polymyxin b sulfate and trimethoprim sulfate

polymyxin b sulfate and trimethoprim sulfate is an FDA-registered drug product whose active ingredient is POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE. It is labelled by REMEDYREPACK INC. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 70518-4381, application ANDA211572, label effective 20260909. It is one of 2 FDA drug label records sharing the active ingredient POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE are most often described in connection with: usage polymyxin, trimethoprim ophthalmic, solution usp, treatment surface, ocular bacterial, infections including, blepharoconjunctivitis caused, susceptible strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 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.

CONTRAINDICATIONS Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

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.

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

FDA lists 2 drug label records with POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is polymyxin b sulfate and trimethoprim sulfate used for?
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, …

Who makes polymyxin b sulfate and trimethoprim sulfate?
REMEDYREPACK INC. is the labeler of record for polymyxin b sulfate and trimethoprim sulfate. 2 FDA label records share the active ingredient POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does polymyxin b sulfate and trimethoprim sulfate come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is polymyxin b sulfate and trimethoprim sulfate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE?
Yes. 2 FDA drug label records list POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has polymyxin b sulfate and trimethoprim sulfate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.