CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Dispensing Solutions, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Cyclobenzaprine HCl 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, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl 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 HCl 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. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic cri

Podsumowanie produktu:

Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are round, white, film-coated tablets imprinted DAN and 5658 supplied in bottles of 100, 500 and 1000. Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Manufactured by:                                                                                                                                                                                       Watson Laboratories, Inc.                                                                                                                                                                         Corona, CA 92880 USA Distributed by:                                                                                                                                                                                            Watson Pharma, Inc.                                                                                                                                                                                 Parsippany, NJ 07054 Revised: April 2013                                                                   174655-1

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
DISPENSING SOLUTIONS, INC.
----------
CYCLOBENZAPRINE
HYDROCHLORIDE
TABLETS USP
REVISED: APRIL 2013
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine
salt. 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-(5_H_-dibenzo[_a,d_]cyclohepten-5-
ylidene)-_N,N_-dimethyl-1-propanamine hydrochloride, and has the
following structural formula:
C
H N•HCl
M.W. 311.9
Cyclobenzaprine hydrochloride tablets, USP are available for oral
administration as 5 mg, 7.5 mg and 10
mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg
tablets contain the following
inactive ingredients: colloidal silicon dioxide, croscarmellose
sodium, dibasic calcium phosphate,
hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium
stearate, microcrystalline
cellulose, 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 (γ) and alpha
(α) motor systems.
Pharmacological studies in animals showed a similarity between the
effects of cyclo