Loteprednol Etabonate (Ophthalmic Suspension)

Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as:

• Allergic conjunctivitis
• Acne rosacea
• Superficial punctate keratitis
• Herpes zoster keratitis
• Iritis
• Cyclitis

It is also indicated for the treatment of post-operative inflammation following ocular surgery.

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. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.

However, 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.

Shake the bottle vigorously before using

Steroid responsive disease treatment: Apply 1 to 2 drops of Loteprednol into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely.

Post-Operative Inflammation: Apply 1 to 2 drops of Loteprednol into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

Loteprednol, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Loteprednol is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Local reactions (e.g. blurred vision, burning, itching, dry eye), photophobia, headache, rhinitis, pharyngitis. Prolonged use may increase IOP, which may be associated with possible development of glaucoma and infrequent optic nerve damage; posterior sub-capsular cataract formation and perforation of the globe where there is thinning of the cornea or sclera.

It is Pregnancy Category C. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

• Shake the bottle well before use
• Patients should be advised not to allow the dropper tip to touch the eye, eyelid, fingers, or any other surface to prevent contamination
• Patients should be advised not to wear soft contact lenses when using this drug
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• The possibility of fungal infections of the cornea should be considered after long-term steroid dosing
• The use of steroids may delay wound healing.

Ophthalmic Steroid preparations.

Protect from light. Store in cool & dry place. Keep out of the reach of children. Do not use more than 4 weeks after opening. Shake well before using.