pharmacopeia
GET
/api/v1/drug/chlordiazepoxide

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 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 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 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 risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

2D structure
7-chloro-4-hydroxy-N-methyl-5-phenyl-3H-1,4-benzodiazepin-2-imine
SMILES CN=C1CN(C(=C2C=C(C=CC2=N1)Cl)C3=CC=CC=C3)O
InChIKey BUCORZSTKDOEKQ-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: GABA A Modulators; Monoamine Oxidase Inhibitors.

GABA AMonoamine Oxidase

Indications

Sourced from openFDA
  • Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Contraindications

Sourced from openFDA
  • Chlordiazepoxide HCl capsules are contraindicated in patients with known hypersensitivity to the drug.contraindicated

Dosage & administration

Sourced from openFDA

Because of the wide range of clinical indications for chlordiazepoxide HCl, the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. ADULTS USUAL DAILY DOSE Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety 5 mg or 10 mg, 3 or 4 times daily Relief of Severe Anxiety Disorders and Symptoms of Anxiety 20 mg or 25 mg, 3 or 4 times daily Geriatric Patients , or in the presence of debilitating disease. 5 mg, 2 to 4 times daily Preoperative Apprehension and Anxiety On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM 1 hour prior to surgery. PEDIATRIC PATIENTS USUAL DAILY DOSE Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) For the relief of withdrawal symptoms of acute alcoholism, the parenteral form is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled up to 300 mg per day. Dosage should then be reduced to maintenance levels. *See package insert for Sterile Chlordiazepoxide Hydrochloride.

Warnings & precautions

Sourced from openFDA

Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including chlordiazepoxide, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use 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. If a decision is made to prescribe chlordiazepoxide concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of chlordiazepoxide than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking chlordiazepoxide, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see DRUG INTERACTIONS ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.

Adverse reactions

Sourced from openFDA

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. Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent, and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide HCl treatment. Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When chlordiazepoxide HCl treatment is protracted, periodic blood counts and liver function tests are advisable. To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Use in specific populations

Sourced from openFDA

Pregnancy Advise pregnant females that use of chlordiazepoxide HCl late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see Warnings, Neonatal Sedation and Withdrawal Syndrome and Precautions , Pregnancy ). Instruct patients to inform their healthcare provider if they are pregnant. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to chlordiazepoxide HCl during pregnancy (see Precautions, Pregnancy ) .

Overdosage

Sourced from openFDA

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

Approval history

Sourced from openFDA
  • Sep 1, 1966NDANDA012750Bausch
  • Jun 10, 1976ANDAANDA084768Barr
  • Jun 10, 1976ANDAANDA084769Barr
  • Jun 10, 1976ANDAANDA083116Barr
  • Jun 15, 1976ANDAANDA084041Chartwell Rx
  • Jun 15, 1976ANDAANDA084678Chartwell Rx
  • Jun 15, 1976ANDAANDA084679Chartwell Rx
  • Sep 21, 1977ANDAANDA085461Bausch

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,050 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea1919.3%
  2. 2Diarrhoea1879.1%
  3. 3Fatigue1778.6%
  4. 4Drug Ineffective1487.2%
  5. 5Pain1366.6%
  6. 6Headache1276.2%
  7. 7Dizziness1205.9%
  8. 8Abdominal Pain1135.5%
  9. 9Vomiting1045.1%
  10. 10Asthenia1014.9%
  11. 11Weight Decreased1004.9%
  12. 12Dyspnoea984.8%
  13. 13Arthralgia974.7%
  14. 14Abdominal Pain Upper944.6%
  15. 15Constipation934.5%

Literature

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Recent PubMed references pinned to Chlordiazepoxide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Chlordiazepoxide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Chlordiazepoxide work?
Mechanism-of-action classes: GABA A Modulators; Monoamine Oxidase Inhibitors.
What is Chlordiazepoxide used for?
According to FDA labeling, Chlordiazepoxide carries indications including: Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Chlordiazepoxide?
Chlordiazepoxide is classified as Benzodiazepine derivatives, Benzodiazepine, GABA A Modulators, Monoamine Oxidase Inhibitors, Increased Central Nervous System GABA Activity.
What are the brand names for Chlordiazepoxide?
Chlordiazepoxide is marketed under brand names including Librax.
What are the contraindications for Chlordiazepoxide?
Chlordiazepoxide labeling lists contraindications including: Chlordiazepoxide HCl capsules are contraindicated in patients with known hypersensitivity to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for chlordiazepoxide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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