Drugs List

Therapeutic Indications

Uses

Cataplexy associated with narcolepsy
Depressive illness
Phobic or obsessional states

Contraindications

Children under 18 years
Within 2 weeks of discontinuing selegiline
Within 3 weeks of discontinuing MAOIs
Atrioventricular block
Breastfeeding
Long QT syndrome
Mania
Narrow angle glaucoma
Porphyria
Pregnancy
Recent myocardial infarction
Severe hepatic disorder
Torsade de pointes

Precautions and Warnings

Elderly
Electroconvulsive therapy
Family history of long QT syndrome
Predisposition to epileptic disorder
Predisposition to glaucoma
Predisposition to prolongation of QT interval
Suicidal ideation
Wearing of contact lenses
Bipolar disorder
Cardiac arrhythmias
Cardiac conduction defects
Cardiovascular disorder
Chronic constipation
Depression
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
History of mania
History of torsade de pointes
Hyperthyroidism
Hypotension
Lactose intolerance
Neuroblastoma
Phaeochromocytoma
Prostate disorder
Psychosis
Raised intra-ocular pressure
Urinary retention

Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain lactose
Correct hypokalaemia before treatment
Monitor blood pressure before starting treatment
Consider monitoring ECG in patients at risk of QT prolongation
Dental check-ups advisable during long-term treatment
Monitor cardiac function during prolonged treatment
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor hepatic function on long term therapy
Monitor patient initially- response may take 2 or more weeks
Monitor serum electrolytes
Advise patient to report any new or worsening depression/suicidal ideation
Advise patients/carers to seek medical advice if suicidal intent develops
Anticholinergic effect may cause corneal damage in contact lens wearers
Increased risk of fractures in patients over 50 years
May cause activation of latent psychosis
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Do not withdraw this drug suddenly
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Alcohol may enhance side effects
Advise patient grapefruit products may increase plasma level

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.

Many patients with panic disorders experience intensified anxiety symptoms at the beginning of treatment. This paradoxical effect is most pronounced during the first few days and usually subsides within two weeks.

In patients with cyclic affective disorders, hypomanic or manic episodes have been reported. In these cases it may be necessary to reduce dose or withdraw clomipramine.

Use in Porphyria

Contraindicated in porphyria

Pregnancy and Lactation

Pregnancy

Clomipramine is contraindicated during pregnancy.

The manufacturer does not recommend using clomipramine during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Dyspnoea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms have been reported during first few hours or days in neonates.

Lactation

Clomipramine is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues clomipramine or discontinues breastfeeding. Available data indicates clomipramine is expressed in human breast milk in small quantities. Effects on exposed infants are unknown.

Side Effects

'Unmasking' of psychoses
Abdominal disorders
Aggression
Agitation
Agranulocytosis
Allergic alveolitis
Allergic skin reactions
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Arrhythmias
Ataxia
Breast enlargement
Changes in libido
Changes of blood pressure
Concentration difficulties
Conduction disturbances
Confusion
Constipation
Convulsions
Delirium
Depersonalisation
Diarrhoea
Disorientation
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
ECG changes
EEG changes
Eosinophilia
Erectile dysfunction
Fatigue
Galactorrhoea
Glaucoma
Hair loss
Hallucinations
Headache
Hepatitis with or without jaundice
Hot flushes
Hyperpyrexia
Hypomania
Impaired memory
Inappropriate secretion of antidiuretic hormone
Increase of liver transaminases
Increased risk of fractures
Insomnia
Leucopenia
Mania
Micturition disorders
Muscle weakness
Muscular hypertonia
Mydriasis
Myoclonus
Nausea
Neuroleptic malignant syndrome
Nightmares
Oedema
Palpitations
Paraesthesia
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pruritus
Purpura
Rash
Restlessness
Sinus tachycardia
Sleep disturbances
Speech disturbances
Suicidal tendencies
Sweating
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urticaria
Visual disturbances
Vomiting
Weight changes
Worsening depression
Yawning

Presentation

Oral formulations of clomipramine.

