Chlordiazepoxide Hydrochloride

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Known hypersensitivity to chlordiazepoxide, other benzodiazepines, or any ingredient in the formulation.c d e

• Many manufacturers state that benzodiazepines are contraindicated in patients with acute angle-closure glaucoma but may be administered to patients with open-angle glaucoma who are receiving appropriate therapy; however, clinical rationale for this contraindication has been questioned.b

Warnings/Precautions

Warnings

Performance of activities requiring mental alertness and physical coordination may be impaired.b c d e

Concurrent use of other CNS depressants may cause additive or potentiated CNS depression.c d e (See Specific Drugs and Laboratory Tests under Interactions.)

Paradoxical reactions (e.g., excitement, stimulation, acute rage) reported in psychiatric patients and in hyperactive aggressive children.b c d e

Some retrospective studies suggest increased risk of congenital malformations in infants of mothers who received chlordiazepoxide during the first trimester of pregnancy. b c d e f Since use of anxiolytics is rarely urgent, their use during the first trimester almost always should be avoided.b c d e

Benzodiazepines should not be used in patients with depressive neuroses or psychotic reactions in which anxiety is not prominent.b

Possible tolerance, psychologic dependence, and physical dependence following prolonged use.b

Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.c d e

Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates).b c d e Symptoms may be relieved by tapering the dosage.b c d e

General Precautions

Use with caution in depressed patients; potential for suicidal tendencies.c d e Prescribe and dispense drug in the smallest feasible quantity.b

When used in fixed combination with clidinium bromide or amitriptyline hydrochloride, consider the cautions, precautions, and contraindications associated with the concomitant agent.a d e

Exacerbation of porphyria reported; use with caution in patients with this disease.c

Monitor blood counts and liver function tests periodically during prolonged therapy.b c d Blood dyscrasias (including agranulocytosis), jaundice, and hepatic dysfunction reported occasionally.c d

Specific Populations

Category D.f (See Fetal/Neonatal Morbidity under Cautions.)

Many benzodiazepines are distributed into milk;b f distribution of chlordiazepoxide into milk should be expected.f Discontinue nursing or the drug.b

Safety and efficacy of chlordiazepoxide hydrochloride not established in children <6 years of age.a c

Safety and efficacy of the chlordiazepoxide hydrochloride-clidinium bromide and the chlordiazepoxide-amitriptyline hydrochloride fixed combinations not established in pediatric patients.a d e

Response of children to CNS drugs may be unpredictable; initiate therapy at low dosage and increase as required.a c (See Dosage under Dosage and Administration.)

Monitor hyperactive, aggressive children for paradoxical reactions (e.g., excitement, stimulation, acute rage).c

Prolonged elimination of chlordiazepoxide and its metabolites.b

Possible increased risk of drowsiness, ataxia, and confusion; generally preventable by proper dosage adjustment, but occasionally may be observed at reduced dosages.a c e

No overall differences in safety and efficacy of chlordiazepoxide in fixed combination with amitriptyline hydrochloride in geriatric patients relative to younger adults; however, increased sensitivity cannot be ruled out.d

Initiate therapy at low dosages; gradually increase dosage if needed and tolerated.a c d e (See Geriatric or Debilitated Patients under Dosage and Administration.)

Prolonged elimination of chlordiazepoxide and its metabolites.b Use with caution.b c d Use smallest effective dosage.a

Use with caution.b c d

Common Adverse Effects

Drowsiness,b c d e ataxia,b c e confusion.b c e

Storage

Oral

25°C (may be exposed to 15–30°C).c

Store in a dry place at 25°C (may be exposed to 15–30°C).d

25°C (may be exposed to 15–30°C).i

In the U.S.

• Librium

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Antianxiety

Pharmacologic Class: Chlordiazepoxide

Chlordiazepoxide is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before a surgery. It may also be used to treat symptoms of alcohol withdrawal.

Chlordiazepoxide is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

chlordiazepoxide hydrochloride is available only with your doctor's prescription.