Chlordiazepoxide/Clidinium

DEA Class;  Rx

Common Brand Names; Librax

  • Gastrointestinal Agents, Other

Oral benzodiazepine/antimuscarinic combination 
Used to control emotional and somatic factors in gastrointestinal disorders and for adjunct treatment for irritable bowel syndrome and peptic ulcer disease 
Common ADRs include anticholinergic effects and drowsiness

Indicated to control emotional and somatic factors in gastrointestinal disorders, for the adjunctive treatment of peptic ulcer disease, or for symptomatic treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Hypersensitivity

Glaucoma

Prostatic hypertrophy

Benign bladder neck obstruction

Severe respiratory depression

  • Drowsiness
  • Ataxia
  • Confusion
  • Skin eruptions,
  • Edema
  • Menstrual irregularities
  • Nausea
  • Constipation
  • Xerostomia
  • Extrapyramidal symptoms
  • Libido, increased/decreased
  • Agranulocytosis
  • Jaundice
  • Hepatic dysfunction

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

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

Adults

40 mg/day PO chlordiazepoxide and 20 mg/day PO clidinium.

Elderly

40 mg/day PO chlordiazepoxide and 20 mg/day PO clidinium.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Chlordiazepoxide hydrochloride/Clidinium bromide

capsule

  • 5mg/2.5mg

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