PREDNISOLONE SODIUM PHOSPHATE solution/ drops

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Доступна с:

Bausch & Lomb Incorporated

Администрация маршрут:

OPHTHALMIC

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Prednisolone sodium phosphate ophthalmic solution, 1% or 1/8% is for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation, corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Prednisolone sodium phosphate ophthalmic solution, 1%, is recommended for moderate to severe inflammations, particularly when unusually rapid control is desired. In stubborn cases of anterior segment eye disease, systemic adrenocortical hormone therapy may be required. When deeper ocular structures are involved, systemic therapy is necessary. The use of this preparation is contraindicated in the presence of: The use of this preparation is always

Обзор продуктов:

Prednisolone sodium phosphate ophthalmic solution USP, 1% is supplied in a plastic squeeze bottle with a white cap and a controlled drop tip in the following size: 10 mL bottle - NDC 24208-715-10 Storage: Store between 15°C to 25°C (59°F to 77°F). Protect from light. Keep tightly closed. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: April 2023 9101406 (Folded) 9101506 (Flat)

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PREDNISOLONE SODIUM PHOSPHATE- PREDNISOLONE SODIUM
PHOSPHATE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
PREDNISOLONE SODIUM
PHOSPHATE OPHTHALMIC
SOLUTION, USP
1%
(STERILE)
RX ONLY
DESCRIPTION
Prednisolone sodium phosphate ophthalmic solution USP, 1%, is a
sterile solution for
ophthalmic administration having the following composition:
EACH ML CONTAINS:
ACTIVE: prednisolone sodium phosphate 10 mg (1%) [equivalent to 9.1
mg/mL
prednisolone phosphate] in a buffered isotonic solution containing:
INACTIVES:
hypromellose, monobasic and dibasic sodium phosphate, sodium chloride,
edetate
disodium and purified water. Sodium hydroxide and/or hydrochloric acid
may be added
to adjust the pH (6.2-8.2).
PRESERVATIVE: benzalkonium chloride 0.01%.
The chemical name for prednisolone sodium phosphate is Pregna-1,
4-diene - 3, 20-
dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11 β) -,
which has the
following structural formula:
CLINICAL PHARMACOLOGY
Prednisolone sodium phosphate causes inhibition of inflammatory
response to inciting
agents of mechanical, chemical, or immunological nature. No generally
accepted
explanation of this steroid property has been advanced.
INDICATIONS AND USAGE
Prednisolone sodium phosphate ophthalmic solution, 1% or 1/8% is for
the treatment of
steroid responsive inflammatory conditions of the palpebral and bulbar
conjunctiva,
cornea, and anterior segment of the globe, such as allergic
conjunctivitis, acne rosacea,
superficial punctate keratitis, herpes zoster keratitis, iritis,
cyclitis, selected infective
conjunctivitis when the inherent hazard of steroid use is accepted to
obtain an advisable
diminution in edema and inflammation, corneal injury from chemical,
radiation, or thermal
burns, or penetration of foreign bodies.
Prednisolone sodium phosphate ophthalmic solution, 1%, is recommended
for moderate
to severe inflammations, particularly when unusually rapid control is
desired. In stubborn
cases of anterior segment eye disease, systemic adrenocortical hormone
therapy may
be