chlordiazepoxide/clidinium (Rx)

Brand and Other Names:Librax
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

chlordiazepoxide/clidinium

capsule

  • 5mg/2.5mg
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Peptic Ulcer, IBS, & Enterocolitis

1-2 cap PO q6-8hr ac and hs

Possibly effective

  • Based on a review by the National Academy of Sciences – National Research Council and/or other information, FDA as classified the indications as follows:
  • “Possibly” effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), and acute enterocolitis
  • Final classification of the less-than-effective indications requires further investigation

Safety and efficacy not established

Avoid; high incidence of anticholinergic effects and uncertain effectiveness; avoid except in short-term situations to decrease secretions (Beers Criteria)

Use smallest effective dose

Not to exceed 2 capsules PO per day initially; may increase gradually as needed and tolerated

Ataxia, oversedation, or confusion may occur more frequently in elderly patients

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Interactions

Interaction Checker

and chlordiazepoxide/clidinium

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Drowsiness

            Ataxia

            Confusion

            Skin eruptions,

            Edema

            Menstrual irregularities

            Nausea

            Constipation

            Xerostomia

            Extrapyramidal symptoms

            Libido, increased/decreased

            Agranulocytosis

            Jaundice

            Hepatic dysfunction

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            Warnings

            Black Box Warnings

            Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation

            Contraindications

            Hypersensitivity

            Glaucoma

            Prostatic hypertrophy

            Benign bladder neck obstruction

            Severe respiratory depression

            Cautions

            Decrease dose in debilitated or elderly patients

            Paradoxical reactions to chlordiazepoxide have occurred (eg, excitement, stimulation, acute rage)

            Anterograde amnesia reported with benzodiazepine use

            May cause anticholinergic effects

            May cause CNS depression, which may impair ability to perform hazardous tasks, including operating heavy machinery, driving

            Use caution in hot weather; may cause heat prostration

            Avoid coadministration of other CNS depressants, including alcohol

            Withdrawal symptoms may occur if abruptly discontinued after prolonged use

            Caution in patients with clinical depression especially if suicidal risk may be present

            Caution in patients with impaired gag reflex or respiratory disease

            Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; if a decision is made to prescribe the drug concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use; follow patients closely for signs and symptoms of respiratory depression and sedation; advise both patients and caregivers about risks of respiratory depression and sedation when the drug is used with opioids

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            Pregnancy & Lactation

            Pregnancy Category: D; increased risk of congenital malformations associated with use of benzodiazepines during 1st trimester

            Lactation: Distributed in breast milk, avoid use; anticholinergic agents are known to inhibit lactation

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Chlordiazepoxide: Benzodiazepine; depresses all levels of CNS, including limbic and reticular formation, possibly by increasing gamma-aminobutyric acid (GABA) activity, a major inhibitory neurotransmitter

            Clidinium: Anticholinergic agent; elicits antispasmodic and antisecretory effects on GI tract  

            Pharmacokinetics

            Half-Life: 6-24 h (chlordiazepoxide)

            Metabolites: Metabolized in liver to active metabolites; demoxepam, desmethylchlordiazepoxide, desmethyldiazepam, oxazepam

            Excretion: Urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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