FDA label ebd654ab-24bd-e75a-dcaa-041ec0d930dd

openFDA label record#

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

SPL set ID
c4adbc81-6681-4e12-f8ab-5d1cb7723aad
SPL ID
ebd654ab-24bd-e75a-dcaa-041ec0d930dd
Version
6
Effective date
2010-04-01
Source export date
2026-08-01
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:04

Boxed warning cross-check#

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boxed warning

DIRECTIONS FOR PREPARING EYEDROPS 1. Use aseptic technique. 2. Tear off aluminum seals, and remove and discard rubber plugs from both drug and diluent containers. 3. Pour diluent into drug container. 4. Remove dropper assembly from its sterile wrapping. Holding dropper assembly by the screw cap and, WITHOUT COMPRESSING RUBBER BULB, insert into drug container and screw down tightly. 5. Shake for several seconds to ensure mixing. 6. Do not cover nor obliterate instructions to patient regarding storage of eyedrops.

Warnings cross-check#

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warnings

WARNINGS 1. 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. 2. Caution should be observed in treating glaucoma with echothiophate iodide for ophthalmic solution in patients who are at the same time undergoing treatment with systemic anticholinesterase medications for myasthenia gravis, because of possible adverse additive effects. (See “ PRECAUTIONS, Drug Interactions ” for further information.)

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS 1. 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. 2. Stinging, burning, lacrimation, lid muscle twitching, conjunctival and ciliary redness, browache, induced myopia with visual blurring may occur. 3. Activation of latent iritis or uveitis may occur. 4. 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, reduction in strength of the drops or 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. 5. Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals. 6. Lens opacities occurring in patients under treatment for glaucoma with echothiophate iodide for ophthalmic solution have been reported and similar changes have been produced experimentally in normal monkeys. Routine examinations should accompany clinical use of the drug. 7. Paradoxical increase in intraocular pressure may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine. 8. Cardiac irregularities.