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NORTRIPTYLINE COLONIS 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 for example 10mg three to four times daily and be increased as required. Alternatively, the total daily dose may be given once a day, usually given at night.
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.
Note:
For doses over 20mg, Nortriptyline Colonis 25mg/5ml Oral Solution should be used. 2). 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.
The 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.
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.
In the listing below the following convention is used:
MedDRA system organ class / preferred term Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
g. 4) Withdrawal symptoms: Abrupt cessation of treatment after prolonged therapy may produce nausea, headache and malaise.
Class Effects:
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRs and TCAs. The mechanism leading to this risk is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
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. 3). 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.
1. Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and coronary artery insufficiency. 5). Severe liver disease Mania Nortriptyline is contraindicated for the nursing mother and for children under the age of six years.
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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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. 2). Reduced renal function Renal failure does not affect kinetics of nortriptyline.
This medicinal product can be given in usual doses to patients with renal failure. Reduced hepatic function In case of reduced liver function careful dosing and, if possible, a serum level determination is advisable. 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. A double-ended dosing spoon is provided with the product. 5 ml dose and the larger spoon measures 5 ml.
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. Cardiac arrhythmias are likely to occur with high dosage.
They may also occur 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 proarrhythmic risk. 5). If concomitant treatment with buprenorphine and 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.
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 patient may be aroused by the use of nortriptyline. If possible, the use of nortriptyline should be avoided in patients with narrow angle glaucoma or symptoms suggestive of prostatic hypertrophy.
The possibility of a suicide attempt by a depressed patient remains after the initiation of treatment. This possibility should be considered in relation to the quantity of drug dispensed at any one time. When it is essential, nortriptyline may be administered with electroconvulsive therapy, although the hazards may be increased.
Both elevation and lowering of blood sugar levels have been reported. Significant hypoglycaemia was reported in a Type II diabetic patient maintained on chlorpropamide (250mg/day), after the addition of nortriptyline (125mg/day). Anaesthetics given during tricyclic antidepressant therapy may increase the risk of arrhythmias and hypotension.
5). Nortriptyline should be used with caution in patients with urinary retention, pylorus stenosis or paralytic ileus. Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather.
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, self-harm and hostility to be related to these compounds. This risk cannot be excluded with […]