Classes
DEA Class; Rx
Common Brand Names; Librax
- Gastrointestinal Agents, Other
Description
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
Indications
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.
Contraindications
Hypersensitivity
Glaucoma
Prostatic hypertrophy
Benign bladder neck obstruction
Severe respiratory depression
Adverse Effects
- Drowsiness
- Ataxia
- Confusion
- Skin eruptions,
- Edema
- Menstrual irregularities
- Nausea
- Constipation
- Xerostomia
- Extrapyramidal symptoms
- Libido, increased/decreased
- Agranulocytosis
- Jaundice
- Hepatic dysfunction
Warnings
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 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
Maximum Dosage
40 mg/day PO chlordiazepoxide and 20 mg/day PO clidinium.
40 mg/day PO chlordiazepoxide and 20 mg/day PO clidinium.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Chlordiazepoxide hydrochloride/Clidinium bromide
capsule
- 5mg/2.5mg