CYCLOBENZAPRINE HYDROCHLORIDE capsule, film coated, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Sterling Knight Pharmaceuticals,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, USP 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) inhi

Резиме производа:

Cyclobenzaprine hydrochloride tablets, USP 5 mg are supplied as butterscotch yellow-colored, capsule-shaped, film-coated convex tablets, debossed with "AN40" on one side and plain on the other side. They are available as follows: 100 count bottle      NDC 69336-104-10 500 count bottle      NDC 69336-104-50   1000 count bottle    NDC 69336-104-11 Cyclobenzaprine hydrochloride tablets, USP 10 mg are supplied as butterscotch yellow, round, filmcoated convex tablets, debossed with "AN41" on one side and plain on the other side. They are available as follows: 100 count bottle       NDC 69336-105-10 500 count bottle       NDC 69336-105-50 1000 count bottle      NDC 69336-105-11 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. This container is not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Rx Only Distributed by Sterling-Knight Pharmaceuticals, LLC Ripley, MS 38663 Rev. 11-2016-00

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE,
FILM
COATED, EXTENDED RELEASE
STERLING KNIGHT PHARMACEUTICALS,LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
STERLING-KNIGHT PHARMACEUTICALS, LLC
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS , USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic
amine salt with the empirical
formula C
H
N·HCl and a molecular weight of 311.9. 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, USP 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, USP is supplied as a 5 mg or 10 mg
tablet for oral administration.
Cyclobenzaprine hydrochloride tablets USP, 5 mg and 10 mg, contain the
following inactive
ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C
Blue #2 aluminum lake,
FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
silicon dioxide, 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 withi