Elavil (Amitriptyline) Patient Information: Side Effects and Drug Images at RxList

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May 27, 2012

Elavil

Antidepressants: Get the Facts »

What does the new study say about the ineffectiveness of antidepressants?

In findings published in the February issue of the journal PloS Medicine, researchers conclude that when taken as a whole, the data show that only a small group of the most severely depressed patients benefit from taking one of the antidepressants.

For less severely depressed patients, the antidepressants were found to work no better than placebos, leading the researchers to conclude that most patients who take antidepressants probably shouldn't be on them.

Does this study contradict numerous positive studies on antidepressants?

Yes, it does. In a statement, American Psychiatric Association President-elect Nada Stotland, MD, maintains that studies like this one, which compare a single drug to placebo, do not accurately reflect the way doctors prescribe antidepressants today.

Stotland says many people who are depressed do n...

Read the Antidepressants: Get the Facts article »

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Please Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Elavil
(amitriptyline HCI)

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 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).

DRUG DESCRIPTION

Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C₂₀H₂₃N·HCl.

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.

Each Milliliter of the Sterile Solution Contains: Amitriptyline hydrochloride: 10 mg; Dextrose: 44 mg; Water for Injection, q.s.:1 ml

Added as Preservatives: Methylparaben: 1.5 mg; Propylparaben: 0.2 mg

Last reviewed on RxList: 10/12/2010
This monograph has been modified to include the generic and brand name in many instances.