Lonsurf Description

Each Lonsurf Film-coated Tablet 15 mg/6.14 mg, for oral use, contains 15 mg of trifluridine and 6.14 mg of tipiracil equivalent to 7.065 mg of tipiracil hydrochloride as active ingredients.
Each Lonsurf Film-coated Tablet 20 mg/8.19 mg, for oral use, contains 20 mg of trifluridine and 8.19 mg of tipiracil equivalent to 9.420 mg of tipiracil hydrochloride as active ingredients.
Lonsurf contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5.
Trifluridine: Trifluridine, a nucleoside metabolic inhibitor, is described chemically as 2'-deoxy-5-(trifluoromethyl) uridine.
Trifluridine has a molecular formula C₁₀H₁₁F₃N₂O₅ and a molecular weight of 296.20. Trifluridine is a white crystalline powder, soluble in water, ethanol, 0.01 mol/L hydrochloric acid, 0.01 mol/L sodium hydroxide solution; freely soluble in methanol, acetone; sparingly soluble in 2-propanol, acetonitrile; slightly soluble in diethyl ether; and very slightly soluble in isopropyl ether.
Tipiracil hydrochloride: Tipiracil hydrochloride, a thymidine phosphorylase inhibitor, is described chemically as 5-chloro-6-[(2-iminopyrrolidin-1-yl)methyl]pyrimidine-2,4-(1H,3H)-dione monohydrochloride or 2,4-(1H,3H)-pyrimidinedione,5-chloro-6-[(2-imino-1-pyrrolidinyl)methyl] hydrochloride (1:1).
Tipiracil hydrochloride has a molecular formula C₉H₁₁ClN₄O₂·HCl and a molecular weight of 279.12. Tipiracil hydrochloride is a white crystalline powder, soluble in water, 0.01 mol/L hydrochloric acid, and 0.01 mol/L sodium hydroxide; slightly soluble in methanol; very slightly soluble in ethanol; and practically insoluble in acetonitrile, 2-propanol, acetone, diisopropyl ether, and diethyl ether.
Excipients/Inactive Ingredients: Lonsurf Film-coated Tablet 15 mg/6.14 mg contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, and magnesium stearate.
Lonsurf Film-coated Tablet 20 mg/8.19 mg contains the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide (red), and magnesium stearate.
Both Lonsurf Film-coated Tablet 15 mg/6.14 mg and Lonsurf Film-coated Tablet 20 mg/8.19 mg are imprinted with ink containing shellac, ferric oxide (red), ferric oxide (yellow), titanium dioxide, FD&C Blue No. 2 - Lakes, carnauba wax, and talc.