Drugs List

Therapeutic Indications

Uses

Depressive illness
Nocturnal enuresis

Unlicensed Uses

Neuropathic pain

Contraindications

Children under 6 years
Within 2 weeks of discontinuing MAOIs
Within 2 weeks of discontinuing selegiline
Acute porphyria
Atrioventricular block
Cardiac arrhythmias
Galactosaemia
Long QT syndrome
Mania
Recent myocardial infarction
Severe hepatic disorder
Torsade de pointes

Precautions and Warnings

Anaesthesia
Elderly
Electroconvulsive therapy
Family history of long QT syndrome
Females of childbearing potential
Predisposition to epileptic disorder
Predisposition to narrow angle glaucoma
Suicidal ideation
Agitation
Benign prostatic hyperplasia
Bipolar disorder
Breastfeeding
Cardiovascular disorder
Chronic constipation
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of mania
History of torsade de pointes
History of urinary retention
Lactose intolerance
Narrow angle glaucoma
Panic disorders
Paralytic ileus
Phaeochromocytoma
Pregnancy
Psychosis
Pyloric stenosis
Raised intra-ocular pressure
Schizophrenia
Thyroid dysfunction
Urinary retention

Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Patients with diabetes may experience fluctuations in blood glucose
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients with cardiovascular disease
Monitor serum electrolytes
Nocturnal enuresis - reassess need for treatment after 3 months
Plasma level monitoring may be useful: refer to local guidelines
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Advise patients/carers to seek medical advice if suicidal intent develops
Aggressive behaviour may occur
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Increased risk of fractures in patients over 50 years
May aggravate anxiety and agitation
May exacerbate schizophrenia
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Treatment of children with nocturnal enuresis-behavioural changes may occur
Avoid abrupt withdrawal
Discontinue at least 7 days prior to scheduled surgery
Discontinue if serious allergic or anaphylactic reaction occurs
Limit prescribing quantity due to suicide risk
Not licensed for all indications in all age groups
Reduce dose in elderly
Start treatment at lowest recommended dose
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment
Advise patient to avoid exposure to direct sunlight

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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.

Other psychiatric conditions for which nortriptyline is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

Pregnancy and Lactation

Pregnancy

Use nortriptyline with caution during pregnancy.

There is limited published information regarding the safety of nortriptyline when used in pregnancy, however the limited evidence does not show an association between nortriptyline and congenital malformations (Briggs et al, 2015). Schaefer (2015) states that nortriptyline is the preferred drug when administering tricyclic antidepressant during pregnancy. The manufacturer suggests nortriptyline should only be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the foetus.

Lactation

Use nortriptyline with caution during breastfeeding.

Nortriptyline is excreted into breast milk in such low concentrations that are considered too small to be harmful. However the manufacturer states nortriptyline should be avoided in breastfeeding. Hale (2014) states that nortriptyline is considered safe to use during breastfeeding as many studies have been unable to detect the drug in maternal milk or in the infant, even after prolonged exposure. Schaefer (2015) states that nortriptyline is the preferred drug when administering tricyclic antidepressant during breastfeeding, however the lowest effective dose should always be administered. The Drugs and Lactation Database (LactMed) also supports Schaefer (2015).

Side Effects

Abdominal cramps
Agitation
Agranulocytosis
Alopecia
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Ataxia
Black tongue
Blood sugar changes
Blurred vision
Bone marrow depression
Breast enlargement
Changes in libido
Confusion
Constipation
Decreased appetite
Delusions
Diarrhoea
Disorientation
Disturbances in accommodation
Dizziness
Drowsiness
Drug fever
Dry mouth
EEG changes
Eosinophilia
Epigastric distress
Extrapyramidal effects
Fatigue
Flushing
Galactorrhoea
Gingivitis
Gynaecomastia
Hallucinations
Headache
Heart block
Hepatitis
Hepatocellular necrosis
Hypertension
Hypomania
Hypotension
Impotence
Inappropriate secretion of antidiuretic hormone
Inco-ordination
Increased risk of fractures
Insomnia
Jaundice
Leucopenia
Liver function disturbances
Micturition disorders
Mydriasis
Myocardial infarction
Nausea
Nightmares
Nocturia
Numbness
Oedema
Palpitations
Panic attack
Paraesthesia in extremities
Paralytic ileus
Paranoia
Parotid swelling
Peripheral neuropathy
Petechiae
Photosensitivity
Pruritus
Psychosis
Purpura
Rash
Restlessness
Seizures
Stomatitis
Stroke
Sublingual adenitis
Suicidal tendencies
Sweating
Tachycardia
Taste disturbances
Testicular swelling
Thrombocytopenia
Tingling sensation
Tinnitus
Tremor
Urinary frequency
Urinary retention
Urinary tract dilatation
Urticaria
Vomiting
Weakness
Weight changes
Withdrawal symptoms

Presentation

Oral formulations of nortriptyline.

