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(desvenlafaxine) Extended-release Tablets
KHEDEZLA Extended-release Tablets for oral administration contains desvenlafaxine, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (Odesmethylvenlafaxine) 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 C16H25NO2. Desvenlafaxine has a molecular weight of 263.38. The structural formula is shown below.
* Chiral Centre
Desvenlafaxine is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent.
KHEDEZLA is formulated as an extended-release tablet for once-a-day oral administration.
Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, respectively.
Inactive ingredients for the 50 mg tablet consist of citric acid monohydrate, hypromellose, microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide, and film coating, which consist of titanium dioxide, polyethylene glycol, talc, polyvinyl alcohol and iron oxides.
Inactive ingredients for the 100 mg tablet consist of citric acid monohydrate, hypromellose, microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide, and film coating, which consist of titanium dioxide, polyethylene glycol, talc, polyvinyl alcohol, iron oxides, and FD&C yellow #6.
Last reviewed on RxList: 10/14/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Khedezla Information
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