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Fixed-dose combination

Chlordiazepoxide and Clidinium

Also known as chlordiazepoxide hydrochloride, clidinium bromide
Available on requestControlled substance
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Chlordiazepoxide and Clidinium is a fixed-dose combination of an anticholinergic and a benzodiazepine indicated to control emotional and somatic factors in gastrointestinal disorders. It is available as capsules for oral use. MedsAcross supplies Chlordiazepoxide and Clidinium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anticholinergic, Benzodiazepine, Cholinergic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Digestive/GI System Activity Alteration, GI Motility Alteration
US FDA first approval
1 September 1966
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule
Fixed-dose combination of
Chlordiazepoxide, Clidinium
Identifiers
RxCUI 611854CAS 8015-20-1Q48566781

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Librax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax 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.

Source: US FDA prescribing information

Dosing overview

Recommended Dosage Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Librax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime. Recommended Geriatric Dosage Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Librax capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions. Discontinuation or Dosage Reduction of Librax To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Librax or reduce the dosage.

Source: US FDA prescribing information

Contraindications

Librax is 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.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning: 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. Risks From Concomitant Use with Opioids Concomitant use of benzodiazepines, including Librax, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs - in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

Source: US FDA prescribing information

Side effects

No side effects or manifestations not seen with either compound alone have been reported with the administration of Librax. However, since Librax contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients — particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Source: US FDA prescribing information

Interactions

Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of Librax and opioids, and follow patients closely for respiratory depression and sedation.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Chlordiazepoxide and Clidinium, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Chlordiazepoxide and Clidinium 5 mg/2.5 mg capsuleOralGeneric nameChlordiazepoxide and Clidinium—US FDAAvailable on request
Librax 5 mg/2.5 mg capsuleOralChlordiazepoxide and ClidiniumBausch HealthUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 1 September 1966Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Chlordiazepoxide and Clidinium available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Chlordiazepoxide and Clidinium and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Chlordiazepoxide and Clidinium have?

The catalogue lists 1 brand names for Chlordiazepoxide and Clidinium, including Librax.

Is Chlordiazepoxide and Clidinium approved by the US FDA?

Yes. The US FDA first approved Chlordiazepoxide and Clidinium on 1 September 1966, according to Drugs@FDA.

Does Chlordiazepoxide and Clidinium need cold chain shipping?

No listed presentation of Chlordiazepoxide and Clidinium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Librax prescribing information (Bausch Health). U.S. National Library of Medicine, DailyMed. Retrieved 13 January 2023

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