CHLORDIAZEPOXIDE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composition:

CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide HCl capsules USP are 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 HCl capsules USP 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 HCl capsules are 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 occurred following abrup

Product summary:

Chlordiazepoxide Hydrochoride Capsules USP, 5 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a yellow opaque body filled with white powder, imprinted in black ink barr 158, packaged in Chlordiazepoxide Hydrochloride Capsules USP, 10 mg are available as a two-piece hard gelatin capsule with a black opaque cap and a green opaque body filled with white powder, imprinted in white ink barr 033, packaged in Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink barr 159, available in Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 8/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE - CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES USP CIV
RX ONLY
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
contains 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 monoethyl ether, FD&C red no. 40, methyl paraben,
propyl paraben, sodium, sodium
lauryl sulfate, sodium propionate, and soya lecithin.
CLINICAL PHARMACOLOGY
Chlordiazepoxide HCl 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 level