Description

Gentamicin Sulfate Injection

Healthy Inc is a specialized global supplier and exporter of high-potency aminoglycoside antibiotics. We provide high-purity Gentamicin Sulfate Injection (80 mg / 2 ml), sourced from WHO–GMP certified sterile injectable facilities. This “Sepsis & Synergy” specialist is a top export to surgical wards, burn units, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the cost-effective backbone for treating severe Gram-negative infections and providing synergistic power in Endocarditis.

Product Overview

This formulation contains Gentamicin Sulfate, a broad-spectrum aminoglycoside antibiotic derived from Micromonospora purpurea.

The “Concentration-Dependent” Killer:

• Mechanism (The “Ribosome Wrecker”): Gentamicin binds irreversibly to the 30S subunit of the bacterial ribosome. This causes misreading of the genetic code and inhibits protein synthesis, leading to rapid bacterial death (Bactericidal).
• Synergy (The “Multiplier”): It is rarely used alone for Staph/Enterococcus. However, when combined with a Cell Wall Inhibitor (like Penicillin or Vancomycin), it penetrates the damaged wall to kill the bacteria from within. This “Synergy” is the standard of care for Infective Endocarditis.
• Post-Antibiotic Effect (PAE): Gentamicin continues to suppress bacterial growth even after blood levels drop below the MIC. This allows for “Once-Daily Dosing” regimens that maximize killing power while minimizing toxicity.

Product Composition & Strength

We supply this product as a Sterile Solution in Glass Ampoules or Vials.

*Pack Sizes: Tray of 5 Ampoules, 10 Ampoules, 50 Ampoules, or 100 Ampoules.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Color Stability: Gentamicin solutions can turn yellow/brown due to oxidation. We use precise amounts of Sodium Metabisulfite and Nitrogen headspace protection to ensure the solution remains water-clear throughout its shelf life.
• Sulfite Management: While sulfites are necessary antioxidants, they can cause allergic reactions. Our labeling clearly highlights this for asthmatic patients.

Therapeutic Indications (Human Use)

Indicated for serious infections caused by aerobic Gram-negative bacteria (Pseudomonas, Proteus, Klebsiella, E. coli, etc.):

• Sepsis / Bacteremia: Empirical therapy (with a beta-lactam).
• Infective Endocarditis: Synergistic therapy for Enterococcal or Staphylococcal valve infections.
• Urinary Tract Infections (UTI): Severe Pyelonephritis (Resistant to other drugs).
• Pelvic Inflammatory Disease (PID): Often combined with Clindamycin or Metronidazole.
• Burn Wound Infections: Pseudomonas coverage.

Dosage & Administration

Recommended Dosage (Strictly as per Physician – Narrow Therapeutic Index):

• Route: Intravenous (IV) Infusion or Intramuscular (IM).
• Traditional Dosing: 3 to 5 mg/kg/day in 3 divided doses (every 8 hours).
• Once-Daily Dosing (Preferred): 5 to 7 mg/kg as a single daily infusion. (Reduces kidney toxicity).
• Renal Impairment: Dose adjustment is MANDATORY. Extend the interval (e.g., every 24, 36, or 48 hours) based on Creatinine Clearance.
• TDM: Therapeutic Drug Monitoring (measuring blood levels) is recommended to prevent toxicity.

Safety Warnings (CRITICAL):

• Nephrotoxicity (Kidney Damage): Gentamicin accumulates in the renal cortex. Causes Acute Tubular Necrosis (ATN). usually reversible if caught early. Monitor Creatinine.
• Ototoxicity (Hearing/Balance Loss): Can cause PERMANENT hearing loss (cochlear) or dizziness/vertigo (vestibular). Risk increases with duration > 7 days.
• Neuromuscular Blockade: Can cause respiratory paralysis if given rapidly or with muscle relaxants (anesthesia). Infuse slowly over 30-60 mins.
• Pregnancy: Category D (Risk of fetal deafness). Avoid unless life-saving.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.