CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Alembic Pharmaceuticals Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 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 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

Přehled produktů:

Cyclobenzaprine hydrochloride, USP 5 mg tablets are supplied as butterscotch yellow colored film-coated capsule shaped convex tablets, debossed with "C11" on one side and plain on the other side. The tablets are supplied as follows: 100 count bottle          62332-646-31 500 count bottle          62332-646-71 1000 count bottle        62332-646-91 Cyclobenzaprine hydrochloride, USP 7.5 mg tablets are supplied as white colored film-coated round shaped convex tablets, debossed with "C17" on one side and plain on the other side. The tablets are supplied as follows: 100 count bottle      62332-649-31  1000 count bottle    62332-649-91 Cyclobenzaprine hydrochloride, USP 10 mg tablets are supplied as butterscotch yellow colored film coated, round shaped convex tablets, debossed with "C77" on one side and plain on the other side. The tablets are supplied as follows: 100 count bottle          62332-647-31 500 count bottle          62332-647-71 1000 count bottle        62332-647-91 STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). [See USP Controlled Room Temperature]. This container is not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For more information, call Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA                                                                         Revised.: 11/2021

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CYCLOBENZAPRINE HYDROCHLORIDE - CYCLOBENZAPRINE HYDROCHLORIDE TABLET,
FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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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 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-(5Hdibenzo[a,d]cyclohepten-5-ylidene)-N,
N-dimethyl-1-
propanamine hydrochloride, and has the following structural formula:
Cyclobenzaprine hydrochloride, USP is supplied as a 5 mg, 7.5 mg and
10 mg tablet for
oral administration.
Each 5mg, 7.5mg and 10mg contains cyclobenzaprine hydrochloride and
the following
inactive ingredients: croscarmellose sodium, hypromellose, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol,
silicon dioxide, talc, and titanium dioxide. In addition, the 5mg and
10mg tablet contains
D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow
#6 aluminum
lake.
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
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