DUREZOL 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:

Alcon Laboratories, Inc.

INN (Tên quốc tế):

DIFLUPREDNATE

Thành phần:

DIFLUPREDNATE 0.5 mg in 1 mL

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

DUREZOL® (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. DUREZOL is also indicated for the treatment of endogenous anterior uveitis. The use of DUREZOL, 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 dose that was concurrently found in the t

Tóm tắt sản phẩm:

DUREZOL (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 0065-9240-07 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

Đặc tính sản phẩm

DUREZOL- DUREZOL EMULSION
ALCON LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUREZOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUREZOL.
DUREZOL (DIFLUPREDNATE OPHTHALMIC EMULSION)
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
DUREZOL
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
DUREZOL contains 0.05% difluprednate, as a sterile preserved
ophthalmic emulsion for topical ophthalmic
use only. (3)
CONTRAINDICATIONS
DUREZOL, 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 corticosteroids may result in posterior subcapsular
cataract formation. (5.2)
DELAYED HEALING: The use of steroids after cataract surgery may delay
healing and increase the
incidence of bleb