This brand name drug is no longer available in the US generic versions are available.

Indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

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. 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.

This drug is not recommended for use during the acute recovery phase following myocardial infarction.

It should be noted that amitriptyline hydrochloride tablets are not approved for use in treating bipolar depression.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

It should be used with caution in patients with a history of seizures and, because of its atropine-like action, in patients with a history of urinary retention, angle-closure glaucoma or increased intraocular pressure. In patients with angle-closure glaucoma, even average doses may precipitate an attack.

Geriatric patients are particularly sensitive to the anticholinergic side effects of tricyclic antidepressants including amitriptyline hydrochloride. Peripheral anticholinergic effects include tachycardia, urinary retention, constipation, dry mouth, blurred vision, and exacerbation of narrow angle glaucoma. Central nervous system anticholinergic effects include cognitive impairment, psychomotor slowing, confusion, sedation, and delirium. Elderly patients taking amitriptyline hydrochloride may be at increased risk for falls.

Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, including amitriptyline hydrochloride, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. Myocardial infarction and stroke have been reported with drugs of this class.

Both elevation and lowering of blood sugar levels have been reported.

Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.

The pupillary dilation that occurs following use of many antidepressant drugs including amitriptyline hydrochloride tablets may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

While on therapy with amitriptyline hydrochloride, patients should be advised to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

ELAVIL should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously When it is desired to replace a monoamine oxidase inhibitor with ELAVIL, a minimum of 14 days should be allowed to elapse after the former is discontinued. ELAVIL should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

When possible, the drug should be discontinued several days before elective surgery.

Amitriptyline hydrochloride may block the antihypertensive action of guanethidine or similarly acting compounds.

ELAVIL should not be given with Cisapride due to the potential for increased QT interval and increased risk for arrhythmia.

Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient’s clinical response and not on the basis of plasma levels.

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.

An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide).

While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Hyperpyrexia has been reported when amitriptyline hydrochloride is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs.

Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 mg to 150 mg of amitriptyline hydrochloride.

Close supervision is required when amitriptyline hydrochloride is given to hyperthyroid patients or those receiving thyroid medication.

Amitriptyline has been shown to cross the placenta. Although a causal relationship has not been established, there have been a few reports of adverse events, including CNS effects, limb deformities, or developmental delay in infants whose mothers had taken amitriptyline during pregnancy.

Because of the potential for serious adverse reactions in nursing infants from amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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• Adult dosage for outpatients greater than 150 mg per day. GoToSource

• Preventing syncopal episodes. GoToSource

• Parkinson’s disease. GoToSource

• Chronic tension type headache. GoToSource

• Prophylactic treatment for migraines. GoToSource

• Irritable bowel syndrome. GoToSource

• Gastrointestinal pain disorders including refractory functional dyspepsia. GoToSource

• Interstitial cystitis. GoToSource

• Chronic pain caused by temporomandibular joint disorders. GoToSource

• Vulvodynia. GoToSource

• Juvenile idiopathic arthritis. GoToSource

• Somatoform pain disorder. GoToSource

• Peripheral neuropathy. GoToSource

• Chronic cough resulting from post viral vagal neuropathy. GoToSource

• Fibromyalgia. GoToSource

• Multiple sclerosis, chronic fatigue syndrome and amyotrophic lateral sclerosis. GoToSource

• Borderline personality disorder. GoToSource

• Arthritic pain. GoToSource

• Chronic pruritus. GoToSource

• Bulimia nervosa. GoToSource

• Anxiety disorder. GoToSource

• Panic disorder. GoToSource

• Post-traumatic stress disorder. GoToSource

• Insomnia. GoToSource

• Attention deficit hyperactivity disorder. GoToSource

• Drug-induced headache. GoToSource

• Depressed phase of bipolar affective disorder. GoToSource

• Use in patients under the age of 12. GoToSource

• Cyclic vomiting syndrome. GoToSource

• Cystic fibrosis. GoToSource

• Alcohol abuse/dependence. GoToSource

Suicidal ideation and behavior (suicidality). GoToSource

Orthostatic hypotension. GoToSource

Constipation. GoToSource

Reduced brain function and death in elderly patients. GoToSource

Liver injury. GoToSource

Seizures. GoToSource

Preeclampsia. GoToSource

Restless legs syndrome. GoToSource

Impaired gallbladder emptying. GoToSource

Hyponatremia. GoToSource

Weight gain and increased risk of diabetes. GoToSource

Increased risk of fractures and falls. GoToSource

Tinnitus. GoToSource

Venous thromboembolism. GoToSource 

Sexual dysfunction. GoToSource

Cardiac arrhythmias, sinus tachycardia and myocardial infarctions. GoToSource

Lawsuits filed for reduced brain function and death in elderly patients and suicide.