Chlordiazepoxide

FDA label, Epic Pharma LLC, oral, effective 2022-03-08. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

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 for 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 ). • The use of benzodiazepines, including chlordiazepoxide hydrochloride capsules, exposes users to risk 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 capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). • The continued use of benzodiazepines, including chlordiazepoxide hydrochloride capsules, may lead to clinically significant physical dependence. The risk of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride 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 capsules or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).

Dosing in kidney impairment

Hypotension may be combated by the use of Levophed ® (norepinephrine) or Aramine (metaraminol). Dialysis is of limited value. There have been occasional reports of excitation in patients following chlordiazepoxide hydrochloride overdosage; if this occurs barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested.

Drug interactions

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Label text (1 paragraph)

Drug Interactions The concomitant use of benzodiazepines 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 benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

Contraindications

Chlordiazepoxide Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to the drug.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

C

Likelihood score C: Probable rare cause of clinically apparent liver injury.

Chlordiazepoxide is an orally available benzodiazepine used for therapy of anxiety disorders and alcohol withdrawal syndromes. As with other benzodiazepines, chlordiazepoxide is not associated with serum aminotransferase or alkaline phosphatase elevations during therapy, and clinically apparent liver injury from chlordiazepoxide has been reported but is rare.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Chlordiazepoxide (NIDDK, public domain)Chapter updated Jun 22, 2023

Pregnancy and lactation

Breastfeeding (LactMed)

No information is available on the use of chlordiazepoxide during breastfeeding. Because the drug and metabolites could accumulate in the breastfed infant, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. If chlordiazepoxide is used, monitor the infant for sedation, poor feeding and poor weight gain.

Alternatives LactMed suggests considering:
Source: LactMed: Chlordiazepoxide (NICHD, public domain)Revised Jan 15, 2024

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

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