CLOPIXOL Solution for injection Ref.[8463] Active ingredients: Zuclopenthixol

Posology

Adults

Dosage and dosage interval should be adjusted according to the patient’s symptoms and response to treatment.

The usual dosage range of zuclopenthixol decanoate is 200 – 500 mg every one to four weeks, depending on response, but some patients may require up to 600 mg per week. The maximum single dose at any one time is 600 mg. For example, 1200 mg every 2 weeks should not be given. In patients who have not previously received depot antipsychotics, treatment is usually started with a small dose (e.g. 100 mg) to assess tolerance. An interval, of at least one week should be allowed before the second injection is given at a dose consistent with the patient’s condition.

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.

Injection volumes of greater than 2 ml should be distributed between two injection sites.

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.

Paediatric population

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

Patients with renal impairment

Clopixol can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage.

Patients with hepatic impairment

Use with caution in patients with liver disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised.

Method of administration

By deep intramuscular injection into the upper outer buttock or lateral thigh.

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

Symptoms

Somnolence, 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

Treatment is symptomatic and supportive. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted.

Adrenaline (epinephrine) must not be used in these patients. There is no specific antidote.

Clopixol Injection:

1 ml ampoules: 36 months.

10 ml vials: 36 months (unopened), shelf life after opening vials: 1 day

Clopixol Conc. Injection:

48 months.

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

Clopixol Injection

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

Pack size: 10 ampoules per box. 10 ml clear glass vials with a rubber stopper secured with an aluminium collar having a fliptop cap. Pack size: 1 vial per box.

Clopixol Conc. Injection

Ampoules containing 1 ml of 500 mg/ml zuclopenthixol decanoate in thin vegetable oil.

Pack size: 5 ampoules per box.

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