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Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline Hydrochloride) - Summary

 
 



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 major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets 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. Chlordiazepoxide and Amitriptyline hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).

 

SUMMARY

Chlordiazepoxide and amitriptyline hydrochloride tablets combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. Each film coated tablet for oral administration contains 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt) or 10 mg chlordiazepoxide and 25 mg amitriptyline as the hydrochloride salt).

Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone.

Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.


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NEWS HIGHLIGHTS

Published Studies Related to Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline)

Clinical experience in the therapy of bites from exotic snakes in Berlin. [1992.11]
Since there are nearly no indigenous poisonous snakes in Germany, snake bites by poisonous snakes are rare... Despite serious coagulopathy in two of the patients and respiratory arrest in one, all survived without sequelae.

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Clinical Trials Related to Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline)

Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal [Completed]
A randomized, double-blind controlled trial comparing treatment outcomes between chloriazepide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.

Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder [Completed]
The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is effective in treatment of moderate to severe depression

Outpatient Treatment of Alcohol Withdrawal Syndrome [Completed]
The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients. Objectives:

- Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication

- Clinically controlled trial of two regimens for medical treatment of alcohol

withdrawal syndrome

- Outpatient treatment of alcohol withdrawal syndrome

A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study [Recruiting]
Non-cardiac chest pain is a common clinical problem encountered in our practice but at present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but altered motility of the esophagus and psychological factors including anxiety have been implicated as important factors. Reports of the single use of anticholinergic drugs and anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of no value. However the use of the combination therapy, especially with a double blind fashion have not been reported. On that basis, we propose to use a combination of anti-cholinergic and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic drugs in the treatment of non-cardiac chest pain.

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Page last updated: 2006-01-31

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