Presentation

Lotepro Plus Sterile Ophthalmic Suspension: Each ml contains Loteprednol Etabonate INN 5 mg and Tobramycin USP 3 mg.

Description

Lotepro plus is a sterile, multiple dose topical anti-inflammatory corticosteroid, Loteprednol Etabonate and antibiotic, Tobramycin combination for ophthalmic use. 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

Lotepro plus is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Dosage & Administration

Shake the bottle vigorously before using.

Apply 1 or 2 drops of Lotepro plus into the conjunctival sac of the affected eye(s) every 4 to 6 hours.

During the initial 24 to 48 hours, the dosing may be increased, to every 1 to 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Side Effects

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.

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema.

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 after cataract surgery may delay healing

? If super infection occurs, appropriate therapy should be initiated.

Use in Pregnancy & Lactation

Pregnancy : Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation : It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when it is administered to a nursing woman.

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 Plus Sterile Ophthalmic Suspension: Each plastic dropper bottle containing 5 ml Sterile Ophthalmic Suspension.