SPL Set ID: edf18b33-a226-44f8-9f42-c409e691ee64
1 drug(s) with this SPL Set ID
Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16 H 25 NO 2 (free base) and C 16 H 25 NO 2 •C 4 H 6 O 4 •H 2 O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet consist of microcrystalline cellulose, hydroxypropyl methyl cellulose, colloidal silicon dioxide, isopropyl alcohol, talc, magnesium stearate and film coating, which consists of Hypromellose, Polyethylene Glycol 400, Polyethylene Glycol 6000, Talc, Titanium Dioxide, Red Iron Oxide and Yellow Iron Oxide. Inactive ingredients for the 100 mg tablet consist of microcrystalline cellulose, hydroxypropyl methyl cellulose, colloidal silicon dioxide, isopropyl alcohol, talc, magnesium stearate and film coating, which consists of Hypromellose, Polyethylene Glycol 400, Polyethylene Glycol 6000, Talc, Titanium Dioxide, Red Iron Oxide, Yellow Iron Oxide and FD&C Yellow No. 6 Al. Lake str