Amitriptyline hydrochloride patient counseling information

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Amitriptyline
AMITRIPTYLINE HYDROCHLORIDE®
FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Amitriptyline
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Patient Counseling Information

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amitriptyline and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness and Suicidal Thoughts or Actions” is available for amitriptyline. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking amitriptyline.

While on therapy with amitriptyline hydrochloride, patients should be advised to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle.[1]

References

  1. "AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]".

Adapted from the FDA Package Insert.