DIFLUPREDNATE OPHTHALMIC EMULSION- difluprednate ophthalmic emulsion

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Difluprednate (UNII: S8A06QG2QE) (Difluprednate - UNII:S8A06QG2QE)

Dostępny od:

Dr. Reddy's Laboratories Inc.

Droga podania:

OPHTHALMIC

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Difluprednate ophthalmic emulsion (0.05%) is a topical corticosteroid, indicated for the treatment of inflammation and pain associated with ocular surgery. Difluprednate ophthalmic emulsion (0.05%) is also indicated for the treatment of endogenous anterior uveitis. The use of difluprednate ophthalmic emulsion (0.05%), as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 to 10 mcg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered t

Podsumowanie produktu:

Difluprednate ophthalmic emulsion (0.05%) is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following size: 5 mL in one bottle (NDC 43598-588-11) Storage and Handling Store at 15°C to 25°C (59°F to 77°F). Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DIFLUPREDNATE OPHTHALMIC EMULSION- DIFLUPREDNATE OPHTHALMIC EMULSION
DR. REDDY'S LABORATORIES INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIFLUPREDNATE
OPHTHALMIC EMULSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DIFLUPREDNATE OPHTHALMIC EMULSION.
DIFLUPREDNATE, OPHTHALMIC EMULSION (0.05%) FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Difluprednate ophthalmic emulsion (0.05%) is a topical corticosteroid
that is indicated for:
The treatment of inflammation and pain associated with ocular surgery
(1.1)
The treatment of endogenous anterior uveitis (1.2)
DOSAGE AND ADMINISTRATION
For the treatment of inflammation and pain associated with ocular
surgery instill one drop into the
conjunctival sac of the affected eye 4 times daily beginning 24 hours
after surgery and continuing
throughout the first 2 weeks of the postoperative period, followed by
2 times daily for a week and then a
taper based on the response. (2.1)
For the treatment of endogenous anterior uveitis instill one drop into
the
conjunctival sac of the affected eye 4 times daily for 14 days
followed by tapering as clinically indicated.
(2.2)
DOSAGE FORMS AND STRENGTHS
Difluprednate ophthalmic emulsion contains 0.05% difluprednate, as a
sterile preserved emulsion for
topical ophthalmic use only. (3)
CONTRAINDICATIONS
Difluprednate ophthalmic emulsion (0.05%), as with other ophthalmic
corticosteroids, is contraindicated in
most active viral diseases of the cornea and conjunctiva including
epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal
diseases of ocular structures. (4)
WARNINGS AND PRECAUTIONS
Intraocular pressure (IOP) increase- Prolonged use of corticosteroids
may result in glaucoma with
damage to the optic nerve, defects in visual acuity and fields of
vision. If this product is used for 10 days
or longer, IOP should be monitored. (5.1)
Cata