CHLORDIAZEPOXIDE HYDROCHLORIDE- chlordiazepoxide hydrochloride capsule, gelatin coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)

Disponible desde:

NuCare Pharmaceuticals, Inc.

Designación común internacional (DCI):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composición:

CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Chlordiazepoxide Hydrochloride Capsule is indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Chlordiazepoxide Hydrochloride Capsule in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Chlordiazepoxide Hydrochloride Capsule is contraindicated in patients with known hypersensitivity to the drug. Chlordiazepoxide hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurre

Resumen del producto:

10 mg hard gelatin capsules in bottles of 30 NDC- 68071-2145-3 with S252 imprinted on the opaque black cap and Solco’s logo "S" imprinted on the opaque green body. Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). [see USP Controlled Room Temperature]. Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Distributed by: Solco Healthcare U.S., LLC Cranbury, NJ 08512 Rev. 10/12 OE1413

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE, GELATIN
COATED
NUCARE PHARMACEUTICALS, INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP
GELATIN COATED
RX ONLY
DESCRIPTION:
Chlordiazepoxide Hydrochloride Capsules, USP, the original
Chlordiazepoxide Hydrochloride and
prototype for the benzodiazepine compounds, was synthesized and
developed at Hoffmann-La Roche
Inc. It is a versatile therapeutic agent of proven value for the
relief of anxiety. Chlordiazepoxide
Hydrochloride Capsule is among the safer of the effective
psychopharmacologic compounds available,
as demonstrated by extensive clinical evidence.
Chlordiazepoxide Hydrochloride is available as capsules containing 5
mg, 10 mg or 25 mg
chlordiazepoxide hydrochloride. Each capsule also contains corn
starch, lactose monohydrate and talc.
Gelatin capsule shells may contain methyl and propyl parabens,
Titanium Dioxide, Gelatin and potassium
sorbate, with the following dye systems: 5-mg capsules - FD&C Yellow
No. 6 plus D&C Yellow No.
10 and FD&C Green No. 3. 10-mg capsules - D&C Yellow No. 10, FD&C Blue
No. 1, FD&C Green
No. 3, FD&C Yellow No. 6 plus FD&C Red No. 40. 25-mg capsules - D&C
Yellow No. 10 and FD&C
Green No. 3.
Chlordiazepoxide hydrochloride is
7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-
oxide hydrochloride. A white to practically white crystalline
substance, it is soluble in water. It is
unstable in solution and the powder must be protected from light. The
molecular weight is 336.22. The
structural formula of chlordiazepoxide hydrochloride is as follows:
CLINICAL PHARMACOLOGY:
Chlordiazepoxide hydrochloride has antianxiety, sedative,
appetite-stimulating and weak analgesic
actions. The precise mechanism of action is not known. The drug blocks
EEG arousal from stimulation
of the brain stem reticular formation. It takes several hours for peak
blood levels to be reached and the
half-life of the drug is between 24 and 48 hours. After the drug is
discontinued plasma levels decline
slowly over a period of se