Generic

Loteprednol Etabonate

Indications

Loteprednol etabonate is used to treat steroid-responsive inflammatory diseases of the palpebral and bulbar conjunctiva, cornea, and anterior region of the globe, including:

• Conjunctivitis due to allergies
• Rosacea acne
• The term “superficial punctate keratitis” refers to a kind of keratitis
• Keratitis due to herpes zoster
• Iritis \sCyclitis

It is also used to treat post-operative inflammation following eye surgery.

Pharmacology

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no universally recognized explanation for how ocular corticosteroids work.

Corticosteroids, on the other hand, are hypothesized to function by inducing phospholipase A2 inhibitory proteins known as lipocortin’s. It is thought that these proteins regulate the production of powerful inflammatory mediators like prostaglandins and leukotrienes by limiting the release of their common precursor arachidonic acid. Phospholipase A2 liberates arachidonic acid from membrane phospholipids.

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 postoperative period.

Interaction

Loteprednol Etabonate is not predicted to alter the pharmacokinetics of systemically given medicinal drugs because it is not found in plasma after topical treatment.

Contraindications

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

Loteprednol is also contraindicated in those who have a known or suspected allergy to any of the preparation’s components or to other corticosteroids.

Side Effects

Photophobia, headache, rhinitis, pharyngitis, and local responses (such as impaired vision, burning, itching, and dry eyes). Prolonged usage may raise IOP, which may be linked to the development of glaucoma and rare optic nerve injury; posterior subcapsular cataract formation; and globe perforation if the cornea or sclera is thinning.

Pregnancy & Lactation

It falls under Pregnancy Category C. It is unknown if topical ocular corticosteroid treatment might result in sufficient systemic absorption to create measurable amounts in human milk.

Precautions & Warnings

• To avoid contamination, patients should be cautioned not to allow the dropper tip to come into contact with their eyes, eyelids, fingers, or any other surface.
• When using this medication, patients should be instructed not to wear soft contact lenses.
• If this product is used for more than 10 days, the intraocular pressure should be monitored.
• After long-term steroid treatment, the potential of corneal fungal infections should be recognized.
• Steroid usage may cause wound healing to be delayed.

Therapeutic Class

Preparations for Ophthalmic Steroids

Storage Conditions

Keep out of direct sunlight. Keep in a cool, dry place. Keep out of children’s reach. Do not use it after 4 weeks of opening. Before usage, give it a good shake.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.