CYCLOBENZAPRINE HYDROCHLORIDE tablet film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Qualitest Pharmaceuticals

INN (Mezinárodní Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Složení:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
QUALITEST PHARMACEUTICALS
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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 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 in animals showed a similarit