FEXMID cyclobenzaprine hydrochloride tablet film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Shionogi Inc.

INN (Διεθνής Όνομα):

CYCLOBENZAPRINE HYDROCHLORIDE

Σύνθεση:

CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FEXMID- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
SHIONOGI INC.
----------
FEXMID
7.5 MG
CYCLOBENZAPRINE HCL TABLETS USP
REVISED: OCTOBER 2014
RX ONLY
184152-3
DESCRIPTION
Fexmid
(cyclobenzaprine hydrochloride) is a white, crystalline tricyclic
amine salt. 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-(5_H_-dibenzo[_a,d_]cyclohepten-5-
ylidene)-_N,N_-dimethyl-1-propanamine hydrochloride, and has the
following structural formula:
Fexmid is available for oral administration as 7.5 mg tablets. Fexmid
contains the following inactive
ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic
calcium phosphate,
hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium
stearate, microcrystalline
cellulose, and titanium dioxide.
CLINICAL PHARMACOLOGY
Fexmid 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 similarity between the
effects of cyclobenzaprine and the
structurally related tricyclic antidepressants, including reserpine
antagonism, norepinephrine
potentiation, potent peripheral and cent