Lanoxicaps (Digoxin) - Description

DESCRIPTION

LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence“glycosides”).

Digoxin is described chemically as (3β,5β,12β)-3-[(O -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1↔4)- O -2,6-dideoxy-β- D-ribo- hexopyranosyl-(1→4)-2,6-dideoxy-β- D - ribo -hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C₄₁H₆₄O₁₄, its molecular weight is 780.95, and its structural formula is:

Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.

LANOXICAPS is a stable solution of digoxin enclosed within a soft gelatin capsule for oral use. Each capsule contains the labeled amount of digoxin USP dissolved in a solvent comprised of polyethylene glycol 400 USP, 8 percent ethyl alcohol, propylene glycol USP, and purified water USP. Inactive ingredients in the capsule shell include D&C Yellow No. 10 (0.1-mg and 0.2-mg Capsules), FD&C Blue No. 1 (0.2-mg Capsule), gelatin, glycerin, methylparaben and propylparaben (added as preservatives), purified water, and sorbitol. Capsules are printed with edible ink.