Phospholine Iodide® (echothiophate iodide for ophthalmic solution)

Rx only

Chemical name: (2-mercaptoethyl) trimethylammonium iodide O,O-diethyl phosphorothioate

Structural formula

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.

Echothiophate iodide for ophthalmic solution is a long-acting cholinesterase inhibitor for topical use which enhances the effect of endogenously liberated acetylcholine in iris, ciliary muscle, and other parasympathetically innervated structures of the eye. It thereby causes miosis, increase in facility of outflow of aqueous humor, fall in intraocular pressure (IOP), and potentiation of accommodation.

Echothiophate iodide for ophthalmic solution will depress both plasma and erythrocyte cholinesterase levels in most patients after a few weeks of eyedrop therapy.

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

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 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.

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 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.
5. Prolonged use may cause conjunctival thickening, obstruction of nasolacrimal canals.
6. Lens opacities have been reported with echothiophate iodide.
7. Paradoxical increase in IOP may follow anticholinesterase instillation. This may be alleviated by prescribing a sympathomimetic mydriatic such as phenylephrine.
8. Cardiac irregularities.

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 and attach to the drug container.
5. Shake for several seconds to ensure mixing.
6. Do not cover nor obliterate instructions to patient regarding administration and storage of eyedrops.

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

FERA^®
PHARMACEUTICALS

NDC 48102-053-05

Phospholine Iodide^®

(echothiophate iodide
for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

This package contains sterile
echothiophate iodide with 40 mg
potassium acetate (sodium
hydroxide or acetic acid may have
been incorporated to adjust pH
during manufacturing) and 5 mL
(1/6 fl oz) sterile aqueous diluent,
in individual bottles for dispensing
5 mL of eyedrops of strength
shown when reconstituted.

Rx only

NDC 48102-054-05

Rx only

Phospholine Iodide^®

(echothiophate iodide
for ophthalmic solution)

0.125% (1/8%) 6.25 mg/5 mL

Each 5 mL contains 6.25 mg of echothiophate iodide
With 40 mg Potassium Acetate for preparing 5 mL eyedrops.

See Prescribing Information.

NDC 48102-055-05

STERILE DILUENT
FOR PREPARING
Phospholine Iodide^®

(echothiophate iodide

for ophthalmic solution)

5 mL (1/6 fl oz)

EYEDROPS