Dosing and uses of Librax (chlordiazepoxide/clidinium)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
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
Librax (chlordiazepoxide/clidinium) adverse (side) 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
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)
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
Pregnancy and 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 of Librax (chlordiazepoxide/clidinium)
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
