CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE- chlordiazepoxide hcl 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:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chlordiazepoxide hydrochloride and clidinium bromide capsule 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 capsule 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 capsule contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride and

Product summary:

Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP is available in green opaque cap, green opaque body, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, size "4" hard gelatin capsules imprinted with "ML" on cap and "5/2.5" on body with black ink, filled with white to off-white powder. Bottles of 100                                   NDC 42571-381-01 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.   Dispense in tight, light-resistant container as defined in USP/NF. Manufactured by: Micro Labs Limited Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc.                  Somerset, NJ 08873 Rev. 04/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BROMIDE CAPSULE
Micro Labs Limited
----------
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride (klor" dye az" e pox' ide
HYE-droe-KLOR-ide) and Clidinium Bromide (kli din' ee um broe' 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 capsule 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
capsule
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 chlordiazepoxide hydrochloride a

Summary of Product characteristics

CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE - CHLORDIAZEPOXIDE HCL AND
CLIDINIUM BROMIDE CAPSULE
MICRO LABS LIMITED
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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, 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 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, 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 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 BROMIDE CAPSULES OR REDUCE THE DOSAGE (SEE WARNINGS AND
D