Source: FDA, National Drug Code (US) Revision Year: 2022
TOBREX (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.
Each mL of TOBREX (tobramycin ophthalmic solution) 0.3% contains:
Active: tobramycin 0.3% (3 mg).
Preservative: benzalkonium chloride 0.01% (0.1 mg).
Inactives: boric acid, purified water, sodium chloride, sodium hydroxide and/or sulfuric acid (to adjust pH), sodium sulfate, and tyloxapol. TOBREX (tobramycin ophthalmic solution) 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.
Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.
The chemical structure of tobramycin is:
Molecular Weight = 467.52
Molecular Formula: C18H37N5O9
Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)}0{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6)}-2-deoxystreptamine.
| How Supplied |
|---|
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TOBREX (tobramycin ophthalmic solution) 0.3% is supplied as a 5 mL sterile solution, packaged in a 8 mL low density polyethylene white bottle and natural dispensing plug and white polypropylene closure as follows: 5 mL containing tobramycin 0.3% (3 mg/mL) NDC 0065-0643-05 Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 |
| Drug | Countries | |
|---|---|---|
| TOBREX | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United States, South Africa |
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