CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Chlordiazepoxide Hydrochloride (UNII: MFM6K1XWDK) (Chlordiazepoxide - UNII:6RZ6XEZ3CR), Clidinium Bromide (UNII: 91ZQW5JF1Z) (Clidinium - UNII:BO76JF850N)

Mevcut itibaren:

Dr. Reddy's Laboratories Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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. Controlled Substance Chlordiazepoxide hydrochloride and clidinium bromide capsules contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide hy

Ürün özeti:

Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg are available in hard gelatin capsules with light blue cap and dark blue body, imprinted “RDY” on cap and “706” on body with black ink and are free from physical defects. These are supplied in bottles of 100’s and 500’s. Bottles of 100 NDC 43598-706-01 Bottles of 500 NDC 43598-706-05 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. Rx Only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 USA Made in India Revised: 05/2023

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Dr. Reddy's Laboratories Inc.
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MEDICATION GUIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide
(klor” dye az” e pox’ ide hye” droe klor’ ide and 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 capsules contains
a benzodiazepine
medicine. Taking chlordiazepoxide hydrochloride and clidinium bromide
capsules with opioid
medicines, alcohol, or other centralnervous 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 presc

Ürün özellikleri

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
DR. REDDY'S LABORATORIES 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 CHLODIAZEPOXIDE 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 T