FDA label 7000bf19-96f6-445a-a882-9a8cc6ccd3ac

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.)

PRECAUTIONS General 1. Gonioscopy is recommended prior to initiation of therapy. Routine examination to detect lens opacity should accompany clinical use of echothiophate iodide for ophthalmic solution. 2. Where there is a quiescent uveitis or a history of this condition, anticholinesterase therapy should be avoided or used cautiously because of the intense and persistent miosis and ciliary muscle contraction that may occur. 3. While systemic effects are infrequent, proper use of the drug requires digital compression of the nasolacrimal ducts for a minute or two following instillation to minimize drainage into the nasal chamber with its extensive absorption area. To prevent possible skin absorption, hands should be washed following instillation. 4. Temporary or permanent discontinuance of medication is necessary if cardiac irregularities occur. 5. Anticholinesterase drugs should be used with extreme caution, if at all, in patients with marked vagotonia, bronchial asthma, spastic gastrointestinal disturbances, peptic ulcer, pronounced bradycardia and hypotension, recent myocardial infarction, epilepsy, parkinsonism, and other disorders that may respond adversely to vagotonic effects. 6. Anticholinesterase drugs should be employed prior to ophthalmic surgery only as a considered risk because of the possible occurrence of hyphema. 7. Echothiophate iodide for ophthalmic solution should be used with great caution, if at all, where there is a prior history of retinal detachment. 8. Temporary discontinuance of medication is necessary if salivation, urinary incontinence, diarrhea, profuse sweating, muscle weakness, or respiratory difficulties occur. 9. Patients receiving echothiophate iodide for ophthalmic solution who are exposed to carbamate- or organophosphate-type insecticides and pesticides (professional gardeners, farmers, workers in plants manufacturing or formulating such products, etc.) should be warned of the additive systemic effects possible from absorption of the pesticide through the respiratory tract or skin. During periods of exposure to such pesticides, the wearing of respiratory masks, and frequent washing and clothing changes may be advisable.

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. 4 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.