CYCLOBENZAPRINE HYDROCHLORIDE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

cyclobenzaprine hydrochloride (UNII: 0VE05JYS2P) (cyclobenzaprine - UNII:69O5WQQ5TI)

Dostopno od:

Contract Pharmacy Services-PA

INN (mednarodno ime):

cyclobenzaprine hydrochloride

Sestava:

cyclobenzaprine hydrochloride 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Cyclobenzaprine HCl tablets 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 tablets 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 tablets 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 days after their discont

Povzetek izdelek:

Cyclobenzaprine HCl Tablets, USP are available in the following strengths and package sizes: 10 mg (Yellow, round, film-coated, debossed with TL177 on one side and plain on the other side) Blisters of 30’s NDC 67046-119-30 Blisters of 60’s NDC 67046-119-60 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured by: Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 02/07 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--04/2010--NJW

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET
CONTRACT PHARMACY SERVICES-PA
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CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine
salt with the empirical formula
C
H N•HCI and a molecular weight of 311.9. It has a melting point of
217º C, and a pKa of 8.47 at
25º 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
HCI 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 Tablets, for oral administration, are available in
the following strengths: 5 mg and
10 mg.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, lactose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow.
Cyclobenzaprine HCl tablets 5 mg also
contains FD&C yellow #6.
CLINICAL PHARMACOLOGY
Cyclobenzaprine HCI 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 animals showed a similarity be