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Tofranil-PM (Imipramine Pamoate) - Summary

 
 



BOX WARNING

Suicidality and Antidepressant Drugs

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 imipramine pamoate 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. Imipramine pamoate is not approved for use in pediatric patients ( see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use ).

 

TOFRANIL-PM SUMMARY

Tofranil-PM (imipramine pamoate capsules), is a tricyclic antidepressant, available as capsules for oral administration. The 75-, 100-, 125-, and 150-mg capsules contain imipramine pamoate equivalent to 75, 100, 125, and 150 mg of imipramine hydrochloride.

Tofranil-PM (imipramine) is indicated for the following:

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.


See all Tofranil-PM indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tofranil-PM (Imipramine)

Activating neurons that trigger depression could help treat it, study suggests
Source: Anxiety / Stress News From Medical News Today [2014.04.19]
Researchers from the Icahn School of Medicine at Mount Sinai found that activating neurons linked to stress-induced depression may actually increase resilience to the condition.

Stroke Rounds: Depression Tied to Worse Stroke Outcomes (CME/CE)
Source: MedPage Today Cardiovascular [2014.04.17]
(MedPage Today) -- Depression was found to be a significant and independent risk factor for poor stroke outcomes in a study from the U.K., and recovery from depression within a year did not alter long-term risk.

Symptoms of depression surge in young men during early fatherhood
Source: Depression News From Medical News Today [2014.04.16]
Depression can hit young fathers hard -- with symptoms increasing dramatically during some of the most important years of their children's lives, a new Northwestern MedicineR study has found.

Study: When depression does not respond to treatment
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2014.04.15]
Notwithstanding numerous advances in the pharmacological treatment of depression, approximately 70% of patients do not remit after first-line antidepressant treatment.

Preschool Depression Strong Predictor of Later MDD
Source: Medscape Psychiatry & Mental Health Headlines [2014.04.14]
Preschoolers with depressive syndrome run a significantly increased risk for major depression later in childhood.
Medscape Medical News

more news >>

Published Studies Related to Tofranil-PM (Imipramine)

Comparison between imipramine and imipramine combined with pseudoephedrine in 5-12-year-old children with uncomplicated enuresis: a double-blind clinical trial. [2011.02]
OBJECTIVE: Monosymptomatic nocturnal enuresis is a common entity, with a prevalence of 10% at the age of 7 years. For its primary treatment, we compared the effect of combination medical therapy (imipramine with pseudoephedrine) with imipramine alone... CONCLUSION: The additive pharmacologic effects of imipramine with pseudoephedrine for the treatment of monosymptomatic nocturnal enuresis in children were well tolerated, and gave significantly faster results than single drug therapy using imipramine. The moderate-to-high recurrence rate following discontinuation of medical treatment indicates the need for a longer term study involving more cases. Crown Copyright (c) 2010. Published by Elsevier Ltd. All rights reserved.

Comparison between imipramine and imipramine combined with pseudoephedrine in 5-12-year-old children with uncomplicated enuresis: a double-blind clinical trial. [2011]
imipramine alone... CONCLUSION: The additive pharmacologic effects of imipramine with pseudoephedrine

Serum zinc level in depressed patients during zinc supplementation of imipramine treatment. [2010.11]
BACKGROUND: Recurrent major depression is associated with decreased blood zinc concentrations that may be increased by effective antidepressant therapy. Some clinical investigations point to alterations of the zinc level in blood as a potential marker of depression... CONCLUSIONS: Serum zinc is a state marker of depression. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Low-dose gabapentin as useful adjuvant to opioids for neuropathic cancer pain when combined with low-dose imipramine. [2010.06]
PURPOSE: Painful neuropathic conditions of cancer pain often show little response to nonopioid and opioid analgesics but may be eased by antidepressants and anticonvulsants. Although gabapentin is effective in the treatment of neuropathic pain in patients with cancer, some patients experience intolerable side effects sufficient to warrant discontinuation. The aim of this study was to see whether low-dose gabapentin is effective in treating cancer-related neuropathic pain when combined with low-dose imipramine... CONCLUSION: Low-dose gabapentin-antidepressant combination with opioids was effective in managing neuropathic cancer pain without severe adverse effects.

Treatment of unipolar psychotic depression: a randomized, double-blind study comparing imipramine, venlafaxine, and venlafaxine plus quetiapine. [2010.03]
CONCLUSION: That unipolar psychotic depression should be treated with a combination of an antidepressant and an antipsychotic and not with an antidepressant alone, can be considered evidence based with regard to venlafaxine-quetiapine vs. venlafaxine monotherapy. Whether this is also the case for imipramine monotherapy is likely, but cannot be concluded from the data.

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Clinical Trials Related to Tofranil-PM (Imipramine)

Imipramine and Pregabalin Combination in Painful Polyneuropathy [Not yet recruiting]
Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.

Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome [Recruiting]
The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in patients with longlasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing both pain and other symptoms of bodily distress for patients with BDS. Control conditions are pill placebo. Study duration is 19 weeks for each of the 140 patients.

The Efficacy of Imipramine in Treatment of Functional Dyspepsia [Recruiting]
The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in treatment of functional dyspepsia. This is a double blind randomised placebo controlled trial in which consecutive patients with diagnosis of functional dyspepsia will be studied. After exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be evaluated for treatment response, which is defined as satisfactory relief of dyspeptic symptoms at the end of 12-week treatment.

Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn [Recruiting]
Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown

Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio) [Recruiting]
Drug therapy in patients with chronic low back pain is a major challenge for physicians. One of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient. Usually one of the classes of pain medication is given to patients with a similar clinical picture, although different pain mechanisms may be responsible for this clinical picture.

Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason why an unique drug produces different responses (from a lacking analgesic effect up to excessive effect or side-effects.

Quantitative sensory testing is a method that documents alterations in the pain perception system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for anticipation of drug efficacy.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Tofranil-PM has an overall score of 9. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Tofranil-PM review by 31 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   panic attacks
Dosage & duration:   25mg taken 1 daily for the period of 3 years
Other conditions:   tachycardia
Other drugs taken:   propranolol
  
Reported Results
Benefits:   After 2-3 weeks complete abatement of panic attack symptoms. After one year tried to stop taking them but within 3 weeks symptoms were back. continued for two more years and stopped taking them. Have not had any symptoms for @10 years now
Side effects:   hyperactivity for up to 8 hrs after taking.
Comments:   started at 5 mg then increased every 5-7 days up to 25 mg. Hyperactivity decreased with longer treatment

See all Tofranil-PM reviews / ratings >>

Page last updated: 2014-04-19

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