clomipramine hydrochloride: clinical use

Prescribing considerations

• Treat hypokalaemia before initiation and review medicines that prolong QT or increase clomipramine exposure.
• Assess suicide and overdose risk, particularly early in treatment and after changes.
• Use particular caution with cardiovascular disease, epilepsy, hypotension, chronic constipation, hyperthyroidism, adrenal-medullary tumours, renal or hepatic impairment and in older adults.
• Abrupt withdrawal can produce gastrointestinal, neurological and psychological symptoms; cataplexy may also worsen.
• The selected adult indications are not recommended for children or adolescents because evidence is insufficient.

Contraindications and cautions

• Hypersensitivity to clomipramine, relevant excipients or related dibenzazepine tricyclic antidepressants.
• Recent myocardial infarction, heart block or other cardiac arrhythmia.
• Severe liver disease.
• Concurrent or insufficiently separated MAOI treatment, including reversible MAO-A inhibitors such as moclobemide.
• Narrow-angle glaucoma.
• Urinary retention.
• Mania.

Monitoring

• Suicidal thinking, behavioural change and clinical worsening during early treatment and following changes.
• Blood pressure before treatment and when clinically indicated.
• Cardiac function and ECG in cardiovascular disease and older adults; assess potassium and interacting QT-prolonging medicines.
• Cardiac and hepatic function during long-term treatment; hepatic enzymes and renal function in relevant organ impairment.
• Blood count if fever, sore throat, mouth ulcers or other infection symptoms occur.
• Anticholinergic burden, constipation, urinary retention, cognition, falls risk and dental health.

Clinical pharmacology

Clomipramine inhibits serotonin and noradrenaline reuptake, with serotonin reuptake inhibition predominating. Its active metabolite, desmethylclomipramine, contributes to activity. Extensive first-pass metabolism and variable CYP-mediated clearance produce substantial interpatient variation in exposure.

Formulation and product differences

• The selected product is a hard capsule for oral use.
• The selected capsule contains lactose monohydrate.
• The selected 10 mg capsule contains Sunset yellow (E110), which may cause allergic reactions.
• The capsule should be swallowed whole; it is not a modified-release preparation.

Capsule

Route: Oral

Strengths: 10 mg, 25 mg, 50 mg