BOXED WARNING Increased mortality in elderly patients with dementia-related psychosis treated with antipsychotics; not approved for dementia-related psychosis.
FDA dosing
Population
Start
Target
Max
Schizophrenia
Adults
20 mg BID
up to 80 mg BID
100 mg BID
Bipolar I, acute manic/mixed
Adults
40 mg BID
40-80 mg BID
80 mg BID
Bipolar I maintenance (adjunct to lithium/valproate)
Adults
40-80 mg BID
40-80 mg BID
Acute agitation in schizophrenia (IM)
Adults
10 mg q2h or 20 mg q4h IM
40 mg/day
Titration Adjust at intervals of ≥2 days (schizophrenia)
Renal Oral: no adjustment needed. IM: use caution — cyclodextrin excipient renally cleared
Hepatic Undefined
Instructions
Take capsules with food; swallow whole — do not open, crush, or chew
IM for agitation ≤3 consecutive days; switch to oral as soon as possible
MAOI switch: ≥14 days after stopping an MAOI before starting; ≥3 days after stopping ziprasidone before an MAOI
Contraindications
Known QT prolongation (incl. congenital long QT), recent acute MI, or uncompensated heart failure
Concomitant use of other QT-prolonging drugs
MAOIs (concurrently or within 14 days) due to risk of serotonin syndrome
Cautions
QT prolongation and risk of sudden death; avoid with other QT-prolonging drugs and in electrolyte disturbance
Serotonin syndrome (may occur even alone)
Neuroleptic malignant syndrome
Severe cutaneous reactions (DRESS, Stevens-Johnson)
Tardive dyskinesia
Metabolic changes: hyperglycemia, dyslipidemia, weight gain
Orthostatic hypotension
Leukopenia/neutropenia/agranulocytosis
Seizures
Cerebrovascular events and increased mortality in elderly with dementia-related psychosis
Adverse reactions
Somnolence
Respiratory tract infection
Extrapyramidal symptoms
Dizziness
Akathisia
Nausea
Abnormal vision
Asthenia
Vomiting
Pregnancy Third-trimester exposure risks neonatal extrapyramidal/withdrawal symptoms; epidemiologic data show no clear risk of major birth defects.
Lactation Present in human milk; monitor infant for excess sedation, irritability, poor feeding, and extrapyramidal symptoms.
⚠ BOXED WARNING
Increased mortality in elderly patients with dementia-related psychosis