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Drug Catalog - Product Detail

TOBRAMYCIN 3MG/ML SOL 5ML

NDC Mfr Size Str Form
70069-0131-01 SOMERSET THERAPEUTICS 5 0.3% SOLUTION
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PACKAGE FILES

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Generic Name
TOBRAMYCIN
Substance Name
TOBRAMYCIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA207444
Description
DESCRIPTION Tobramycin ophthalmic solution 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. 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: C 18 H 37 N 5 O 9 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. Image
How Supplied
HOW SUPPLIED Tobramycin ophthalmic solution USP, 0.3% is supplied as a 5 mL sterile solution, packaged in a 10 mL white LDPE bottle and natural LDPE nozzle and White HDPE cap as follows: 5 mL containing tobramycin 0.3% (3 mg/mL)… NDC 70069- 131 -01. Storage: Store at 2° to 25°C (36° to 77°F). After opening, tobramycin ophthalmic solution 0.3% can be used until the expiration date on the bottle. For Product Inquiry call +1-800-417-9175 Revised: June, 2021 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 PSSO0483 ST-TBR11/P/06
Indications & Usage
INDICATIONS AND USAGE Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
Dosage and Administration
DOSAGE AND ADMINISTRATION In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.