Tobramycin Ophthalmic Solution 3 mg/mL
Tobramycin Ophthalmic Solution · SOLUTION/ DROPS · Alembic Pharmaceuticals Limited
Tobramycin Ophthalmic Solution is a solution/ drops containing tobramycin ophthalmic solution at 3 mg/mL, taken ophthalmic. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- Tobramycin Ophthalmic Solution
- Generic Name
- Tobramycin Ophthalmic Solution
- NDC Code (Product)
46708-518- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA211847
- Drug Class
- Aminoglycoside Antibacterial [EPC]
- Marketing Start
- 04/19/2019
Recall History
Akorn, Inc.
CGMP Deviations:
Akorn, Inc.
CGMP Deviations:
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Full Prescribing Information
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. Clinical studies have shown tobramycin to be safe and effective for use in children.
Dosage & 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.
Warnings
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
CONTRAINDICATIONS Tobramycin ophthalmic solution, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
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.
Frequently Asked Questions
What is Tobramycin Ophthalmic Solution used for?
Tobramycin Ophthalmic Solution contains Tobramycin Ophthalmic Solution. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Tobramycin Ophthalmic Solution a controlled substance?
Tobramycin Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Tobramycin Ophthalmic Solution?
The generic name for Tobramycin Ophthalmic Solution is Tobramycin Ophthalmic Solution. There are no other listed brand versions of Tobramycin Ophthalmic Solution.
What is the NDC code for Tobramycin Ophthalmic Solution 3 mg/mL?
The NDC (National Drug Code) for Tobramycin Ophthalmic Solution 3 mg/mL is 46708-518, listed by Alembic Pharmaceuticals Limited.
Other Tobramycin Ophthalmic Solution Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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