FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin Ophthalmic Solution USP, 0.3% occurs, discontinue use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tobramycin Ophthalmic Solution USP, 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 USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.
History
There is currently no drug history available for this drug.
Other Information
Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.
Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:
Chemical Name:
O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 → 4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)}-2-deoxystreptamine.
Each mL contains:
Active: Tobramycin 3 mg (0.3%). Inactives: Boric Acid, Sodium Chloride, Sodium Sulfate, Tyloxapol, Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and Water for Injection. Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
Sources
Tobramycin Solution/ Drops Manufacturers
- Henry Schein Inc.
- Blenheim Pharmacal, Inc.
Tobramycin Solution/ Drops | Blenheim Pharmacal, Inc.
In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
- Mwi
- Akorn, Inc.
- Stat Rx Usa Llc
- Remedyrepack Inc.
- Remedyrepack Inc.
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