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:

KAISER FOUNDATION HOSPITALS

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclobenzaprine HCl 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 HCl 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 HCl 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 within 14 days after their discont

Product summary:

Cyclobenzaprine HCl Tablets, USP are available in the following strength and package sizes: 10 mg (Yellow, round, film-coated, debossed with TL177 on one side and plain on the other side) Bottles of 30 (NDC 0179-0057-30) Bottles of 50 (NDC 0179-0057-50) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured by: Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 02/07 Repackaged by: Kaiser Foundation Hospitals Livermore, CA 94551, USA.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
KAISER FOUNDATION HOSPITALS
----------
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine
salt with the empirical formula C
H
N•HCI and a molecular weight of 311.9. It has a melting point of
217º C, and a pKa of 8.47 at 25º
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
HCI 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 HCl Tablets, for oral administration, are available in
the following strength: 10 mg.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, lactose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow.
CLINICAL PHARMACOLOGY
Cyclobenzaprine HCI 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 rela