CYCLOBENZAPRINE HYDROCHLORIDE tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

TruPharma, LLC

INN (Међународно име):

CYCLOBENZAPRINE HYDROCHLORIDE

Састав:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 should be used only for short periods (up to 2 or 3 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 withi

Резиме производа:

Cyclobenzaprine Hydrochloride Tablets, USP are supplied as follows: Cyclobenzaprine Hydrochloride Tablets, USP, 5 mg tablets are capsule-shaped, white, film coated tablets, debossed MP 578 on one side and plain on the other side Bottles of 100                   NDC 52817-190-10 Bottles of 500                   NDC 52817-190-50 Bottles of 1000             NDC 52817-190-00 Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg tablets are round, white, film coated tablets, debossed MP 577 on one side and plain on the other side Bottles of 100                   NDC 52817-191-10 Bottles of 500                   NDC 52817-191-50 Bottles of 1000             NDC 52817-191-00 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Manufactured by: Frontida BioPharm, Inc Philadelphia, PA 19124 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev00, April 2017

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET
TRUPHARMA, LLC
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CYCLOBENZAPRINE HYDROCHLORIDE, USP
RX ONLY
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic
amine salt with the molecular
formula C
H N • 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
hydrochloride 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 available as 5 mg and
10 mg tablets for oral
administration.
Cyclobenzaprine hydrochloride tablets USP contain the following
inactive ingredients: colloidal
silicon dioxide, corn starch, hypromellose, lactose, magnesium
stearate, microcrystalline cellulose,
polyethylene glycol, and propylene glycol.
CLINICAL PHARMACOLOGY
Cyclobenzaprine hydrochloride 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 th