CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine 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:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 10 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 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 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 day

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. The two dosage strengths are supplied as follows: 10 mg – 30 count blistercard           NDC 0615-8084-39 10 mg – 15 count blistercard           NDC 0615-8084-05 10 mg – 30 count unit-dose box      NDC 0615-8084-30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
DESCRIPTION
Cyclobenzaprine hydrochloride, USP 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 hydrochloride,
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:
Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet
for oral
administration.
Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet
for oral
administration.
Cyclobenzaprine hydrochloride 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 hydrochloride 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).
CLINICAL PHARMACOLOGY
Cyclobenzaprine hydrochloride 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
20
21
a
models. Animal studies indicate that cyclobenzaprine does not act at
the neuromuscular
junction or directly on skeletal muscle. Such st