Ziprasidone


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Schizophrenia As ziprasidone HCl: Initial: 20 mg bid, may increase at intervals of not <2 days up to 80 mg bid. Maintenance: 20 mg bid. Acute mixed or manic episodes in bipolar disorder As ziprasidone HCl: Initial: 40 mg bid, increased to 60-80 mg bid on the 2nd day. Adjust subsequent doses according to patient's response and tolerance level. Maintenance treatment of bipolar I disorder (adjunctive therapy to either lithium or valproate): Continue at the same dosage on which the patient was initially stabilised w/in 40-80 mg bid. IM Acute agitation in schizophrenia As ziprasidone mesilate: 10-20 mg. Max: 40 mg/day for 3 consecutive days. Doses of 10 mg may be given 2 hrly and doses of 20 mg may be repeated 4 hrly. Switch to oral therapy as soon as possible.
Dosage Details
Intramuscular
Acute agitation in patients with schizophrenia
Adult: As ziprasidone mesilate: 10-20 mg as needed, to max 40 mg daily for 3 consecutive days. Doses of 10 mg may be given 2 hrly and doses of 20 mg may be repeated 4 hrly. Switch to oral therapy as soon as possible.
Elderly: Lower initial dose and slower titration.

Oral
Schizophrenia
Adult: As ziprasidone HCl: Initially, 20 mg bid, increase if necessary at intervals of not <2 days up to 80 mg bid. Maintenance: 20 mg bid.
Elderly: Lower initial dose and slower titration.

Oral
Acute manic episodes of bipolar disorder, Acute mixed episodes of bipolar disorder
Adult: As ziprasidone HCl: Initially, 40 mg bid, increased to 60 mg or 80 mg bid on the 2nd day. Adjust subsequent doses according to patient's response and tolerance level. Maintenance treatment of bipolar I disorder (adjunctive therapy to either lithium or valproate): Continue at the same dosage on which the patient was initially stabilised w/in 40-80 mg bid.
Elderly: Lower initial dose and slower titration.
Administration
Should be taken with food.
Reconstitution
Add 1.2 mL of sterile water for inj to the vial to obtain a soln containing 20 mg/mL.
Contraindications
Patient w/ history of QT prolongation or cardiac arrhythmias, recent acute MI or decompensated heart failure. Concurrent use w/ other drugs known to prolong the QT interval.
Special Precautions
Patient w/ history of seizures or conditions that lower the seizure threshold, CV or cerebrovascular disease, conditions which predispose to hypotension. Renal impairment. Elderly w/ dementia-related psychosis. Pregnancy and lactation.
Adverse Reactions
Somnolence, rash or urticaria, GI disturbances, dizziness, flu-like symptoms, HTN, headache, agitation, confusion, dyspnoea, orthostatic hypotension, increased prolactin levels, wt gain, sexual dysfunction, extrapyramidal symptoms, tardive dyskinesia, hyperglycaemia. Rarely, cholestatic jaundice, hepatitis, seizures, leucopenia, neutropenia, thrombocytopenia, hyperlipidaemia.
Potentially Fatal: Life-threatening arrhythmias e.g. torsades de pointes and sudden death, neuroleptic malignant syndrome, agranulocytosis, drug reaction w/ eosinophilia and systemic symptoms (DRESS).
IM/Parenteral/PO: C
Patient Counseling Information
This drug may cause somnolence, impairment of judgment, thinking or motor skills, if affected, do not drive, operate machinery or perform hazardous tasks. Avoid alcohol.
MonitoringParameters
Monitor serum electrolytes if on concurrent diuretic therapy. Monitor ECG in patients who show symptoms of torsades de pointes (e.g. syncope, dizziness, palpitations); wt gain. Closely monitor worsening of glucose control in patients w/ pre-existing DM. Frequently monitor CBC during 1st few mth of therapy in patients w/ pre-existing low leucocyte count or history of drug-induced leucopenia or neutropenia.
Overdosage
Symptoms: Minimal sedation, slurred speech, transitory HTN, extrapyramidal symptoms, somnolence, tremor, anxiety. Management: Establish and maintain an airway, ensure adequate oxygenation and ventilation. Consider admin of activated charcoal together w/ a laxative, gastric lavage (after intubation for unconscious patient); established IV access. Treat hypotension and circulatory collapse w/ IV fluids. In case of severe extrapyramidal symptoms, anticholinergic medication should be given.
Drug Interactions
May antagonise effects of levodopa and dopaminergics. May enhance effects of other CNS depressants and certain antihypertensives. Altered metabolism w/ CYP3A4 inducers (e.g. carbamazepine), and inhibitors (e.g. ketoconazole).
Potentially Fatal: Increased risk of arrhythmias w/ drugs known to prolong QT interval (e.g. dofetilide, quinidine, sotalol, other class Ia and III antiarrhythmics, moxifloxacin, pimozide, sparfloxacin, thioridazine).
Food Interaction
Absorption is increased up to 2-fold in the presence of food. Additive CNS effects w/ alcohol.
Action
Description: Ziprasidone, a benzylisothiazolylpiperazine is an atypical antipsychotic which may produce antischizophrenic effect by the antagonism of central dopamine D2 receptors and central type 2 serotonergic (5-HT2) receptors.
Pharmacokinetics:
Absorption: Well absorbed from the GI tract. Food may double the absorption. Time to peak plasma concentration: 6-8 hr (oral); w/in 1 hr (IM).
Distribution: Volume of distribution: 1.5 L/kg. Plasma protein binding: Approx 99%.
Metabolism: Extensively hepatic by aldehyde oxidase (approx 66% of a dose) and by the CYP3A4 isoenzyme.
Excretion: Mainly as metabolites via faeces (approx 66%) and urine (approx 20%); <5% as unchanged drug. Mean terminal elimination half-life: Approx 7 hr (oral); approx 2-5 hr (IM).
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 15-30°C. Reconstituted soln: Store between 15-30°C for up to 24 hr or 2-8°C for up to 7 days. Protect from light.
MIMS Class
ATC Classification
N05AE04 - ziprasidone ; Belongs to the class of indole derivatives antipsychotics.
Disclaimer: This information is independently developed by MIMS based on Ziprasidone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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