Drug Detail:Chlordiazepoxide and clidinium (Chlordiazepoxide and clidinium [ klor-dye-az-e-pox-ide-and-kli-di-nee-um ])
Drug Class: Anticholinergics / antispasmodics
Usual Adult Dose for Peptic Ulcer
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day
Comments:
- The dosage should be individualized, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
Uses:
- Control of emotional and somatic factors in gastrointestinal disorders
- Adjunctive treatment of acute enterocolitis, irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon), and peptic ulcer
Usual Adult Dose for Irritable Bowel Syndrome
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day
Comments:
- The dosage should be individualized, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
Uses:
- Control of emotional and somatic factors in gastrointestinal disorders
- Adjunctive treatment of acute enterocolitis, irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon), and peptic ulcer
Usual Adult Dose for Enterocolitis
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Maintenance dose: 1 to 2 capsules orally 3 to 4 times a day
Comments:
- The dosage should be individualized, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
Uses:
- Control of emotional and somatic factors in gastrointestinal disorders
- Adjunctive treatment of acute enterocolitis, irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon), and peptic ulcer
Usual Geriatric Dose for Peptic Ulcer
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated
Comments:
- The dosage should be individualized to the lowest effective dose, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
- Initial doses should not exceed 2 capsules/day.
Uses:
- Adjunctive therapy in the treatment of peptic ulcer treatment
- Control of emotional and somatic factors in gastrointestinal disorders
- Treatment of acute enterocolitis
- Treatment of irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon)
Usual Geriatric Dose for Irritable Bowel Syndrome
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated
Comments:
- The dosage should be individualized to the lowest effective dose, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
- Initial doses should not exceed 2 capsules/day.
Uses:
- Adjunctive therapy in the treatment of peptic ulcer treatment
- Control of emotional and somatic factors in gastrointestinal disorders
- Treatment of acute enterocolitis
- Treatment of irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon)
Usual Geriatric Dose for Enterocolitis
Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated
Comments:
- The dosage should be individualized to the lowest effective dose, and should be determined by the diagnosis and the patient's response.
- Doses should be administered before meals and at bedtime.
- Initial doses should not exceed 2 capsules/day.
Uses:
- Adjunctive therapy in the treatment of peptic ulcer treatment
- Control of emotional and somatic factors in gastrointestinal disorders
- Treatment of acute enterocolitis
- Treatment of irritable bowel syndrome (e.g., irritable colon, mucous colitis, spastic colon)
Renal Dose Adjustments
Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.
Liver Dose Adjustments
Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.
Dose Adjustments
Concomitant use with opioids:
- Use should be limited to patients for whom alternative treatment options are inadequate.
- The lowest effective dosage and duration of treatment should be used.
- Patients should be monitored for respiratory depression and sedation.
Debilitated patients:
- The lowest effective dosage and duration of treatment should be used.
- Chlordiazepoxide 5 mg-clidinium 2.5 mg capsules:
- Initial dose: 1 capsule orally 2 times a day, increasing the dose gradually as needed and tolerated
Withdrawal regimens: Cautious and gradual withdrawal of this drug should be performed over an extended period.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to either active component or to any of the ingredients
- In the presence of glaucoma
- Patients with benign bladder neck obstruction and prostatic hypertrophy
US BOXED WARNINGS:
RISKS FROM CONCOMITANT USE WITH OPIOIDS:
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and/or death.
- Concomitant prescribing of these drugs should be reserved for use in patients for whom alternative treatment options are inadequate.
- Dosages and durations should be limited to the minimum required.
- Patients should be followed for signs/symptoms of respiratory depression and sedation.
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug should be taken before meals and at bedtime.
Storage requirements:
- Store at or below 25C; protect from light and moisture.
Monitoring:
- HEMATOLOGIC: Blood counts periodically during protracted treatment
- HEPATIC: Liver function tests periodically during protracted treatment
- NERVOUS SYSTEM: Sedation, especially when given with opioids
- RESPIRATORY: Respiratory depression, especially when given with opioids
Patient advice:
- This medicine may increase the risk of suicidal thoughts and behavior. Patients should be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Patients should report any behavior of concern to their healthcare provider as soon as possible.
- This drug may cause drowsiness, dizziness, and reduced alertness. Patients should not drive a car or operate dangerous machinery until they know how this drug affects them.
- Patients should avoid drinking alcohol or taking other drugs that may cause sleepiness or dizziness while taking this drug until they talk to their healthcare provider.
- Patients should be told to contact their healthcare provider before increasing/decreasing the dose or discontinuing treatment.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.