Generic

Loteprednol Etabonate

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.

Pharmacology

Corticosteroids slow or prevent healing by inhibiting the inflammatory response to a number of triggering factors. They prevent inflammation-related edema, fibrin deposition, capillary dilatation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation. The mechanism of action of ocular corticosteroids is not well understood.

Corticosteroids, on the other hand, are hypothesized to work by inducing phospholipase A2 inhibitory proteins known as lipocortins. These proteins are thought to regulate the manufacture of powerful inflammatory mediators including prostaglandins and leukotrienes.

Dosage & Administration

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.

Interaction

Loteprednol Etabonate is not predicted to impact the pharmacokinetics of systemically delivered medicinal drugs because it is not detected in plasma after topical application.

Contraindications

Loteprednol, like other ophthalmic corticosteroids, is contraindicated in the treatment of most viral diseases of the cornea and conjunctiva, such as epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as mycobacterial infections of the eye and fungal diseases of ocular structures.

Individuals with known or suspected hypersensitivity to any of the components in this medication, as well as other corticosteroids, should avoid taking loteprednol.

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.

Pregnancy & Lactation

It’s a Pregnancy Category C situation. It’s unclear whether corticosteroids given topically in the eyes would cause enough systemic absorption to produce detectable levels in human milk.

Precautions & Warnings

• Before using, give the bottle a good shake.
• To avoid contamination, patients should be told not to touch their eyes, eyelids, fingers, or any other surface with the dropper tip.
• When using this medication, patients should be told not to wear soft contact lenses.
• Intraocular pressure should be monitored if this product is used for more than 10 days.
• After long-term steroid use, the likelihood of fungal infections of the cornea should be recognized.
• Steroids may cause a delay in wound healing.

Therapeutic Class

Ophthalmic Steroid preparations

Storage Conditions

Pharmaceutical Name

General Pharmaceuticals Ltd.