国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
Cephalon, LLC
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 15 mg
ORAL
PRESCRIPTION DRUG
AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) 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, and limitation of motion. Limitations of Use: - AMRIX 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. - AMRIX has 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. These adverse reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruri
AMRIX extended-release capsules are available in 15 and 30 mg strengths, packaged in bottles of 60 capsules. AMRIX 15 mg capsules (NDC 63459-700-60) are orange/orange and are embossed in blue ink with “15 mg” on the body, and Cephalon “C” logo, “Cephalon”, and a dashed band on the cap. AMRIX 30 mg capsules (NDC 63459-701-60) are blue/red and are embossed in white ink with “30 mg” on the body, and Cephalon “C” logo, “Cephalon”, and a dashed band on the cap. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].
New Drug Application
AMRIX- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE CEPHALON, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMRIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMRIX. AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES), FOR ORAL USE INITIAL U.S. APPROVAL: 1977 INDICATIONS AND USAGE AMRIX is a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. (1) Limitations of Use: AMRIX should be used only for short periods (up to 2 or 3 weeks) (1) AMRIX has not been found effective in the treatment of spasticity or cerebral palsy (1) DOSAGE AND ADMINISTRATION Recommended adult dose for most patients is 15 mg taken once daily. Some patients may require 30 mg taken once daily (2) Recommended to take doses at approximately same time each day (2) Instruct patients to swallow AMRIX capsules intact or to sprinkle capsule contents on a tablespoon of applesauce and swallow immediately without chewing (2) Use for periods longer than 2 or 3 weeks is not recommended (2) DOSAGE FORMS AND STRENGTHS Extended-release capsules: 15 and 30 mg (3) CONTRAINDICATIONS Hypersensitivity to any component of this product (4) Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation (4) During acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure (4) Hyperthyroidism (4) WARNINGS AND PRECAUTIONS Serotonin syndrome has been reported with cyclobenzaprine when used in combination with other serotonergic drugs (5.1) Cyclobenzaprine is structurally related to tricyclic antidepressants which have been reported to produce adverse cardiovascular effects or CNS depressant effects (5.2) Use in the elderly is not recommended (5.3) Use in patients with hepatic impairment is not recommended (5.4) Use with caution in pati 阅读完整的文件