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:

REMEDYREPACK INC.

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. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle             NDC 69097-845-07 5 mg – 1000 count bottle           NDC 69097-845-15 10 mg – 100 count bottle           NDC 69097-846-07 10 mg – 1000 count bottle         NDC 69097-846-15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE TABLET, FILM COATED
REMEDYREPACK INC.
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CYCLOBENZAPRINE HCL 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
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:
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).
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 o