CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Quality Care Products LLC

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs. Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.

Termék összefoglaló:

Cyclobenzaprine Hydrochloride Tablets, USP are available in the following strength and package sizes: 7.5 mg (White, round, film coated tablets, debossed with “C 735” on one side and plain on the other side) 55700-239-30 55700-239-60 55700-239-90 55700-239-01 Store between 20 - 25° C (68 - 77° F). [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Distributed by: SA3, LLC. Los Angeles, CA 90064 Rev. # 09/2019                   

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
QUALITY CARE PRODUCTS LLC
----------
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline
powder 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 pK of 8.47 at 25° C. It is freely soluble in water,
in alcohol and in
methanol, sparingly soluble in isopropanol, slightly soluble in
chloroform and in
methylene chloride and insoluble in hydrocarbons. If aqueous solutions
are made
alkaline, the free base separates. Cyclobenzaprine HCl 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 supplied as 7.5 mg
tablets for oral
administration.
Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following
inactive ingredients:
corn starch, hydroxypropyl cellulose, hypromellose, lactose
monohydrate, magnesium
stearate, polyethylene glycol, pregelatinized starch, talc and
titanium dioxide.
CLINICAL PHARMACOLOGY
Cyclobenzaprine HCl 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
(μ) motor
systems.
Pharmacological studies in animals showed a similarity between the