CLOPIXOL ACUPHASE Solution for injection Ref.[51054] Active ingredients: Zuclopenthixol

Posology

Adults

Dosage should be adjusted according to the severity of the patient’s illness.

The usual dosage is 50-150 mg (1-3 ml), repeated if necessary after 2 or 3 days. Some patients may need an additional injection between 1 and 2 days after the first injection.

Clopixol-Acuphase is not intended for long-term use and duration of treatment should not be more than two weeks. The maximum accumulated dosage should not exceed 400 mg and the number of injections should not exceed four.

Older patients

The dosage may need to be reduced in older patients owing to reduced rates of metabolism and elimination. Maximum dosage per injection should be 100 mg.

Paediatric population

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

Patients with renal impairment

Clopixol-Acuphase 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 hepatic disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised.

Maintenance Therapy

Clopixol-Acuphase is not intended for long-term use.

A single injection of Clopixol-Acuphase has an onset of sedative action shortly after injection and an antipsychotic action persisting for 2 to 3 days. In this period, maintenance treatment with tablets or a longer acting depot neuroleptic can be initiated. The possible side-effects of long-term maintenance treatment with a neuroleptic, including tardive dyskinesia, should be considered.

Maintenance treatment where required can be continued with Clopixol tablets, Clopixol Injection or Clopixol Conc. Injection, according to the following guidelines:

1. Introduce Clopixol tablets at a dosage of 20-60 mg/day in divided doses, 2 to 3 days after the last injection of ClopixolAcuphase. If necessary increase the tablet dosage by 10-20 mg each day up to a maximum of 150 mg/day

Or

2. Concomitantly with the last injection of Clopixol-Acuphase, administer 200-400 mg of Clopixol injection or Clopixol Conc. Injection by deep intramuscular injection and repeat the Clopixol injection or Clopixol Conc. injection at intervals of 2 to 4 weeks. Higher dosages or a shorter interval may be necessary.

Method of administration

Deep intramuscular injection into the upper outer buttock or lateral thigh. Injection volumes exceeding 2 ml should be distributed between two injection sites.

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.

3 years.

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

This medicinal product does not require any special temperature storage conditions.

Clear glass ampoules containing 1 mL of zuclopenthixol acetate 5% w/v in thin vegetable oil.

The ampoules are packed in boxes of 5.

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