Data from FDA - Curated by EPG Health - Last updated 19 December 2016
CONTRAINDICATIONS Chlordiazepoxide and amitriptyline hydrochloride is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants.
It should not be given concomitantly with a monoamine oxidase inhibitor.
Chlordiazepoxide and amitriptyline hydrochloride should then be initiated cautiously with gradual
This drug is contraindicated during the
The usual precautions should be observed when treating
The possibility of suicide in
Essential Laboratory Tests Patients on
Drug and Treatment Interactions Because of its amitriptyline component,
Drugs Metabolized by P450 2D6: The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is
Depending on the fraction of drug metabolized by P450 2D6,
An individual who is stable on
While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline and paroxetine,
The extent to which SSRI TCA interactions may pose clinical
Furthermore, whenever one of these other drugs is withdrawn from cotherapy,
The effects of concomitant administration of chlordiazepoxide and amitriptyline hydrochloride and other psychotropic drugs have not been evaluated.
Sedative effects may be additive.
Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants and benzodiazepines,
Pregnancy See WARNINGS section.
Nursing Mothers It is not known whether this drug is excreted in human milk.
As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.
Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets in a child or adolescent must balance
Geriatric Use In elderly and debilitated patients
Of the total number of subjects in clinical studies of chlordiazepoxide and amitriptyline hydrochloride, 74 individuals were 65 years and older.
An additional 34 subjects were between 60 and 69 years of age.
Because elderly patients are more likely to have
Sedating drugs may cause
Clinical studies of chlordiazepoxide and amitriptyline hydrochloride did not include
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the
A patient Medication Guide about “Antidepressant Medicines,
Patients should be given the
Patients should be advised of the following
Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since
Such symptoms should be reported to the patient 's prescriber or health
Symptoms such as these may be associated with
Most frequently reported were drowsiness, dry mouth, constipation,
Other side effects occurring less commonly included
Granulocytopenia, jaundice and hepatic
When treatment with chlordiazepoxide and amitriptyline hydrochloride is prolonged, periodic
However, they are included because they have been reported during therapy with one or both of the components or
Cardiovascular: Hypotension, hypertension, tachycardia, palpitations, myocardial infarction, arrhythmias, heart
Neurologic: Incoordination, ataxia,
Hematologic: Bone marrow
Endocrine: Testicular swelling and gynecomastia in the male, breast enlargement, galactorrhea and minor menstrual
DOSAGE AND ADMINISTRATION Optimum dosage varies with the
The larger portion of the total daily dose may be taken at bedtime.
In some patients,
Some patients respond to smaller doses and can be maintained on 2 tablets daily.
Chlordiazepoxide and amitriptyline hydrochloride tablets in an initial dosage of three or
|Agency product number||6RZ6XEZ3CR|
|Date Last Revised||13-06-2012|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Par Pharmaceutical Inc|
|Warnings||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 stu|