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Drug Information for Cyclobenzaprine Hydrochloride (Mylan Pharmaceuticals Inc.): DESCRIPTION
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Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C20H21N • HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa 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 tablets, USP are available as 5 mg and 10 mg tablets for oral administration. Each 5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. In addition, the 5 mg tablet contains FD&C Blue No. 2 Aluminum Lake and the 10 mg tablet contains lecithin, sodium alginate and yellow iron oxide.
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