Echothiophate Iodide For Ophthalmic Solution

Description

DESCRIPTION Chemical name: (2-mercaptoethyl) trimethylammonium iodide O,O-diethyl phosphorothioate Structural formula Echothiophate iodide for ophthalmic solution occurs as a white, crystalline, water-soluble, hygroscopic solid having a slight mercaptan-like odor. When freeze-dried in the presence of potassium acetate, the mixture appears as a white amorphous deposit on the walls of the bottle. Each package contains materials for dispensing 5 mL of eyedrops: (1) bottle containing sterile echothiophate iodide for ophthalmic solution 6.25 mg (0.125%) with 40 mg potassium acetate. Sodium hydroxide or acetic acid may have been incorporated to adjust pH during manufacturing; (2) a 5 mL bottle of sterile diluent containing chlorobutanol (chloral derivative), 0.55%; mannitol, 1.2%; boric acid, 0.06%; and sodium phosphate, 0.026%; (3) sterilized dropper. Structural Formula

What Is Echothiophate Iodide For Ophthalmic Solution Used For?

INDICATIONS AND USAGE Reduction of Elevated IOP Echothiophate iodide for ophthalmic solution is indicated for the reduction of elevated IOP. Accommodative Esotropia Concomitant esotropias with a significant accommodative component.

Dosage and Administration

DOSAGE AND ADMINISTRATION

Side Effects (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.

Drug Interactions

Drug Interactions Echothiophate iodide for ophthalmic solution potentiates other cholinesterase inhibitors such as succinylcholine or organophosphate and carbamate insecticides. Patients undergoing systemic anticholinesterase treatment should be warned of the possible additive effects of echothiophate iodide for ophthalmic solution.

Contraindications

CONTRAINDICATIONS Active uveal inflammation. Most cases of angle-closure glaucoma without iridectomy, due to the possibility of increasing angle block. Hypersensitivity to the active or inactive ingredients.

Pregnancy and Breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with echothiophate iodide for ophthalmic solution. It is also not known whether echothiophate iodide for ophthalmic solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Echothiophate iodide for ophthalmic solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from echothiophate iodide for ophthalmic solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

How Supplied

HOW SUPPLIED Each package contains sterile echothiophate iodide for ophthalmic solution, sterile diluent, and dropper for dispensing 5 mL eyedrops. NDC 48102-053-05 ................... 6.25 mg package for 0.125% White amorphous deposit on bottle walls. Aluminum crimp seal is green. HANDLING AND STORAGE: Prior to reconstitution: Store under refrigeration (2°C to 8°C). After reconstitution: Store upright at room temperature (approximately 25°C) (68°F to 77° F). Do not refrigerate. Discard any unused solution after 4 weeks. FERA ® PHARMACEUTICALS Distributed by: Fera Pharmaceuticals, LLC Locust Valley, NY 11560 PF053 Rev. 0923