SPL Set ID: 3c2e7083-6ba1-4131-a23f-462b02e5c036
1 drug(s) with this SPL Set ID
Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a micronized sterile white to off-white crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol Chemical name: Chloromethyl 11β, 17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate, 17-(ethyl carbonate). Each mL of Loteprednol etabonate ophthalmic suspension, 0.2% contains: ACTIVE: Loteprednol etabonate, 2 mg (0.2%) PRESERVATIVE ADDED: Benzalkonium chloride, 0.01% INACTIVES: Edetate disodium, glycerin, povidone K90, tyloxapol and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH between 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. 1