Description

Amikacin Sulphate Injection

Healthy Inc is a specialized global supplier and exporter of advanced semi-synthetic aminoglycosides. We provide high-purity Amikacin Sulphate Injection (100mg / 250mg / 500mg), sourced from WHO–GMP certified sterile injectable facilities. This “Reserve Antibiotic” is a top export to intensive care units (ICUs), burn centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the critical line of defense against severe, multi-drug resistant Gram-negative infections.

Product Overview

This formulation contains Amikacin, an aminoglycoside antibiotic derived from Kanamycin A.

The “Resistant Bacteria” Specialist:

• Mechanism (Protein Synthesis Inhibition): Amikacin irreversibly binds to the bacterial 30S ribosomal subunit, blocking the formation of the initiation complex and causing misreading of mRNA. This leads to the production of non-functional proteins and rapid bacterial cell death.
• Resistance Breaker: Its unique chemical structure makes it resistant to many aminoglycoside-inactivating enzymes that degrade Gentamicin and Tobramycin. Therefore, it is often effective against bacteria that have developed resistance to other aminoglycosides.
• Spectrum: Highly active against aerobic Gram-negative bacteria including Pseudomonas aeruginosa, Escherichia coli, Klebsiella, and Acinetobacter. It is also a second-line agent for Multi-Drug Resistant Tuberculosis (MDR-TB).

Product Composition & Strength

We supply this product as a Sterile Liquid in Glass Vials or Ampoules. The solution is clear, colorless to pale yellow, and requires no reconstitution (ready-to-use).

*Pack Sizes: Tray of 10 Ampoules or Box of 1/10 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.

• Sterility Assurance: Manufactured in state-of-the-art aseptic processing lines. We utilize terminal sterilization or aseptic filtration to ensure the product is pyrogen-free and sterile.
• Oxidation Protection: Amikacin is sensitive to oxygen. Our vials are flushed with nitrogen and contain antioxidants (sulfites) to prevent discoloration and potency loss during the shelf life.

Therapeutic Indications (Human Use)

Indicated for the short-term treatment of serious infections due to susceptible strains:

• Severe Systemic Infections: Sepsis (blood poisoning) in adults and neonates.
• Respiratory Tract: Severe pneumonia (hospital-acquired).
• CNS Infections: Meningitis (often intrathecal use considered).
• Urinary Tract: Complicated UTIs resistant to other drugs.
• MDR-TB: As part of a multi-drug regimen for resistant Tuberculosis.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Intramuscular (IM) or Slow Intravenous (IV) Infusion.
• Adults: 15 mg/kg/day divided into 2 or 3 equal doses (every 8-12 hours).
• Renal Impairment: Dose MUST be adjusted based on Creatinine Clearance (CrCl) to avoid toxicity.
• Peak/Trough Levels: Therapeutic Drug Monitoring (TDM) is recommended to ensure efficacy and avoid toxicity.

Safety Warnings (BLACK BOX):

• Ototoxicity (Hearing Loss): Can cause irreversible hearing loss and balance problems (vestibular damage). Risk increases with high doses or prolonged use.
• Nephrotoxicity (Kidney Damage): Can cause kidney failure. Monitor renal function (BUN/Creatinine) regularly.
• Neuromuscular Blockade: Can cause respiratory paralysis (muscle weakness). Use caution with anesthesia or muscle relaxants.
• Hydration: Patients should be well-hydrated during therapy.

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.