SPL Set ID: 41838966-de0b-4855-83b8-2ff6c764ed1f
1 drug(s) with this SPL Set ID
Fexmid ® (cyclobenzaprine hydrochloride) a skeletal muscle relaxant, is a white, crystalline tricyclic amine salt with the empirical formula C 20 H 21 N•HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Fexmid ® is supplied as a 7.5 mg tablet for oral administration. Each 7.5 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, OPADRY White, pregelatinized starch, purified water. Opadry components: Hypromellose, polyethylene glycol/macrogol, talc, titanium dioxide. FDA approved dissolution specifications differ from that of the USP. image