Lotemax (loteprednol etabonate ophthalmic suspension) 0.5%


lotemax

Lotemax is a prescription-only ophthalmic suspension that reduces both internal and external inflammation of the eye, including inflammation resulting from Cataract Surgery and other types of eye surgery.

Clinical studies of Lotemax have been conducted in post-operative inflammation following cataract surgery, acute anterior uveitis, giant papillary conjunctivitis, and seasonal allergic conjunctivitis.  

Indication

  • Lotemax 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, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.

  • Lotemax is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mm Hg) was 1% with Lotemax and 6% with prednisolone acetate 1%. Lotemax should not be used in patients who require a more potent corticosteroid for this indication.

  • Lotemax is also indicated for the treatment of post-operative inflammation following ocular surgery.

 

IMPORTANT RISK INFORMATION

  • Lotemax 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 the ocular structures. Lotemax is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

  • Prolonged use of Lotemax is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation.

  • If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification. Fungal infections of the cornea may develop with prolonged use of corticosteroids

  • Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia

Please click here(354.4 KB, PDF) to view the Lotemax full Prescribing Information.

References

  1. Lotemax US Prescribing Information, April 2006.

US/LGX/12/0052(1)