CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR), CLIDINIUM BROMIDE (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N)

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Chlordiazepoxide hydrochloride and clidinium bromide capsules is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. Chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride a

Product summary:

Chlordiazepoxide hydrochloride and clidinium bromide capsules is available in green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 (NDC 67877-731-01), bottles of 500 (NDC 67877-731-05), blister pack of (10x10) 100 capsules per carton (NDC 67877-731-38), with “CDP/CD” imprinted on the cap and 5/2.5” imprinted on the body of the capsule. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]; Dispense in Tight Containers. Keep out of reach of children . Dispense in tight, light-resistant container as defined in USP/NF. Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: 02/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE
(klor-dye-az-e-POX-ide hye-droe-KLOR-ide)
AND
CLIDINIUM BROMIDE (kli DIN ee um BRO mide) CAPSULES
for oral use
What is the most important information I should know about
chlordiazepoxide hydrochloride and clidinium bromide capsules?
•
Chlordiazepoxide hydrochloride and clidinium bromide capsules contains
a benzodiazepine medicine. Taking
chlordiazepoxide hydrochloride and clidinium bromide capsules with
opioid medicines, alcohol, or other central nervous
system (CNS) depressants (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
hydrochloride and clidinium bromide capsules with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including
chlordiazepoxide hydrochloride and clidinium bromide capsules, which
can lead to overdose or death.
•
Serious side effects including coma and death have happened in people
who have abused or misused benzodiazepines,
including chlordiazepoxide hydrochloride and clidinium bromide
capsules. 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
hydrochloride and clidinium bromide capsules as
prescribed by your healthcare provider.
•
Take chlordiazepoxide hydrochloride and clidinium bromide capsules
exactly as your healthcare provider prescribed.
•
Do not share your chl

Summary of Product characteristics

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE -
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
ASCEND LABORATORIES, LLC
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES USP FOR
ORAL
USE
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 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 (SEE WARNINGS
AND PRECAUTIONS AND PRECAUTIONS, DRUG INTERACTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE HYDROCHLORIDE,
A COMPONENT OF CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
CAPSULES, USP, 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 AND CLIDINIUM BROMIDE
CAPSULES, USP AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK
FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS)_._
_ _
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, USP, 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 AND CLIDINIUM BROMIDE CAPSULES, USP
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 AND CLIDINIUM BROMID