SPL Set ID: e16beec7-9acd-4cd1-be5c-b666ad7d2430
1 drug(s) with this SPL Set ID
Guanfacine extended-release tablets, USP is a once-daily, extended-release formulation of guanfacine hydrochloride, USP in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9 H 9 C l2 N 3 O·HCl corresponding to a molecular weight of 282.55. The chemical structure is: Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains Guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid copolymer, lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, fumaric acid, and glyceryl dibehenate. In addition, the 3-mg and 4-mg tablets also contain ferric oxide and FD&C Blue 2 Al lake. FDA approved dissolution test specifications differ from USP. image description