Lotemax SM®
Loteprednol 0.38% · ophthalmic gel
Steroid
Approved uses
Post-operative inflammation and pain after cataract surgery
1 drop into the conjunctival sac of the affected eye TID beginning the day after surgery, continuing through the first 2 post-operative weeks
TID dosing leaves 74% pain free and 30% with complete cell clearance by day 8.
Contraindications
- Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella.
- Mycobacterial infection of the eye.
- Fungal diseases of ocular structures.
Available Forms0.38% submicron gel (loteprednol etabonate 3.8 mg/g), 5 g in a 10 mL bottle
Mechanism of ActionCorticosteroid: binds and activates the glucocorticoid receptor and is thought to inhibit prostaglandin production through several independent mechanisms, suppressing the edema, fibrin deposition, capillary dilation, leukocyte migration, fibroblast proliferation, and collagen deposition of post-operative inflammation. Systemic exposure is minimal: in 18 healthy adults given 1 drop OU TID for 2 weeks, mean plasma Cmax was 0.13 ng/mL on day 1 and 0.16 ng/mL on day 15, against a 0.05 ng/mL limit of quantitation.
Warnings & Precautions
- IOP elevation and glaucoma: Prolonged corticosteroid use may result in glaucoma with optic nerve damage and defects in visual acuity and visual fields; use with caution in the presence of glaucoma, and monitor IOP if this product is used 10 days or longer.
- Posterior subcapsular cataract: Corticosteroid use may produce it.
- Delayed healing after cataract surgery: Steroids used after cataract surgery may delay healing and increase the incidence of bleb formation.
- Corneal or scleral perforation: In diseases causing thinning of the cornea or sclera, perforations have occurred with topical steroids.
- Prescription renewal: Initial prescription and renewal only after examination with magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. This label sets no day count for the gate.
- Secondary ocular infection: Prolonged use may suppress host response and increase the hazard of secondary ocular infection; in acute purulent conditions of the eye steroids may mask infection or enhance existing infection.
- Viral infection exacerbation: Ocular steroids may prolong the course and worsen the severity of many ocular viral infections including herpes simplex; a history of herpes simplex requires great caution.
- Fungal keratitis: Fungal corneal infection is particularly prone to develop coincidentally with long-term local steroid use; consider fungal invasion in any persistent corneal ulceration where a steroid has been used or is in use, and culture when appropriate.
- Contact lens wear: Lenses should not be worn when the eyes are inflamed.
Common Side Effects
- Clinical trial reactions: No treatment-emergent adverse drug reaction occurred in more than 1% of subjects in the three times daily group compared with vehicle. This label quantifies no individual reaction.
- Corticosteroid class effects: Elevated IOP with infrequent optic nerve damage and visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where the cornea or sclera is thinned.
Pregnancy & LactationPregnancy: No adequate and well controlled studies in pregnant women. Oral dosing produced teratogenicity at clinically relevant doses, with malformations in rabbits at 4.2 times the recommended human ophthalmic dose (spina bifida including meningocele at 0.1 mg/kg, exencephaly and craniofacial malformations at 17 times, abortion and resorption at 256 times) and in rats at 106 times, with reduced offspring survival in rats at 10.6 times. Background risk in the U.S. general population is 2% to 4% for major birth defects and 15% to 20% for miscarriage.
Lactation: No data on the presence of drug in human milk, on effects in the breastfed infant, or on milk production; weigh the developmental and health benefits of breastfeeding against the clinical need and potential adverse effects.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.