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
- 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 |
|---|
| OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 011963 | derived:openfda.application_number |
| application number | NDA011963 | openfda.application_number | |
| brand name | Phospholine Iodide | openfda.brand_name | |
| generic name | ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION | openfda.generic_name | |
| manufacturer name | Fera Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 48102-054-05 | openfda.package_ndc |
| ndc | package | 48102-053-05 | openfda.package_ndc |
| ndc | package | 48102-055-05 | openfda.package_ndc |
| ndc | product | 48102-053 | openfda.product_ndc |
| ndc11 | package | 48102005405 | derived:openfda.package_ndc |
| ndc11 | package | 48102005305 | derived:openfda.package_ndc |
| ndc11 | package | 48102005505 | derived:openfda.package_ndc |
| rxcui | 310049 | openfda.rxcui | |
| rxcui | 205739 | openfda.rxcui | |
| spl id | 66abcfcf-b16e-4181-b1db-96bfba0ab95e | id | |
| spl set id | 8afc8951-db76-4f27-8752-7c0d6aa47244 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.