Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
Ziprasidone is indicated for the treatment of schizophrenia in adults.
Ziprasidone is indicated for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in adults, children and adolescents aged 10-17 years (prevention of episodes of bipolar disorder has not been established – see section 5.1).
The recommended dose, in acute treatment of schizophrenia and bipolar mania, is 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
It is of particular importance not to exceed the maximum dose as the safety profile above 160 mg/day has not been confirmed and ziprasidone is associated with dose-related prolongation of the QT interval (see sections 4.3 and 4.4).
In maintenance treatment of schizophrenia patients, ziprasidone should be administered at the lowest effective dose; in many cases, a dose of 20 mg twice daily may be sufficient.
A lower starting dose is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.
No dose adjustment is required in patients with impaired renal function (see section 5.2).
In patients with hepatic insufficiency, lower doses should be considered (see sections 4.4 and 5.2).
The recommended dose, in acute treatment of bipolar mania, in paediatric patients (age 10 to 17 years) is a single dose of 20 mg on day 1, with food. Ziprasidone should subsequently be administered with food in two daily divided doses, and should be titrated over 1-2 weeks to a target range of 120-160 mg/day for patients weighing ≥45 kg, or to a target range of 60-80 mg/day for patients weighing <45 kg. Subsequent dosing should be adjusted on the basis of individual clinical status within the range of 80-160 mg/day for patients weighing ≥45 kg, or 40-80 mg/day for patients weighing <45 kg. Asymmetric dosing, with morning doses 20 mg or 40 mg less than evening doses, was permitted in the clinical trial (see sections 4.4, 5.1 and 5.2).
It is of particular importance not to exceed the weight-based maximum dose as the safety profile above the maximum dose (160 mg/day for children ≥45 kg and 80 mg/day for children <45 kg has not been confirmed and ziprasidone is associated with dose-related prolongation of the QT interval (see sections 4.3 and 4.4).
The safety and efficacy of ziprasidone in paediatric patients with schizophrenia have not been established (see sections 4.4 and 5.1).
For oral use.
Capsules should be taken with food and swallowed whole without chewing, crushing or opening beforehand because it may affect the absorption of the medication.
Experience with ziprasidone in overdose is limited. The largest confirmed single ingestion of ziprasidone is 12,800 mg. In this case, extrapyramidal symptoms and a QTc interval of 446 msec (with no cardiac sequelae) were reported. In general, the most commonly reported symptoms following overdose are, extrapyramidal symptoms, somnolence, tremor and anxiety.
The possibility of obtundation, seizures or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. There is no specific antidote to ziprasidone.
4 years.
Do not store above 30°C.
Blister: Ziprasidone capsules are presented in aluminium PVC/PVA blisters with aluminium foil lids, in cartons containing 14, 20, 30, 50, 56, 60 or 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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