SPL Set ID: 261c06ce-8708-d659-e063-6294a90ac381
1 drug(s) with this SPL Set ID
Guanfacine extended-release tablets, USP are once-daily, extended-release formulation of guanfacine hydrochloride (HCl) 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 Cl 2 N 3 O∙HCl corresponding to a molecular weight of 282.55. The chemical structure is: Guanfacine HCl 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 HCl equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid and ethyl acrylate copolymer, lactose monohydrate, povidone, colloidal silicon dioxide, microcrystalline cellulose, fumaric acid, and glyceryl dibehenate. In addition, the 3-mg and 4-mg tablets also contain FD&C Blue No. 1 and FD&C Yellow No. 5. FDA approved dissolution test specifications differ from USP. Chemical Stucture