See Supplemental Patient Information
- Worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior may occur in patients with MDD, irrespective of whether they are on antidepressants or not; this risk may persist until significant remission occurs
- Short-term placebo-controlled trials of antidepressant drugs indicated that children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders are at an increased risk of suicidality; the risk of suicidality did not increase in patients >24 yrs of age, and the risk decreased in patients >65 yrs of age [US Black Box Warning]
- Monitor these patients appropriately and observe them closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Anxiety, panic attacks, agitation, irritability, hostility, insomnia, aggressiveness, akathisia (psychomotor restlessness), impulsivity, hypomania, and mania have occurred in adult and pediatric patients receiving antidepressants for MDD and other psychiatric disorders
- Consider changing the therapeutic regimen or even discontinuation of therapy in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms suggestive of worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, and were not part of the patient's presenting symptoms
- Families and caregivers of patients treated with antidepressants should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality and other symptoms. Instruct them to promptly report such symptoms to healthcare providers. Prescribe the smallest quantity consistent with good patient management to reduce the risk of overdose
- A major depressive episode may be the initial presentation of bipolar disorder. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder prior to initiating treatment with an antidepressant, as treating with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder
- Protriptyline is not approved for use in treating bipolar depression
- Antidepressant therapy may produce troublesome patient hostility
- Protriptyline hydrochloride may block the antihypertensive action of guanethidine or similarly acting compounds
- Use with caution in patients with cardiovascular diseases because of the tendency of the drug to produce tachycardia, hypotension, arrhythmias, and prolonged conduction time
- Therapy may cause myocardial infarction and stroke
- Hyperthyroid patients or those receiving thyroid medication may develop arrhythmias when protriptyline is administered
- Protriptyline use in schizophrenic patients may cause an exacerbation of psychosis or may activate latent schizophrenic symptoms
- Therapy in manic-depressive patients may cause symptoms of the manic phase to emerge; paranoid delusions, with/without associated hostility, may be exaggerated. Increased anxiety and agitation may occur when given to overactive or agitated patients
- Concurrent administration of protriptyline and electroshock therapy may increase the hazards of therapy; limit the use to patients for whom it is essential. Discontinue the drug several days before elective surgery
- Both elevation as well as lowering of blood sugar levels have been reported during therapy
- Patients, their families and caregivers should be informed about the benefits and risks associated with protriptyline therapy and should be guided in its appropriate use
- Avoid administration of large doses in depressed patients
- Patients receiving protriptyline should be warned of the risks involved in performing hazardous tasks such as operating machinery or driving a car because the drug may impair the mental and/or physical abilities necessary for performing such tasks
Cautions: Use cautiously in
- Hepatic impairment
- Increased IOP
- History of urinary retention
- History of seizure disorder
- Suicide risk
- Alcohol abuse
- Concomitant use of quinidine
- GI/GU obstruction
- Prostatic hypertrophy
- Angle-closure glaucoma
- Diabetes mellitus
- Asthma
- Parkinson disease
- High environmental temperature
Supplemental Patient Information
- Patient's families and caregivers should be informed and instructed to be alert for the unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and during dose adjustment and immediately report such symptoms to the health professional
- Advise patients to refrain from hazardous activities requiring mental alertness such as operating a machinery or driving an automobile
- Patients should be advised to avoid excessive use of alcohol during the therapy
Pregnancy Category:C
Breastfeeding: Safety unknown. There is no published experience with protriptyline during breastfeeding; other agents may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 June 2011).
