CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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 23155-808-01), 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 this and all medications out of the reach of children. Dispense in tight, light-resistant container as defined in USP. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) L41I-ATP, R-2112 Revised : 11/2021

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

hydrochloride and clidinium bromide capsule
Heritage Pharmaceuticals Inc. d/b/a Avet 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 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 provider.
•
Take chlordiazepoxide hydrochloride and clidinium bromide capsules
exactly as your
healthca

製品の特徴

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES, USP
5 MG/ 2.5 MG
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 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 HY