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Ziprasidone mesylate

Class
Antipsychotics
Subclass
Benzisoxazols
Substance name
Ziprasidone mesylate
Brand names
Geodon®
Common formulations
Powder for parenteral solution
Dosage and administration
Adults patients
Treatment of agitation in patients with schizophrenia
•
Maintenance: 20 mg IM q4h PRN
•
Maximum: 40 mg per day / for 3 days of cumulative use
Indications for use
Labeled indications
Adults
•
Treatment of agitation in patients with schizophrenia
Safety risks
Boxed warnings
Increased risk of mortality
•
Use extreme caution in elderly patients with dementia-related psychosis.
Contraindications
Hypersensitivity to ziprasidone or any of its components
In combination with other drugs that have demonstrated QT prolongation
Known history of QT prolongation
Recent acute myocardial infarction
Uncompensated HF
Warnings and precautions
Aspiration pneumonia
•
Use caution in patients with risk factors such as those with advanced Alzheimer's disease.
Hematologic disorders
•
Use caution in patients with pre-existing low WBC count and history of drug induced leukopenia/neutropenia.
Hyperglycemia, ketoacidosis, hyperosmolar hyperglycemic state
•
Use caution in patients with risk factors for diabetes mellitus.
Hyperprolactinemia
•
Use caution in patients who have a history of breast cancer.
Malignant hyperthermia
•
Use caution in patients with conditions that contribute to an elevation in core body temperature (e.g., strenuous exercise, ambient temperature increase, or dehydration).
Neuroleptic malignant syndrome
•
Use caution in patients with serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms.
Orthostatic hypotension
•
Use caution in patients with known CVD, cerebrovascular disease, or conditions which would predispose patients to hypotension.
Photosensitivity of skin, DRESS syndrome, Stevens-Johnson syndrome, cutaneous adverse reactions, priapism
•
Maintain a high level of suspicion as, ziprasidone has been associated with these adverse events.
Seizure
•
Use caution in patients with a history of seizure disorder or with conditions that potentially lower the seizure threshold.
•
Use caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
Skin rash, urticaria
•
Use caution in longer exposure time in the higher dose patients.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Somnolence, positive postural hypotension, falls
•
Use caution in patients with diseases, conditions, or medications that could exacerbate motor and sensory instability.
Stroke, TIA
•
Use caution in elderly patients with dementia-related psychosis.
Suicidal ideation
•
Use extreme caution in patients with psychotic illness or bipolar disorder.
Tardive dyskinesia
•
Use caution in patients with a history of movement disorder, advanced age, presence of a mood disorder, intellectual disability, CNS injury, prior or current akathisia, significant parkinsonism, or acute dystonic reaction, especially in elderly women.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use with caution.
Renal replacement therapy
Any modality
•
Use with caution.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in humans. Enroll patients in a dedicated pregnancy outcome monitoring registry. Monitor neonates for extrapyramidal and/or withdrawal symptoms and respiratory depression.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Headache, nausea, somnolence
Common 1-10%
•
Agitation, bradycardia, extrapyramidal symptoms, furuncles, hypertension, orthostatic hypotension, personality disorder, abdominal pain, akathisia, anxiety, asthenia, constipation, diarrhea, dizziness, dysmenorrhea, indigestion, injection site pain, insomnia, loss of appetite, paresthesia, priapism, rectal bleeding, sweating, vomiting, speech disturbance
Uncommon < 1%
•
↑QT interval, seizure, syncope
Rare < 0.1%
•
Neuroleptic malignant syndrome, tardive dyskinesia, torsade de pointes
Unknown frequency
•
Acute pancreatitis, agranulocytosis, cerebrovascular accident, DRESS syndrome, death, ↓ WBC count, ↓ blood neutrophil count, ↓ platelet count, diabetes mellitus, dyslipidemia, dystonia, ↑ blood glucose, ↑ liver enzymes, ↑ serum prolactin, metabolic syndrome, pulmonary embolism, dysphagia, weight loss, Stevens-Johnson syndrome, tachycardia, venous thromboembolism
Interactions
Drug(s)
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