Linezolid 100 mg/5 mL Suppliers & Bulk Manufacturers

Available Forms: Oral Suspension

Available Strengths: 100 mg/5 mL

Reference Brands: Zyvox(US & EU)

Category: Critical Care

Linezolid 100 mg/5 mL oral suspension, an oxazolidinone reserve antibiotic for resistant Gram-positive infections in children and tube-fed patients. For hospital buyers, importers and tender agencies.

Product Description:

Linezolid is an oxazolidinone antibacterial. It binds the 23S ribosomal RNA of the bacterial 50S subunit and blocks the initiation complex, so protein synthesis cannot start. It is active against Gram-positive organisms, including MRSA and vancomycin-resistant enterococci. This page covers the oral suspension, usually granules that give 100 mg/5 mL once made up with water. Oral linezolid is almost fully absorbed, so the liquid matches the infusion, serving children, tube-fed patients and those switching early from intravenous therapy.

Labelled uses include pneumonia and complicated skin infections caused by susceptible Gram-positive bacteria, and vancomycin-resistant enterococcal infections; it is also part of WHO regimens for drug-resistant tuberculosis. WHO places linezolid in its Reserve antibiotic group. Courses beyond two weeks need weekly blood counts because of myelosuppression, and longer use can cause peripheral and optic neuropathy. As a weak MAO inhibitor, it calls for caution with serotonergic drugs and tyramine-rich food. The bottle is gently inverted, not shaken, before each dose. Some formulas contain aspartame, a phenylalanine source.

Sourcing notes. Linezolid is prescription-only and usually governed by hospital antimicrobial stewardship. Ask for a CTD or ACTD dossier with bioequivalence data or a biowaiver justification, plus stability for the dry granules and the reconstituted suspension, with zone IVb data for tropical markets. Amber glass or HDPE bottles with a measuring device are usual, kept dry at room temperature. Each lot should come with its CoA, alongside a GMP certificate and CoPP. Give bottle volume, flavour and sweetener needs, dosing device, label language and quantity.