CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE (chlordiazepoxide hydrochloride)
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is indicated for the treatment of Gastrointestinal Disorder; Peptic Ulcer; Irritable Bowel Syndrome; Enterocolitis.
Details
- Status
- Prescription
- First Approved
- 2020-07-07
- Routes
- ORAL
- Dosage Forms
- CAPSULE
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Approval History
What CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Treats
4 indicationsCHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is approved for 4 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal Disorder
- Peptic Ulcer
- Irritable Bowel Syndrome
- Enterocolitis
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Boxed 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 PRECA...
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, USP, 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, USP 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, USP, 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, USP 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, USP or reduce the dosage (see WARNINGS and DOSAGE AND ADMINISTRATION) .
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE FDA Label Details
Indications & Usage
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE is indicated for the treatment of Gastrointestinal Disorder; Peptic Ulcer; Irritable Bowel Syndrome; Enterocolitis.
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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.