DIFLUPREDNATE OPHTHALMIC emulsion

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Sandoz Inc

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. 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 to be a teratogenic

Tóm tắt sản phẩm:

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 sizes: 5 mL in a 8 mL bottle     NDC 0781-6000-78 Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

DIFLUPREDNATE OPHTHALMIC- DIFLUPREDNATE OPHTHALMIC EMULSION
SANDOZ 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
DIFLUPREDNATE (OPHTHALMIC EMULSION)
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Difluprednate ophthalmic emulsion is a topical corticosteroid that is
indicated for:
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DOSAGE AND ADMINISTRATION
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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
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•
•
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ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC., AT
1-800-525-8747 OR FDA
The treatment of inflammation and pain associated with ocular surgery.
(1.1)
The treatment of endogenous anterior uveitis. (1.2)
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)
INTRAOCULAR PRESSURE (IOP) INCREASE: Prolonged use of corticosteroids
may result in glaucoma
with damage to the optic nerve, defects in vis