Neopred

Neopred

difluprednate

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Difluprednate.
Description
Each ml contains Difluprednate INN 0.5 mg.
Excipients/Inactive Ingredients: Preservative: Sorbic Acid BP 0.1%.
Action
Pharmacology: Difluprednate is a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.
Indications/Uses
Neopred is indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of uveitis, ocular surface diseases, e.g. blepharitis & corneal inflammation.
Dosage/Direction for Use
For post-operative: Instill 1 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.
For uveitis: Instill 1 drop into the conjunctival sac of the affected eyes 4 times daily for 14 days.
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.
Contraindications
Difluprednate is contraindicated in most viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.
Special Precautions
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.
Use in children: Safety and effectiveness in pediatric patients have not been established.
Use In Pregnancy & Lactation
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.
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.
Storage
Close the bottle immediately after use.
Discard 30 days after opening.
Store below 30°C & protect from light.
MIMS Class
ATC Classification
S01BA - Corticosteroids, plain ; Used in the treatment of inflammation of the eye.
Presentation/Packing
Ophth emulsion 0.05% w/v x 5 mL.
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