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:

Aurobindo Pharma Limited

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, 5 mg/2.5 mg are available in green cap and green body hard gelatin capsule shells, imprinted with ‘CH/CB’ on cap, ‘5/2.5’ on body with black ink filled with white to off-white granular powder. They are supplied as follows: Bottles of 100            NDC 59651-524-01 Store at 20o to 25○ C (68○ to 77○ F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: June 2023 Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP
(klor-dye-az-e-POX-ide hye-droe-KLOR-ide and kli di' nee um broh myde)
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

Ciri produk

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE -
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
AUROBINDO PHARMA LIMITED
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, USP
FOR ORAL USE
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 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 R