Amitriptyline

Class
Antidepressants
Subclass
Tricyclic antidepressants
Substance name
Amitriptyline hydrochloride
Brand names
Elavil®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Symptomatic relief
Neuropathic pain • Off-label
•
25-150 mg PO daily, in 1-2 divided doses
Treatment
Major depressive disorder • Outpatient management
•
Start at: 25-50 mg PO daily, in 1-3 divided doses
•
Maintenance: 50-100 mg PO qHS
•
Maximum: 150 mg per day
Titrate preferably the late afternoon and/or bedtime doses.
Alternative
•
Start at: 50-100 mg PO qHS
•
Maintenance: 50-100 mg PO qHS
•
Maximum: 150 mg per day
Titrate the bedtime dose in 25-50 mg increments.
Major depressive disorder • Inpatient management
•
Start at: 100-200 mg PO daily, in 1-3 divided doses
•
Maintenance: 50-100 mg PO qHS
•
Maximum: 300 mg per day
Chronic cough • Off-label
•
Start at: 10 mg PO qHS
•
Maximum: 100 mg per day
Diabetic neuropathy • Off-label
•
Start at: 10-25 mg PO qHS
•
Maintenance: 75-150 mg PO qHS
Fibromyalgia • Off-label
•
Start at: 5-10 mg PO qHS
•
Maintenance: 20-30 mg PO qHS
IBS • Off-label
•
Start at: 10 mg PO qHS
•
Maintenance: 30-50 mg PO qHS
Insomnia • Off-label
•
10-25 mg PO qHS
Alternative
•
25-150 mg PO qHS
Postherpetic neuralgia • Off-label
•
Start at: 10-25 mg PO qHS
•
Maintenance: 75-150 mg PO qHS
Titrate in 10-25 mg increments weekly.
Prevention
Headache episodes in patients with chronic tension-type headache • Off-label
•
Start at: 10-25 mg PO qHS
•
Maintenance: 30-75 mg PO qHS
Migraine attacks • Off-label
•
25-150 mg PO qHS
Vomiting episodes in patients with cyclic vomiting syndrome • Off-label
•
Start at: 25 mg PO qHS
•
Maintenance: 75-100 mg PO qHS
Titrate in 10-25 mg increments every 2 weeks.
Other off-label uses
•
Treatment of sialorrhea in patients with ALS
Indications for use
Labeled indications
Adults
•
Treatment of major depressive disorder (inpatient management)
•
Treatment of major depressive disorder (outpatient management)
Off-label indications
Adults
•
Symptomatic relief of neuropathic pain
•
Treatment of chronic cough
•
Treatment of diabetic neuropathy
•
Treatment of fibromyalgia
•
Treatment of insomnia
•
Treatment of IBS
•
Treatment of postherpetic neuralgia
•
Treatment of sialorrhea in patients with ALS
•
Prevention of headache episodes in patients with chronic tension-type headache
•
Prevention of migraine attacks
•
Prevention of vomiting episodes in patients with cyclic vomiting syndrome
Safety risks
Boxed warnings
Suicidal ideation
•
Use extreme caution in patients with major depressive disorder or other psychiatric disorders, particularly in children, adolescents, and young adults. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to amitriptyline or its components
Myocardial infarction in the acute recovery phase
Concomitant use of cisapride
Concomitant use of MAOIs
•
Do not use amitriptyline with or within 14 days of stopping MAOIs.
Warnings and precautions
Acute urinary retention
•
Use caution in patients with a history of urinary retention.
Cardiac arrhythmias
•
Use caution in patients with hyperthyroidism or taking thyroid medications.
Exacerbation of acute angle-closure glaucoma
•
Use caution in patients with a history of angle-closure glaucoma or increased intraocular pressure.
Exacerbation of psychosis
•
Use caution in patients with schizophrenia.
Manic or mixed episodes
•
Use caution in patients at risk for bipolar disorder. Screen all patients with depressive symptoms for the risk of bipolar disorder.
Prolonged QT interval, cardiac arrhythmias, myocardial infarction
•
Use extreme caution in patients with CVDs, as TCAs, particularly when given in high doses, have been reported to cause cardiac arrhythmias, sinus tachycardia, QT prolongation, myocardial infarction, and stroke.
Seizure
•
Use extreme caution in patients with seizure disorder.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No dose adjustment required. Use with caution.
Renal replacement therapy
Continuous renal replacement
•
No dose adjustment required. Use with caution.
Intermittent hemodialysis
•
No dose adjustment required. Use with caution.
Peritoneal dialysis
•
No dose adjustment required. Use with caution.
Hepatic impairment
Any severity
•
Use with caution. Reduce dose.
Substantial chronic alcohol consumption
•
Use with caution. Monitor for toxicity.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Adverse events such as CNS effects, limb deformities, and developmental delays have been observed in infants exposed to amitriptyline during pregnancy. Additionally, infants exposed to TCAs during the last trimester have shown withdrawal symptoms.
Breastfeeding
Halt breastfeeding temporarily.
•
Consider alternative agents that may be safer.
Very low levels in breastfed infants (< 5%).
May potentially cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Orthostatic hypotension
Common 1-10%
•
Acute liver failure, acute cholecystitis, agranulocytosis, ataxia, breast enlargement, cardiac arrhythmias, coma, ↓ blood glucose, ↓ blood neutrophil count, ↓ platelet count, dysarthria, extrapyramidal signs, facial edema, glossitis, gynecomastia, hepatitis, hypertension, ↑ blood eosinophil count, ↑ blood glucose, ↑ body temperature, ↑ intraocular pressure, mydriasis, myocardial infarction, paralytic ileus, parotid gland enlargement, peripheral neuropathy, photosensitivity of skin, purpura, anorexia, black hairy tongue, blurred vision, confusion, constipation, ↓ libido, delusions, diarrhea, dizziness, dry mouth, excessive sweating, galactorrhea, hair loss, insomnia, nausea, nightmares, palpitations, paresthesia, restlessness, seizure, skin rash, tinnitus, urinary frequency, urinary retention, vomiting, weight gain, rheumatoid arthritis, stomatitis, stroke, tachycardia, tardive dyskinesia, testicular swelling, tremor, urticaria
Uncommon < 1%
•
Neuroleptic malignant syndrome
Unknown frequency
•
Cholestasis, serotonin syndrome, ↑QT interval, weight loss, memory impairment, myoclonus, parkinsonism, mania, nightmares, suicidal ideation, hallucinations, somnolence
Interactions
Drug(s)
Check Interactions
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