CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)

Available from:

Preferred Pharmaceuticals, Inc.

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 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 a

Product summary:

Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and “283 ” on other. Bottle of 10 - 68788-9295-0 Bottle of 14 - 68788-9295-1 Bottle of 15 - 68788-9295-5 Bottle of 20 - 68788-9295-2 Bottle of 30 - 68788-9295-3 Bottle of 60 - 68788-9295-6 Bottle of 90 - 68788-9295-9 Bottle of 90 - 68788-9295-8 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Rev: 01/12 Barcode: 283-01-2012 Repackaged by Preferred Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
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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 models. Animal
studies indicate that cyclobenzaprine does not act at the
neuromuscular junction or directly on skeletal
muscle. Such studies show that cycl