CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (International ime):

CYCLOBENZAPRINE HYDROCHLORIDE

Sastav:

CYCLOBENZAPRINE HYDROCHLORIDE 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Cyclobenzaprine hydrochloride tablets 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 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 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 with

Proizvod sažetak:

Cyclobenzaprine Hydrochloride Tablets, USP 5 mg round, orange film-coated tablets, debossed "2631" on one side and debossed "V" on the reverse side. They are supplied as follows: Cyclobenzaprine Hydrochloride Tablets, USP 10 mg round, yellow film-coated tablets, debossed "2632" on one side and debossed "V" on the reverse side. They are supplied as follows: You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride 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 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 supplied as 5 mg and 10
mg tablets for
oral administration.
Each tablet contains the following inactive ingredients:
croscarmellose sodium, FD&C
Yellow #6, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets
also contain FD&C Red
#40 and 10 mg tablets contain D&C Yellow #10 and polysorbate.
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
20
21
a
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