AMRIX- cyclobenzaprine hydrochloride capsule, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)

Boleh didapati daripada:

Cephalon, LLC

INN (Nama Antarabangsa):

CYCLOBENZAPRINE HYDROCHLORIDE

Komposisi:

CYCLOBENZAPRINE HYDROCHLORIDE 15 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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].

Status kebenaran:

New Drug Application

Ciri produk

AMRIX- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
CEPHALON, INC.
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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