Loteprednol Etabonate Ophthalmic Ointment 0.5% w/w
Loteprednol Etabonate 0.5% w/w
Sterile Ointment Base q.s.
Dosage Form: Ophthalmic Ointment
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
Apply a small amount (approximately ½ inch
ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after
surgery and continuing throughout the first 2 weeks of the post-operative
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
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.