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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 disorder 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 under close 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.
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 should consult the laboratory professional staff.
Elderly: 30 to 50mg/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 as primary determinants of dosage changes. Renal impairment Renal failure does not affect kinetics of nortriptyline. This medicinal product can be given in usual doses to patients with renal failure.
and Section
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.
Close supervision of patients and in particular those at high risk should accompany drug therapy 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.
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 (SSRIs and SNRIs) have shown risk of suicidality, self- harm and hostility to be related to these compounds.
1. Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias. Severe hepatic impairment. 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 nonselective MAOIs and minimum one day after discontinuation of the reversible moclobemide. Treatment with MAOIs may be introduced 14 days after discontinuation of nortriptyline.
5.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatic impairment In case of reduced liver function careful dosing and, if possible, a serum level determination is advisable. 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.
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. The percentage of ‘poor metabolisers’ in a population is also affected by its ethnic origin.
4). Duration of treatment The antidepressant effect usually sets in after 2 - 4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time usually up to 6 months after recovery in order to prevent relapse.
Discontinuation of treatment When stopping therapy nortriptyline should be gradually withdrawn over several weeks. Method of administration For oral administration.
This risk cannot be excluded with nortriptyline. In addition nortriptyline is associated with a risk of cardiovascular adverse events in all age groups. Furthermore, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available.
) Withdrawal symptoms, including insomnia, irritability and excessive perspiration, may occur on abrupt cessation of therapy. The use of Nortriptyline in schizophrenic patients may result in an exacerbation of the psychosis or 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.
Patients with cardiovascular disease 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.
Great care is necessary if Nortriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. g. g. includes buprenorphine/ naloxone) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Cardiac arrhythmias are likely to occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. Unmasking of Brugada syndrome has been reported in patients treated with nortriptyline. Brugada syndrome is a rare hereditary disease of the cardiac sodium channel with characteristic ECG changes (ST segment elevation and T wave abnormalities in the right precordial leads), which may lead to cardiac arrest and/or sudden death.
Nortriptyline should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome. 9). Caution should be exercised when treating patients with advance liver disease. QT interval prolongation Cases of QT interval prolongation and arrhythmia have been reported during the postmarketing period.
Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QTprolonging drugs. Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) are known to be conditions increasing the proarrhythmic risk.
The use of Nortriptyline should be avoided, if possible, in patients with a history of epilepsy. If it is used, however, the patients should be observed carefully at the beginning of treatment, for Nortriptyline is known to lower the convulsive threshold.
The elderly are particularly liable to experience adverse reactions, especially agitation, confusion and postural hypotension. Troublesome hostility in a […]