Product Specifications
| Specification | Details |
| Manufacturer / Brand | Fresenius Kabi USA, LLC |
| Manufacturer # / SKU | 63323001002 |
| NDC Number | 63323-0010-02 |
| Active Ingredient | Gentamicin Sulfate |
| Strength | 80 mg / 2 mL (40 mg/mL) |
| Volume per Unit | 2 mL |
| Container Type | Multiple-Dose Vial (MDV) |
| Formulation | Sterile Aqueous Solution with Preservatives |
| Route of Admin | Intramuscular (IM) or Intravenous (IV) |
| Packaging | 25 Vials per Carton |
| Latex Content | Not made with natural rubber latex |
Key Features
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Broad-Spectrum Efficacy: Highly effective against life-threatening Gram-negative infections, including those resistant to other antibiotics.
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Flexible Administration: Can be administered via IM injection or IV infusion (when diluted in compatible solutions like 0.9% NaCl or 5% Dextrose).
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Multiple-Dose Utility: The presence of antimicrobial preservatives makes this vial suitable for clinical environments requiring adjustable dosing from a single unit.
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Therapeutic Equivalence: AP-rated generic equivalent, ensuring hospital-grade quality and efficacy standards.
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Standard Concentration: The 40 mg/mL concentration is the clinical standard for adult dosing and pediatric weight-based calculations.
Clinical Applications
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Septicemia: Treatment of bacterial neonatal sepsis and adult septicemia.
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Respiratory Infections: Management of serious lower respiratory tract infections.
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CNS Infections: Treatment of meningitis caused by susceptible organisms.
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Complicated UTI: Management of severe or recurrent urinary tract infections.
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Bone/Skin Infections: Treatment of osteomyelitis and infected surgical wounds.
⚠️ Black Box Warning: Nephrotoxicity and Ototoxicity. Aminoglycosides can cause significant kidney damage and permanent hearing loss or balance issues. Close monitoring of renal function and serum drug concentrations is required.
⚠️ Safety Alert: Use with caution in patients with pre-existing renal impairment or those receiving other neurotoxic/nephrotoxic drugs.
⚠️ Usage Note: When administered intravenously, the dose should be infused over a period of 30 minutes to 2 hours to minimize the risk of neuromuscular blockade.
