DEPIXOL Solution for injection Ref.[8630] Active ingredients: Flupentixol

Posology

Adults

The usual dosage of flupentixol decanoate lies between 50 mg every 4 weeks and 300 mg every 2 weeks, but some patients may require up to 400 mg weekly. The maximum single dose at any one time is 400 mg. For example, 800 mg ever 2 weeks should not be given. Other patients may be adequately maintained on dosages of 20-40 mg flupentixol decanoate every 2-4 weeks. In patients who have not previously received depot antipsychotic, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patients' condition.

Depixol Injection 20 mg/ml is not intended for use in patients requiring doses of greater than 60 mg (3 ml) of flupentixol. Injection volumes of 2–3 ml should be distributed between two injection sites.

More concentrated solutions of flupentixol decanoate (Depixol Conc Injection or Depixol Low Volume Injection) should be used if doses greater than 3 ml (60 mg) are required.

The injection volumes selected for Depixol Conc Injection or Depixol Low Volume Injection should not exceed 2 ml.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse.

Older patients

In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older patients.

Children

Depixol is not recommended for use in children due to lack of clinical experience.

Patients with reduced renal function

Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4).

Patients with reduced hepatic function

Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised (see section 4.4). Depixol should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

Method of administration

Route of administration

Deep intramuscular injection into the upper outer buttock or lateral thigh.

Dosage and dosage interval should be adjusted according to the patients' symptoms and response to treatment.

Note: As with all oil-based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

Overdosage may cause somnolence or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required.

• Anticholinergic antiparkinson drugs if extrapyramidal symptoms occur
• Sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions
• Noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.

Ampoules 1 ml: 2 years.

Do not store above 25°C.

Keep the ampoules in the outer carton in order to protect from light.

Ampoules containing 1 ml of 200 mg/ml flupentixol decanoate in thin vegetable oil.

Pack size: 5 ampoules per carton.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.