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ChlordiazePOXIDE

Medically reviewed by Drugs.com. Last updated on Jun 30, 2020.

Pronunciation

(klor dye az e POKS ide)

Index Terms

  • Chlordiazepoxide Hydrochloride
  • Librium
  • Methaminodiazepoxide Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Generic: 5 mg, 10 mg, 25 mg

Pharmacologic Category

  • Benzodiazepine

Pharmacology

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the CNS, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization. Benzodiazepine receptors and effects appear to be linked to the GABA-A receptors. Benzodiazepines do not bind to GABA-B receptors (Vinkers 2012).

Distribution

Vd: 3.3 L/kg (Schwartz 1971)

Metabolism

Extensively hepatic to desmethyldiazepam (active and long-acting), desmethylchlordiazepoxide, and demoxepam (Baskin 1982; Schwartz 1971)

Excretion

Urine (1% to 2% unchanged; 3% to 6% as metabolite)

Time to Peak

Serum: 0.5 to 2 hours (Baskin 1982)

Half-Life Elimination

Parent: 24 to 48 hours; demoxepam 14 to 95 hours (Schwartz 1971)

Protein Binding

96% (Baskin 1982)

Use: Labeled Indications

Alcohol withdrawal syndrome: Management of acute alcohol withdrawal symptoms.

Anxiety disorders: Management of anxiety disorders or short-term relief of anxiety symptoms.

Contraindications

Hypersensitivity to chlordiazepoxide or any component of the formulation.

Documentation of allergenic cross-reactivity for benzodiazepines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Note: Reduce dose or avoid use in patients receiving opioids, with significant chronic disease (eg, respiratory compromise), or at increased risk for accumulation (eg, advanced cirrhosis, acute alcoholic hepatitis) (Greenblatt 1978). Closely supervise or avoid use in patients with or at risk for substance use disorders, except for acute situations.

Alcohol withdrawal syndrome, treatment:

Note: Treat acute severe withdrawal initially with an alternative IV benzodiazepine. Clinically stable patients with mild to moderate symptoms at risk of developing severe symptoms may initially receive oral therapy under close monitoring (Hoffman 2020; WFSBP [Soyka 2017]). Regimens provided are examples; refer to institution-specific protocols where available. If the example regimen dosing is not controlling symptoms or escalating doses are required, clinicians need to reconsider course and/or seek a more closely monitored treatment.

Ambulatory, mild withdrawal (eg, CIWA-Ar score ≤15) and no history of seizures or delirium tremens: Note: Use with daily clinician assessments (eg, in-person or remote) of symptom control and tolerability, with adjustment of therapy as indicated. If requiring escalating doses, consider care in a more closely supervised setting (Holt 2020; Muncie 2013). The manufacturer's labeling recommends a maximum dose of 300 mg/day.

Fixed regimen: Oral: Day 1: 50 mg every 6 to 12 hours; Day 2: 25 mg every 6 hours; Day 3: 25 mg twice a day; Day 4: 25 mg at bedtime (Holt 2020).

Symptom-triggered regimen: Note: Alternative in patients with very mild withdrawal (eg, CIWA-Ar score <10) who can reliably self-assess symptoms (Holt 2020).

Oral: Day 1: 50 mg every 6 to 12 hours as needed; Days 2 to 5: 25 mg every 6 hours as needed (Holt 2020).

Inpatient, mild-moderate withdrawal (eg, CIWA-Ar score ≤20): Note: The manufacturer's labeling recommends a maximum dose of 300 mg/day; however, many experts consider a total dose of up to 400 mg/day to be acceptable in patients whose symptoms are controlled (Gordon 2020).

Symptom-triggered regimen (preferred): Oral: 25 to 100 mg as needed (eg, every 1 to 6 hours), determined by symptom severity using a validated severity assessment scale, such as CIWA-Ar (Hoffman 2020; Mayo-Smith 1997; Saitz 1994; WFSBP [Soyka 2017]). In patients whose acute symptoms are not controlled after 3 doses given at hourly intervals (ie, up to a total of 300 mg/day), transition to an alternative IV benzodiazepine (Hoffman 2020).

