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:

Physicians Total Care, 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. 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. 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 μg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 μg/kg/day, and 10 μg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment o

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 size: 5 mL in a 5 mL bottle     NDC 54868-6296-0. Storage 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.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

DUREZOL - DUREZOL EMULSION
PHYSICIANS TOTAL CARE, 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® (DIFUPREDNATE OPHTHALMIC EMULSION) 0.05%
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)
DOSAGE AND ADMINISTRATION
Instill one drop into the conjunctival sac of the affected eye(s) 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) (2)
DOSAGE FORMS AND STRENGTHS
Durezol contains 0.05% difluprednate, as a sterile preserved
ophthalmic emulsion for topical ophthalmic use only. (3) (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) (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). (5)
• Cataracts- Use of corticosteroids may result in posterior
subcapsular cataract formation. (5.2) (5)
• Delayed healing- The use of steroids after cataract surgery may
delay healing and increase the (5)
incidence of bleb formation. In those diseases causing thinning of the
cornea or sclera, perforations have been known to
occur with the use of topical steroids. The initial prescription and
renewal of the medication order beyond 28 days should
be made by a physician only after examina