- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of clomipramine.
Cataplexy associated with narcolepsy
Phobic or obsessional states
Initial dose: 10mg per day, increasing gradually to 30 to 150mg per day if required.
Take in divided doses throughout the day or as a single dose at bedtime.
Maintenance dose: 30 to 50mg per day.
Higher doses may be required, particularly in patients suffering from obsessional or phobic disorders. Once a distinct improvement has set in, the daily dosage may be adjusted to a maintenance level of 50 to 100mg.
In severe cases the dosage can be increased up to a maximum of 250mg per day.
Initial dose: 25mg per day.
Maintenance dose: It is recommended the dose be built up to 100 to 150mg daily, according to the severity of the condition. This should be attained gradually over a period of 2 weeks. The maximum daily dosage is 250mg.
Adjunctive Treatment of Cataplexy Associated with Narcolepsy
Initial dose: 10mg per day.
Maintenance dose:Increase gradually up to 75mg per day or until satisfactory response occurs. The maximum daily dosage is 75mg.
Control of cataplexy should be achieved within 24 hours of reaching the optimal dose.
Initial dose: 10mg per day
Maintenance dose: Increased to optimum level of 30 to 75mg daily with caution under close supervision. This should be reached after about 10 days and maintained until the end of treatment. The maximum daily dosage is 250mg.
Initial dose: 10mg per day.
Children under 18 years
Within 2 weeks of discontinuing selegiline
Within 3 weeks of discontinuing MAOIs
Long QT syndrome
Narrow angle glaucoma
Recent myocardial infarction
Severe hepatic disorder
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to epileptic disorder
Predisposition to glaucoma
Predisposition to prolongation of QT interval
Wearing of contact lenses
Cardiac conduction defects
Glucose-galactose malabsorption syndrome
History of mania
History of torsade de pointes
Raised intra-ocular pressure
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
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.
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.
'Unmasking' of psychoses
Allergic skin reactions
Changes in libido
Changes of blood pressure
Disturbances of appetite
Hepatitis with or without jaundice
Inappropriate secretion of antidiuretic hormone
Increase of liver transaminases
Increased risk of fractures
Neuroleptic malignant syndrome
Prolongation of QT interval
Torsades de pointes
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.
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 ).
Last Full Review Date: December 2019
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.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.