CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Xiromed, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 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. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide.

Tóm tắt sản phẩm:

Chlordiazepoxide hydrochloride and clidinium bromide capsules are available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100 capsules (NDC 70700-185-01), with “VP302” imprinted on the cap of the capsule. 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 for: Xiromed, LLC Florham Park, NJ 07932 Made in the USA PI-185-00 Rev. 03/2021 L41I-XIR, R-2103

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Xiromed, LLC
----------
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
PIL-185-00 Rev. 03/2021
L41I-XIR, R-2103
MEDICATION GUIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules
(klor´´ dye az´´ e pox´ ide hye´´ droe klor´ ide and kli din´
ee um broe´ mide)
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 contain
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 prov

Đặc tính sản phẩm

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
XIROMED, LLC
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, 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 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 DOSAGE AND
ADMINISTRATION).
DESCRIPTION
Chlor