CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Jubilant Cadista Pharmaceuticals Inc.

INN (mednarodno ime):

CYCLOBENZAPRINE HYDROCHLORIDE

Sestava:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 oxidas

Povzetek izdelek:

Cyclobenzaprine Hydrochloride Tablets, USP are available in the following strengths and package sizes: 5 mg (Orange, round, film-coated tablets, debossed with “TL 211” on one side and plain on the other side) Bottles of 100’s   NDC 59746-211-06 Bottles of 1000’s NDC 59746-211-10 7.5 mg (White, round, film coated tablets, debossed  with “C 735” on one side and plain on the other side) Bottles of 30’s     NDC 59746-735-30 Bottles of 100’s   NDC 59746-735-01 Bottles of 1000’s NDC 59746-735-10 10 mg (Yellow, round, film-coated tablets, debossed with “TL 177” on one side and plain on the other side) Bottles of 100’s   NDC 59746-177-06 Bottles of 1000’s NDC 59746-177-10 Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CYCLOBENZAPRINE HYDROCHLORIDE - CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS
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
217º C, and a pKa of
8.47 at 25º 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, for oral administration,
are available in the following
strengths: 5 mg, 7.5 mg and 10 mg.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, lactose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polyvinyl alcohol, talc, titanium dioxide. In addition, the 5 mg
tablet contain FD&C yellow # 6, and both
the 5 mg and 10 mg tablets contain iron oxide yellow.
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