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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Composition:

CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg

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, 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: (NDC 43063-046-03) Bottles of 3 (NDC 43063-046-06) Bottles of 6 (NDC 43063-046-12) Bottles of 12 (NDC 43063-046-15) Bottles of 15 (NDC 43063-046-19) Bottles of 19 (NDC 43063-046-24) Bottles of 24 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
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 Chlordiazepoxide HCl

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, 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 hydrochl