Drug Information for JANTOVEN TABLETS (Warfarin Sodium Tablets, USP) (Upsher-Smith Laboratories, Inc.): DESCRIPTION

  • Jantoven® Tablets (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(a-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its empirical formula is C19H15NaO4, and its structural formula may be represented by the following:

    Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.

    Jantoven® Tablets (Warfarin Sodium Tablets, USP) for oral use contain: 1 mg, 2 mg, 2½ mg, 3 mg, 4 mg, 5 mg, 6 mg, 7½ mg or 10 mg of crystalline warfarin sodium, USP. They also contain:

    All Strengths: Lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch (corn).

    • 1 mg: FD&C Red #40 Aluminum Lake
    • 2 mg: FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake
    • 2½ mg: D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake
    • 3 mg: Brown #75 Synthetic Brown Iron Oxide
    • 4 mg: FD&C Blue #1 Aluminum Lake
    • 5 mg: FD&C Yellow #6 Aluminum Lake
    • 6 mg: Yellow #10 Synthetic Yellow Iron Oxide, Black #85 Synthetic Black Iron Oxide and FD&C Blue #1 Aluminum Lake
    • 7½ mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake
    • 10 mg: Dye Free.
  • Drug Information Provided by National Library of Medicine (NLM).