Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
KVK-TECH, Inc.
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Cyclobenzaprine hydrochloride tablets, USP is 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) in
Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg and 10 mg dosage strength. The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side. Bottles of 100, NDC 10702-006-01 Bottles of 500, NDC 10702-006-50 Bottles of 1000, NDC 10702-006-10 The 10 mg tablets are supplied as yellow colored film coated round shaped biconvex tablets debossed “K 7” on one side and plain on other side. Bottles of 30, NDC 10702-007-03 Bottles of 90, NDC 10702-007-09 Bottles of 100, NDC 10702-007-01 Bottles of 500, NDC 10702-007-50 Bottles of 1000, NDC 10702-007-10 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]. Dispense in a tight, well-closed, container as defined in the USP, with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940-1850 Item ID # 006013/07 06/2018 Manufacturer’s Code: 10702
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED KVK-TECH, INC. ---------- CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP DESCRIPTION Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C H N• 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: Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride. Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow. In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake. In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose. 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 Prečítajte si celý dokument