Tobramycin Ophthalmic Solution

Prescription

Handelsnamen: Tobramycin Ophthalmic Solution

Darreichungsform

Drops

Applikationsweg

OPHTHALMIC

Hersteller

Alembic Pharmaceuticals Limited

About This Medication

DESCRIPTION Tobramycin ophthalmic solution USP, 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 contains: Active : tobramycin 0.3% (3 mg). Preservative : benzalkonium chloride 0.01% (0.1 mg). Inactives : boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution USP, 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260 to 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. tobra-struc

Wirkstoffe

Wirkstoff	Stärke
Tobramycin	-

Indikationen und Anwendung

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. Clinical studies have shown tobramycin to be safe and effective for use in children.

Dosierung und Verabreichung

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.

Side Effects Overview

ADVERSE REACTIONS The most frequent adverse reactions to Tobramycin ophthalmic solution, 0.3% 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 ophthalmic solution. Postmarketing Experience: Additional adverse reactions identified from post-marketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.

Warnhinweise und Vorsichtsmaßnahmen

WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to Tobramycin ophthalmic solution, 0.3% occurs, discontinue use.

Kontraindikationen

CONTRAINDICATIONS Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Frequently Asked Questions

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. Clinical studies have shown tobramycin to be safe and effective for use in children.

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.

WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to Tobramycin ophthalmic solution, 0.3% occurs, discontinue use.

CONTRAINDICATIONS Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

Tobramycin Ophthalmic Solution is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Tobramycin Ophthalmic Solution drug label (National Library of Medicine)
• openFDA — Tobramycin Ophthalmic Solution label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 313415 (NLM Normalized Drug Names)
• NDC Directory — Tobramycin Ophthalmic Solution (FDA National Drug Code)

Medizinischer Haftungsausschluss

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Datenquellen: DailyMed (NLM), openFDA, MFDS