Protriptyline

Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors.

• Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.

• Protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with a monoamine oxidase inhibiting compound.contraindicated

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Usual Adult Dosage Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg. When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms. Minor adverse reactions require reduction in dosage. Major adverse reactions or evidence of hypersensitivity require prompt discontinuation of the drug. The safety and effectiveness of protriptyline in pediatric patients have not been established.

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents and young adults (aged 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analysis of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders including a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.

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, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when protriptyline is administered. Protriptyline is more likely to aggravate agitation and anxiety and produce cardiovascular reactions such as tachycardia and hypotension. Cardiovascular: Myocardial infarction; stroke; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; hypertension; tachycardia; palpitation. Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation; hypomania; exacerbation of psychosis; insomnia, panic, and nightmares. Neurological: Seizures; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of extremities; extrapyramidal symptoms; drowsiness; dizziness; weakness and fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic: Paralytic ileus; hyperpyrexia; urinary retention, delayed micturition, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased intraocular pressure, mydriasis; dry mouth and rarely associated sublingual adenitis.

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As management of overdose 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. MANIFESTATIONS Critical manifestations of overdosage include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS . MANAGEMENT General Obtain an ECG and immediately initiate cardiac monitoring.

• May 3, 2010ANDAANDA090462Sigmapharm Labs Llc
• Nov 19, 2012ANDAANDA202220Epic Pharma Llc

1. 1Fall1213%
2. 2Intentional Product Use Issue1010%
3. 3Product Administration Interrupted88.3%
4. 4Sleep Apnoea Syndrome88.3%
5. 5Anxiety77.3%
6. 6Wrong Technique In Product Usage Process77.3%
7. 7Depression66.3%
8. 8Dizziness66.3%
9. 9Blood Pressure Increased55.2%
10. 10Covid-1955.2%
11. 11Hypertension55.2%
12. 12Illness55.2%
13. 13Weight Increased55.2%
14. 14Abdominal Discomfort44.2%
15. 15Dyspnoea44.2%

Recent PubMed references pinned to Protriptyline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Protriptyline improves spatial memory and reduces oxidative damage by regulating NFκB-BDNF/CREB signaling axis in streptozotocin-induced rat model of Alzheimer's disease.
  Brain research · 2021 · Tiwari V, Mishra A, Singh S, et al.
  PMID 33422534DOI 10.1016/j.brainres.2020.147261
• Protriptyline, a tricyclic antidepressant, inhibits voltage-dependent K+ channels in rabbit coronary arterial smooth muscle cells.
  Acta biochimica et biophysica Sinica · 2020 · An JR, Kang H, Li H, et al.
  PMID 32060505DOI 10.1093/abbs/gmz159
• Effect of Protriptyline on [Ca²⁺]i and Viability in MDCK Renal Tubular Cells.
  The Chinese journal of physiology · 2017 · Cheng HH, Chou CT, Liang WZ, et al.
  PMID 28468029DOI 10.4077/CJP.2017.BAF459
• Effect of protriptyline on [Ca(2+)](i) and viability in MG63 human osteosarcoma cells.
  Toxicology mechanisms and methods · 2016 · Su CK, Chou CT, Lin KL, et al.
  PMID 27790936DOI 10.1080/15376516.2016.1216208
• Ca(2+) Signaling and Cell Death Induced by Protriptyline in HepG2 Human Hepatoma Cells.
  Journal of biochemical and molecular toxicology · 2016 · Wang JL, Chou CT, Liu K, et al.
  PMID 27252039DOI 10.1002/jbt.21820
• The mechanism of protriptyline-induced Ca2+ movement and non-Ca2+-triggered cell death in PC3 human prostate cancer cells.
  Journal of receptor and signal transduction research · 2015 · Chang HT, Chou CT, Yu CC, et al.
  PMID 26096164DOI 10.3109/10799893.2014.1000464
• Molecular investigations of protriptyline as a multi-target directed ligand in Alzheimer's disease.
  PloS one · 2014 · Bansode SB, Jana AK, Batkulwar KB, et al.
  PMID 25141174DOI 10.1371/journal.pone.0105196
• Protriptyline block of the human ether-à-go-go-related gene (HERG) K+ channel.
  Life sciences · 2008 · Jo SH, Hong HK, Chong SH, et al.
  PMID 18191158DOI 10.1016/j.lfs.2007.12.004

The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Protriptyline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
  Completed · Interventional · 38 enrolled · Roxane Laboratories
  NCT00754962updated 2018-01-23
• Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism
  Completed · Phase 4 · Interventional · 27 enrolled · University of Ottawa
  NCT00704860updated 2011-01-19

CPIC-curated drug–gene pairs for Protriptyline. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2D6CPIC B/C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Protriptyline work?

Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors.

What is Protriptyline used for?

According to FDA labeling, Protriptyline carries indications including: Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Protriptyline?

Protriptyline is classified as Non-selective monoamine reuptake inhibitors, Tricyclic Antidepressant, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors, Decreased Serotonin Degradation, Increased Central Nervous System Norepinephrine Activity.

What are the contraindications for Protriptyline?

Protriptyline labeling lists contraindications including: Protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with a monoamine oxidase inhibiting compound.. Always consult the full prescribing information and a clinician.