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NORTRIPTYLINE is a brand name for Nortriptyline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nortriptyline is indicated for the treatment of Major Depressive Episodes in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
The usual adult dose is 25mg three or four times daily. Dosage should begin at a low level and be increased as required. Alternatively, the total daily dose may be given once a day. When doses above 100mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150ng/ml.
Doses above 150mg per day are not recommended. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalised patients who will be underclose supervision.
The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor side-effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. Elderly: 30 to 50 mg/day in divided doses. Dosage should begin at a low level (10 – 20 mg daily) and be increased as required to the maximum dose of 50mg.
If it is considered necessary to use higher dosing in an elderly patient an ECG should be checked and plasma levels of nortriptyline should be monitored. Older patients have been reported to have higher plasma concentrations of the active nortriptyline metabolite 10-hydroxynortriptyline.
In one case, this was associated with apparent cardiotoxicity, despite the fact that nortriptyline concentrations were within the ‘therapeutic range’. Clinical findings should predominate over plasma concentrations asprimary determinants of dosage changes.
Plasma levels:
Optimal responses to nortriptyline have been associated with plasma concentrations of 50 to 150ng/ml. Higher concentrations may be associated with more adverse experiences. Plasma concentrations are difficult to measure, and physicians shouldconsult the laboratory professional staff.
Cytochrome P450 isoenzyme CYP2D6 and poor metabolisers Many antidepressants (tricyclic antidepressants, including nortriptyline, selective serotonin re-uptake inhibitors and others) are metabolised by the hepatic cytochrome P450 isoenzyme P450IID6.
and Section
Paediatric population Use in children and adolescents under the age of 18 Nortriptyline should not be used in the treatment of depression in children and adolescents under the age of 18 years. Studies in depression of this age group did not show a beneficial effect for class of tricyclic antidepressants.
Studies with other classes of antidepressants (SSRI’s and SNRI’s) have shown risk of suicidality, selfharm and hostility to be related to these compounds. This risk cannot be excluded with nortriptyline. In addition, nortriptyline is associated with a risk of cardiovascular adverse events in all age groups.
) Warnings: As improvement may not occur during the initial weeks of therapy, patients, especially those posing a high suicidal risk, should be closely monitored during this period. Suicide/suicidal thoughts or clinical worsening. Depression is associated with an increased risk of suicidal thoughts, Self-harm and suicide (suicide-related events).
This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta- analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
1. Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contraindicated. Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and coronary artery insufficiency. Severe liver disease. Mania.
5). Simultaneous administration of nortriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion,tremor, myoclonus and hyperthermia). Treatment with nortriptyline may be instituted 14 days after discontinuation of irreversible non-selective MAOIs and minimum one day after discontinuation of thereversible moclobemide.
Treatment with MAOIs may be introduced 14 days after discontinuation of nortriptyline.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nortriptyline in United Kingdom.
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Three to ten per cent of the population have reduced isoenzyme activity (‘poor metabolisers’) and may have higher than expected plasma concentrations at usual doses. Thepercentage of ‘poor metabolisers’ in a population is also affected by its ethnic origin.
5 Interactions with other Medicinal products and other forms of Interaction”) Renal failure does not affect the kinetics of nortriptyline.
Duration of treatment:
The antidepressive effect usually sets in after 2-4 weeks. Treatment with antidepressants is symptomatic and should therefore be continued for a sufficient period of time, usually 6 months or longer to prevent recurrence.
Discontinuation:
Treatment should be discontinued gradually, otherwise withdrawal symptoms as headache, sleep disturbances, irritability and malaise could develop. These symptoms are not indicative of addiction. 4). Method of administration For oral administration.
Withdrawal symptoms, including insomnia, irritability, nausea, headache and excessive perspiration, may occur on abrupt cessation of therapy. The use of nortriptyline in schizophrenic patients may result in an exacerbation of the psychosisor may activate latent schizophrenic symptoms.
If administered to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, nortriptyline may cause symptoms of the manic phase to emerge. Cross sensitivity between nortriptyline and other tricyclic antidepressants is a possibility.
Caution should be exercised when treating patients with advanced liver disease. Patients with cardiovascular disease or hypotension should be given nortriptyline only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time.
Myocardial infarction, arrhythmia and strokes have occurred. Arrhythmia and hypotension can occur in patients without prior risk, especially when high doses are prescribed. Therefore patients who receive high doses should be followed up for arrhythmias and hypotension.
Great care is necessary if nortriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Cardiac arrhythmias and severe hypotension are likely to occur with high dosage.
They may alsooccur in patients with pre-existing heart disease taking normal dosage. QT interval prolongation Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period. Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs.
Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) are known to be conditions increasing the proarrythmic risk. Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension.
If possible, discontinue this medicinal product several days beforesurgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated. Great care is necessary if amitriptyline is administered to hyperthyroid patients or to thosereceiving thyroid medication, since cardiac arrhythmias may develop.
Elderly patients are particularly susceptible to orthostatic hypotension. This medical product should be used with caution in patients with convulsive disorders, urinaryretention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus.
In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked. In manic-depressives, a shift towards the manic phase may occur; should the patient enter amanic phase amitriptyline should be discontinued.
As described for other psychotropics, amitriptyline may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients; in addition the depressiveillness itself may affect patients’ glucose balance.
Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather. 5). Serotonin syndrome Concomitant administration of Nortriptyline and buprenorphine containing medicinal […]