Fixed regimen: Note: Fixed dosing is not preferred in this setting; however, some clinicians use fixed doses initially in select inpatients (eg, those with known benzodiazepine requirements).

Oral: Day 1: 50 mg every 6 hours; Days 2 and 3: 25 mg every 6 hours (Mayo-Smith 1997).

Alcohol withdrawal syndrome, prophylaxis (off-label use):

Note: For use when abrupt alcohol cessation is necessary and prevention of withdrawal symptoms is critical (eg, for surgical or other procedure) in patients with history of alcohol withdrawal or prolonged heavy alcohol consumption. Although manufacturer's labeling recommends a maximum dose of 300 mg/day, many experts consider a total dose of up to 400 mg/day to be acceptable in an inpatient setting (Gordon 2020).

Oral: Day 1: 25 to 100 mg every 6 hours; Days 2 and 3: 25 to 50 mg every 6 hours; individualize regimen according to patient history and risk. Assess frequently for withdrawal symptoms and initiate symptom-triggered active treatment if indicated; hold and/or adjust dose(s) for excessive sedation (Gordon 2020).

Anxiety disorders (adjunctive therapy or monotherapy) (alternative agent):

Note: Used only when other preferred agents are unavailable or not tolerated. May be used for short-term symptom relief until concurrent therapy is effective (eg, ≤12 weeks). Long-term low-dose therapy may be considered for select patients when other treatments are ineffective or poorly tolerated (Katzman 2014; WFSBP [Bandelow 2012]).

Oral: Usual range: 5 to 25 mg 2 to 4 times daily; increase gradually based on response and tolerability; patients with mild to moderate symptoms generally respond to total daily doses ≤40 mg. Maximum dose: 100 mg/day in divided doses.

Discontinuation of therapy: In patients receiving extended- or higher-dose benzodiazepine therapy, unless safety concerns require a more rapid withdrawal, gradually withdraw to detect reemerging symptoms and minimize rebound and withdrawal symptoms. Taper total daily dose by 10% to 25% every 1 to 2 weeks based on response and tolerability. The optimal taper rate and duration will vary; durations up to 6 months may be necessary for some patients (Bystritsky 2020; Lader 2011; VA/DoD 2015). For patients on high doses, taper more rapidly in the beginning and slow the reduction rate as the taper progresses because early stages of withdrawal are easier to tolerate. For example, reduce the dose weekly by 25% until half of the dose remains; thereafter, continue to reduce by ~12% every 4 to 7 days (VA/DoD 2015).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Alcohol withdrawal syndrome: Refer to adult dosing.

Anxiety disorders: Oral: Use lower initial doses of 5 mg 2 to 4 times daily and titrate slowly; refer to adult dosing.

Discontinuation of therapy: Refer to adult dosing.

Dosing: Pediatric

Anxiety: Note: Use of chlordiazepoxide as an anxiolytic has been replaced by newer agents (Ipser 2009; Kodish 2011). Children ≥6 years and Adolescents: Oral: Usual dose: 5 mg 2 to 4 times daily; may increase to 10 mg 2 to 3 times daily in some patients. Pediatric patients may have variable response; begin with the lowest dose and slowly titrate.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Consider therapy modification

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CloZAPine: Benzodiazepines may enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination. Some combinations are specifically contraindicated by manufacturers; others may have recommended dose adjustments. If combined, monitor for increased substrate effects. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Disulfiram: May increase the serum concentration of ChlordiazePOXIDE. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Melatonin: May enhance the sedative effect of Benzodiazepines. Monitor therapy

Methadone: Benzodiazepines may enhance the CNS depressant effect of Methadone. Management: Clinicians should generally avoid concurrent use of methadone and benzodiazepines when possible; any combined use should be undertaken with extra caution. Consider therapy modification

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Consider therapy modification

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

OLANZapine: May enhance the adverse/toxic effect of Benzodiazepines. Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression). Olanzapine prescribing information provides no specific recommendations regarding oral administration. Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Oxybate Salt Products: Benzodiazepines may enhance the CNS depressant effect of Oxybate Salt Products. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Teduglutide: May increase the serum concentration of Benzodiazepines. Monitor therapy

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Theophylline Derivatives: May diminish the therapeutic effect of Benzodiazepines. Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse Reactions

