SLYND (drospirenone) is for use as an oral contraceptive. It is supplied as clear to a slightly opaque PVC-PVDC/Aluminum blister cards, each holding of 24 white tablets each containing 4 mg of drospirenone, a synthetic progestational compound and 4 green inert tablets.
Drospirenone is chemically described as (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)1,3’,4’,6,6a,7,8,9,10,11, 12,13,14,15,15a,16-hexadecahydro10,13-dimethylspiro-[17Hdicyclopropa-[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione). It has a molecular weight of 366.5, a molecular formula of C24H30O3, and the structural formula below:
Drospirenone is a white to almost white or slightly yellow crystalline powder. It is a progestin and neutral molecule with slight solubility in water
The active tablet is a 5 mm, round, unscored, film-coated, white tablet that contains 4mg of drospirenone as the active ingredient, and microcrystalline cellulose NF, anhydrous lactose NF, colloidal silicon dioxide NF, magnesium stearate NF, polyvinyl alcohol partially hydrolyzed NF, talc NF, titanium dioxide NF, and polyethylene glycol NF as the inactive ingredients. Each tablet is debossed with the letter “E” on one side and the letter “D” on the other sides.
The inert tablet is a 5 mm, round, unscored, film-coated, green tablet that does not contain drospirenone. Each inert green tablet contains the following inactive ingredients: Lactose monohydrate NF, corn starch NF, povidone 30000 NF, colloidal silicon dioxide NF, magnesium stearate NF, hypromellose NF, talc NF, titanium dioxide USP, polysorbate 2910 NF, triacetin NF, FD&C blue 2 aluminum lake and yellow ferric oxide.