KANAMYCIN SULFATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KANAMYCIN SULFATE (KANAMYCIN SULFATE).
Aminoglycoside antibiotic that irreversibly binds to the 30S ribosomal subunit, inhibiting protein synthesis and causing mRNA misreading.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Renal excretion of unchanged drug accounts for 80-90% of elimination; minor biliary excretion (<1%) and fecal elimination (<1%). |
| Half-life | Terminal elimination half-life is 2-4 hours in adults with normal renal function; prolonged to 30-60 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | Low; approximately 0-10%, primarily to albumin. |
| Volume of Distribution | 0.2-0.4 L/kg; reflects distribution primarily into extracellular fluid. |
| Bioavailability | Intramuscular: ~100%; Oral: <1% (not absorbed); Ophthalmic: minimal systemic absorption (<1%). |
| Onset of Action | Intramuscular: 1-2 hours; Intravenous: immediate; Ophthalmic: 15-30 minutes. |
| Duration of Action | Intramuscular: 8-12 hours; Intravenous: 6-8 hours; Ophthalmic: 4-6 hours. |
15 mg/kg/day IM or IV divided every 8-12 hours; typical adult dose: 500 mg IM every 12 hours or 7.5 mg/kg every 12 hours. Maximum total daily dose: 1.5 g.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 50-90 mL/min: administer every 24 hours. GFR 10-50 mL/min: administer every 24-72 hours. GFR <10 mL/min: administer every 72-96 hours. Dose adjustments based on serum concentrations. |
| Liver impairment | No dose adjustment required for hepatic impairment. Kanamycin is primarily renally eliminated. |
| Pediatric use | Neonates: 7.5-10 mg/kg IV every 12 hours. Infants and children: 15 mg/kg/day IM or IV divided every 8-12 hours. Maximum total daily dose: 1.5 g. |
| Geriatric use | Lower initial and maintenance doses due to age-related decrease in renal function. Monitor renal function and serum concentrations closely. Consider dosing based on ideal body weight and renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KANAMYCIN SULFATE (KANAMYCIN SULFATE).
| Breastfeeding | Excreted into breast milk in small amounts; M/P ratio not established. Use caution in breastfeeding due to potential for infant ototoxicity and nephrotoxicity; monitor infant for diarrhea, rash, and hearing loss. |
| Teratogenic Risk | First trimester: No evidence of teratogenicity in humans, but crosses placenta and may cause fetal ototoxicity. Second and third trimesters: Risk of fetal ototoxicity (irreversible bilateral hearing loss) and nephrotoxicity, especially with prolonged or high-dose therapy. |
■ FDA Black Box Warning
Boxed warnings: Neurotoxicity (ototoxicity vestibular and auditory), nephrotoxicity, and neuromuscular blockade. Risk increases with high doses, prolonged use, renal impairment, and concurrent use of other ototoxic/nephrotoxic drugs. Monitor renal function and drug levels. Avoid in pregnancy.
| Serious Effects |
Hypersensitivity to kanamycin or other aminoglycosides; myasthenia gravis (increased risk of neuromuscular blockade).
| Precautions | Ototoxicity (vestibular and auditory) can be irreversible, especially with renal impairment, high doses, prolonged therapy, or concurrent ototoxic drugs. Nephrotoxicity risk; monitor renal function and serum drug levels. Neuromuscular blockade risk, especially with anesthetics, neuromuscular blocking agents, or in patients with neuromuscular disorders. Superinfection, Clostridium difficile diarrhea. Use caution in elderly, dehydration, and pre-existing renal impairment. |
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| Fetal Monitoring |
| Monitor maternal renal function, serum drug levels (trough <5 mcg/mL, peak 20-35 mcg/mL), and hearing (audiometry before and during therapy). Fetal monitoring for growth and wellbeing if used in pregnancy; neonatal hearing screen at birth. |
| Fertility Effects | No known adverse effects on human fertility; animal studies show reversible testicular atrophy at high doses. |