LIBRAX

Librax Generic Name & Formulations

Legal Class

CIV

General Description

Chlordiazepoxide HCl 5mg, clidinium bromide 2.5mg; caps.

Pharmacological Class

Benzodiazepine + anticholinergic.

How Supplied

Caps—100

Manufacturer

Bausch Health Companies Inc.

Generic Availability

YES

Mechanism of Action

Chlordiazepoxide HCl has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Clidinium bromide is an effective anticholinergic agent with activity approximating that of atropine sulfate against acetylcholine-induced spasms in isolated intestinal strips.

Librax Indications

Indications

Adjunct in peptic ulcer. Irritable bowel syndrome. Acute enterocolitis.

Librax Dosage and Administration

Adult

Individualize. Usually 1–2 caps 3–4 times daily before meals and at bedtime. Elderly or debilitated: max 2 caps daily initially, then may increase gradually.

Children

Not established.

Librax Contraindications

Contraindications

Glaucoma. GI or GU obstruction.

Librax Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Librax Warnings/Precautions

Warnings/Precautions

Risks from concomitant use with opioids; see Interactions. Monitor for paradoxical reactions. Depression. Suicidal tendencies (monitor). Hepatic or renal impairment. Obtain LFTs and blood counts periodically in prolonged use. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Write ℞ for smallest practical amount. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Librax Pharmacokinetics

Metabolism

Hepatic (chlordiazepoxide).

Elimination

Renal. Half-life: 24–48 hours (chlordiazepoxide).

Librax Interactions

Interactions

Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Additive CNS depressant effects with alcohol or other CNS depressants. Concomitant other psychotropic agents (eg, MAOIs, phenothiazines): not recommended. Increased constipation with concomitant other spasmolytic agents and/or a low residue diet. May rarely interfere with oral anticoagulants.

Librax Adverse Reactions

Adverse Reactions

Drowsiness, anticholinergic effects (eg, dry mouth, blurred vision, urinary hesitancy, constipation), ataxia, confusion; rare: jaundice, blood dyscrasias, withdrawal reactions.

Librax Clinical Trials

See Literature

Librax Note

Not Applicable

Librax Patient Counseling