Nortriptyline is an active pharmaceutical ingredient in the Non-Selective Monoamine Reuptake Inhibitors group (N06AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 17, 2026[1]
Nortriptyline is indicated for the relief of symptoms of Depression.
How to take
GBOfficial regulatory label
CACanada· Health Canada
4 products
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
3 Pediatrics). • AVENTYL is contraindicated for concomitant use with MAO inhibitors (see 2 CONTRAINDICATIONS). AVENTYL should not be used within 14 days of initiating or discontinuing MAO inhibitors. • The maximum recommended daily dose is 100 mg/day.
• Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes. 2 Recommended Dose and Dosage Adjustment). • The use of lower dosages for outpatients is more important than for hospitalized patients, who will be treated under close supervision.
• Dosages should be titrated, beginning at a low level and increasing gradually over several weeks, while carefully monitoring for clinical response and noting any evidence of intolerance. Improvement may not occur during the first few weeks or more of treatment.
5 Post-Market Adverse Reactions). • Following remission, maintenance medication may be required for a long period of time at the lowest dose that will maintain remission. • If a patient develops minor side effects, the dosage should be reduced.
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised January 13, 2026[3]
INDICATIONS AND USAGE
Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
How to take
US
Drug interactions
Known interactions involving Nortriptyline. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL163630633 · revised April 17, 2026
[2]Health Canada (DPD) · 00015229 · revised March 22, 2025
[3]FDA DailyMed · 017f7717-e160-41… · revised January 13, 2026 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
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.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]
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.
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.
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.
GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]
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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 17, 2026[1]
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.
This is not medical advice. Consult a qualified healthcare professional.
The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. 2 Recommended Dose and Dosage Adjustment • Adults (≥ 18 years): The recommended dose of AVENTYL is 25 mg, taken orally 3 - 4 times daily.
When initiating treatment with AVENTYL, dosage should begin at a low level and increase gradually, as required. 3 Pediatrics). • Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. The use of AVENTYL in children is not recommended.
When considering the use of AVENTYL (Nortriptyline Hydrochloride Capsules) Page 6 of 34 nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. Dosing in adolescents should be reduced to 30 to 50 mg/day, in divided doses.
• Geriatrics: There is limited data available involving the use of nortriptyline in patients aged 65 and over. Caution should be exercised when using AVENTYL in elderly patients. 4 Geriatrics). 3 Pharmacokinetics). In patients with hepatic impairment, use caution when initiating treatment with AVENTYL.
Lower doses may be required. 4 Administration AVENTYL is administered orally, in the form of capsules. 5 Missed Dose If the patient misses a dose of AVENTYL, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
4 Drug-Drug Interactions). 4 Drug-Drug Interactions). Dependence/Tolerance Though not indicative of addiction, abrupt cessation of treatment following prolonged therapy may produce withdrawal symptoms, including flu-like symptoms, dizziness, nausea, headache, agitation, malaise, and abdominal cramping.
As with other antidepressants, sudden discontinuation of nortriptyline treatment may also increase the risk of relapse. 1 Dosing Considerations; 8 ADVERSE REACTIONS, Withdrawal). Driving and Operating Machinery Nortriptyline may cause somnolence, dizziness, and confusion.
Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Endocrine and Metabolism In hyperthyroid patients or those receiving thyroid medication, NORTIPTYLINE may cause cardiac arrhythmias (see 8 ADVERSE REACTIONS, Cardiovascular).
Nortriptyline may affect blood sugar levels. Both elevation and lowering of blood sugar levels AVENTYL (Nortriptyline Hydrochloride Capsules) Page 10 of 34 have been reported with nortriptyline (see 8 ADVERSE REACTIONS, Endocrine). A case of significant hypoglycemia has been reported in a Type II diabetic patient maintained on chlorpropamide (250 mg/day) after the addition of nortriptyline (125 mg/day).
