DIFLUPREDNATE emulsion

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

DIFLUPREDNATE (UNII: S8A06QG2QE) (DIFLUPREDNATE - UNII:S8A06QG2QE)

Dostupno od:

Exelan Pharmaceuticals, Inc.

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. The use of difluprednate ophthalmic emulsion, 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. Teratogenic Effects 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 1-10 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

Proizvod sažetak:

Difluprednate ophthalmic emulsion 0.05% is a sterile, white colour homogenous topical ophthalmic emulsion supplied in a white opaque LDPE bottle with a controlled drop tip and a pink cap in the following size: 5 mL in a 5 mL bottle (NDC 76282-708-50) Storage and Handling Store at 15-25°C (59-77°F). Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DIFLUPREDNATE - DIFLUPREDNATE EMULSION
EXELAN PHARMACEUTICALS, 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.<BR><BR>DIFLUPREDNATE
OPHTHALMIC EMULSION 0.05%<BR>INITIAL U.S. APPROVAL:
2008<BR>
INDICATIONS AND USAGE
Difluprednate ophthalmic emulsion 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 ophthalmic
emulsion for topical ophthalmic use only. (3)
CONTRAINDICATIONS
Difluprednate ophthalmic emulsion, 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)
Cataracts-Use of corticos