CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Sunrise Pharmaceutical, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. 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. Chlordiaz

Rezumat produs:

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are available in light green opaque cap and light green opaque body containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottle of 100 (NDC 11534-197-01), with black imprint “N36” on both the cap and body. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children. Dispense in a tight, light-resistant container as defined in USP/NF. Manufactured by: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 5355/00 Rev. 07/2021

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE
HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
Sunrise Pharmaceutical, Inc.
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MEDICATION GUIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide (klor dye az e
POKS ide hahy druh klohr id & kli
DI nee um broh myde) 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 affect 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 C

Caracteristicilor produsului

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE-
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE
SUNRISE PHARMACEUTICAL, INC.
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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