Phospholine Iodide

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

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

Brand name
Phospholine Iodide
Generic name
ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION
Manufacturer
Fera Pharmaceuticals, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
8afc8951-db76-4f27-8752-7c0d6aa47244
SPL ID
66abcfcf-b16e-4181-b1db-96bfba0ab95e
Version
5
Effective date
2025-07-07
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:12
Harmonized routes table
Harmonized routes
OPHTHALMIC

Warnings cross-check#

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warnings

WARNINGS Succinylcholine should be administered only with great caution, if at all, prior to or during general anesthesia to patients receiving anticholinesterase medication because of possible respiratory or cardiovascular collapse. Caution should be observed in treating elevated IOP with echothiophate iodide for ophthalmic solution in patients who are at the same time undergoing treatment with systemic anticholinesterase medications, because of possible adverse additive effects.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Although the relationship, if any, of retinal detachment to the administration of echothiophate iodide for ophthalmic solution has not been established, retinal detachment has been reported in a few cases during the use of echothiophate iodide for ophthalmic solution in adult patients without a previous history of this disorder. Stinging, burning, lacrimation, lid muscle twitching, conjunctival and ciliary redness, browache, induced myopia with visual blurring may occur. Activation of latent iritis or uveitis may occur. Iris cysts may form, and if treatment is continued, may enlarge and obscure vision. This occurrence is more frequent in children. The cysts usually shrink upon discontinuance of the medication or by reducing the frequency of instillation. Rarely, they may rupture or break free into the aqueous. Regular examinations are advisable when the drug is being prescribed for the treatment of accommodative esotropia. Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals. Lens opacities have been reported with echothiophate iodide. Paradoxical increase in IOP may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine. Cardiac irregularities.

Reported adverse events (FAERS/openFDA)#

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