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Gentamicin Sulfate Injection, USP, 80 mg/2 mL (40 mg/mL), 2 mL Multiple-Dose Vials
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Gentamicin Sulfate Injection, USP, 80 mg/2 mL (40 mg/mL), 2 mL Multiple-Dose Vials

SKU FRE 63323001002

$82.00

Packaging: 25 Vials per Carton. Confirm the selling unit with customer care before ordering if unclear.

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Brand
Fosun Pharma USA Inc

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Product details

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

  • Broad-Spectrum Efficacy: Highly effective against life-threatening Gram-negative infections, including those resistant to other antibiotics.

  • Flexible Administration: Can be administered via IM injection or IV infusion (when diluted in compatible solutions like 0.9% NaCl or 5% Dextrose).

  • Multiple-Dose Utility: The presence of antimicrobial preservatives makes this vial suitable for clinical environments requiring adjustable dosing from a single unit.

  • Therapeutic Equivalence: AP-rated generic equivalent, ensuring hospital-grade quality and efficacy standards.

  • Standard Concentration: The 40 mg/mL concentration is the clinical standard for adult dosing and pediatric weight-based calculations.

Clinical Applications

  • Septicemia: Treatment of bacterial neonatal sepsis and adult septicemia.

  • Respiratory Infections: Management of serious lower respiratory tract infections.

  • CNS Infections: Treatment of meningitis caused by susceptible organisms.

  • Complicated UTI: Management of severe or recurrent urinary tract infections.

  • 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.