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Chlordiazepoxide/Amitriptyline HCL

Risk From Concomitant Use With Opioids

Risk From Concomitant Use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS).

The use of benzodiazepines, including LIMBITROL, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing LIMBITROL and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS).

The continued use of benzodiazepines, including LIMBITROL, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of LIMBITROL after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue LIMBITROL  reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressanttreated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors (see WARNINGS). LIMBITROL is not approved for use in pediatric patients (see PRECAUTIONS).


FDA and Industry Communications

Index to FDA Safety Information - amitriptyline-chlordiazepoxide

Patient Counseling Information

Medication Guides

Patient Medication Guide - LIMBITROL and LIMBITROL DS

Package Inserts

Chlordiazepoxide/Amitriptyline

Updated March 2021