CYCLOBENZAPRINE HYDROCHLORIDE- cyclobenzaprine tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cipla USA Inc.

INN (mednarodno ime):

CYCLOBENZAPRINE HYDROCHLORIDE

Sestava:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE TABLET, FILM COATED
CIPLA USA 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
20
21
a
primarily within the central nervous system at brain stem as o