10-20% bound to serum albumin
Volume of Distribution	0.2-0.4 L/kg, indicating limited distribution primarily to extracellular fluid
Bioavailability	Intramuscular: approximately 100%; Topical: negligible systemic absorption; Ophthalmic: negligible systemic absorption
Onset of Action	Intramuscular: 30-60 minutes; Topical: local effect within 24-48 hours; Ophthalmic: 15-30 minutes
Duration of Action	Intramuscular: 6-8 hours; Topical: varies with formulation; Ophthalmic: 6-8 hours

Classification & Brands

Dosing & administration

1-2 mg/kg IV every 8 hours for 7-10 days, targeting peak serum concentration of 6-10 mcg/mL and trough <2 mcg/mL.

Dosage form	INJECTABLE
Renal impairment	For CrCl 30-60 mL/min: administer every 12-18 hours; CrCl 15-29 mL/min: every 24 hours; CrCl <15 mL/min: every 48-72 hours or based on serum levels. Hemodialysis: administer 1-2 mg/kg post-dialysis.
Liver impairment	No dose adjustment required for hepatic impairment; monitor serum levels as changes in volume of distribution may occur.
Pediatric use	Neonates (0-4 weeks): 2.5 mg/kg IV every 12 hours; Infants and children: 1-2.5 mg/kg IV every 8 hours; adjust based on renal function and therapeutic drug monitoring.
Geriatric use	Initial dose of 1 mg/kg IV, then adjust based on renal function (CrCl calculated using Cockcroft-Gault) and serum concentrations; monitor nephrotoxicity and ototoxicity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for U-GENCIN (U-GENCIN).

Breastfeeding	Gentamicin is excreted into breast milk in low concentrations (M/P ratio approximately 0.3-0.5). The absolute infant dose is less than 1% of the maternal therapeutic dose, which is considered negligible. However, caution is advised due to potential gut flora alterations and theoretical ototoxicity. Use with monitoring for infant diarrhea or candidiasis.
Teratogenic Risk	U-GENCIN (gentamicin) is an aminoglycoside antibiotic. There is no evidence of major teratogenicity in human studies, but it carries a risk of fetal nephrotoxicity and ototoxicity, especially in the second and third trimesters. Prolonged exposure may lead to sensorineural hearing loss. Use only if clearly needed and monitor fetal well-being.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to gentamicin or other aminoglycosides. Avoid in pregnancy due to risk of fetal harm (categorization not defined in standard sources; use only if clearly needed).