DEXAMETHASONE SODIUM PHOSPHATE solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

dexamethasone sodium phosphate (UNII: AI9376Y64P) (dexamethasone - UNII:7S5I7G3JQL)

Dostopno od:

Rebel Distributors Corp

Pot uporabe:

OPHTHALMIC

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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. 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 diseases of ocul

Povzetek izdelek:

Dexamethasone sodium phosphate ophthalmic solution USP, 0.1% is available in a 5 mL DROP-TAINER® Dispenser Bottle. NDC 21695-847-05 Store at controlled room temperature 15° - 30°C (59° - 86°F). Rx Only Rev: March 2006 Dist. By: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 USA Mfd. By: ALCON Manufacturing, Ltd. Fort Worth, Texas 76134 USA AAA728-0306 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
SOLUTION
REBEL DISTRIBUTORS CORP
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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-16α-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 burns, or pene