Librax

— THERAPEUTIC CATEGORIES —
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    How Supplied

    Librax is available in light green opaque capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide in bottles of 100, with “LIBRAX® ICN” imprinted on the body of the capsule. 

    Storage

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

    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.

    Boxed Warning

    Risks from Concomitant Use with Opioids

    • Risk of profound sedation, respiratory depression, coma and death with opioids.

    • Reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required. Monitor for signs and symptoms of respiratory depression and sedation. 

    Abuse, Misuse, and Addiction

    • Risk of abuse, misuse, and addiction, that can potentially lead to overdose and death. Prior to initiating treatment, evaluate the risk for each patient and monitor regularly during treatment for the development of any addiction, abuse, and misuse.

    Dependence and Withdrawal Reactions

    • Continued use may lead to clinically significant physical dependence.

    • Increased risk for dependence and withdrawal with longer treatment duration and higher daily dose.

    • Abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions. 

    • Gradually taper to discontinue Librax or reduce dose to reduce the risk for 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.

    Warnings/Precautions

    Risks From Concomitant Use with Opioids 

    • Risk of profound sedation, respiratory depression, coma and death with opioids.

    • Reserve concomitant use in those for whom alternative options are inadequate. If a decision is made to prescribe Librax concomitantly with opioids, prescribe the lowest effective dose and minimum duration of concomitant use. Monitor for signs and symptoms of respiratory depression and sedation. 

    Abuse, Misuse, and Addiction

    • Risk of abuse, misuse, and addiction, that can potentially lead to overdose and death. Prior to initiating treatment, evaluate the risk for each patient and monitor regularly during treatment for the development of any addiction, abuse, and misuse.

    • Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants).

    • Assess the patient and institute early treatment appropriately if substance use disorder is suspected.

    Dependence and Withdrawal Reactions

    • Continued use may lead to clinically significant physical dependence.

    • Increased risk for dependence and withdrawal with longer treatment duration and higher daily dose.

    • Abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions. 

    • Gradually taper to discontinue Librax or reduce dose to reduce the risk for withdrawal reactions.

    Effects on the Ability to Drive or Operate Machinery 

    • Caution against hazardous occupations requiring complete mental alertness, such as driving or operating machinery.

    Neonatal Sedation and Withdrawal Syndrome

    • Monitor neonates exposed to Librax during pregnancy and labor for signs of sedation and monitor neonates exposed to Librax during pregnancy for signs of withdrawal; manage these neonates accordingly.

    CNS Adverse Reactions

    • Limit dose to the smallest effective amount in geriatric or debilitated patients (no more than 2 Librax caps per day initially, may be increased gradually as needed and tolerated).

    • Do not administer Librax with other psychotropic agents.

    Pregnancy Considerations

    Risk Summary

    • Chlordiazepoxide Hydrochloride: Neonates born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal.

    • Clidinium Bromide: There is an absence of published data on orally administered clidinium bromide in pregnant women.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Librax during pregnancy or labor for sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Librax during pregnancy for signs of withdrawal.

    Nursing Mother Considerations

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Librax and any potential adverse effects on the breastfed infant from Librax or from the underlying maternal condition.  

    • Monitor infants exposed to Librax for sedation, poor feeding and poor weight gain.

    Pediatric Considerations

    Safety and effectiveness of Librax in pediatric patients have not been established. 

    Geriatric Considerations

    In general, use caution when selecting dosage for an elderly patient.

    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

    Patient Counseling

    Abuse, Misuse, and Addiction

    • Advise patients about the risks for abuse, misuse, and addiction, which can result in overdose and death. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction.

    Withdrawal Reactions

    • Inform patients that the continued use of Librax may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Librax may precipitate acute withdrawal reactions.

    • Instruct patients that abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions and requires a slow taper. 

    Concomitant Use with Opioids and Other CNS Depressants 

    • Advise patients that the use of Librax with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider.

    Pregnancy

    • Advise pregnant females that use of Librax late in pregnancy may result in sedation and/or withdrawal symptoms in newborns.

    Nursing

    • Patients should consult their healthcare provider if they are breastfeeding or intend to breastfeed.

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