Amitriptyline Hydrochloride — Active Pharmaceutical Ingredient

Amitriptyline Hydrochloride is an active pharmaceutical ingredient found in 18 FDA-approved drug products. Forms: TABLET, CONCENTRATE, INJECTABLE. Routes: ORAL, INJECTION.

This content is for informational purposes only. Always consult a healthcare professional.

Amitriptyline Hydrochloride (18 brand names, 3 dosage forms, 2 routes)

Available dosage forms: TABLET, CONCENTRATE, INJECTABLE.

Routes of administration: ORAL, INJECTION.

Brand Names

  • AMITID
  • AMITRIL
  • AMITRIPTYLINE HYDROCHLORIDE
  • CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
  • ELAVIL
  • ENDEP
  • ETRAFON 2-10
  • ETRAFON 2-25
  • ETRAFON-A
  • ETRAFON-FORTE
  • LIMBITROL
  • LIMBITROL DS
  • PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
  • TRIAVIL 2-10
  • TRIAVIL 2-25
  • TRIAVIL 4-10
  • TRIAVIL 4-25
  • TRIAVIL 4-50

Boxed Warning

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. Anyone considering the use of amitriptyline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amitriptyline hydrochloride tablets are not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).

Indications and Usage

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

Contraindications

Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It 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 amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarction.

Adverse Reactions

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.

Drug Interactions

Topiramate 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.

Overdosage

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose, As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.