Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in plastic dropper bottles in two sizes: NDC 63187-902-02. . . . . . . . . . . . 2 mL NDC 63187-902-05. . . . . . . . . . . . 5 mL; Principal Display Panel Text for Container Label: NDC 63187-902-05 Tobramycin Ophthalmic Solution, USP 0.3% 5 mL Sterile Rx only 63187-902-05
- HOW SUPPLIED: Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in plastic dropper bottles in two sizes: NDC 63187-902-02. . . . . . . . . . . . 2 mL NDC 63187-902-05. . . . . . . . . . . . 5 mL
- Principal Display Panel Text for Container Label: NDC 63187-902-05 Tobramycin Ophthalmic Solution, USP 0.3% 5 mL Sterile Rx only 63187-902-05
Overview
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 C 18 H 37 N 5 O 9 , 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 Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Structural Formula
Indications & Usage
: 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.
Dosage & Administration
: 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.
Warnings & Precautions
WARNINGS: 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.
Contraindications
: Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
The most frequent adverse reactions to tobramycin ophthalmic solution are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Storage & Handling
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from excessive heat. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 GTM00N Rev. 11/11
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