Those patients with reduced activity of drug metabolizing enzymes, such as the cytochrome P450 isoenzyme P450 2D6 (debrisoquin hydroxylase), may have higher plasma concentrations of nortriptyline when given usual doses. 3 Pharmacokinetics).
Genitourinary Due to its anticholinergic activity, nortriptyline may cause urinary retention (see 8 ADVERSE REACTIONS, Anticholinergic). Extreme caution should be used when AVENTYL is given to patients with a history of urinary retention.
4 Drug- Drug Interactions). Monitoring and Laboratory Tests Plasma concentrations are difficult to measure. Healthcare providers should consult with laboratory professional staff. 1 Dosing Considerations). Neurologic • Seizures Nortriptyline is known to lower convulsive threshold.
Extreme caution should be exercised when using AVENTYL in patients with a history of seizures. Patients should be followed closely when nortriptyline is administered in these patients. Troublesome patient hostility may be aroused by the use of nortriptyline.
Epileptiform seizures may accompany its administration, as may happen with other drugs of its class. • Serotonin toxicity/Serotonin syndrome Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition and has been reported with tricyclic antidepressants.
g. g. anxiety, agitation, hypomania). 4 Drug-Drug Interactions). If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. • Electroconvulsive Therapy (ECT) There is limited clinical experience in the concurrent administration of ECT and antidepressant drugs.
When it is essential, AVENTYL may be administered concurrently with ECT, if such treatment is essential. However, the possibility of increased risk, relative to benefits, should be considered. Discontinue the drug for several days, if possible, prior to ECT.
Ophthalmologic Due to anticholinergic activity, nortriptyline may cause an increase in intraocular pressure. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). Psychiatric All patients being treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behaviour, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania and mania have been reported in adults, adolescents and children being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type AVENTYL (Nortriptyline Hydrochloride Capsules) Page 12 of 34 and/or suicidal thoughts and […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
, Potential association with behavioural and emotional changes, including self-harm). 3 Pediatrics). • AVENTYL is contraindicated for concomitant use with MAO inhibitors (see 2 CONTRAINDICATIONS). AVENTYL should not be used within 14 days of initiating or discontinuing MAO inhibitors.
• The maximum recommended daily dose is 100 mg/day. • Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes. 2 Recommended Dose and Dosage Adjustment). • The use of lower dosages for outpatients is more important than for hospitalized patients, who will be treated under close supervision.
• Dosages should be titrated, beginning at a low level and increasing gradually over several weeks, while carefully monitoring for clinical response and noting any evidence of intolerance. Improvement may not occur during the first few weeks or more of treatment.
5 Post-Market Adverse Reactions). • Following remission, maintenance medication may be required for a long 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. 2 Recommended Dose and Dosage Adjustment • Adults (≥ 18 years): The recommended dose of AVENTYL is 25 mg, taken orally 3 - 4 times daily.
When initiating treatment with AVENTYL, dosage should begin at a low level and increase gradually, as required. 3 Pediatrics). • Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use. The use of AVENTYL in children is not recommended.
When considering the use of AVENTYL (Nortriptyline Hydrochloride Capsules) Page 6 of 34 nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. Dosing in adolescents should be reduced to 30 to 50 mg/day, in divided doses.
• Geriatrics: There is limited data available involving the use of nortriptyline in patients aged 65 and over. Caution should be exercised when using AVENTYL in elderly patients. 4 Geriatrics). 3 Pharmacokinetics). In patients with hepatic impairment, use caution when initiating treatment with AVENTYL.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
AVENTYL is contraindicated: • in patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Cross- sensitivity between nortriptyline and other dibenzazepines is a possibility. 4 Drug-Drug Interactions; 5 OVERDOSAGE). • during the acute recovery period following myocardial infarction.
This is not medical advice. Consult a qualified healthcare professional.
Nortriptyline hydrochloride is not recommended for children. Nortriptyline hydrochloride is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized 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. Usual Adult Dose 25 mg three or four times daily; dosage should begin at a low level and be increased as required.
