polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL
polymyxin b sulfate and trimethoprim sulfate · SOLUTION/ DROPS · Somerset Therapeutics, LLC
polymyxin b sulfate and trimethoprim sulfate is a solution/ drops containing polymyxin b sulfate and trimethoprim sulfate at 10000 [iU]/mL, taken ophthalmic. Manufactured by Somerset Therapeutics, LLC.
Key Facts
- Brand Name
- polymyxin b sulfate and trimethoprim sulfate
- Generic Name
- polymyxin b sulfate and trimethoprim sulfate
- NDC Code (Product)
70069-311- Manufacturer
- Somerset Therapeutics, LLC
- Strength
- 10000 [iU]/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA211572
- Drug Class
- Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
- Marketing Start
- 08/06/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. * * Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Dosage & Administration
DOSAGE AND ADMINISTRATION In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to polymyxin B sulfate and trimethoprim ophthalmic solution occurs, discontinue use. Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
Contraindications
CONTRAINDICATIONS Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Frequently Asked Questions
What is polymyxin b sulfate and trimethoprim sulfate used for?
polymyxin b sulfate and trimethoprim sulfate contains polymyxin b sulfate and trimethoprim sulfate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is polymyxin b sulfate and trimethoprim sulfate a controlled substance?
polymyxin b sulfate and trimethoprim sulfate is not classified as a controlled substance by the DEA.
What is the generic name for polymyxin b sulfate and trimethoprim sulfate?
The generic name for polymyxin b sulfate and trimethoprim sulfate is polymyxin b sulfate and trimethoprim sulfate. There are 5 other brand versions of polymyxin b sulfate and trimethoprim sulfate.
What is the NDC code for polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL?
The NDC (National Drug Code) for polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL is 70069-311, listed by Somerset Therapeutics, LLC.
Other polymyxin b sulfate and trimethoprim sulfate Dosages
Other Polymyxin Brands
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- Polymyxin B Sulfate and Trimethoprim10000 [USP'U]/mL63187-631
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)