SPL Set ID: 00d506a4-74d6-4838-b008-3f9e7c017e08
1 drug(s) with this SPL Set ID
Nisoldipine is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is (±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-( o -nitrophenyl)-3,5-pyridinedicarboxylate, C 20 H 24 N 2 O 6 , and has the structural formula: Nisoldipine is a yellow crystalline powder, practically insoluble in water, but soluble in acetone, ethanol and methanol. It has a molecular weight of 388.4. Nisoldipine extended-release tablets are film-coated monolithic tablets containing a hydrogel which provides for the controlled release of the drug. Nisoldipine extended-release tablets contain either 8.5 mg, 17 mg, 25.5 mg or 34 mg of nisoldipine for once-a-day oral administration. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the following product specific coloring agents are used: The 8.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 17 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 25.5 mg tablets also contain red iron oxide and yellow iron oxide. The 34 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. Nisoldipine Structural Formula