CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Mylan Institutional Inc.

INN (International Adı):

CYCLOBENZAPRINE HYDROCHLORIDE

Kompozisyon:

CYCLOBENZAPRINE HYDROCHLORIDE 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 within

Ürün özeti:

Cyclobenzaprine Hydrochloride Tablets, USP are available containing 10 mg of cyclobenzaprine hydrochloride, USP. The 10 mg tablets are butterscotch yellow film-coated, round, unscored tablets debossed with M on one side of the tablet and 751 on the other side. They are available as follows: NDC 51079-644-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-644-19 – Robot Ready blister packages of 25 (25 cards of 1 tablet each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A S-12205 R1 9/15

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
MYLAN INSTITUTIONAL INC.
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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 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 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 as 5 mg, 7.5
mg and 10 mg tablets for oral
administration. Each 5 mg, 7.5 mg and 10 mg tablet contains
cyclobenzaprine hydrochloride and the
following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene
glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. In
addition, the 5 mg tablet contains FD&C
Blue No. 2 Aluminum Lake and the 10 mg tablet contains lecithin,
sodium alginate and yellow iron
oxide.
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