Drugs List

Therapeutic Indications

Uses

Depressive illness
Nocturnal enuresis

Unlicensed Uses

Neuropathic pain

Dosage

Adults

Elderly

Children

Contraindications

Children under 6 years
Within 2 weeks of discontinuing MAOIs
Within 2 weeks of discontinuing selegiline
Acute porphyria
Atrioventricular block
Cardiac arrhythmias
Galactosaemia
Long QT syndrome
Mania
Recent myocardial infarction
Severe hepatic disorder
Torsade de pointes

Precautions and Warnings

Anaesthesia
Elderly
Electroconvulsive therapy
Family history of long QT syndrome
Females of childbearing potential
Predisposition to epileptic disorder
Predisposition to narrow angle glaucoma
Suicidal ideation
Agitation
Benign prostatic hyperplasia
Bipolar disorder
Breastfeeding
Cardiovascular disorder
Chronic constipation
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of mania
History of torsade de pointes
History of urinary retention
Lactose intolerance
Narrow angle glaucoma
Panic disorders
Paralytic ileus
Phaeochromocytoma
Pregnancy
Psychosis
Pyloric stenosis
Raised intra-ocular pressure
Schizophrenia
Thyroid dysfunction
Urinary retention

Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Patients with diabetes may experience fluctuations in blood glucose
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients with cardiovascular disease
Monitor serum electrolytes
Nocturnal enuresis - reassess need for treatment after 3 months
Plasma level monitoring may be useful: refer to local guidelines
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Advise patients/carers to seek medical advice if suicidal intent develops
Aggressive behaviour may occur
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Increased risk of fractures in patients over 50 years
May aggravate anxiety and agitation
May exacerbate schizophrenia
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Treatment of children with nocturnal enuresis-behavioural changes may occur
Avoid abrupt withdrawal
Discontinue at least 7 days prior to scheduled surgery
Discontinue if serious allergic or anaphylactic reaction occurs
Limit prescribing quantity due to suicide risk
Not licensed for all indications in all age groups
Reduce dose in elderly
Start treatment at lowest recommended dose
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Female: Ensure adequate contraception during treatment
Advise patient to avoid exposure to direct sunlight

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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.

Other psychiatric conditions for which nortriptyline is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

Pregnancy and Lactation

Pregnancy

Use nortriptyline with caution during pregnancy.

There is limited published information regarding the safety of nortriptyline when used in pregnancy, however the limited evidence does not show an association between nortriptyline and congenital malformations (Briggs et al, 2015). Schaefer (2015) states that nortriptyline is the preferred drug when administering tricyclic antidepressant during pregnancy. The manufacturer suggests nortriptyline should only be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the foetus.

Lactation

Use nortriptyline with caution during breastfeeding.

Nortriptyline is excreted into breast milk in such low concentrations that are considered too small to be harmful. However the manufacturer states nortriptyline should be avoided in breastfeeding. Hale (2014) states that nortriptyline is considered safe to use during breastfeeding as many studies have been unable to detect the drug in maternal milk or in the infant, even after prolonged exposure. Schaefer (2015) states that nortriptyline is the preferred drug when administering tricyclic antidepressant during breastfeeding, however the lowest effective dose should always be administered. The Drugs and Lactation Database (LactMed) also supports Schaefer (2015).

Side Effects

Abdominal cramps
Agitation
Agranulocytosis
Alopecia
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Ataxia
Black tongue
Blood sugar changes
Blurred vision
Bone marrow depression
Breast enlargement
Changes in libido
Confusion
Constipation
Decreased appetite
Delusions
Diarrhoea
Disorientation
Disturbances in accommodation
Dizziness
Drowsiness
Drug fever
Dry mouth
EEG changes
Eosinophilia
Epigastric distress
Extrapyramidal effects
Fatigue
Flushing
Galactorrhoea
Gingivitis
Gynaecomastia
Hallucinations
Headache
Heart block
Hepatitis
Hepatocellular necrosis
Hypertension
Hypomania
Hypotension
Impotence
Inappropriate secretion of antidiuretic hormone
Inco-ordination
Increased risk of fractures
Insomnia
Jaundice
Leucopenia
Liver function disturbances
Micturition disorders
Mydriasis
Myocardial infarction
Nausea
Nightmares
Nocturia
Numbness
Oedema
Palpitations
Panic attack
Paraesthesia in extremities
Paralytic ileus
Paranoia
Parotid swelling
Peripheral neuropathy
Petechiae
Photosensitivity
Pruritus
Psychosis
Purpura
Rash
Restlessness
Seizures
Stomatitis
Stroke
Sublingual adenitis
Suicidal tendencies
Sweating
Tachycardia
Taste disturbances
Testicular swelling
Thrombocytopenia
Tingling sensation
Tinnitus
Tremor
Urinary frequency
Urinary retention
Urinary tract dilatation
Urticaria
Vomiting
Weakness
Weight changes
Withdrawal symptoms

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last full review date: March 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Nortriptyline 10mg Capsules. Kent Pharmaceuticals Limited. Revised December 2019.

Summary of Product Characteristics: Nortriptyline 25mg Capsules. Kent Pharmaceuticals Limited. Revised December 2019.

Summary of Product Characteristics: Nortriptyline 10mg Film-coated Tablets. Focus Pharmaceuticals Limited. Revised August 2016.

Summary of Product Characteristics: Nortriptyline 25mg Film-coated Tablets. Focus Pharmaceuticals Limited. Revised August 2016.

Summary of Product Characteristics: Nortriptyline 50mg Film-coated Tablets. Focus Pharmaceuticals Limited. Revised August 2016.

Summary of Product Characteristics: Nortriptyline 10mg Oral Solution. Colonis Pharma Limited. Revised June 2019.

Summary of Product Characteristics: Nortriptyline 20mg Oral Solution. Colonis Pharma Limited. Revised June 2019.