KANTREX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KANTREX (KANTREX).
Aminoglycoside antibiotic that binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis and causing mRNA misreading.
| Metabolism | Minimally metabolized; primarily excreted unchanged by glomerular filtration. |
| Excretion | Renal: 80-100% as unchanged drug via glomerular filtration; fecal: <1% |
| Half-life | 2-3 hours (normal renal function); prolonged to 30-50 hours in anuria; clinically significant accumulation in renal impairment requires monitoring |
| Protein binding | 0-10% (low, primarily to albumin) |
| Volume of Distribution | 0.26-0.4 L/kg (primarily extracellular fluid; does not cross blood-brain barrier) |
| Bioavailability | IM: ~100%; oral: <1% (non-absorbable); intraperitoneal: ~100% |
| Onset of Action | IM: 15-30 minutes; IV: immediate; oral: not absorbed systemically (only for bowel decontamination) |
| Duration of Action | 6-8 hours (IM/IV); prolonged in renal impairment |
15 mg/kg/day IM or IV divided every 8-12 hours (not to exceed 1.5 g/day)
| Dosage form | CAPSULE |
| Renal impairment | CrCl 50-90 mL/min: 7.5 mg/kg every 12 hours; CrCl 10-50 mL/min: 7.5 mg/kg every 24-48 hours; CrCl <10 mL/min: 7.5 mg/kg every 48-72 hours or per serum levels |
| Liver impairment | No specific Child-Pugh based modifications; use with caution in hepatic impairment |
| Pediatric use | Infants and children: 7.5-15 mg/kg/day IM/IV divided every 8-12 hours; neonates (<7 days): 7.5 mg/kg every 12 hours; >7 days: 7.5 mg/kg every 8 hours |
| Geriatric use | Reduce dose based on renal function; initial dose may be 5-7.5 mg/kg, then adjust per CrCl and serum levels |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KANTREX (KANTREX).
| Breastfeeding | Excreted into breast milk in small amounts (M/P ratio not determined). Oral bioavailability in infants is low due to poor gastrointestinal absorption; however, potential for alteration of infant gut microbiota and direct toxicity (ototoxicity/nephrotoxicity) exists. Use with caution, weighing benefit to mother against risk to infant. |
| Teratogenic Risk | FDA Pregnancy Category D. Aminoglycosides cross the placenta. First trimester: Risk of ototoxicity and nephrotoxicity in the fetus, though specific structural teratogenicity is not established. Second and third trimesters: Potential for fetal eighth cranial nerve damage (auditory and vestibular) and renal impairment, especially with prolonged or high-dose maternal therapy. Avoid use in pregnancy unless clearly needed. |
■ FDA Black Box Warning
Aminoglycosides can cause neurotoxicity (including vestibular and auditory ototoxicity) and nephrotoxicity. Risk is higher with renal impairment, high doses, prolonged use, or concurrent use of other nephrotoxic or ototoxic drugs. Monitoring renal function and serum drug levels is essential.
| Serious Effects |
Hypersensitivity to kanamycin or other aminoglycosides; history of severe toxic reaction to aminoglycosides; myasthenia gravis (relative).
| Precautions | Ototoxicity (vestibular and auditory) may be irreversible; monitor for tinnitus, dizziness, hearing loss. Nephrotoxicity risk; monitor renal function and adjust dose accordingly. Neuromuscular blockade risk, especially in patients with myasthenia gravis or receiving neuromuscular blocking agents. Avoid concomitant use with other nephrotoxic or ototoxic drugs. |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum drug concentrations (peak and trough) to avoid toxicity; assess renal function (serum creatinine, BUN) and hearing (audiometry) in the mother. For fetus/newborn: consider auditory screening and renal function assessment if maternal exposure is prolonged or at high doses. |
| Fertility Effects | No specific data on fertility impairment. Aminoglycosides may affect ovarian function indirectly in animals, but human data are lacking. |