SPL Set ID: 30e61110-5bc8-4134-8456-538558479735
1 drug(s) with this SPL Set ID
Cyclobenzaprine hydrochloride is a skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) 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 hydrochloride is designated chemically as 3-( 5H -dibenzo[ a,d ] cyclohepten-5-ylidene)- N,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 mg and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: diethyl phthalate NF, ethylcellulose NF (Ethocel Standard 10 Premium), gelatin, Opadry ® Clear YS-1-7006, sugar spheres NF (20 to 25 mesh), and titanium dioxide. Cyclobenzaprine hydrochloride 15 mg extended-release capsules also contain D&C yellow #10, FD&C green #3, and FD&C red #40. Cyclobenzaprine hydrochloride 30 mg extended-release capsules also contain FD&C blue #1, FD&C blue #2, FD&C red #40, and FD&C yellow #6. Structural Formula