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Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL

Polymyxin B Sulfate and Trimethoprim · SOLUTION · Sandoz Inc

1 Recall on Record
Plain English

Polymyxin B Sulfate and Trimethoprim is a solution containing polymyxin b sulfate and trimethoprim at 10000 [USP'U]/mL, taken ophthalmic. Manufactured by Sandoz Inc.

Key Facts

Brand Name
Polymyxin B Sulfate and Trimethoprim
Generic Name
Polymyxin B Sulfate and Trimethoprim
NDC Code (Product)
61314-628
Manufacturer
Sandoz Inc
Strength
10000 [USP'U]/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
ANDA064211
Marketing Start
04/16/1998

Recall History

1 Recall on Record
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

ocular hyperaemia21 reports
eye pruritus20 reports
eye irritation18 reports
eye swelling18 reports
eye pain11 reports
pain11 reports
lacrimation increased10 reports
drug hypersensitivity9 reports
drug ineffective9 reports
eye discharge9 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution 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.

Frequently Asked Questions

What is Polymyxin B Sulfate and Trimethoprim used for?

Polymyxin B Sulfate and Trimethoprim contains Polymyxin B Sulfate and Trimethoprim. It is a solution taken ophthalmic. Consult your doctor for specific uses.

Is Polymyxin B Sulfate and Trimethoprim a controlled substance?

Polymyxin B Sulfate and Trimethoprim is not classified as a controlled substance by the DEA.

What is the generic name for Polymyxin B Sulfate and Trimethoprim?

The generic name for Polymyxin B Sulfate and Trimethoprim is Polymyxin B Sulfate and Trimethoprim. There are 2 other brand versions of Polymyxin B Sulfate and Trimethoprim.

What is the NDC code for Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL?

The NDC (National Drug Code) for Polymyxin B Sulfate and Trimethoprim 10000 [USP'U]/mL is 61314-628, listed by Sandoz Inc.

Product NDC

61314-628

Package NDC

61314-628-10

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)