VIOCIN SULFATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIOCIN SULFATE (VIOCIN SULFATE).
Viomycin sulfate inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, interfering with mRNA translation.
| Metabolism | Not extensively metabolized; primarily excreted unchanged by glomerular filtration. |
| Excretion | Renal (70-90% unchanged) via glomerular filtration; minor biliary/fecal (<5%). |
| Half-life | 2-4 hours in normal renal function; prolonged to 24-40 hours in anuria. |
| Protein binding | Low: approximately 10%; primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg; distributes mainly in extracellular fluid. |
| Bioavailability | IM: nearly 100% (drug is only administered intramuscularly). |
| Onset of Action | IM: 1-2 hours for therapeutic serum levels. |
| Duration of Action | 8-12 hours; dosing interval must be adjusted in renal impairment to avoid accumulation and ototoxicity. |
1-2 g intramuscularly every 12 hours (2 divided doses) for 2-4 months; maximum daily dose 2 g.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >80 mL/min: 1-2 g every 12h; CrCl 50-80 mL/min: 1-2 g every 24h; CrCl 30-50 mL/min: 1-2 g every 48h; CrCl 10-30 mL/min: 1-2 g every 72h; CrCl <10 mL/min: 1-2 g every 96h; dosing based on viomycin (component of viocin sulfate). Monitor drug levels. |
| Liver impairment | No specific adjustments for Child-Pugh class A, B, or C; use caution and monitor renal function as drug is renally eliminated. |
| Pediatric use | 15 mg/kg intramuscularly every 12 hours; not to exceed 1 g/day. |
| Geriatric use | Start at lower end of dosing range (e.g., 1 g every 24-48h) based on renal function; adjust according to CrCl; monitor for ototoxicity and nephrotoxicity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIOCIN SULFATE (VIOCIN SULFATE).
| Breastfeeding | Viomycin is excreted into human breast milk in low concentrations; M/P ratio not established. Potential for infant gastrointestinal disturbance, ototoxicity, and nephrotoxicity. American Academy of Pediatrics considers compatible with breastfeeding, but caution advised due to theoretical risks. |
| Teratogenic Risk | Viocin sulfate (viomycin) is an aminoglycoside antibiotic. In the first trimester, there is potential for irreversible bilateral sensorineural hearing loss due to ototoxicity. In the second and third trimesters, continued risk of fetal ototoxicity and nephrotoxicity. Category D: positive evidence of human fetal risk. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to viomycin, pre-existing severe renal impairment, pregnancy (potential fetal harm).
| Precautions | Nephrotoxicity, ototoxicity (vestibular and auditory), and neuromuscular blockade. Monitor renal function and audiometry. Use with caution in patients with renal impairment or myasthenia gravis. |
Loading safety data…
| Fetal Monitoring | Maternal: audiometry before and during therapy, serum viomycin trough concentrations (target <5 mcg/mL), renal function tests (serum creatinine, BUN, urinalysis). Fetal: serial ultrasound for growth, amniotic fluid volume assessment due to nephrotoxicity, newborn hearing screen after delivery. |
| Fertility Effects | No specific human studies on fertility. Animal studies show no direct effect on fertility. Potential for ovarian toxicity at high doses not established in humans. Use during pregnancy may affect fetal gonadal development theoretically, but data lacking. |