PREDNISOLONE ACETATE suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Physicians Total Care, Inc.

INN（国際名）:

PREDNISOLONE ACETATE

構図:

PREDNISOLONE ACETATE 10 mg in 1 mL

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 conjunctivitides, 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 Acetate Ophthalmic Suspension USP, 1% is contraindicated 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 USP, 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. Safety and effective

製品概要:

Prednisolone Acetate Ophthalmic Suspension USP, 1% is supplied in a white round low density polyethylene DROP-TAINER® * dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 5mL - NDC 54868-4293-2 10mL - NDC 54868-4293-1 15mL - NDC 54868-4293-0 STORAGE: STORE at 8°- 24°C (46°- 75°F) in an UPRIGHT position. Rx Only Revised: November 2007 *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd. Dist. by: FALCON Pharmaceuticals Ltd. Fort Worth, Texas 76134 USA Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 9003146-1007 Distributed by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

認証ステータス:

New Drug Application Authorized Generic

製品の特徴

PREDNISOLONE ACETATE - PREDNISOLONE ACETATE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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PREDNISOLONE ACETATE
OPHTHALMIC SUSPENSION USP, 1%
DESCRIPTION
Prednisolone Acetate Ophthalmic Suspension USP, 1% is an
adrenocortical steroid product prepared as
a sterile ophthalmic suspension. The active ingredient is represented
by the chemical structure:
Established name: Prednisolone Acetate
Chemical name: Pregna-1,4-diene-3,20-dione,
21-(acetyloxy)-11,17-dihydroxy-,(11β)-.
EACH ML CONTAINS:ACTIVE: prednisolone acetate 1.0%. PRESERVATIVE:
benzalkonium chloride 0.01%.
VEHICLE: hypromellose. INACTIVES: dibasic sodium phosphate,
polysorbate 80, edetate disodium,
glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified
water.
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and probably delay or
slow healing. They inhibit the edema, fibrin deposition, capillary
dilation, leukocyte migration,
capillary proliferation, fibroblast proliferation, deposition of
collagen, and scar formation associated
with inflammation. There is no generally accepted explanation for the
mechanism of action of ocular
corticosteroids. However, corticosteroids are thought to act by the
induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
Corticosteroids are capable of producing a rise in intraocular
pressure.
INDICATIONS AND USAGE
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
conjunctivitides, when the inherent hazard of steroid
use is accepted to ob