CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

American Health Packaging

INN (Международно Name):

CYCLOBENZAPRINE HYDROCHLORIDE

Композиция:

CYCLOBENZAPRINE HYDROCHLORIDE 5 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Cyclobenzaprine hydrochloride tablets, USP is 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 monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs. Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Hyperthyroidism. Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when Cyclobenzaprine hydrochloride tablets, USP are administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. These are not indicative of addiction.

Каталог на резюме:

Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg dosage strength. The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side. Unit dose packages of 30 (5 x 6) NDC 68084-753-25 Unit dose packages of 50 (5 x 10) NDC 68084‐753‐65 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
AMERICAN HEALTH PACKAGING
----------
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP
8275321/0423
RX ONLY
DESCRIPTION
Cyclobenzaprine hydrochloride 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 pKa 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 is designated chemically as 3-(
_5H_-dibenzo [ _a,d_]
cyclohepten-5-ylidene)- _N,N_-dimethyl-1-propanamine hydrochloride,
and has the
following structural formula:
Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration
contains 5 mg
Cyclobenzaprine hydrochloride.
Each 10 mg Cyclobenzaprine hydrochloride tablet for oral
administration contains 10 mg
Cyclobenzaprine hydrochloride.
Each tablet contains the following inactive ingredients: lactose
monohydrate,
microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
magnesium stearate,
carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide
yellow.
In addition, 5 mg tablets also contain polyvinyl alcohol, talc,
lecithin, and FD&C yellow # 6
/ sunset yellow FCF aluminum lake.
In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake,
FD&C yellow # 6
aluminum lake, and hypromellose.
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
20
21
junction or directly on skeletal muscle. Such studies show that
cyclobenzaprine acts
primarily within the central nervous system at brain stem as opposed