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LOTEMAX (loteprednol etabonate ophthalmic suspension) 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 (loteprednol etabonate ophthalmic suspension) 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 (loteprednol etabonate ophthalmic suspension) 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 mmHg) was 1% with LOTEMAX (loteprednol etabonate ophthalmic suspension) and 6% with prednisolone acetate 1%. LOTEMAX (loteprednol etabonate ophthalmic suspension) should not be used in patients who require a more potent corticosteroid for this indication.
DOSAGE AND ADMINISTRATION
SHAKE VIGOROUSLY BEFORE USING.
Steroid Responsive Disease Treatment: Apply one to two drops of LOTEMAX (loteprednol etabonate ophthalmic suspension) 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. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS).
Post-Operative Inflammation: Apply one to two drops of LOTEMAX (loteprednol etabonate ophthalmic suspension) 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.
LOTEMAX® (loteprednol etabonate ophthalmic suspension) is supplied in a plastic bottle with a controlled drop tip in the following sizes:
2.5 mL (NDC 24208-299-25) - AB29904
5 mL (NDC 24208-299-05) - AB29907
10 mL (NDC 24208-299-10) - AB29909
15 mL (NDC 24208-299-15) - AB29911
DO NOT USE IF NECKBAND IMPRINTED WITH “Protective Seal” AND YELLOW IS NOT INTACT.
Storage: Store upright between 15°-25°C (59°-77°F).
DO NOT FREEZE.
KEEP OUT OF REACH OF CHILDREN.
Revised April 2006. Bausch & Lomb Incorporated, Tampa, Florida 33637. FDA revision date: 8/30/2001
Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.
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