CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Alembic Pharmaceuticals Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Chlordiazepoxide hydrochloride and clidinium bromide capsules are 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 are 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 contain chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hydrochloride

Ringkasan produk:

Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP are opaque light green cap/opaque light green body hard gelatin capsule, size “3” having imprinting “A” on cap and “333” on body with black ink, filled with white to off white powder. Bottle of 100 capsules with child resistant closure, NDC 62332-744-31 Bottle of 1000 capsules, NDC 62332-744-91 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF. Medication Guide available at https://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals Limited Bedminster, NJ 07921, USA Revised: 02/2023

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Chlordiazepoxide Hydrochloride (klor” dye az” e pox’ ide hye”
droe klor’ ide)
and
Clidinium Bromide (kli din’ ee um broe’ mide)
Capsules, USP
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:
o shallow or slowed breathing
o breathing stops (which may lead to the heart stopping)
o 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.
o 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.
o You can develop an addiction even if you take chlordiazepoxide
hydrochloride and clidinium
bromide capsules as prescribed by your healthcare provider.
o Take chlordiazepoxide hydrochloride and clidinium bromide capsules
exactly as your healthcare
provider prescribed.
o Do no

Ciri produk

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE -
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
ALEMBIC PHARMACEUTICALS INC.
----------
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 RE