ELAVIL IN-HOME WITHDRAWAL AND TAPERING PROGRAM

Elavil blocks the neurotransmitter acetylcholine in the central and peripheral nervous system, and it's this action that contributes to the numerous side effects, including weight gain, changes in appetite, nausea, constipation, nervousness, muscle stiffness, blurred vision and urinary retention. Elavil should not be abruptly or rapidly discontinued due to the potential of severe withdrawal symptoms. It is recommended to do a slow taper to help minimize symptoms. 

Amitriptyline (Elavil) is the most widely used Tricyclic Antidepressant prescribed to treat depression, anxiety, bipolar disorder, attention deficit hyperactivity disorder, insomnia, neuropathic pain and migraines.

Amitriptyline (Elavil) is often used off-label for migraine prevention, yet a study in San Diego showed melatonin was more effective for migraine prevention than Amitriptyline.

Amitriptyline was developed by Merck and initially synthesized in 1960 and approved by the FDA in 1961. Amitriptyline is on the World Health Organization's (WHO) list of most important medications needed in a basic health system.

Elavil also exerts minimal action on Serotonin but significantly on Norepinephrine and these two neurotransmitters also affect the adrenal 'flight-or-fight' system, dream sleep, mood, memory and cardiovascular function.

Elavil side effects may include seizures, urinary retention and a number of heart issues. In the United States and Australia, Amitriptyline is listed as a pregnancy category C drug, meaning it may cause problems during pregnancy. Elavil is known to interact with MAO Inhibitors and SSRIs, risking Serotonin Syndrome.

In June 2011, researchers at the University of East Anglia, Norich, United Kingdom, investigated the anticholinergic burden (ACB) meaning the blocking of acetylcholine, and listed the results. They found that Amtriptyline (Elavil) rated a three, meaning severe due to the reduction in cognitive abilities, adverse side effects and increase in mortality risk.

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ELAVIL WITHDRAWAL SYMPTOMS MAY INCLUDE:

drowsiness, dizziness, dry mouth, blurred vision, constipation, weight gain, or trouble urinating, myocardial infarction, arrhythmia, hypotension, hypertension, palpitation, tachycardia, coma, seizures, hallucinations; delusions, confused states; disorientation, incoordination, tremors, peripheral neuropathy, abnormal involuntary movements, tardive dyskinesia, dysarthria, disturbed concentration, anxiety, insomnia, restlessness, nightmares, drowsiness, dizziness, weakness, fatigue, headache, syndrome of inappropriate ADH secretion, tinnitus, hyperpyrexia, urinary retention, dilation of urinary tract, constipation, blurred vision, increased ocular pressure, skin rash, urticarial, edema of face and tongue, bone marrow depression, nausea, vomiting, anorexia, stomatitis; peculiar taste, diarrhea, black tongue, testicular swelling, breast enlargement – female, increased or decreased libido, impotence, elevation and lowering of blood sugar levels, alopecia, weight gain or loss, urinary frequency, increased perspiration 

ELAVIL SIDE EFFECTS MAY INCLUDE: 

dizziness, aggression, anxiety, balance issues , blurred vision, brain zaps, concentration impairment, constipation, crying spells, depersonalization, diarrhea, dizziness. electric shock sensations, fatigue, flatulence, flu-like symptoms, hallucinations, hostility, highly emotional, indigestion, irritability, impaired speech, insomnia, jumpy nerves, lack of coordination, lethargy, migraine headaches / increased headaches, nausea, nervousness, over-reacting to situations, paranoia, repetitive thoughts or songs, sensory & sleep disturbances, severe internal restlessness (akathisia), stomach cramps, tremors, tinnitus (ear ringing or buzzing), tingling sensations, troubling thoughts, visual hallucinations / illusions, vivid dreams, speech or visual changes, worsened depression

ELAVIL ADVERSE REACTIONS MAY INCLUDE: per PDR 

Severe: visual impairment, liguria, seizures, suicidal ideation, ventricular tachycardia, myocardial infarction, cardiomyopathy, torsade de pointes, arrhythmia exacerbation, heart failure, stroke, AV block, tardive dyskinesia, ocular hypertension, ileus, hepatic failure, vasculitis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), angioedema, lupus-like symptoms, SIADH, neuroleptic malignant syndrome-like symptoms, serotonin syndrome, agranulocytosis

Moderate: orthostatic hypotension, memory impairment, constipation, blurred vision, palpitations, sinus tachycardia, peripheral vasodilation, urinary retention, amblyopia, hostility, depression, impulse control symptoms, hallucinations, akathisia, delirium, psychosis, mania, edema, hypertension, hypotension, QT prolongation, PR prolongation, dysarthria, ataxia, confusion, peripheral neuropathy, involuntary movements, EEG changes, cycloplegia, hepatitis, stomatitis, jaundice, erythema, eosinophilia, hyperglycemia, hyponatremia, ejaculation dysfunction, hypoglycemia, galactorrhea, impotence (erectile dysfunction), testicular swelling, hyperthermia, leukopenia, thrombocytopenia, neutropenia, withdrawal

Mild: xerostomia, drowsiness, lethargy, weight gain, tremor, dizziness, hyperhidrosis, insomnia, asthenia, dyspepsia, anxiety, paresthesias, fatigue, headache, nausea, diarrhea, rhinitis, anorexia, abdominal pain, pruritus, syncope, polydipsia, agitation, paranoia, restlessness, irritability, weakness, nightmares, weight loss, mydriasis, tongue discoloration, vomiting, dysgeusia, increased urinary frequency, alopecia, rash, urticaria, photosensitivity, breast enlargement, gynecomastia, libido increase, libido decrease, purpura, tinnitus

ELAVIL BOXED WARNINGS: per PDR 

Children, suicidal ideation 

 The safety and efficacy of amitriptyline (ELAVIL) for the treatment of depression have not been established in children less than 12 years of age. In October 2004, the FDA directed manufacturers of all antidepressants to include a boxed warning detailing the risk of suicide in pediatric patients, including children and adolescents less than 18 years of age, as well as young adults. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with SSRIs and other antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in children or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increase or decrease; such observation would generally include at least weekly face-to-face contact with patients during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between visits. It is unknown if the suicidality risk in children and young adults extends to longer-term therapy (i.e., beyond several months). The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary psychiatric disorder. All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with amitriptyline. In patients who exhibit changes in symptoms, worsening of depression or suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. Antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.

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According to the FDA: 

Withdrawal Symptoms After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.  These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants. 

References:

https://www.ncbi.nlm.nih.gov/books/NBK537225/

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085966s095,085969s084,085968s096,085971s075,085967s076,085970s072lbl.pdf

https://www.healthline.com/health/amitriptyline-oral-tablet#highlights

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