CHLORDIAZEPOXIDE HYDROCHLORIDE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composition:

CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Chlordiazepoxide Hydrochloride Capsules, USP are available in the following presentations: 5 mg hard gelatin capsules in bottles of 100 (NDC- 43547-251-10), with S251 imprinted on the opaque green cap and Solco’s logo "S" imprinted on the opaque yellow body. 10 mg hard gelatin capsules in bottles of 100 (NDC- 43547-252-10), with S252 imprinted on the opaque black cap and Solco’s logo "S" imprinted on the opaque green body. 25 mg hard gelatin capsules in bottles of 100 (NDC- 43547-253-10), with S253 imprinted on the opaque green cap and Solco’s logo "S" imprinted on the opaque white 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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Contract Pharmacy Services-PA
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This Medication Guide has been approved by the U.S. Food and Drug
Administration Issued: 8/2016
Revised: 8/2017
Document Id: 58113333-a25f-2cd0-e053-2991aa0a35ef
34391-3
Set id: 58113333-a25e-2cd0-e053-2991aa0a35ef
Version: 1
Effective Time: 20170831
Contract Pharmacy Services-PA

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE, GELATIN
COATED
CONTRACT PHARMACY SERVICES-PA
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CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP 912 935
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 per