CYCLOBENZAPRINE- cyclobenzaprine hydrochloride tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Rising Health, LLC

INN (इंटरनेशनल नाम):

CYCLOBENZAPRINE HYDROCHLORIDE

रचना:

CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 c

उत्पाद समीक्षा:

Cyclobenzaprine Hydrochloride Tablets, USP 7.5 mg are round, white, film-coated tablets imprinted WATSON and 3330 supplied in bottles of 100 (NDC 57237-266-01). 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: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Manufactured for: Citron Pharma LLC  East Brunswick, NJ 08816  Issued: June 2016 PIC26601-00                    234110

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CYCLOBENZAPRINE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
RISING HEALTH, LLC
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CYCLOBENZAPRINE HCL TABLETS USP
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:
Cyclobenzaprine hydrochloride tablets, USP are available for oral
administration as 7.5 mg
tablets. Cyclobenzaprine hydrochloride 7.5 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 reserpine
antagonism, norepinephrine
p