DEXAMETHASONE SODIUM PHOSPHATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

DEXAMETHASONE SODIUM PHOSPHATE

Composition:

DEXAMETHASONE PHOSPHATE 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Funga

Product summary:

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 Storage: Store between 15°-30°C (59°-86°F). DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN. Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
SOLUTION/
DROPS
REBEL DISTRIBUTORS CORP
----------
DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP,
0.1% DEXAMETHASONE PHOSPHATE EQUIVALENT
(STERILE)
RX ONLY
FOR USE IN THE EYES OR EARS
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.
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28
2
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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 inflamma