TYKERB Film-coated tablet Ref.[11065] Active ingredients: Lapatinib

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N-(3-chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)6[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine bis(4-methylbenzenesulfonate) monohydrate. It has the molecular formula C29H26ClFN4O4S (C7H8O3S)2H2O and a molecular weight of 943.5 g/mol.

Lapatinib ditosylate monohydrate has the following chemical structure:

Lapatinib is a yellow solid, and its solubility in water is 0.007 mg/mL and in 0.1N HCl is 0.001 mg/mL at 25°C.

Each 250 mg tablet of TYKERB contains 405 mg of lapatinib ditosylate monohydrate, equivalent to 398 mg of lapatinib ditosylate or 250 mg lapatinib free base.

The inactive ingredients of TYKERB are:

Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

Coating: Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.

Dosage Forms and Strengths

250 mg tablets — oval, biconvex, orange, film-coated with ‘GS XJG’ debossed on one side.

How Supplied

The 250 mg tablets of TYKERB are oval, biconvex, orange, and film-coated with ‘GS XJG’ debossed on one side and are available in:

Bottles of 150 tablets: NDC 0078-0671-19

Drugs

Drug Countries
TYKERB Australia, Brazil, Canada, Hong Kong, Israel, Japan, Mexico, New Zealand, Singapore, Turkey, United States, South Africa

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