Last reviewed · How we verify
Librax (CLIDINIUM)
Librax (Chlordiazepoxide and Clidinium) is an anticholinergic medication originally developed by Roche and currently owned by the same company. It targets the muscarinic acetylcholine receptor M3 to treat enterocolitis and irritable bowel syndrome. Librax is a small molecule medication that is off-patent, meaning it is no longer protected by patents. As a result, there are currently no generic manufacturers of the medication. Despite its off-patent status, Librax remains a commercially available medication.
At a glance
| Generic name | CLIDINIUM |
|---|---|
| Sponsor | Roche |
| Drug class | Anticholinergic |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Enterocolitis
- Irritable bowel syndrome
Boxed warnings
- 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) .
Common side effects
- Drowsiness
- Ataxia
- Confusion
- Syncope
- Skin eruptions
- Edema
- Minor menstrual irregularities
- Nausea
- Constipation
- Extrapyramidal symptoms
- Increased libido
- Decreased libido
Key clinical trials
- Stellate Ganglion Block Versus Oral Medication in Treatment of Palmar Hyperhidrosis (NA)
- A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Librax CI brief — competitive landscape report
- Librax updates RSS · CI watch RSS
- Roche portfolio CI