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:

IPG PHARMACEUTICALS, INC.

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclobenzaprine hydrochloride tablets, USP 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 hydrochloride tablets, USP 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 tablets, USP 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) inhi

Product summary:

Cyclobenzaprine hydrochloride tablets, USP are available in 7.5 mg dosage strengths. The dosage strengths are supplied as follows: The 7.5 mg tablets are white, round shaped, biconvex, film coated tablets debossed with ‘RE ’ on one side and ‘33 ’ on other side. NDC 71085-010-01 Bottles of 1000 Store between 20° - 25° C (68° - 77° F). [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: IPG Pharmaceuticals, Inc. Tempe, AZ 85281

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
IPG PHARMACEUTICALS, INC.
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline
powder with the molecular
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, in alcohol and in
methanol, sparingly soluble in isopropanol,
slightly soluble in chloroform and in methylene chloride and insoluble
in hydrocarbons. 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 a 7.5 mg
tablets for oral administration.
Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following
inactive ingredients: corn starch,
hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium
stearate, polyethylene
glycol, pregelatinized starch, 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 studies in animals showed a similarity bet