Source: FDA, National Drug Code (US) Revision Year: 2018
BELVIQ/BELVIQ XR (lorcaserin hydrochloride) is a serotonin 2C receptor agonist for oral administration used for chronic weight management. Lorcaserin hydrochloride is chemically designated as (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate. The empirical formula is C11H14ClN·HCl·0.5H2O, and the molecular weight of the hemihydrate form is 241.16 g/mol.
The structural formula is:
Lorcaserin hydrochloride hemihydrate is a white to off-white powder with solubility in water greater than 400 mg/mL.
Each BELVIQ tablet contains 10.4 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 10.0 mg anhydrous lorcaserin hydrochloride, and the following inactive ingredients: silicified microcrystalline cellulose NF; hydroxypropyl cellulose NF; croscarmellose sodium NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP, FD&C blue #2/indigo carmine aluminum lake; and magnesium stearate NF.
Each BELVIQ XR extended-release tablet contains 20.8 mg of crystalline lorcaserin hydrochloride hemihydrate, equivalent to 20.0 mg anhydrous lorcaserin hydrochloride, and the following inactive ingredients: microcrystalline cellulose NF; mannitol USP; hypromellose USP; ethylcellulose dispersion Type B NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C yellow #6/sunset yellow FCF aluminum lake; iron oxide yellow NF; iron oxide red NF; and magnesium stearate NF.
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BELVIQ 10-mg tablets are blue-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “10” on the other side and are available as follows:
BELVIQ XR 20-mg extended-release tablets are orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:
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| Drug | Countries | |
|---|---|---|
| BELVIQ | Brazil, United States |
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