Predicot Ophthalmic Emulsion 0.05%

Uses

Predicot Ophthalmic Emulsion 0.05% is used for the treatment of inflammation and pain associated with ocular surgery. It is also used for the treatment of uveitis, ocular surface diseases, e.g. blepharitis & corneal inflammation.

Predicot Ophthalmic Emulsion 0.05% is also used to associated treatment for these conditions: Anterior Uveitis (AU), Endogenous Anterior Uveitis, Eye Pain, Ocular Inflammation, Pain of the eye

How Predicot Ophthalmic Emulsion 0.05% works

Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Dosage

Predicot Ophthalmic Emulsion 0.05% dosage

For the treatment of inflammation and pain associated with ocular surgery: Instill 1 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 post-operative period, followed by 2 times daily for a week and then a taper based on the response.

For the treatment of endogenous anterior uveitis: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

For blepharitis: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily for 1 week & then once daily for 1 week.

For pseudophakic cystoid macular edema: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily.

Side Effects

Glaucoma with optic nerve damage, visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Toxicity

Preclinical pharmacokinetic and toxicity studies have established that difluprednate ophthalmic emulsion 0.05% given 4 times a day is not toxic to the eye.

Precaution

• For ophthalmic use only.
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity & visual field, and in posterior subcapsular cataract formation.
• Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Interaction

Specific drug interaction studies have not been conducted with Predicot Ophthalmic Emulsion 0.05% 0.05% ophthalmic emulsion.

Food Interaction

Elimination Route

Predicot Ophthalmic Emulsion 0.05% penetrates the corneal epithelium rapidly and effectively. Low systemic absorption.

Elimination Route

78.5% of radioactivity was excreted aftert 24 hours, and 99.5% by 7 days after a single dose of labeled difluprednate instilled in the right eyes of pigmented rabbits.

Pregnancy & Breastfeeding use

Use in pregnancy: 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 fetus.

Use in lactation: It is not known whether difluprednate passes into breast milk. Caution should be exercised when it is administered to a nursing mother.

Contraindication

Predicot Ophthalmic Emulsion 0.05% is contraindicated in most viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.

Special Warning

Use in children: Safety and effectiveness in pediatric patients have not been established.

Acute Overdose

Over dosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Innovators Monograph

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