CYCLOBENZAPRINE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

New Horizon Rx Group, LLC

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

구성:

CYCLOBENZAPRINE HYDROCHLORIDE 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 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 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 af

제품 요약:

The tablets are supplied as follows: 30 count bottle NDC 31722-080-01 Cyclobenzaprine hydrochloride 10 mg tablets are supplied as butterscotch yellow, round, film-coated convex tablets, debossed with "AN41" on one side and plain on the other side: Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C - 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 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. Manufactured by: Amneal Pharmaceuticals Patterson, NJ 07504 Manufactured For: New Horizon Rx Group, LLC Kenner, LA 70062 MF# 306 Rev. 11/13

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CYCLOBENZAPRINE HYDROCHLORIDE - CYCLOBENZAPRINE HYDROCHLORIDE TABLET
NEW HORIZON RX GROUP, LLC
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
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
hydrochloride, 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, 10 mg is supplied as a 10 mg tablet
for oral administration.
Cyclobenzaprine hydrochloride tablets USP, 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 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.
Pharmac