Lotemax
LOTEMAX®
(loteprednol etabonate) Ophthalmic Suspension 0.5%
STERILE OPHTHALMIC SUSPENSION
DRUG DESCRIPTION
LOTEMAX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.
Loteprednol etabonate is represented by the following structural formula:
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Chemical Name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Each mL contains
ACTIVE: Loteprednol Etabonate 5 mg (0.5%);
INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol.
Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5-5.6.
The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Generic Name: Loteprednol Etabonate Ophthalmic Suspension
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