FEXMID- cyclobenzaprine hydrochloride tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Quality Care Products, LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Fexmid is 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. Fexmid 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. Fexmid has 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 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred

Produkto santrauka:

Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted WATSON and 3330. 55700-726-30 55700-726-60 55700-726-90 Pharmacist: Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for: Casper Pharma LLC Suite 1101C 2 Tower Center Blvd East Brunswick, NJ 08816 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Issued: 04/2016 PIBN01404122016                    232128

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FEXMID- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED
QUALITY CARE PRODUCTS, LLC
----------
FEXMID
7.5 MG
CYCLOBENZAPRINE HCL TABLETS USP
RX ONLY
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 central anticholinergi