CYCLOBENZAPRINE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Sammensetning:

CYCLOBENZAPRINE 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. Hyper

Produkt oppsummering:

Cyclobenzaprine Hydrochloride Tablets USP, 5 mg are round, white, film-coated tablets imprinted WATSON and 3256 supplied in: bottles of 15  NDC 54868-5597-1 bottles of 30  NDC 54868-5597-0 bottles of 60  NDC 54868-5597-3 bottles of 90  NDC 54868-5597-2. Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are round, white, film-coated tablets imprinted DAN and 5658 supplied in: bottles of 15  NDC 54868-1110-5 bottles of 20  NDC 54868-1110-3 bottles of 30  NDC 54868-1110-2 bottles of 60  NDC 54868-1110-8 bottles of 90  NDC 54868-1110-0 bottles of 100  NDC 54868-1110-9 bottles of 120  NDC 54868-1110-1. Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Watson Laboratories, Inc. Corona, CA 92880 USA Rev: April 2005 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CYCLOBENZAPRINE HYDROCHLORIDE - CYCLOBENZAPRINE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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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 cyclobenzaprine and the
structurally related tricyclic antidepressants, including res