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Amitriptyline
Medical Information
Triazolopyridine derivative
Trazodone (Desyrel)
Selective Serotonin Reuptake Inhibitors (SSRIs)
Celexa (Citalopram)
Lexapro (Escitalopram)
Paxil (Paroxetine)
Prozac (Fluoxetine)
Zoloft (Sertraline)
Norepinephrine and dopamine reuptake inhibitors (NDRIs)
Wellbutrin (Bupropion)
Serotonin and norepinephrine reuptake inhibitors (SNRIs)
Cymbalta (Duloxetine)
Effexor XR (Venlafaxine)
Miscellaneous Anxiolytics
Buspar (Buspirone)
Tricyclic Antidepressants
Amitriptyline (Elavil)

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Common Brand Name: Elavil

Generic Name: Amitriptyline HCL

The following product information is not intended to replace the physician's or manufacturer's instructions.

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Common medical uses:
Amitriptyline is in a class of drugs called tricyclic antidepressants. Amitriptyline is used to treat depression, obsessive - compulsive disorders, and bed-wetting in children over 6 years of age (enuresis). This medication also may be used to treat chronic pain and eating disorders. Amitriptyline helps treat depression by moderating certain chemicals in the brain (like serotonin and norepinephrine) that are responsible for mood. This medication is sometimes prescribed for other uses.

Amitriptyline dosage:
Depression: Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of adverse effects.

Initial Dosage For Adults: For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.

An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.

Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

Adolescent and Elderly Patients: In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

Maintenance: The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.

Usage in pediatric patients: Amitriptyline is not FDA-approved for use in children <12 years of age.

Amitriptyline is not FDA approved for the treatment of bipolar depression.

Amitriptyline dosage for unlabeled uses:

Pain management (unlabeled): 10 to 25 mg at bedtime or 2 to 3 hours before bedtime, may increase as tolerated to 100 mg/day [2].

Fibromyalgia (unlabeled): 25 mg before bedtime [3].

Migraine prophylaxis (unlabeled): initial dose 10 to 25 mg at bedtime; usual dose 150 mg

Amitriptyline side effects:
Side effects from this drug are common. It may cause:

  • Anticholinergic effects: paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth.
  • Allergic: skin rash; urticaria; photosensitization; edema of face and tongue.
  • Cardiovascular: orthostatic hypotension, tachycardia, ECG changes (nonspecific), AV conduction changes, cardiomyopathy (rare), MI, stroke, heart block, arrhythmia, syncope, hypertension, palpitation
  • Central nervous system: restlessness, dizziness, insomnia, sedation, fatigue, anxiety, cognitive function impaired, seizure, extrapyramidal symptoms, coma, hallucinations, confusion, disorientation, coordination impaired, ataxia, headache, nightmares, hyperpyrexia
  • Dermatologic: allergic rash, urticaria, photosensitivity, alopecia
  • Endocrine & metabolic: syndrome of inappropriate ADH secretion
  • Gastrointestinal: weight gain, xerostomia, constipation, paralytic ileus, nausea, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, black tongue
  • Genitourinary: urinary retention
  • Hematologic: bone marrow depression, purpura, eosinophilia
  • Neuromuscular & skeletal: numbness, paresthesia, peripheral neuropathy, tremor, weakness
  • Ocular: blurred vision, mydriasis, ocular pressure increased
  • Otic: tinnitus
  • Miscellaneous: diaphoresis, withdrawal reactions (nausea, headache, malaise)
  • Postmarketing and/or case reports: neuroleptic malignant syndrome (rare), serotonin syndrome (rare)

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.

Pregnancy & Lactation:

Pregnancy Risk: C. Amitriptyline crosses the human placenta. CNS effects, limb deformities and developmental delay have been noted in case reports.

Lactation. Amitriptyline enters breast milk. Generally, it is not recommended to breast-feed if taking antidepressants because of the long half-life, active metabolites, and the potential for side effects in the infant.

Amitriptyline precautions:
Before using Amitriptyline HCL tell your doctor what prescription and nonprescription medications you are taking. Tell your doctor your medical history: enlarged prostate, glaucoma, difficulty urinating, thyroid disease, breathing problems, seizure problems, alcohol use, mental or emotional problems, liver, kidney, or heart disease, any drug allergies. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Amitriptyline HCL should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. You should know that Amitriptyline HCl may cause dizziness or drowsiness. Do not drive a car or operate machinery until you know how this medication affects you. Avoid alcoholic beverages, because alcohol can add to the drowsiness caused by this drug. Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.

