Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
MedVantx, Inc.
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Cyclobenzaprine Hydrochloride Tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine Hydrochloride Tablets USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine Hydrochloride Tablets USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) inhibi
Cyclobenzaprine Hydrochloride Tablets USP are available as: 10 mg Yellow, round, film-coated, unscored tablets debossed with 563 on one side and PLIVA on the other side. Available in bottles of 100, 500 and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured in Czech Republic By: TEVA Czech Industries, s.r.o. Opava-Komarov, Czech Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. D 5/2013
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED MEDVANTX, INC. ---------- CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP 563 Rx only DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the chemical name C H N•HCl, and a molecular weight of 311.85. It has a melting point of 217°C, and a pK 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, USP is designated chemically as 3-(5_H_-dibenzo[_a,d_]cyclohepten-5-ylidene)-_N_,_N_- dimethyl-1propanamine hydrochloride, and has the following structural formula: C H N•HCL M.W. 311.9 Each tablet for oral administration contains 10 mg cyclobenzaprine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, corn starch, crospovidone, hypromellose, magnesium stearate, pregelatinized corn starch, polyethylene glycol, polysorbate 80, titanium dioxide, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, and FD&C Yellow #6 aluminum lake. CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (g) and alpha (a) motor systems. Pharmacological Διαβάστε το πλήρες έγγραφο