CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Direct_Rx

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side. They are supplied as follows: Bottles of 10: Bottles of 100: Bottles of 500: Bottles of 1000: Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side. They are supplied as follows: Bottles of 10: Bottles of 90: Bottles of 100: Bottles of 180: Bottles of 270: Bottles of 500: Bottles of 1000 Bottles of 5000: You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
DIRECT_RX
----------
CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine
salt with the empirical
formula C20H21N • 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 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:
[structural formula for cyclobenzaprine.]
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.
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 similarity between the
effects of
cyclobenz