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:

Citron Pharma LLC

INN (International Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Composition:

CYCLOBENZAPRINE HYDROCHLORIDE 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 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 monoamin

Product summary:

Cyclobenzaprine Hydrochloride Tablets USP, 5 mg are yellow-orange, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘87’ on one side and plain on other side.                Bottles of 100              NDC 57237-190-01                Bottles of 500              NDC 57237-190-05                Bottles of 1,000           NDC 57237-190-99 Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are butterscotch yellow, biconvex, 5-sided D-shaped film-coated tablets, debossed with ‘D’ and ‘32’ on one side and plain on other side.                Bottles of 100              NDC 57237-191-01                Bottles of 500              NDC 57237-191-05                Bottles of 1,000           NDC 57237-191-99 Store at 20° to 25°C (68° to 77°F); exursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Citron Pharma LLC Suite - 1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/19/1993 Made in India Issued: 01/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE - CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
CITRON PHARMA LLC
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic
amine salt with the molecular
formula C
H N • HCl and a molecular weight of 311.9. It has a melting point of
217ºC, and a pK of
8.47 at 25ºC. 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 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 is supplied as 5 mg or 10 mg tablets for
oral administration. Each tablet
contains the following inactive ingredients: lactose monohydrate,
pregelatinized starch, croscarmellose
sodium, magnesium stearate, hypromellose, polyethylene glycol, and
titanium dioxide. In addition 5 mg
also contains D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum
lake and 10 mg also
contains yellow iron oxide.
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 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 ani