CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clinical Solutions Wholesale

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclobenzaprine hydrochloride 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. Cyclobenzaprine hydrochloride 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 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 dis

Product summary:

The tablets are supplied as follows: 30 count blister pack NDC 58118-0541-08 Cyclobenzaprine hydrochloride 10 mg tablets are supplied as butterscotch yellow, round, film-coated convex tablets, debossed with "AN41" on one side and plain on the other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). [See USP Controlled Room Temperature]. This is a bulk package. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
CLINICAL SOLUTIONS WHOLESALE
----------
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 is supplied as a 10 mg tablet for oral
administration.
Cyclobenzaprine hydrochloride tablets 10 mg contain the following
inactive ingredients:
croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2
aluminum lake, FD&C
Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide,
talc, and titanium dioxide.
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 stud