Drugplain

polymyxin b sulfate and trimethoprim sulfate 10000 [iU]/mL

polymyxin b sulfate and trimethoprim sulfate · SOLUTION/ DROPS · REMEDYREPACK INC.

No Recall History
Plain English

This is an antibiotic eye drop combination used to treat bacterial eye infections. It works by stopping bacterial growth through two different mechanisms of action.

Key Facts

Brand Name
polymyxin b sulfate and trimethoprim sulfate
Generic Name
polymyxin b sulfate and trimethoprim sulfate
NDC Code (Product)
70518-4381
Manufacturer
REMEDYREPACK INC.
Strength
10000 [iU]/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA211572
Drug Class
Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
Marketing Start
07/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity3 reports
blood pressure decreased1 reports
chills1 reports
gastrointestinal disorder1 reports
hypersensitivity1 reports
sleep disorder1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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?

This is an antibiotic eye drop combination used to treat bacterial eye infections. It works by stopping bacterial growth through two different mechanisms of action.

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 70518-4381, listed by REMEDYREPACK INC..

Product NDC

70518-4381

Package NDC

70518-4381-0

Other polymyxin b sulfate and trimethoprim sulfate Dosages

Other Polymyxin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)