As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Elderly and Adolescent Patients 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride.
Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS). Use of Nortriptyline Hydrochloride With Other MAOIs, Such as Linezolid or Methylene Blue Do not start nortriptyline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome.
In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS). In some cases, a patient already receiving nortriptyline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue.
If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, nortriptyline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered.
The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with nortriptyline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with nortriptyline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 13, 2026[3]
ADVERSE REACTIONS
Note - Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic 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.
Neurologic - Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. Anticholinergic - Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.
Allergic - Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs. Hematologic - Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.
Gastrointestinal - Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black-tongue. Endocrine - Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.
Other - Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia. Withdrawal Symptoms - Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
USOfficial regulatory label· Warnings and precautions· revised January 13, 2026[3]
WARNINGS
Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.
There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications.
These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. No suicides occurred in any of the pediatric trials. , beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 13, 2026[3]
CONTRAINDICATIONS
Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome.
The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting nortriptyline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).
Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Myocardial Infarction Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
This is not medical advice. Consult a qualified healthcare professional.
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.
Lower doses may be required. 4 Administration AVENTYL is administered orally, in the form of capsules. 5 Missed Dose If the patient misses a dose of AVENTYL, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule.
5 OVERDOSAGE Overdose of tricyclic antidepressants may manifest with doses as small as 50 mg in a child. Of patients who are alive at initial presentation, a mortality rate of between 0% and 15% has been reported. Symptoms of overdose of tricyclic antidepressants may begin within several hours of oral ingestion.
1 Adverse Reaction Overview). An effect on cardiac conduction, similar to that of quinidine, may be seen with slowing of conduction, prolongation of the QRS complex and QT intervals, right bundle branch and AV block, ventricular tachyarrhythmias (including Torsade de pointes and fibrillation), and death.
1 seconds is predictive of more severe toxicity. The absence of sinus tachycardia does not ensure a benign course. - adrenergic blockade, and cardiac depression. In a healthy young person, prolonged resuscitation may be effective; one patient was reported to survive 5 hours of cardiac massage.
AVENTYL (Nortriptyline Hydrochloride Capsules) Page 7 of 34 In managing overdose, consider the possibility of multiple drug overdose, interactions among drugs, and unusual drug kinetics in your patients. Protect the patient's airway and support ventilation and perfusion.
Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.
Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Ventricular arrhythmias, especially when accompanied by lengthened QRS intervals, may respond to alkalinization by hyperventilation or administration of sodium bicarbonate.
It is important to monitor and manage serum electrolyte levels. Refractory arrhythmias may respond to propranolol, bretylium, or lidocaine. 4 Drug-Drug Interactions). Seizures may respond to diazepam. Phenytoin has pharmacologic properties that may be helpful in dealing with both the […]
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Such monitoring should include daily observation by families and caregivers. Prescriptions for nortriptyline hydrochloride capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
It should be noted that nortriptyline hydrochloride capsules are not approved for use in treating bipolar depression. Patients with cardiovascular disease should be given nortriptyline hydrochloride 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. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, nortriptyline hydrochloride should be used with great caution in patients who have glaucoma or a history of urinary retention.
Patients with a history of seizures should be followed closely when nortriptyline hydrochloride is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if nortriptyline hydrochloride is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
Nortriptyline hydrochloride may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly. Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.
The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including nortriptyline hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St.
John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). , nausea, vomiting, diarrhea).
Patients should be monitored for the emergence of serotonin syndrome. The concomitant use of nortriptyline hydrochloride with MAOIs intended to treat psychiatric disorders is contraindicated. Nortriptyline hydrochloride should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue.
All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses.
There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking nortriptyline hydrochloride. Nortriptyline hydrochloride should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).
If concomitant use of nortriptyline hydrochloride with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with nortriptyline hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Use in Pregnancy Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards.
Animal reproduction studies have yielded inconclusive results. image description