Lotepro Eye Drops (Loteprednol Etabonate 0.5%)

Therapeutic Group: Ophthalmic Steroidal Preparations

Lotepro Sterile Ophthalmic Suspension: Each ml contains Loteprednol Etabonate 5 mg.

Loteprednol Etabonate is a topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is structurally similar to other corticosteroids. It is highly lipid soluble which enhances its penetration into cells.

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.

Shake the bottle vigorously before using Steroid responsive disease treatment: Apply 1 to 2 drops of Lotepro 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 Lotepro 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.

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.

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

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

Pregnancy: It is Pregnancy Category C. Lactation: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Pediatric use Safety and effectiveness in pediatric patients have not been established. Drug Interaction No information provided.

No information provided. Storage Protect from light. Store in cool and dry place Keep out of the reach of children Do not use more than 4 weeks after opening Shake well before using.

Lotepro Sterile Ophthalmic Suspension: Plastic dropper bottle containing 5ml Sterile Ophthalmic Suspension.