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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 relief of symptoms of Depression.
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. The elderly: 30 to 50mg/day in divided dosesOlder 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.
Many antidepressants (tricyclic antidepressants, including nortriptyline, selective serotonin re-uptake inhibitors and others) are metabolised by the hepatic cytochrome P450 isoenzyme CYP2D6. 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. Method of administration For oral administration.
not known (cannot be estimated from the available data). Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.
Cardiovascular:
Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.
Psychiatric:
Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. 4).
Neurological:
Numbness, tingling, paraesthesia of extremities; inco ordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration of EEG patterns; tinnitus.
Anticholinergic:
Dry mouth and, rarely, associated sublingual adenitis or gingivitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.
Allergic:
Rash, petechiae, urticaria, itching, photosensitisation (avoid excessive exposure to sunlight); oedema (general or of face and tongue), drug fever, crosssensitivity with other tricyclic drugs.
Haematological:
Bone-marrow depression, including agranulocytosis; aplastic anaemia; eosinophilia; purpura; thrombocytopenia.
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 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. 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.
1. Recent myocardial infarction, any degree of heart block or other cardiac arrhythmias. Severe liver disease Mania Nortriptyline is contraindicated for the nursing mother and for children under the age of six years. 5.
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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Gastro-intestinal:
Nausea and vomiting, anorexia, epigastric distress, diarrhoea; peculiar taste, stomatitis, abdominal cramps, black tongue, constipation, paralytic ileus.
Endocrine:
Gynaecomastia in the male; breast enlargement and galactorrhoea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate secretion of antidiuretic hormone.
Other:
Jaundice (simulating obstructive); altered liver function, hepatitis and liver necrosis; weight gain or loss; sweating; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.
4) Withdrawal symptoms: Though these are not indicative of addiction, 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.
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. 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). 5). , nausea, vomiting, diarrhoea). If concomitant treatment with other serotonergic drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
If serotonin syndrome is suspected, dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Excipient:
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.