Amitriptyline drug interactions:
Many drugs can interact with Amitriptyline HCL, resulting in side effects or decreased effectiveness of the medication. Inform your doctor what prescription and nonprescription medicines you take.
Drugs that may interact with Amitriptyline HCL include:

  • Altretamine: Concurrent use may cause orthostatic hypertension.
  • Amphetamines: TCAs may enhance the effect of amphetamines; monitor for adverse CV effects.
  • Anticholinergics: Combined use with TCAs may produce additive anticholinergic effects.
  • Antihypertensives: Amitriptyline inhibits the antihypertensive response to bethanidine, clonidine, debrisoquin, guanadrel, guanethidine, guanabenz, guanfacine; monitor BP; consider alternate antihypertensive agent.
  • Beta-agonists: When combined with TCAs may predispose patients to cardiac arrhythmias.
  • Bupropion: May increase the levels of tricyclic antidepressants; based on limited information, monitor response.
  • Carbamazepine: Tricyclic antidepressants may increase carbamazepine levels; monitor.
  • Cholestyramine and colestipol: May bind TCAs and reduce their absorption; monitor for altered response.
  • Cisapride: May increase the risk of QTc prolongation and/or arrhythmia; concurrent use is contraindicated.
  • Clonidine: Abrupt discontinuation of clonidine may cause hypertensive crisis; amitriptyline may enhance the response (also see note on antihypertensives).
  • CNS depressants: Sedative effects may be additive with TCAs; monitor for increased effect; includes benzodiazepines, barbiturates, antipsychotics, ethanol, and other sedative medications.
  • CYP2D6 inhibitors: May increase the levels/effects of amitriptyline; example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.
  • Epinephrine (and other direct alpha-agonists): Pressor response to I.V. epinephrine, norepinephrine, and phenylephrine may be enhanced in patients receiving TCAs.
  • Fenfluramine: May increase tricyclic antidepressant levels/effects.
  • Hypoglycemic agents (including insulin): TCAs may enhance the hypoglycemic effects of tolazamide, chlorpropamide, or insulin; monitor for changes in blood glucose levels; reported with chlorpropamide, tolazamide, and insulin.
  • Levodopa: Tricyclic antidepressants may decrease the absorption (bioavailability) of levodopa; rare hypertensive episodes have also been attributed to this combination.
  • Linezolid: Hyperpyrexia, hypertension, tachycardia, confusion, seizures, and deaths have been reported with agents which inhibit MAO (serotonin syndrome); this combination should be avoided.
  • Lithium: Concurrent use with a TCA may increase the risk for neurotoxicity.
  • MAO inhibitors: Hyperpyrexia, hypertension, tachycardia, confusion, seizures, and deaths have been reported (serotonin syndrome); this combination should be avoided.
  • Methylphenidate: Metabolism of amitriptyline may be decreased.
  • Phenothiazines: Serum concentrations of some TCAs may be increased; in addition, TCAs may increase concentration of phenothiazines; monitor for altered clinical response.
  • QTc prolonging agents: Concurrent use of tricyclic agents with other drugs which may prolong QTc interval may increase the risk of potentially fatal arrhythmias; includes type Ia and type III antiarrhythmics agents, selected quinolones (sparfloxacin, gatifloxacin, moxifloxacin, grepafloxacin), cisapride, and other agents.
  • Ritonavir: Combined use of high-dose tricyclic antidepressants with ritonavir may cause serotonin syndrome in HIV-positive patients; monitor.
  • Sucralfate: Absorption of tricyclic antidepressants may be reduced with coadministration.
  • Sympathomimetics, indirect-acting: Tricyclic antidepressants may result in a decreased sensitivity to indirect-acting sympathomimetics; includes dopamine and ephedrine; also see interaction with epinephrine (and direct-acting sympathomimetics).
  • Tramadol: Tramadol's risk of seizures may be increased with TCAs.
  • Valproic acid: May increase serum concentrations/adverse effects of some tricyclic antidepressants.
  • Warfarin (and other oral anticoagulants): Amitriptyline may increase the anticoagulant effect in patients stabilized on warfarin; monitor INR.

Missed dose:
If you take several doses per day, do not take it if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. If you take Amitriptyline HCl once a day at bedtime, and do not remember to take it until the next morning, skip the missed dose. Do not double the dose to catch up.

Overdose:
Symptoms of overdose include agitation, confusion, hallucinations, urinary retention, hypothermia, hypotension, ventricular tachycardia, and seizures. Treatment is symptomatic and supportive. Alkalinization by sodium bicarbonate and/or hyperventilation may limit cardiac toxicity.

Storage:
Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze liquid forms of Amitriptyline HCL. Do not allow anyone else to use Amitriptyline HCL.

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References:

  • 1. U.S. Food and Drug Administration. Amitriptyline U.S. Prescribing Information
  • 2. McQuay HJ, Carroll D, Glynn CJ. Low dose amitriptyline in the treatment of chronic pain. Anaesthesia. 1992 Aug;47(8):646-52. PubMed
  • 3. Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986 Nov;29(11):1371-7. PubMed


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