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Chlordiazepoxide

Pronouncation: (klor-DIE-aze-ee-POX-ide)
Class: Benzodiazepine

Trade Names:
Librium
- Capsules 5 mg
- Capsules 10 mg
- Capsules 25 mg
- Powder for injection 100 mg

Apo-Chlordiazepoxide (Canada)

Pharmacology

Feedback for Chlordiazepoxide

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Compare with other drugs.

Potentiates action of GABA to produce CNS depression.

Pharmacokinetics

Absorption

T _max is 0.5 to 4 h.

Distribution

96% protein bound.

Metabolism

Metabolized in the liver to the major metabolite desmethylchlordiazepoxide and to several inactive intermediate metabolites.

Elimination

The t _½ is 5 to 30 h. Excreted in the urine, with 1% to 2% as unchanged drug and 3% to 6% as a conjugate.

Indications and Usage

Management of anxiety disorders; relief of acute alcohol withdrawal symptoms; relief of preoperative apprehension and anxiety.

Unlabeled Uses

Treatment of irritable bowel syndrome.

Contraindications

Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; shock; coma.

Dosage and Administration

Individualize dosage. Acute symptoms may be rapidly controlled IM or IV, with subsequent oral treatment (max, 300 mg/day).

Children older than 6 yr of age

PO 5 mg 2 to 4 times daily; may be increased to 10 mg 2 to 3 times daily.

Children older than 12 yr of age

IM 25 to 50 mg

Mild to Moderate Anxiety
Adults

PO 5 to 10 mg 3 or 4 times daily.

Severe Anxiety
Adults

PO 20 to 25 mg 3 or 4 times daily.

Initial dose

IM/IV 50 to 100 mg, then 25 to 50 mg 3 to 4 times daily.

Elderly or Debilitated Patients

PO 5ߙmg 2 to 3 times daily. IM/IV 25 to 50 mg.

Preoperative Apprehension/Anxiety
Adults

PO 5 to 10 mg 3 or 4 times daily on days preceding surgery. IM 50 to 100 mg 1 h prior to surgery.

Acute Alcohol Withdrawal
Adults

IM/IV 50 to 100 mg; repeat every 2 to 4 h as needed. PO 50 to 100 mg, repeat as needed (max oral or parenteral dose is 300 mg/day).

General Advice

Administer prescribed dose without regard to meals but administer with food if GI upset occurs.

Injection
Reconstitute powder for injection immediately before administration. Do not administer if particulate matter, cloudiness, or discoloration noted. Discard any unused solution. Do not save for future use.
For IM administration, reconstitute powder for injection using supplied special diluent and following manufacturer's guidelines. Do not use diluent if it is opalescent or hazy.
Administer deep IM injection slowly into upper outer quadrant of gluteus muscle.
Do not administer solution prepared with IM diluent via IV route because of bubbles that form during reconstitution.
For IV administration reconstitute powder for injection using 5 mL sterile normal saline for injection or sterile water for injection.
Administer IV injection slowly over 1 min.
Do not administer solution prepared for IV injection via IM route because of pain on injection.

Storage/Stability

Store capsules and powder for injection at controlled room temperature (59° to 86°F).

Drug Interactions

Alcohol and CNS depressants

Additive CNS depressant effects are possible.

Azole antifungal agents (eg, itraconazole, ketoconazole), fluvoxamine, isoniazid, nefazodone, protease inhibitors (eg, indinavir)

May increase chlordiazepoxide plasma concentrations.

Cigarette smoking, theophyllines

May antagonize sedative effects.

Cimetidine, oral contraceptives, disulfiram, omeprazole

May increase effects of chlordiazepoxide with excessive sedation and impaired psychomotor function.

Digoxin

May increase serum digoxin concentrations.

Rifamycins

May decrease chlordiazepoxide plasma concentrations.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

CV collapse; hypotension; hypertension; tachycardia; bradycardia; edema; phlebitis or thrombosis at IV sites.

