Source: Health Products and Food Branch (CA) Revision Year: 2018
ELAVIL (amitriptyline hydrochloride) is indicated in the drug management of depressive illness.
ELAVIL may be used in depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression. Endogenous depression is more likely to be alleviated than are other depressive states. ELAVIL , because of its sedative action, is also of value in alleviating the anxiety component of depression.
As with other tricyclic antidepressants, ELAVIL may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions.
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
Outpatient Adults: The recommended initial dose for ambulatory patients is 25 mg 3 times a day. Depending upon tolerance and response, this may be increased to a total of 150 mg a day. Increases are made preferably in the late afternoon and/or bedtime doses. The sedative effect is usually rapidly apparent. The antidepressant activity may be evident within 3 or 4 days or may take up to 30 days to develop adequately.
Hospitalized Patients: Severely ill or 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.
Pediatric Patients: The use of amitriptyline in pediatric patients is not recommended (see WARNINGS, Pediatrics).
Adolescent and Elderly Patients: When considering the use of amitriptyline in adolescent or elderly patients, the potential risks must be balanced with clinical need (see WARNINGS). In general, lower dosages are recommended for these patients. In those patients who may not tolerate higher doses, 50 mg daily may be satisfactory. The dose may be administered in divided doses or as a single dose preferably in the evening or at bedtime.
Maintenance: When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. The usual maintenance dose is 50 to 100 mg/day in divided doses; however, in suitable patients, the total daily dosage may be given in a single dose, preferably at bedtime. It is appropriate to continue maintenance therapy throughout the active phase of the depression and for the expected duration of the depressive episode, in order to lessen the possibility of relapse.
Plasma Levels: Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or non-compliance is suspected. Adjustments in dosage should be made according to the patient’s clinical response and not on the basis of plasma levels.
High doses may cause temporary confusion, disturbed concentration, or transient visual hallucinations. Overdosage may cause drowsiness, hypothermia, tachycardia and other arrhythmic abnormalities, such as bundle branch block, ECG evidence of impaired conduction, congestive heart failure, disorders of ocular motility, convulsions, severe hypotension, stupor, coma, polyradiculoneuropathy and constipation. Other symptoms may be agitation, hyperactive reflexes, muscle rigidity, vomiting, hyperpyrexia, or any of those listed under ADVERSE REACTIONS. Symptoms of overdose may vary in severity depending on various factors such as the amount of drug absorbed, the interval between drug ingestion and start of treatment, and the age of the patient.
In patients with glaucoma, even average doses may precipitate an attack.
For the most current information for management of a suspected overdose, contact your regional Poison Control Center.
Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.
In managing overdose, consider the possibility of multiple drug overdose, interactions among drugs, and unusual drug kinetics.
Treatment is symptomatic and supportive. Cardiac arrhythmias and CNS involvement pose the greatest threat and may occur suddenly even when initial symptoms appear to be mild. Therefore, patients who may have ingested an overdosage of amitriptyline, particularly children, should be hospitalized and kept under close surveillance.
Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during the period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose (see WARNINGS); these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.
EMESIS IS CONTRAINDICATED. All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include, large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage.
A maximal limb lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH >7.60 or a pCO <20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine or bretylium. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide and procainamide and flecainide).
In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.
In patients with CNS depression early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin).
Store at room temperature (15°C to 30°C). Keep in a tightly closed container.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
