Pamelor (Nortriptyline Hydrochloride) - Summary

PAMELOR SUMMARY

Pamelor^®
(nortriptyline HCl) capsules, USP
(nortriptyline HCl) oral solution, USP

Pamelor^® (nortriptyline HCl) is a tricyclic antidepressant.

Pamelor^® (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

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NEWS HIGHLIGHTS

Published Studies Related to Pamelor (Nortriptyline)

Nortriptyline for treating enuresis in ADHD--a randomized double-blind controlled clinical trial. [2012]
enuresis in children with ADHD... CONCLUSIONS: Administration of nortriptyline for treating enuresis in ADHD has

Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders. [2011.10.19]
A sizeable proportion of migraineurs in need of preventive therapy do not significantly benefit from monotherapy. The objective of the study is to conduct a randomized controlled trial testing whether combination therapy of topiramate and nortriptyline is useful in patients who had less than 50% decrease in headache frequency with the use of the single agents...

Melancholic, atypical and anxious depression subtypes and outcome of treatment with escitalopram and nortriptyline. [2011.07]
CONCLUSIONS: Melancholic, atypical or anxious depression, are not sufficiently robust differential predictors of outcome to help clinician choose between SSRI and tricyclic antidepressants. There is a need to investigate other predictors of outcome. Copyright (c) 2011 Elsevier B.V. All rights reserved.

Genetic variants in the serotonin transporter influence the efficacy of bupropion and nortriptyline in smoking cessation. [2011.06.09]
Aims We investigated whether variants in the serotonin transporter gene (SLC6A4) influence smoking cessation rates using antidepressant therapy (i.e.Prospective studies have to assess if this can improve cessation rates when treatment is targeted at individuals based on their genotypes.

A double-blind randomized controlled trial of low doses of propranolol, nortriptyline, and the combination of propranolol and nortriptyline for the preventive treatment of migraine. [2009.12]
Few trials have evaluated combination of two or more drugs in the preventive treatment of migraine. In this study three therapeutic regimens were compared: (a) propranolol, at a dose of 40 mg per day, (b) nortriptyline, at a dose of 20 mg per day, and (c) the combination of these two drugs in these dosages...

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Clinical Trials Related to Pamelor (Nortriptyline)

Nortriptyline for Idiopathic Gastroparesis [Recruiting]
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.

Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia [Recruiting]
The purpose of this study is to determine if use of Nortriptyline will improve symptoms and quality of life in patients who have nonulcer dyspepsia.

Preventing the Return of Depression in Elderly Patients [Completed]
The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant.

This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation [Completed]
Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.

Pain Treatment for Sciatica [Completed]
This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in treating other kinds of pain from nerve damage.

Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study.

Participants will provide a medical history and occupational and other social information. They will undergo a neurological examination, routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being.

This "cross-over" study consists of several parts, including a baseline study and four different treatment regimens. During each part, patients keep a daily log in which they rate their pain, record other procedures they undergo, such as injections and manipulations, and record medication side effects.

In the first week of the study, patients remain on their current medications. Any antidepressants or opioids are stopped gradually before starting the drug trials. After the first week, patients go through the following four drug trials in random order:

1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg. to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it looks like the test drug but has no active ingredient.)

2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30 mg. to 90 mg. and an inert placebo for nortriptyline.

3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone.

4. Active placebo and inactive placebo-Patients take an active placebo-in this case benztropine-and an inert placebo. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug-in this case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended dosage.

For each drug regimen, the medication dose is increased gradually over 5 weeks until the maximum tolerated dose is reached. At the end of each regimen, patients are taken off the study drugs over a 12-day tapering period and are off drugs completely for another 2 days.

Patients are seen by a doctor or nurse at the 7-week point in each study period. After all the drug trials are finished, patients repeat the questionnaires they filled out at the beginning of the study. Patients and their doctors will be informed of the medications that were effective in each individual's care.

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Reports of Suspected Pamelor (Nortriptyline) Side Effects

Drug Ineffective (16),  Weight Increased (8),  Thrombosis (7),  Headache (7),  Oedema Peripheral (7),  Rash (7),  Agitation (6),  Somnolence (6),  Fatigue (6),  Drug Hypersensitivity (6), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Pamelor review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		depression
Dosage & duration:		10-50mg taken daily for the period of 18 months
Other conditions:		facial nerve pain, migraines, upper back pain
Other drugs taken:		topamax (topiramate)
		Reported Results
Benefits:		This medication was greatly effective in alleviating my depression, more effective than SSRIs or SNRIs I have tried. Also, the effects did not seem to wear off with time (over the course of treatment, 9-12 months) which I experienced with celexa and effexor xr. The facial pain was also decreased, this medication is also used as a treatment for nerve pain.
Side effects:		One of the most unfortunate side effects of all tricyclic antidepressants for many people is weight gain. I was 'lucky' that I did not gain weight, but I was almost totally unable to lose weight despite diligent nutrition and exercise. The medication also increased my heart rate. I was unable to take it at night (which is the common prescribing practice) as the accelerated heart rate would keep me awake. Taking it in the AM seemed to work around this problem but may have caused some daytime fatigue/sleepiness (this is why is it usually prescribed to be taken at night).
Comments:		I began at 10mg then worked up to a 50mg dose. I had relatively good suppression of depressive symptoms at all doses, higher doses being better. The higher doses did not seem to increase the weight gain/heart rate side effects any more than the lower doses (as in non-dose-dependent effects).

Pamelor review by 44 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		musle relaxant
Dosage & duration:		40mg taken every night for the period of 5years
Other conditions:		generaly healthy
Other drugs taken:		nothing
		Reported Results
Benefits:		As I was able to relax my headache almost disappeared. The headache was due to stiff jaw syndrome. The symptoms should ease after two months but I feel relief the first day I start taking medicine. I was able to concentrate again and the most important I did not feel tired.
Side effects:		I felt sleepy. I put about 3kg weight. After 2 months side effects ease and then disappeared.
Comments:		take 40mg of the medicine every night before slip.