Source: Medicines Authority (MT) Revision Year: 2022 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Nortrilen is indicated in adults for treatments of:
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability. Dosages exceeding 150 mg/day should preferably be restricted to hospitalised patients (up to 200-250 mg).
Initially 50 mg once a day administered in the morning or 25 mg 2-3 times daily gradually increased, if necessary, by 25 mg every other day up to 100-150 mg once a day or 50 mg 2-3 times daily (rarely 200 mg daily in hospitalised patients). The additional doses are primarily administered in the morning.
The maintenance dose is the same as the optimal therapeutic dose.
Patients over 60 years of age: Initially 10 mg 2-3 times daily or 25 mg once a day, gradually increased, if necessary, every other day up to 150 mg daily. The additional doses are primarily administered in the morning.
The maintenance dose is the same as the optimal therapeutic dose.
Nortrilen is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
The safety and efficacy of Nortrilen in children aged below 18 years have not been established.
No data are available.
Nortriptyline can be given in usual doses to patients with renal failure.
Careful dosing and, if possible, a serum level determination is advisable.
The antidepressant effect usually sets in after 2 to 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. In patients with recurrent depression (unipolar) maintenance therapy may need to be continued for a number of years to prevent new episodes.
When stopping therapy the drug should be gradually withdrawn during several weeks.
Dose increases are made preferably in the morning.
The tablets are swallowed with water.
There is considerably individual variability in response to overdose. Children are especially susceptible to cardiotoxicity and seizures. In adults more than 500 mg have caused moderate to serious intoxication and less than 1000 mg have been fatal.
The symptoms can occur slowly and insidious or abruptly and surprisingly. During the first hours somnolence or excitation, agitation and hallucinations. Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility. Convulsions. Fever. Sudden occurrence of CNS depression. Lowered consciousness progressing into coma. Respiratory depression.
Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation). The ECG characteristically show prolonged PR interval, widening of the QRS-complex, QT prolongation, T-wave flattening or inversion, ST segment depression, and varying degrees of heart block progressing to cardiac standstill.
Widening of the QRS-complex usually correlates well with the severity of the toxicity following acute overdoses. Heart failure, hypotension, cardiogenic shock. Metabolic acidosis, hypokalemia.
During awakening possibly again confusion, agitation and hallucinations and ataxia.
Patients should be admitted to hospital (intensive care unit) and closely monitored even in apparently uncomplicated cases. The treatment is symptomatic and supportive.
ABC’s (airway, breathing and circulation) should be assessed and treated as appropriate. Patency of the airway is maintained by intubation, where required. Treatment in a respirator is advised to prevent a possible respiratory arrest. Continuous ECG-monitoring of cardiac function for 3-5 days is advised. Urea and electrolytes should be checked, in particular for low potassium. Urine output should be monitored. Arterial blood gases should be checked, in particular for acidosis. Consider gastric lavage only if within one hour of a potentially fatal overdose. Give 50 g of charcoal if within one hour of ingestion.
Treatment of the following will be decided on a case by case basis:
Unrest and convulsions may be treated with diazepam.
5 years.
This medicinal product does not require any special storage conditions.
10 mg: 50 and 100 tablets in High Density Polyethylene (HDPE) container.
25 mg: 50 and 100 tablets in High Density Polyethylene (HDPE) container.
Not all pack sizes may be marketed.
No special requirements.
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