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Polymyxin B Sulfate and Trimethoprim

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Polymyxin B Sulfate and Trimethoprim
Generic name
POLYMYXIN B SULFATE AND TRIMETHOPRIM
Manufacturer
NuCare Pharmaceuticals,Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
60f5cfcf-cdb2-0e45-e053-2991aa0ae85a
SPL ID
1d8e3ec4-a0b3-e6d9-e063-6294a90aeab8
Version
6
Effective date
2024-07-18
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:23:52
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

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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.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.