Lupred(Difluprednate)

Therapeutic Group: Analgesic, Anti Inflammatory

Presentation

Lupred™Sterile Ophthalmic Emulsion: Each ml contains Difluprednate INN 0.5 mg.

Description

Difluprednate is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. It is structurally similar to other corticosteroids. Difluprednate is thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins, which control the biosynthesis of potent inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Indications

Difluprednate is indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of endogenous anterior uveitis, inflammation that affects the front part of the eye.

Dosage & Administration

Postoperative ocular inflammation: 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.
Uveitis: Instill one drop into the conjunctival sac of the affected eye(s) 4 times daily for 14 days.

Side Effects

Glaucoma with optic nerve damage, visual acuity and vision field defects, cataract formation, secondary ocular infections by suppression of host response and perforation of the globe may occur with prolonged use.

Precautions

• For ophthalmic use only
• Intraocular pressure (IOP) increase: If the product is used for 10 days or longer, IOP should be monitored
• Cataract: Use of corticosteroids may result in cataract formation
• Delayed healing: The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation
• Bacterial infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections
• Viral infections: Use of a corticosteroid in patients with a history of herpes simplex requires great caution
• Fungal infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long term local steroid application

Use in Pregnancy & Lactation

Pregnancy: Pregnancy category C. Use of Difluprednate in pregnancy has not been evaluated. It should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.
Lactation: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when Difluprednate is administered to a nursing mother.

Pediatric use
Safety and effectiveness in pediatric patients have not been established.

Geriatric use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Storage

• Do not store above 300C
• Do not use more than 4 weeks after opening
• Keep out of the reach of children

Commercial Pack

Lupred™Sterile Ophthalmic Emulsion: Each plastic dropper bottle contains 5 ml sterile ophthalmic emulsion.