CNS

Drowsiness; confusion; ataxia; dizziness; fatigue; apathy; memory impairment; disorientation; anterograde amnesia; restlessness; headache; slurred speech; loss of voice; stupor; coma; euphoria; irritability; vivid dreams; psychomotor retardation; paradoxical reactions (eg, anger, hostility, mania, insomnia, muscle spasms); syncope; extrapyramidal symptoms.

Dermatologic

Rash.

EENT

Visual or auditory disturbances; depressed hearing; blurred vision.

GI

Constipation; diarrhea; dry mouth; coated tongue; nausea; anorexia; vomiting.

Genitourinary

Menstrual irregularities; increase or decrease in libido.

Hematologic

Blood dyscrasias including agranulocytosis; anemia; thrombocytopenia; leukopenia; neutropenia.

Hepatic

Abnormal LFTs; hepatic function impairment including hepatitis and jaundice.

Miscellaneous

Dependency/withdrawal syndrome.

Precautions

Monitor

CBC

Ensure that CBC with differential and liver enzymes are evaluated periodically in patient on prolonged therapy.

Injection administration

Ensure that a benzodiazepine-receptor antagonist (eg, flumazenil), oxygen, and resuscitation and intubation equipment are available when medication is administered by IV injection.

Parenteral therapy

Closely observe patient who has received parenteral therapy for at least 3 h, preferably at bed rest. Use side rails and be prepared to assist patient with ambulation if necessary.

Periodic therapy review

Ensure that therapy is periodically reviewed to determine if therapy needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.

Response to treatment

Frequently assess patient for response to treatment. Notify health care provider if condition does not appear to improve or worsens.

Withdrawal

If treatment is to be discontinued, or the dose reduced, gradually taper the dose and monitor patient for withdrawal symptoms. If significant withdrawal symptoms develop (eg, increased anxiety, tremor, muscle or abdominal cramps, sweating) reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.

Pregnancy

Category D . Avoid especially in first trimester because of possible increased risk of congenital malformations.

Lactation

Excreted in breast milk.

Children

Initial dose should be small and gradually increased. Oral form not recommended in children younger than 6 yr of age; parenteral form not recommended in children younger than 12ߙyr of age.

Elderly

Initial dose should be small and gradually increased. Use with caution in patients with limited pulmonary reserve.

Renal Function

Observe caution to avoid accumulation of drug.

Hepatic Function

Observe caution to avoid accumulation of drug.

Debilitated patients

Initial dose should be small and gradually increased. Use with caution in patients with limited pulmonary reserve.

Drug dependency

Prolonged use can lead to dependency. Withdrawal syndrome has occurred within 4 to 6 wk of treatment, especially if drug is abruptly discontinued. For discontinuation after long-term treatment, use caution and taper dosage.

Psychiatric disorders

Not intended for patients with primary depressive disorder, psychosis, or disorders in which anxiety is not prominent.

Parenteral administration

Reserved primarily for acute states.

Suicide

Use with caution in patients with suicidal tendencies; do not allow access to large quantities of drug.

Overdosage

Symptoms

Drowsiness, confusion, somnolence, impaired coordination, diminished reflexes, lethargy, ataxia, hypotonia, hypotension, hypnosis, coma, death.

Patient Information

Advise patient or caregiver to read the patient information leaflet before starting therapy and with each refill.
Advise patient that medication is usually started at a low dose and then gradually increased until max benefit is obtained.
Caution patient that medication may be habit forming and to take as prescribed and not to stop taking or change the dose unless advised to do so by health care provider.
Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
Advise patient that if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take 2 doses at the same time.
Advise patient that if medication needs to be discontinued it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
Advise patient with anxiety to take medication as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress reduction, counseling).
Instruct patient to contact health care provider if symptoms do not appear to be getting better, are getting worse, or if bothersome adverse reactions (eg, drowsiness, memory impairment) occur.
Advise patient that drug may cause drowsiness or impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

Injection
Advise patient or caregiver that medication will be prepared by a health care provider and administered in a health care setting under close observation when oral therapy is not feasible.