Loteprednol Etabonate Ophthalmic Ointment 0.5% is a

sterile, topical corticosteroid for ophthalmic use. Corticosteroids inhibit the

inflammatory response to a variety of inciting agents and probably delay or

slow healing. They inhibit the edema, fibrin deposition, capillary dilation,

leukocyte migration, capillary proliferation, fibroblast proliferation, deposition

of collagen, and scar formation associated with inflammation.

Corticosteroids are thought to act by the induction of

phospholipase A2 inhibitory proteins, collectively called lipocortins. It is

postulated that these proteins control the biosynthesis of potent mediators of

inflammation 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. Corticosteroids are capable of

producing a rise in intraocular pressure (IOP). The mechanism by which

ophthalmic corticosteroids increase intraocular pressure is not known.

Indication & Usage: EDNOL Ophthalmic Ointment is a corticosteroid

indicated for the treatment of post-operative inflammation and pain following

ocular surgery.

Warnings & 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 even though it may be difficult in

children and uncooperative patients.

Use of corticosteroids may result in posterior subcapsular cataract formation.

Patients should not wear contact lenses during their course of therapy with

Loteprednol Etabonate Ophthalmic Ointment.

Loteprednol Etabonate ophthalmic ointment 0.5% should not be used in

children following ocular surgery. Its use may interfere with amblyopia

treatment by hindering the child's ability to see out of the operated eye.

Adverse Effect: Adverse reactions associated with ophthalmic steroids

include elevated intraocular pressure, which may be associated with optic

nerve damage, visual acuity and field defects, posterior subcapsular cataract

formation, secondary ocular infection from pathogens including herpes

simplex, and perforation of the globe where there is thinning of the cornea or

sclera.

Information to Patients: Follow the instructions that are provided by your

doctor and if the adverse effects persist, discontinue the usage and contact

your doctor immediately.

Presentation: EDNOL Ophthalmic Ointment is available in 5g pack of

Laminated Plastic Tube.