DEXAMETHASONE SODIUM PHOSPHATE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

から入手可能:

Dispensing Solutions, Inc.

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

For the treatment of the following conditions: Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctuate 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 or thermal burns, or penetration of foreign bodies. Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Epithelial herpes simplex keratitis (dendritic keratitis). Acute infectious stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fun

製品概要:

Dexamethasone sodium phosphate ophthalmic solution USP, 0.1% is available in a 5 mL DROP-TAINER®* Dispenser Bottle. NDC 61314-294-05 Store at controlled room temperature 15° - 30°C (59° - 86°F). Rx Only Revised: March 2006    *DROP-TAINER is a registered trademark of Alcon Research, Ltd.    9004571-0409    Dist. By: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 USA Mfd. By: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-757-9195 [e-mail]

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM PHOSPHATE
SOLUTION
DISPENSING SOLUTIONS, INC.
----------
DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION, USP
EQUIVALENT TO DEXAMETHASONE PHOSPHATE 0.1%
STERILE
DESCRIPTION:
Dexamethasone sodium phosphate ophthalmic solution is a clear,
colorless to pale yellow topical
steroid solution for ophthalmic or otic administration.
Glucocorticoids are adrenocortical steroids,
both naturally occurring and synthetic. Dexamethasone is a synthetic
analog of naturally occurring
glucocorticoids (hydrocortisone and cortisone). Dexamethasone sodium
phosphate is a water soluble,
inorganic ester of dexamethasone. It is approximately three thousand
times more soluble in water at
25°C than hydrocortisone.
Dexamethasone sodium phosphate is 9-fluoro-11 β, 17-dihydroxy-16
-methyl-21-
(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt and has the
following structural formula:
EACH ML CONTAINS: ACTIVE: dexamethasone sodium phosphate equivalent to
1mg (0.1%) dexamethasone
phosphate. PRESERVATIVE: benzalkonium chloride 0.01%. Inactives:
monobasic sodium phosphate,
sodium chloride, dibasic sodium phosphate, edetate disodium, monobasic
sodium phosphate and/or
dibasic sodium phosphate to adjust pH (6.6 to 7.8) and water for
injection.
CLINICAL PHARMACOLOGY:
Dexamethasone sodium phosphate suppresses the inflammatory response to
a variety of agents and it
probably delays or slows healing. No generally accepted explanation of
these steroid properties has
been advanced.
INDICATIONS AND USAGE:
For the treatment of the following conditions:
OPHTHALMIC: Steroid responsive inflammatory conditions of the
palpebral and bulbar conjunctiva,
cornea, and anterior segment of the globe, such as allergic
conjunctivitis, acne rosacea, superficial
punctuate 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 or thermal bur