Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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.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
Images
Patient Handout
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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- Compare formulary status to other drugs in the same class.
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