April 26, 2017
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Lonsurf

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Lonsurf

LONSURF
(trifluridine and tipiracil) Tablets

DRUG DESCRIPTION

LONSURF contains trifluridine and tipiracil hydrochloride at a molar ratio of 1:0.5.

Trifluridine

Trifluridine, an antineoplastic thymidine-based nucleoside analogue, is described chemically as 2'-deoxy-5-(trifluoromethyl) uridine, and has the following structural formula:

Trifluridine - Structural Formula Illustration

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 5chloro-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), and has the following structural formula:

Tipiracil hydrochloride - Structural Formula Illustration

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.

LONSURF Tablet (15 mg trifluridine/6.14 mg tipiracil)

Each film-coated tablet of LONSURF, 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. LONSURF tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, and magnesium stearate.

LONSURF Tablet (20 mg trifluridine/8.19 mg tipiracil)

Each film-coated tablet of LONSURF, 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 tablets contain the following inactive ingredients: lactose monohydrate, pregelatinized starch, stearic acid, hypromellose, polyethylene glycol, titanium dioxide, ferric oxide, and magnesium stearate.

Both film-coated tablets (LONSURF 15 mg/6.14 mg and 20 mg/8.19 mg) are imprinted with ink containing shellac, ferric oxide red, ferric oxide yellow, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, carnauba wax, and talc.

Last reviewed on RxList: 4/14/2017
This monograph has been modified to include the generic and brand name in many instances.

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