Neomycin and Polymyxin B Sulfates and Dexamethasone

openFDA label record#

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

Brand name
Neomycin and Polymyxin B Sulfates and Dexamethasone
Generic name
NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE
Manufacturer
Proficient Rx LP
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
21c9b34c-af88-4c9e-9b6c-32d78d34ba7e
SPL ID
84f8a211-aaba-4d86-b71c-9a0632217c9e
Version
5
Effective date
2023-05-01
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:18:14
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

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warnings

WARNINGS: NOT FOR INJECTION. Do not touch tube tip to any surface, as this may contaminate the contents. Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Products containing neomycin sulfate may cause cutaneous sensitization. Employment of steroid medication in the treatment of herpes simplex requires great caution.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.