Drug Class: Psychotherapeutic combinations
Usual Adult Dose for Anxiety
Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
- Initial dose: 3 to 4 tablets orally per day, given in divided doses
- Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Comments:
- Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
- The larger portion of the total dose may be given at bedtime.
- A single daily dose (given at bedtime) may be sufficient for some patients.
Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety
Usual Adult Dose for Depression
Amitriptyline 25 mg-chlordiazepoxide 10 mg tablets:
- Initial dose: 3 to 4 tablets orally per day, given in divided doses
- Maintenance dose: 2 to 6 tablets orally per day, given in divided doses
Comments:
- Doses should be reduced to the lowest effective amount once a satisfactory response is obtained.
- The larger portion of the total dose may be given at bedtime.
- A single daily dose (given at bedtime) may be sufficient for some patients.
Use: Treatment of patients with moderate to severe depression associated with moderate to severe anxiety
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Elderly patients and/or those who do not tolerate higher doses:
Amitriptyline 12.5 mg-chlordiazepoxide 5 mg tablets:
- Initial dose: 3 to 4 tablets orally per day, given in divided doses
Precautions
US BOXED WARNINGS:
- RISKS FROM CONCOMITANT USE WITH OPIOIDS: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Concomitant prescribing should be reserved for patients for whom alternative treatment options are inadequate. Doses and durations should be limited to the minimum required. Patients should be monitored for signs/symptoms of respiratory depression and sedation.
- SUICIDALITY AND ANTIDEPRESSANT DRUGS: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior/suicidality in children, adolescents, and young adults in short-term studies of MDD and other psychiatric disorders. Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in the risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. This drug is not approved in pediatric patients.
This drug is not recommended for use in children.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule IV
Dialysis
Data not available
Other Comments
Storage requirements: Protect from light and humidity.
General:
- Lower doses are recommended for elderly patients.
- Decreases in insomnia, feelings of guilt or worthlessness, agitation, psychic/somatic anxiety, suicidal ideation, and anorexia may occur within the first week of treatment.
Monitoring:
- Hematologic: Periodic blood counts
- Hepatic: Periodic liver function tests
Patient advice:
- Patients should be instructed to tell their healthcare provider about all of the medicines that they take, including prescription and non-prescription medicines.
- 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.
- Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
- This medicine may cause impaired judgment, thinking, or motor skills; patients should not drive a car or operate dangerous machinery until they know how this drug affects them.
- Patients and their caregivers should be told to report any signs/symptoms of respiratory depression or profound sedation.