Frequency not defined

Cardiovascular: Edema, syncope

Central nervous system: Abnormal electroencephalogram, ataxia, confusion, drowsiness, drug-induced extrapyramidal reaction

Dermatologic: Skin rash

Endocrine & metabolic: Change in libido, menstrual disease

Gastrointestinal: Constipation, nausea

Hematologic & oncologic: Agranulocytosis, bone marrow depression

Hepatic: Hepatic insufficiency, jaundice

Miscellaneous: Paradoxical reaction

ALERT: U.S. Boxed Warning

Risks from concomitant use of benzodiazepines and opioids:

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Warnings/Precautions

Concerns related to adverse effects:

• Anterograde amnesia: Benzodiazepines have been associated with anterograde amnesia (Nelson 1999).

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Paradoxical reactions: Paradoxical reactions, including hyperactive or aggressive behavior, have been reported with benzodiazepines; risk may be increased in adolescent/pediatric patients, geriatric patients, or patients with a history of alcohol use disorder or psychiatric/personality disorders (Mancuso 2004).

• Sleep-related activities: Hazardous sleep-related activities such as sleep-driving, cooking and eating food, and making phone calls while asleep have been noted with benzodiazepines (Dolder 2008).

Disease-related concerns:

• Depression: Use caution in patients with depression, particularly if suicidal risk may be present.

• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Psychological and physical dependence, as well as tolerance to sedative and anticonvulsive effects, may occur with prolonged use (Vinkers 2012).

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Porphyria: Use with caution in patients with porphyria.

• Renal impairment: Use with caution in patients with renal impairment.

• Respiratory disease: Use with caution in patients with respiratory disease (Smoller 1996).

Concurrent drug therapy issues:

• Benzodiazepines and opioids: [US Boxed Warning]: The concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use 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.

Special populations:

• Debilitated patients: Use with caution in debilitated patients; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation.

• Elderly: Avoid use; if used, use with caution in the elderly; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation. Elderly patients may be at an increased risk of death with use; risk has been found highest within the first 4 months of use in elderly dementia patients (Jennum 2015; Saarelainen 2018).

• Fall risk: Use with extreme caution in patients who are at risk of falls; benzodiazepines have been associated with falls and traumatic injury (Nelson 1999).

• Pediatric: Use with caution in children; active metabolites with extended half-lives may lead to delayed accumulation and adverse effects, including ataxia and over-sedation.

Other warnings/precautions:

• Tolerance: Chlordiazepoxide is a long half-life benzodiazepine. Duration of action after a single dose is determined by redistribution rather than metabolism. Tolerance does not develop to the anxiolytic effects (Vinkers 2012). Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired sedative effect.

• Withdrawal: Rebound or withdrawal symptoms may occur following abrupt discontinuation or large decreases in dose. Use caution when reducing dose or withdrawing therapy; decrease slowly and monitor for withdrawal symptoms. Flumazenil may cause withdrawal in patients receiving long-term benzodiazepine therapy.

Monitoring Parameters

Respiratory and cardiovascular status (including orthostasis); mental status; paradoxical reactions (eg, excitement, stimulation, acute rage); if used for ethanol withdrawal, signs/symptoms of ethanol withdrawal

Pregnancy Considerations

Chlordiazepoxide crosses the human placenta and fetal serum concentrations are similar to those in the mother. Teratogenic effects have been observed with some benzodiazepines (including chlordiazepoxide); however, additional studies are needed. The incidence of premature birth and low birth weights may be increased following maternal use of benzodiazepines; hypoglycemia and respiratory problems in the neonate may occur following exposure late in pregnancy. Neonatal withdrawal symptoms may occur within days to weeks after birth and “floppy infant syndrome” (which also includes withdrawal symptoms) has been reported with some benzodiazepines (Bergman 1992; Iqbal 2002; Wikner 2007).

Patient Education

What is this drug used for?

• It is used to treat anxiety.

• It is used to treat alcohol withdrawal.

• It is used to ease anxiety before surgery.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Constipation

• Menstrual changes

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Change in balance

• Severe fatigue

• Anxiety

• Confusion

• Swelling

• Trouble moving

• Sex drive changes

• Infection

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.