CHLORDIAZEPOXIDE HYDROCHLORIDE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Avera McKennan Hospital

Designación común internacional (DCI):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composición:

CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death [see WARNINGS, DRUG INTERACTIONS].
•
•
•
DESCRIPTION
Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine
compounds. It is a versatile
therapeutic agent of proven value for the relief of anxiety.
Chlordiazepoxide hydrochloride is among
the safer of the effective psychopharmacologic compounds available, as
demonstrated by extensive
clinical evidence.
Chlordiazepoxide hydrochloride is 7-chloro-2-
(methylamino)-5-phenyl-3_H_-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
structural formula is:
C
H ClN O • HCl M.W. 336.22
Each capsule, for oral administration, contains either 5 mg, 10 mg or
25 mg of chlordiazepoxide
hydrochloride, USP and has the following inactive ingredients:
anhydrous lactose, D&C yellow no. 10,
FD&C blue no. 1, FD&C blue no. 1 aluminum lake, gelatin, hydrogenated
vegetable oil,
microcrystalline cellulose, pharmaceutical glaze, and titanium
dioxide. The 5 mg and 25 mg also contain
D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C
red no. 40 aluminum lake,
propylene glycol, and synthetic black iron oxide. In addition, the 5
mg contains D&C red no. 33 and the
10 mg also contains butyl paraben, edetate calcium disodium, dimethyl
polysiloxane, ethylene glycol
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
16
14
3
monoethyl ether, FD&C red no. 40, methyl paraben, propyl paraben,
sodium