Clinical Pharmacology Details


ZIPRASIDONE HCL


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Indications & Dose:

Management of schizophrenia and other psychotic disorders, and for maintenance of clinical improvement and prevention of relapse during continuation therapy.



Adults: 40 mg twice daily, to be 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



IM: 10 mg q2hr or 20 mg q4hr; not to exceed 40 mg/day; use IM for up to 3 days, and switch to PO if continuing past this time

Contraindications:

 Known hypersensitivity to ziprasidone or any of the excipients; Known QT interval prolongation including congenital long QT Syndrome; Recent myocardial infarction; Uncompensated heart failure; Cardiac arrhythmias requiring treatment with Class IA and III antiarrhythmic drugs.


Children: Safety and effectiveness in children under 18 years have not been established.


Elderly: Generally, no dosage adjustment is required in elderly patients (65 years and over).


Renal Impairment: No dosage adjustment is required in patients with renal impairment.


Hepatic Impairment: In patients with mild to moderate hepatic insufficiency, lower doses should be considered. There is a lack of experience in patients with


severe hepatic insufficiency and ziprasidone should be used with caution in this group. (See Section Pharmacokinetic Properties.)


Use in Smokers: No dosage adjustment is required in patients who smoke. 

Side Effects:

 The following adverse reactions have been reported during post-marketing experience:


Cardiovascular: postural hypotension.


Heart Rate/Rhythm: tachycardia


Psychiatric: insomnia


Skin and Appendages: rash. 

Cautions:

Precautions:

Interaction:

DRUGS


antihypertensives Additive antihypertensive effects carbamazepine: Possibly decreased blood ziprasidone level CNS depressants: Increased


CNS depression dopamine agonists, levodopa: Decreased therapeutic effects of these drugs drugs that prolong


QT interval (including quinidine, dofetilide, pimozide, sotalol, thioridazine, and sparfloxacin): Increased risk of prolonged QT or QTc interval,


torsades de pointes, and sudden death ketoconazok: Possibly increased blood ziprasidone level 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: