Description

Tobramycin Injection

Healthy Inc is a specialized global supplier and exporter of critical care antimicrobials and life-saving antibiotics. We provide high-purity Tobramycin Injection (40 mg/ml), manufactured in WHO–GMP certified sterile facilities. This “Anti-Pseudomonal” aminoglycoside is a mandatory export to intensive care units (ICU), pulmonology centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a heavy-duty intervention for severe, life-threatening Gram-negative infections, particularly those caused by multi-drug resistant Pseudomonas aeruginosa.

Product Overview

This formulation contains Tobramycin Sulfate, a narrow-spectrum, highly potent aminoglycoside antibiotic derived from Streptomyces tenebrarius.

The “Gram-Negative” Specialist:

• Mechanism (Ribosomal Inhibition): Tobramycin is rapidly bactericidal. It passively diffuses through porin channels in the outer membrane of Gram-negative bacteria and then actively transports across the inner cell membrane. It irreversibly binds to the specific receptor proteins on the 30S ribosomal subunit, causing misreading of the mRNA. This produces defective, toxic proteins that quickly lead to bacterial cell death.
• The Pseudomonas Advantage: While similar to Gentamicin, Tobramycin boasts an intrinsic, superior in vitro activity against Pseudomonas aeruginosa, making it the preferred aminoglycoside for respiratory exacerbations in cystic fibrosis patients and severe hospital-acquired pneumonias (HAP).
• Synergistic Action: It is frequently administered in combination with a beta-lactam antibiotic (like Piperacillin-Tazobactam or Ceftazidime). The beta-lactam breaks down the bacterial cell wall, allowing massive amounts of Tobramycin to flood into the bacteria, creating a lethal synergistic effect.

Product Composition & Strength

We supply this product as a Sterile, Clear, Colorless to Pale Yellow Aqueous Solution in glass vials or ampoules.

*Pack Sizes: Tray of 5/10 Vials or Box of 50 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.

• Oxidation Control: Aminoglycoside solutions are highly susceptible to oxidation. Our compounding lines utilize a rigorous Nitrogen purging protocol to displace oxygen from the vial headspace, working in tandem with the Sodium Metabisulfite antioxidant to ensure a stable, 24-month to 36-month shelf life.
• Aseptic Integrity: Manufactured using validated terminal sterilization or aseptic filtration (depending on the specific pack presentation) to guarantee the 100% pyrogen-free standard required for direct central-line intravenous infusion.

Therapeutic Indications (Human Use)

Indicated for the treatment of severe systemic infections caused by susceptible Gram-negative bacilli:

• Septicemia & Bacteremia: Life-threatening bloodstream infections.
• Lower Respiratory Tract Infections: Severe pneumonias, particularly in patients with cystic fibrosis or mechanical ventilation.
• Central Nervous System (CNS) Infections: Meningitis (often requiring specialized intrathecal administration if IV penetration is insufficient).
• Intra-abdominal Infections: Peritonitis (usually combined with an anaerobic-coverage antibiotic like Clindamycin or Metronidazole).
• Complicated Urinary Tract Infections (cUTIs): Severe pyelonephritis unresponsive to first-line agents.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Specialist):

• Route: Intramuscular (IM) Injection or Slow Intravenous (IV) Infusion.
• Standard Adult Dosing (Traditional): 3 mg/kg/day administered in 3 equally divided doses every 8 hours.
• Extended-Interval Dosing (Once-Daily): 5 to 7 mg/kg administered IV once every 24 hours. (This method maximizes the concentration-dependent bactericidal effect while minimizing nephrotoxic accumulation).
• IV Infusion Guidelines: The calculated dose must be diluted in 50 to 100 ml of 0.9% Normal Saline or 5% Dextrose and infused slowly over 20 to 60 minutes.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Nephrotoxicity): Aminoglycosides concentrate in the renal cortex, causing acute tubular necrosis. Renal function (serum creatinine, BUN) must be monitored daily. Dose adjustments are mandatory in patients with renal impairment.
• BLACK BOX WARNING (Ototoxicity): Can cause irreversible damage to the 8th cranial nerve, resulting in permanent hearing loss (cochlear toxicity) and extreme vertigo/loss of balance (vestibular toxicity).
• Neuromuscular Blockade: Rapid IV push or high doses can cause severe neuromuscular blockade, leading to respiratory paralysis, particularly if combined with anesthesia or muscle relaxants.
• Therapeutic Drug Monitoring (TDM): Serum peak and trough concentrations of Tobramycin must be routinely measured to ensure efficacy (peak) and prevent toxic accumulation (trough).

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 Critical Care Antibiotics, 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.