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. |
| Molecular Weight | 685.7 |
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 | Avoid due to potential nephrotoxicity and ototoxicity; use only if no alternative and life-threatening infection. |
| 2nd trimester | Use only if clearly needed; monitor fetal effects as aminoglycosides may cause fetal harm. |
| 3rd trimester | Avoid near term due to risk of neonatal toxicity; may cause eighth cranial nerve damage. |
Clinical note
Comprehensive clinical and safety monograph for VIOCIN SULFATE (VIOCIN SULFATE).
| Placental transfer | Crosses placenta; fetal serum concentrations may reach 50% of maternal levels. |
| Breastfeeding | Excreted into breast milk in low concentrations; however, poor oral absorption minimizes systemic exposure to infant. Caution advised due to potential for alteration of infant gut flora and direct toxicity. Consider risk-benefit. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to viomycin or other aminoglycosidesMyasthenia gravis (may exacerbate weakness)
| 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. |
| Food/Dietary | No clinically significant food interactions have been reported with viomycin sulfate. However, maintain adequate hydration with meals to support renal function. Avoid excessive salt intake if edema or hypertension is a concern. No specific dietary restrictions required. |
| Clinical Pearls |
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| Lactation Rating |
| L3 (Moderately Safe) |
| 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. |
| 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. |
| Viomycin sulfate is an aminoglycoside-like antibiotic used as a second-line agent for multidrug-resistant tuberculosis. Monitor for nephrotoxicity (serum creatinine, BUN) and ototoxicity (audiometry at baseline and periodically). Administer via deep IM injection only, rotate sites to minimize sterile abscess formation. Avoid concurrent use of other nephrotoxic or ototoxic drugs (e.g., aminoglycosides, loop diuretics). Dose adjustment required in renal impairment (CrCl < 50 mL/min). Electrolyte disturbances (especially hypokalemia, hypomagnesemia) may exacerbate neuromuscular blockade. In patients with myasthenia gravis or Parkinson's disease, use extreme caution due to risk of respiratory depression. |
| Patient Advice | This medication is given as an injection into a muscle, typically by a healthcare provider; do not attempt to self-administer. · Report any hearing loss, ringing in the ears, dizziness, or balance problems immediately. · Watch for signs of kidney problems: decreased urination, swelling, fatigue, or unusual thirst. · Drink plenty of fluids unless instructed otherwise by your doctor. · Avoid taking other medications that can harm your kidneys or hearing, such as certain pain relievers (e.g., NSAIDs) or water pills (diuretics), without consulting your doctor. · Report any injection site pain, redness, or hard lumps; these may require site rotation. · If you have muscle weakness, trouble breathing, or vision changes, seek immediate medical attention. · Complete the full course of therapy as prescribed; do not miss doses even if you feel better. |