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PRESCRIBING INFORMATION ARGATROBAN

NDA 20-883/S-014. Page 4. PRESCRIBING INFORMATION . ARGATROBAN . Injection DESCRIPTION. ARGATROBAN is a synthetic direct thrombin inhibitor derived from L-arginine. The chemical name for ARGATROBAN is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[ [(1,2,3,4-tetrahydro-3-methyl-8 . quinolinyl)sulfonyl]amino]pentyl]-4-meth yl-2-piperidinecarboxylic acid, monohydrate. ARGATROBAN has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). ARGATROBAN consists of a mixture of R and S. stereoisomers at a ratio of approximately 65:35.

The mean ACTs produced in this study ranged from 1.39 to 1.82 times baseline, and the mean aPTTs ranged from 1.96 to 3.4 times baseline. When Argatroban was administered as a ... venous and arterial thrombosis. Whereas initial treatment …

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