Source: FDA, National Drug Code (US) Revision Year: 2022
ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.
Loteprednol etabonate:
Chemical name:
chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Tobramycin:
Chemical name:
O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)O[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxystreptamine
Each mL contains:
Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5 to 6.2. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg.
Dosage Forms and Strengths |
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Ophthalmic suspension containing 5 mg/mL (0.5%) loteprednol etabonate and 3 mg/mL (0.3%) tobramycin. |
How Supplied |
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ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension) 0.5%/0.3% is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes: NDC 24208-358-05 5 mL fill in a 7.5 mL bottle NDC 24208-358-10 10 mL fill in a 10 mL bottle USE ONLY IF IMPRINTED NECKBAND IS INTACT. Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 USA |
Drug | Countries | |
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ZYLET | Brazil, Israel, Singapore, Turkey, United States |
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