البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
TruPharma, LLC
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 5 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 should be used only for short periods (up to 2 or 3 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 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) inhibitors or withi
Cyclobenzaprine Hydrochloride Tablets, USP are supplied as follows: Cyclobenzaprine Hydrochloride Tablets, USP, 5 mg tablets are capsule-shaped, white, film coated tablets, debossed MP 578 on one side and plain on the other side Bottles of 100 NDC 52817-190-10 Bottles of 500 NDC 52817-190-50 Bottles of 1000 NDC 52817-190-00 Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg tablets are round, white, film coated tablets, debossed MP 577 on one side and plain on the other side Bottles of 100 NDC 52817-191-10 Bottles of 500 NDC 52817-191-50 Bottles of 1000 NDC 52817-191-00 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Manufactured by: Frontida BioPharm, Inc Philadelphia, PA 19124 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev00, April 2017
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET TRUPHARMA, LLC ---------- CYCLOBENZAPRINE HYDROCHLORIDE, USP RX ONLY CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular 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: Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and propylene glycol. 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 (γ) and alpha (α) motor systems. Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and th اقرأ الوثيقة كاملة