"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
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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 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 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. 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).
Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water.
Elavil (amitriptyline HCl) is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg tablets and as a sterile solution for intramuscular use. Inactive ingredients of the tablets are calcium phosphate, cellulose, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, starch, stearic acid, talc, and titanium dioxide. 10 mg amitriptyline HCl tablets also contain FD&C Blue 1. 25 mg amitriptyline HCl tablets also contain D&C Yellow 10, FD&C Blue 1, and FD&C Yellow 6. 50 mg amitriptyline HCl tablets also contain D&C Yellow 10, FD&C Yellow 6 and iron oxide. 75 mg amitriptyline HCl tablets also contain FD&C Yellow 6. 100 mg amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Red 40. 150 mg amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Yellow 6.
Added as Preservatives: Methylparaben: 1.5 mg; Propylparaben: 0.2 mg
What are the precautions when taking amitriptyline (Elavil)?
See also Warning section.
Before taking amitriptyline, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (such as nortriptyline), or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide,...
Last reviewed on RxList: 10/12/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Elavil Information
- Elavil Drug Interactions Center: amitriptyline oral
- Elavil Side Effects Center
- Elavil Overview including Precautions
- Elavil FDA Approved Prescribing Information including Dosage
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