DEXAMETHASONE SODIUM PHOSPHATE solution/ drops

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:

Bausch & Lomb Incorporated

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 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 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. Fung

製品概要:

Dexamethasone sodium phosphate ophthalmic solution USP, 0.1% is supplied in a plastic squeeze bottle with a white cap and a controlled drop tip in the following size: 5 mL fill in a 10 mL bottle - NDC 24208-720-02 Storage: Store between 15°C to 25°C (59°F to 77°F). 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 © 2022 Bausch & Lomb Incorporated or its affiliates Revised: August 2022 9100205 (Folded) 9100305 (Flat)

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
DEXAMETHASONE SODIUM PHOSPHATE
OPHTHALMIC SOLUTION, USP
0.1%
(EQUIVALENT TO 0.1% DEXAMETHASONE PHOSPHATE)
(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.
Chemical Name: 9-fluoro-11β,
17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1,4-
diene-3, 20-dione disodium salt.
EACH ML CONTAINS: ACTIVE: dexamethasone sodium phosphate [equivalent
to 1 mg
(0.1%) dexamethasone phosphate]. INACTIVES: sodium citrate, sodium
borate,
creatinine, polysorbate 80, edetate disodium dihydrate, purified
water. Hydrochloric acid
may be added to adjust pH (6.6-7.8).
PRESERVATIVES: sodium bisulfite 0.1%, phenylethyl alcohol 0.25%,
benzalkonium
chloride 0.02%.
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 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
or thermal burns, or penetration of foreign bodies