DIFLUPREDNATE- difluprednate ophthalmic emulsion

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Amneal Pharmaceuticals NY LLC

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Difluprednate ophthalmic emulsion, 0.05%, a topical corticosteroid, is 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, 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 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 to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate, since difluprednate is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate is administered to a nursing woman. Difluprednate was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate to prednisolone acetate ophthalmic suspension, 1%. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Ringkasan produk:

Difluprednate Ophthalmic Emulsion, 0.05% is a sterile, white milky aqueous topical ophthalmic emulsion and supplied in white LDPE opaque bottle with a LDPE natural nozzle and HDPE pink cap. It is available as follows: 5 mL in 5 mL Container:                                NDC 69238-1380-3 Storage and Handling Store at 15° to 25°C (59° to 77°F). Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DIFLUPREDNATE- DIFLUPREDNATE OPHTHALMIC EMULSION
AMNEAL PHARMACEUTICALS NY LLC
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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, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2008
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, 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 posterio