Drugs List

Therapeutic Indications

Uses

Cataplexy associated with narcolepsy
Depressive illness
Phobic or obsessional states

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Within 2 weeks of discontinuing selegiline
Within 3 weeks of discontinuing MAOIs
Atrioventricular block
Breastfeeding
Long QT syndrome
Mania
Narrow angle glaucoma
Porphyria
Pregnancy
Recent myocardial infarction
Severe hepatic disorder
Torsade de pointes

Precautions and Warnings

Elderly
Electroconvulsive therapy
Family history of long QT syndrome
Predisposition to epileptic disorder
Predisposition to glaucoma
Predisposition to prolongation of QT interval
Suicidal ideation
Wearing of contact lenses
Bipolar disorder
Cardiac arrhythmias
Cardiac conduction defects
Cardiovascular disorder
Chronic constipation
Depression
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
History of mania
History of torsade de pointes
Hyperthyroidism
Hypotension
Lactose intolerance
Neuroblastoma
Phaeochromocytoma
Prostate disorder
Psychosis
Raised intra-ocular pressure
Urinary retention

Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain lactose
Correct hypokalaemia before treatment
Monitor blood pressure before starting treatment
Consider monitoring ECG in patients at risk of QT prolongation
Dental check-ups advisable during long-term treatment
Monitor cardiac function during prolonged treatment
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor hepatic function on long term therapy
Monitor patient initially- response may take 2 or more weeks
Monitor serum electrolytes
Advise patient to report any new or worsening depression/suicidal ideation
Advise patients/carers to seek medical advice if suicidal intent develops
Anticholinergic effect may cause corneal damage in contact lens wearers
Increased risk of fractures in patients over 50 years
May cause activation of latent psychosis
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
Do not withdraw this drug suddenly
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Alcohol may enhance side effects
Advise patient grapefruit products may increase plasma level

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.

Many patients with panic disorders experience intensified anxiety symptoms at the beginning of treatment. This paradoxical effect is most pronounced during the first few days and usually subsides within two weeks.

In patients with cyclic affective disorders, hypomanic or manic episodes have been reported. In these cases it may be necessary to reduce dose or withdraw clomipramine.

Use in Porphyria

Contraindicated in porphyria

Pregnancy and Lactation

Pregnancy

Clomipramine is contraindicated during pregnancy.

The manufacturer does not recommend using clomipramine during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Dyspnoea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms have been reported during first few hours or days in neonates.

Lactation

Clomipramine is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues clomipramine or discontinues breastfeeding. Available data indicates clomipramine is expressed in human breast milk in small quantities. Effects on exposed infants are unknown.

Side Effects

'Unmasking' of psychoses
Abdominal disorders
Aggression
Agitation
Agranulocytosis
Allergic alveolitis
Allergic skin reactions
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Arrhythmias
Ataxia
Breast enlargement
Changes in libido
Changes of blood pressure
Concentration difficulties
Conduction disturbances
Confusion
Constipation
Convulsions
Delirium
Depersonalisation
Diarrhoea
Disorientation
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
ECG changes
EEG changes
Eosinophilia
Erectile dysfunction
Fatigue
Galactorrhoea
Glaucoma
Hair loss
Hallucinations
Headache
Hepatitis with or without jaundice
Hot flushes
Hyperpyrexia
Hypomania
Impaired memory
Inappropriate secretion of antidiuretic hormone
Increase of liver transaminases
Increased risk of fractures
Insomnia
Leucopenia
Mania
Micturition disorders
Muscle weakness
Muscular hypertonia
Mydriasis
Myoclonus
Nausea
Neuroleptic malignant syndrome
Nightmares
Oedema
Palpitations
Paraesthesia
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pruritus
Purpura
Rash
Restlessness
Sinus tachycardia
Sleep disturbances
Speech disturbances
Suicidal tendencies
Sweating
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urticaria
Visual disturbances
Vomiting
Weight changes
Worsening depression
Yawning

Withdrawal Symptoms and Signs

Abrupt withdrawal should be avoided due to the risk of withdrawal symptoms such as nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, nervousness and anxiety.

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: December 2019

Reference Sources

Summary of Product Characteristics: Clomipramine 50mg Capsules, Hard. Generics [UK] Ltd t/a Mylan. Revised April 2016.
Summary of Product Characteristics: Clomipramine 50mg Capsules. TEVA UK Ltd. Revised June 2015.