Description

Tigecycline for Injection

Healthy Inc is a specialized global supplier and exporter of advanced, last-resort antimicrobial therapies. We provide high-purity Tigecycline for Injection (50 mg), manufactured in WHO–GMP certified sterile lyophilization facilities. This “First-in-Class Glycylcycline” is a mandatory export to intensive care units (ICU), infectious disease centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical salvage therapy for complicated, multi-drug resistant (MDR) bacterial infections where standard treatments have failed.

Product Overview

This formulation contains Tigecycline, a broad-spectrum intravenous antibiotic structurally derived from minocycline, belonging to the glycylcycline class.

The “Resistance-Breaking” Specialist:

• Mechanism (Enhanced Ribosomal Blockade): Like traditional tetracyclines, Tigecycline binds to the 30S ribosomal subunit, preventing amino-acyl tRNA from entering the A-site, thus halting bacterial protein synthesis. However, its unique 9-t-butylglycylamido substitution gives it a massive binding affinity—overcoming the two major mechanisms of tetracycline resistance: ribosomal protection proteins and active efflux pumps.
• Broad-Spectrum Salvage: It exhibits profound bacteriostatic activity against a wide range of Gram-positive, Gram-negative, atypical, and anaerobic organisms. It is highly valued for its efficacy against Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococci (VRE), and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae.
• The Pseudomonas Exception: Crucially, Tigecycline is not active against Pseudomonas aeruginosa or Proteus species.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder (Distinctive Orange to Orange-Yellow Cake) in glass vials.

*Pack Sizes: Single Vial or Tray of 10 Vials.

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.

• Oxidative Stability & Colorimetry: Tigecycline is exceptionally sensitive to oxidation. Our lyophilization cycle operates under strict nitrogen blanketing. The inclusion of L-Arginine acts as an essential stabilizer to maintain the API’s integrity. A high-quality cake will remain distinctly orange; our quality assurance guarantees zero degradation prior to seal.
• Sterile Lyophilization: Aseptic filtration and filling within Grade A cleanrooms ensure a pyrogen-free profile, vital for critically ill, septic patients receiving central line infusions.

Therapeutic Indications (Human Use)

Indicated strictly for the treatment of specific complicated infections in adults when alternative treatments are not suitable:

• Complicated Skin and Skin Structure Infections (cSSSI): Including those caused by MRSA and susceptible Gram-negative anaerobes.
• Complicated Intra-abdominal Infections (cIAI): Severe peritoneal infections requiring broad-spectrum anaerobic and aerobic coverage.
• Community-Acquired Bacterial Pneumonia (CABP): For susceptible strains. (Note: Not indicated for Hospital-Acquired or Ventilator-Associated Pneumonia).

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Specialist):

• Route: Intravenous (IV) Infusion ONLY.
• Standard Adult Dose: An initial loading dose of 100 mg, followed by 50 mg every 12 hours.
• Infusion Time: Must be administered as a slow IV infusion over 30 to 60 minutes.
• Hepatic Impairment: In patients with severe hepatic impairment (Child-Pugh C), the initial 100 mg loading dose is maintained, but the maintenance dose must be reduced to 25 mg every 12 hours.
• Reconstitution Protocol: Gently swirl the vial until dissolved. Do not shake vigorously. Dilute the reconstituted solution immediately into a 100 ml IV bag.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (All-Cause Mortality): An increase in all-cause mortality has been observed across Phase 3 and 4 clinical trials in patients treated with Tigecycline compared to comparator antibiotics. Tigecycline should be reserved for use in situations when alternative treatments are not suitable.
• Hepatotoxicity: Cases of severe liver dysfunction and hepatic failure have been reported.
• Acute Pancreatitis: Fatal cases of acute pancreatitis have occurred; discontinue if clinical symptoms suggest pancreatic inflammation.
• Tooth Development: Like traditional tetracyclines, it may cause permanent tooth discoloration and enamel hypoplasia if used during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years).

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.