PREDNISOLONE ACETATE suspension/ drops

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

제공처:

Pacific Pharma, Inc.

관리 경로:

OPHTHALMIC

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Prednisolone acetate ophthalmic suspension 1% is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prednisolone acetate ophthalmic suspension 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

제품 요약:

Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with pink high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-05 10 mL in 15 mL bottle - NDC 60758-119-10 15 mL in 15 mL bottle - NDC  60758-119-15 Store at up to 25°C (77°F). Protect from freezing. Store in an upright position. Revised: 0 3 /202 4 Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI0119

승인 상태:

New Drug Application Authorized Generic

제품 특성 요약

PREDNISOLONE ACETATE- PREDNISOLONE ACETATE SUSPENSION/ DROPS
PACIFIC PHARMA, INC.
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PREDNISOLONE ACETATE
OPHTHALMIC SUSPENSION, USP 1%
STERILE
DESCRIPTION
Prednisolone acetate ophthalmic suspension, USP 1% is a sterile,
topical anti-
inflammatory agent for ophthalmic use. Its chemical name is 11ß,17,
21-
Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the
following structure:
STRUCTURAL FORMULA:
prednisolone acetate
Each mL of Prednisolone acetate ophthalmic suspension 1% contains:
ACTIVE: prednisolone acetate (microfine suspension) 1%
INACTIVES: benzalkonium chloride as preservative; boric acid; edetate
disodium;
hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium
chloride; and
sodium citrate.
The pH during its shelf life ranges from 5.0 - 6.0.
CLINICAL PHARMACOLOGY
Prednisolone acetate is a glucocorticoid that, on the basis of weight,
has 3 to 5 times the
anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit
the edema, fibrin
deposition, capillary dilation, and phagocytic migration of the acute
inflammatory
response, as well as capillary proliferation, deposition of collagen,
and scar formation.
INDICATIONS AND USAGE
Prednisolone acetate ophthalmic suspension 1% is indicated for the
treatment of
steroid-responsive inflammation of the palpebral and bulbar
conjunctiva, cornea, and
anterior segment of the globe.
CONTRAINDICATIONS
Prednisolone acetate ophthalmic suspension 1% is contraindicated in
acute untreated
purulent ocular infections, in most viral diseases of the cornea and
conjunctiva including
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures.
Prednisolone acetate ophthalmic suspension 1% is also contraindicated
in individuals
with known or suspected hypersensitivity to any of the ingredients of
this preparation
and to other corticosteroids.
WARNINGS
Prolonged use of corticosteroids may result in posterior subcapsular
cataract for