PHOSPHOLINE IODIDE- echothiophate iodide for ophthalmic solution kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

echothiophate iodide (UNII: BA9QH3P00T) (echothiophate - UNII:0F350BVT6S)

Disponible desde:

Fera Pharmaceuticals, LLC

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Echothiophate iodide for ophthalmic solution is indicated for the reduction of elevated IOP. Concomitant esotropias with a significant accommodative component. - 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.

Resumen del producto:

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

Estado de Autorización:

New Drug Application

Ficha técnica

PHOSPHOLINE IODIDE- ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION
FERA PHARMACEUTICALS, LLC
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PHOSPHOLINE IODIDE®
(ECHOTHIOPHATE IODIDE FOR
OPHTHALMIC SOLUTION)
RX ONLY
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.
CLINICAL PHARMACOLOGY
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.
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.
CONTRAINDICATIONS
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 act