mianserin hydrochloride: clinical use

Prescribing considerations

• Not indicated for children or adolescents under 18 years.
• Closely monitor depression, suicidality and behavioural changes, particularly early in treatment and after changes.
• Review suitability carefully in epilepsy, recent myocardial infarction, heart block, arrhythmia, diabetes, renal or hepatic impairment, narrow-angle glaucoma, prostatic symptoms and phaeochromocytoma.
• Inform the anaesthetist if surgery is planned.

Contraindications and cautions

• Hypersensitivity to mianserin or an excipient.
• Mania.
• Severe liver disease.
• Breastfeeding.

Monitoring

• Obtain a full blood count every four weeks during the first three months, followed by ongoing clinical monitoring.
• Stop treatment and obtain an urgent full blood count if fever, sore throat, stomatitis or another sign of infection develops.
• Monitor liver function where clinically indicated and stop if jaundice occurs.
• Consider blood-pressure monitoring with concurrent antihypertensive treatment.
• Monitor phenytoin concentrations and provide additional monitoring with coumarin anticoagulants.

Clinical pharmacology

Mianserin is a sedating tetracyclic antidepressant that blocks presynaptic alpha-adrenoceptors and increases brain noradrenaline turnover. It has antihistamine activity, little effect on central serotonin uptake and no significant anticholinergic activity. It undergoes extensive first-pass hepatic metabolism and is excreted mainly as urinary metabolites.

Formulation and product differences

• The selected product is a round, white, convex film-coated tablet marked “MI 30” on one side and “G” on the reverse.
• The tablet should be swallowed whole without chewing.
• The formulation contains maize starch, calcium hydrogen phosphate, magnesium stearate and a film coat containing titanium dioxide.

Tablet

Route: Oral

Strengths: 10 mg, 30 mg