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:

Stat Rx USA

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

For the treatment of the following conditions:  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.  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. Fungal diseas

製品概要:

Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1%, is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: 5 mL - Prod. No. 04407 STERILE OPHTHALMIC SOLUTION Rx only FOR USE IN THE EYES OR EARS Store between 15°-30°C (59°-86°F). DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM PHOSPHATE
SOLUTION/
DROPS
STAT RX USA
----------
DEXAMETHASONE SODIUM PHOSPHATE - SOLUTION / DROPS
DESCRIPTION
Dexamethasone Sodium Phosphate Ophthalmic Solution USP, is a sterile,
topical steroid solution. The
active ingredient is represented by the following structural formula:
C
H FNa O P
Mol. wt. 516.41
Chemical Name: 9-fluoro-11β,
17-dihydroxy-16α-methyl-21-[phosphonooxy]pregna-1, 4-diene-3,20-
dione disodium salt.
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 at 25°C than hydrocortisone.
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 ADDED: 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 have
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.
Otic
22
28
2
8
Steroid responsiv