Lotepred 0.5% Ophthalmic Gel 5g Tube

Ophthalmic gel: Instill one to two drops of Loteprednol Gel Sterile Ophthalmic Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.
Since Lotepred is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occur in 5%-15% of patients treated with Lotepred sterile ophthalmic suspension. (0.2%-0.5%) In clinical studies, these included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis.

Pregnancy Category C. For Loteprednol Etabonate, no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown, and it should not be used in pregnancy unless clearly necessary. 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 Loteprednol is administered to a nursing woman.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If Lotepred is used for 10 days or longer, intraocular pressure should be monitored. Fungal invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients should also be advised not to wear contact lenses during their course of therapy.

Store below 30 degrees C in a dry place protected from light. Do not touch the tube tip to any surface. The contents should not be used one month after the first opening of the tube. Protect from freezing.