Presentation

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

Description

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.

Indications

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.

Dosage & Administration

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.

Side Effects

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.

Precautions

? 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.

Use in Pregnancy & Lactation

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.

Over Dose

No information provided.

Storage

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.

Commercial Pack

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