CYCLOBENZAPRINE HYROCHLORIDE- cyclobenzaprine hydrochloride tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Rebel Distributors Corp

DCI (Denominação Comum Internacional):

CYCLOBENZAPRINE HYDROCHLORIDE

Composição:

CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Cyclobenzaprine hydrochloride tablets, USP 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, USP are 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, USP 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

Resumo do produto:

Cyclobenzaprine hydrochloride tablets, USP are available in 7.5 mg strength. The dosage strength is supplied as follows: The 7.5 mg tablets are white, round shaped, biconvex, film coated tablets debossed with ‘RE’ on one side and ‘33’ on the other side. NDC 42254-239-30 Bottles of 30 NDC 42254-239-60 Bottles of 60 Store between 20° - 25° C (68° - 77° F) [See USP controlled room temperature] You may report side effects to FDA at 1-800-FDA-1088. Distributed by: KLE 2 Inc 3731 S. Robertson Blvd Culver City, CA 90232 August 2011 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CYCLOBENZAPRINE HYROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless
crystalline powder with the
molecular 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, in alcohol and
in methanol, sparingly soluble in
isopropanol, slightly soluble in chloroform and in methylene chloride
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 a 7.5 mg
tablets for oral administration.
Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following
inactive ingredients: corn starch,
hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium
stearate, polyethylene
glycol, pregelatinised starch, talc 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 (g) and alpha
(μ) motor systems.
Pharmacological studies in animals showed a similarity betw