CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Internationale Bezeichnung):

CYCLOBENZAPRINE HYDROCHLORIDE

Zusammensetzung:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Cyclobenzaprine hydrochloride tablets 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 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 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 with

Produktbesonderheiten:

Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side, supplied in blisterpacks of 30 tablets.   Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side, supplied in blisterpacks of 30 and 15 tablets and unit dose boxes of 30 tablets. 

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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 pK 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 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 5 mg and 10
mg tablets for oral
administration.
Each tablet contains the following inactive ingredients:
croscarmellose sodium, FD&C Yellow #6,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40
and 10 mg tablets contain D&C
Yellow #10 and polysorbate.
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 (γ) and alpha
(α) motor systems.
Pharmacological studies in animals showed a