《BONIVA (ibandronate sodium) TABLETS》.pdf

V3.13 1  2 BONIVA 3 (ibandronate sodium) 4 TABLETS 5 6 Rx only 7 DESCRIPTION 8 BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits 9 osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N- 10 methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, 11 monohydrate with the molecular formula C H NO P Na ⋅H 0 and a molecular weight of 9 22 7 2 2 12 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water 13 and practically insoluble in organic solvents. Ibandronate sodium has the following 14 structural formula: OH O P OH CH CH CH CH CH N CH CH C OH . H O 3 2 2 2 2 2 2 2 CH 3 O P ONa 15 OH 16 BONIVA is available as a white, oblong, 2.5-mg film-coated tablet for daily oral 17 administration or as a white, oblong, 150-mg film-coated tablet for once-monthly oral 18 administration. One 2.5-mg film-coated tablet contains 2.813 mg ibandronate 19 monosodium monohydrate, equivalent to 2.5 mg free acid. One 150-mg film-coated 20 tablet