CYCLOBENZAPRINE tablet, film coated 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:

DIRECT RX

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclobenzaprine HCl 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 HCl 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 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. Hyp

Product summary:

Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with 'IG' on one side and "282" on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with 'IG' on one side and "283" on other

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE- CYCLOBENZAPRINE TABLET, FILM COATED
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
DIRECT RX
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CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic
amine salt with the
empirical formula C20H21N•HCl and a molecular weight of 311.9. It
has a melting point
of 217˚C, and a pKa 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, USP is
designated
chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N,
N-dimethyl-1-propanamine
hydrochloride, and has the following structural formula:
Image
Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral
administration.
Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral
administration.
Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive
ingredients: lactose
monohydrate, microcrystalline cellulose, pregelatinized starch,
colloidal silicon dioxide,
magnesium stearate and opadry beige (hypromellose 6cP, titanium
dioxide, PEG 400,
iron oxide yellow and iron oxide red).
Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive
ingredients:
lactose monohydrate, microcrystalline cellulose, pregelatinized
starch, colloidal silicon
dioxide, magnesium stearate and opadry yellow (hypromellose 3cp,
hypromellose 6cp,
titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).
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 a