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:

Redpharm Drug Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide HCl capsules 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 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 is a Schedule IV controlled substance. Chlordiazepoxide is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic pur

Product summary:

Chlordiazepoxide Hydrochloride 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 “stylized barr” 158, packaged in bottles of 100 (NDC 0555-0158-02) and 500 (NDC 0555-0158-04) capsules. 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 “stylized barr” 033, packaged in bottles of 100 (NDC 0555-0033-02) and 1000 (NDC 0555-0033-05) capsules. 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 “stylized barr” 159, available in bottles of 100 (NDC 0555-0159-02) and 500 (NDC 0555-0159-04) capsules. 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. Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. J 2/2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Redpharm Drug Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride ( klorʺ dye azʺ e poxʹ
ide hyeʺ droe klorʹ ide) Capsules, C-IV
What is the most important information I should know
about Chlordiazepoxide HCl?
•
Chlordiazepoxide HCl is a benzodiazepine
medicine. Taking benzodiazepines with opioid
medicines, alcohol, or other central nervous
system depressants (CNS) (including street
drugs) can cause severe drowsiness, breathing
problems (respiratory depression), coma and
death. Get emergency help right away if any of
the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart
stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know
how taking Chlordiazepoxide HCl with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a
risk of abuse, misuse, and addiction with
benzodiazepines, including Chlordiazepoxide
HCl, which can lead to overdose and serious side
effects including coma and death.
•
Serious side effects including coma and
death have happened in people who have
abused or misused benzodiazepines,
including Chlordiazepoxide HCl. These
serious side effects may also include
delirium, paranoia, suicidal thoughts or
actions, seizures, and difficulty breathing.
Call your healthcare provider or go to the
nearest hospital emergency room right
away if you get any of these serious side
effects.
•
You can develop an addiction even if you
take Chlordiazepoxide HCl exactly as
prescribed by your healthcare provider.
•
Take Chlordiazepoxide HCl exactly as
your healthcare provider prescribed.
•
Do not share your Chlordiazepoxide HCl
with other people.
•
Keep Chlordiazepoxide HCl in a safe
place and away from children.
•
Physical dependence and withdrawal reactions.
Chlordiazepoxide HCl can cause physical
dependence and withdrawal reactions, especially
if you continue to take Chlordiazepoxide HCl for
several days to several weeks.
•
Do not suddenly stop taking Chlordiaze

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
REDPHARM DRUG INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULES, EXPOSES USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION,
WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE AND MISUSE OF
BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF OTHER
MEDICATIONS, ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS ASSOCIATED
WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES. BEFORE
PRESCRIBING CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES AND THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULES, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL
DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL INCREASE WITH
LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT
DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULES AFTER CONTINUED USE MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE
RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES OR REDUCE THE DOSAGE (SEE
DOSAGE AND ADMINISTRATION AND WARNINGS).
DESCRIPTION
Chlordiazepoxide hydrochloride, USP is the prototype for the
benzodiazepine
compounds. It is a versatile therapeutic agent of proven value for the
relief of anxiety.
Chlordiazepoxide hydrochloride, US