LIBRAX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LIBRAX (LIBRAX).

How it works

Chlordiazepoxide is a benzodiazepine that enhances GABA-A receptor activity, increasing chloride ion conductance and causing CNS depression. Clidinium is an anticholinergic that blocks muscarinic acetylcholine receptors, reducing gastrointestinal motility and secretions.

What the body does with it

Metabolism	Chlordiazepoxide is hepatically metabolized via N-demethylation and hydroxylation by CYP3A4 and CYP2C19 enzymes, producing active metabolites (desmethylchlordiazepoxide, demoxepam, nordazepam, oxazepam). Clidinium is primarily excreted unchanged in urine and feces with minimal hepatic metabolism.
Excretion	Chlordiazepoxide (CDX): Renal (1-2% unchanged, 4-6% as metabolites), biliary/fecal (minor). Clidinium bromide: Fecal (50-60% as unchanged drug), renal (40-50% as metabolites and unchanged).
Half-life	Chlordiazepoxide: 5-30 hours (terminal half-life; increases with age, liver disease; active metabolite desmethyldiazepam has half-life 30-200 hours). Clidinium: 3-4 hours.
Protein binding	Chlordiazepoxide: 96-98% (albumin). Clidinium: >90% (albumin).
Volume of Distribution	Chlordiazepoxide: 2-4 L/kg (extensive tissue distribution). Clidinium: 0.5 L/kg.
Bioavailability	Chlordiazepoxide oral: 100% (well absorbed). Clidinium oral: 10-20% (low oral bioavailability due to first-pass metabolism).
Onset of Action	Oral: Chlordiazepoxide 30-60 minutes; clidinium 30-60 minutes.
Duration of Action	Chlordiazepoxide: 24-48 hours (due to long half-life of parent and active metabolites). Clidinium: 3-6 hours.

Classification & Brands

Dosing & administration

1-2 capsules orally 3-4 times daily (each capsule contains chlordiazepoxide 5 mg and clidinium 2.5 mg).

Dosage form	CAPSULE
Renal impairment	For GFR <30 mL/min: decrease dose by 50% or extend interval to 8-12 hours; use with caution due to risk of accumulation.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	Not recommended for children under 12 years; for ages 12-18: 1 capsule orally 3-4 times daily (based on adult dose, no weight-based data).
Geriatric use	Initiate at 1 capsule orally 2-3 times daily; titrate carefully due to increased sensitivity, risk of sedation, and fall risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LIBRAX (LIBRAX).

Breastfeeding	Chlordiazepoxide and its metabolites are excreted in breast milk. M/P ratio not established. Risk of infant sedation, poor feeding, and withdrawal. Avoid breastfeeding or use alternatives.
Teratogenic Risk	First trimester: Possible increased risk of congenital malformations (cleft palate, cardiac defects) based on benzodiazepine component (chlordiazepoxide). Second/third trimester: Risk of fetal benzodiazepine exposure leading to floppy infant syndrome, neonatal withdrawal, and CNS depression. Anticholinergic component (clidinium) may cause neonatal anticholinergic effects.

Warnings & precautions

■ FDA Black Box Warning

Concomitant use of benzodiazepines with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concurrent use for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to chlordiazepoxide, clidinium, or any component","Narrow-angle glaucoma","Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy)","Myasthenia gravis","Severe hepatic impairment","Concurrent use with ketoconazole or itraconazole (CYP3A4 inhibitors increasing benzodiazepine levels)"]

Clinical Precautions

Precautions

["Risk of dependence and withdrawal reactions","Concomitant use with opioids (see black box warning)","CNS depressant effects including drowsiness and ataxia","Anticholinergic effects such as constipation, urinary retention, blurred vision","Use in elderly or debilitated patients requires dose reduction","Potential for paradoxical reactions (excitement, hyperactivity)"]

Clinical Tips & Counseling

Drug interactions

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LIBRAX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LIBRAX (LIBRAX).

How it works

What the body does with it

Metabolism	Chlordiazepoxide is hepatically metabolized via N-demethylation and hydroxylation by CYP3A4 and CYP2C19 enzymes, producing active metabolites (desmethylchlordiazepoxide, demoxepam, nordazepam, oxazepam). Clidinium is primarily excreted unchanged in urine and feces with minimal hepatic metabolism.
Excretion	Chlordiazepoxide (CDX): Renal (1-2% unchanged, 4-6% as metabolites), biliary/fecal (minor). Clidinium bromide: Fecal (50-60% as unchanged drug), renal (40-50% as metabolites and unchanged).
Half-life	Chlordiazepoxide: 5-30 hours (terminal half-life; increases with age, liver disease; active metabolite desmethyldiazepam has half-life 30-200 hours). Clidinium: 3-4 hours.
Protein binding	Chlordiazepoxide: 96-98% (albumin). Clidinium: >90% (albumin).
Volume of Distribution	Chlordiazepoxide: 2-4 L/kg (extensive tissue distribution). Clidinium: 0.5 L/kg.
Bioavailability	Chlordiazepoxide oral: 100% (well absorbed). Clidinium oral: 10-20% (low oral bioavailability due to first-pass metabolism).
Onset of Action	Oral: Chlordiazepoxide 30-60 minutes; clidinium 30-60 minutes.
Duration of Action	Chlordiazepoxide: 24-48 hours (due to long half-life of parent and active metabolites). Clidinium: 3-6 hours.

Classification & Brands

Dosing & administration

1-2 capsules orally 3-4 times daily (each capsule contains chlordiazepoxide 5 mg and clidinium 2.5 mg).

Dosage form	CAPSULE
Renal impairment	For GFR <30 mL/min: decrease dose by 50% or extend interval to 8-12 hours; use with caution due to risk of accumulation.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated.
Pediatric use	Not recommended for children under 12 years; for ages 12-18: 1 capsule orally 3-4 times daily (based on adult dose, no weight-based data).
Geriatric use	Initiate at 1 capsule orally 2-3 times daily; titrate carefully due to increased sensitivity, risk of sedation, and fall risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LIBRAX (LIBRAX).

Breastfeeding	Chlordiazepoxide and its metabolites are excreted in breast milk. M/P ratio not established. Risk of infant sedation, poor feeding, and withdrawal. Avoid breastfeeding or use alternatives.
Teratogenic Risk	First trimester: Possible increased risk of congenital malformations (cleft palate, cardiac defects) based on benzodiazepine component (chlordiazepoxide). Second/third trimester: Risk of fetal benzodiazepine exposure leading to floppy infant syndrome, neonatal withdrawal, and CNS depression. Anticholinergic component (clidinium) may cause neonatal anticholinergic effects.