chlordiazepoxide/clidinium (Rx)

Brand and Other Names:Librax
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

chlordiazepoxide/clidinium

capsule

  • 5mg/2.5mg

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

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    Contraindicated

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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

            Addiction, abuse, and misuse

            • On September 2020, FDA addressed serious risks of benzodiazepine addiction, abuse, and misuse, which can lead to overdose and death
            • Physical dependence can occur when taken steadily for several days to weeks, even as prescribed
            • Stopping abruptly or reducing dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening
            • Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes; before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction
            • Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions
            • Risks of dependence and withdrawal increase with longer treatment duration and higher daily dose; although injection is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, including seizures, which can be life-threatening; use gradual taper when discontinuing therapy to reduce withdrawal reactions risk

            Contraindications

            Hypersensitivity

            Glaucoma

            Prostatic hypertrophy

            Benign bladder neck obstruction

            Severe respiratory depression

            Cautions

            Decrease dose in debilitated or elderly patients

            Concomitant administration with other psychotropic agents not recommended; if such combination seems indicated, give careful consideration to pharmacology of agents to be employed, particularly when known potentiating compounds such as MAO inhibitors and phenothiazines are to be used; usual precautions in treating patients with impaired renal or hepatic function should be observed

            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

            Although clinical studies have not established a cause and effect relationship, variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride

            Use caution in hot weather; may cause heat prostration

            Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

            Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate

            For patients using treated more frequently than recommended, to reduce risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose)

            Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use

            In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months

            Usual precautions are indicated when chlordiazepoxide hydrochloride is used to treat anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary

            Caution in patients with impaired gag reflex or respiratory disease

            Concomitant use of opioid analgesics and benzodiazepines increases risk of drug-related mortality compared to use of opioids alone; if decision made to prescribe drug concomitantly with opioids, prescribe 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 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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            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
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.