Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

dynastat_product

Indications¹

Cap Treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy. Treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. Inj Rapid control of agitation in schizophrenic patients when oral administration therapy is inappropriate.

Clinical Evidence

Significant improvement in controlling the overall symptoms of an acute exacerbation of schizophrenia²

A 6-week, double-blind, placebo-controlled, multicentre study of 302 patients with acute exacerbation of schizophrenia or schizoaffective disorder. After a 3–7 day washout period, patients were randomized to receive either ziprasidone 80 mg/day, ziprasidone 160 mg/day or placebo for 6 weeks.

Effective in improving positive and negative symptoms of schizophrenia

Significant improvement in positive and negative syndrome scale (PANSS) scores after 6 weeks³

Safety Profile¹

CI:	Known QT interval prolongation including congenital long QT syndrome. Recent myocardial infarction. Uncompensated heart failure. Arrhythmias treated with class IA & III antiarrhythmic drugs. Lactation.

SP:	Patients at risk of arrhythmia, eg, bradycardia, electrolyte imbalance, concomitant use with other drugs that prolong the QT. Discontinue if QTc interval >500 msec and if patient develops neuroleptic malignant syndrome (NMS) or unexplained high fever without additional clinical manifestations of NMS. Tardive dyskinesia, seizure. Avoid alcohol. Elderly with dementia-related psychosis. May impair ability to drive or operate machinery. Pregnancy, hepatic insufficiency. Vial Not recommended in elderly >65 years.

AR:	Somnolence; agitation, insomnia; akathisia, dizziness, dystonia, extrapyramidal syndrome, headache, hypertonia, tremor; abnormal vision; constipation, dry mouth, dyspepsia, increased salivation, nausea, vomiting; asthenia. Vial Injection site pain.

DI:	Class IA & III antiarrhythmics, drugs that prolong QT interval, centrally acting drugs, alcohol.

Dosages¹

Cap Adults Schizophrenia 40–80 mg bid. Max: 80 mg bid. Dosage adjustments should occur at intervals of not <2 days. Maintenance: 20 mg bid. Bipolar mania Initially 40 mg bid, may be increased to 60 or 80 mg bid on second day and subsequently adjusted to 40–80 mg bid.

Vial Initially, 10–20 mg IM. Repeat doses: If the initial dose was 10 mg, repeat doses may be given as 10 mg 2 hourly up to max 40 mg/day. If the initial dose was 20 mg, repeat doses may be given as 10 mg after 4 hours and thereafter 10 mg 2 hourly up to max 40 mg/day. Max treatment duration: 3 consecutive days.

Strengths¹

Cap 20 mg, 40 mg, 60 mg, 80 mg.
Vial 20 mg/mL.

Packing¹

Cap 20 mg x 60's. 40 mg x 60's. 60 mg x 60's. 80 mg x 60's.
Vial 20 mg/mL x 1's.

References

1. MIMS Annual Hong Kong. 2007/2008 edition.
2. Daniel DG, et al. Neuropsychopharmacology 1999;20:491-505.
3. Weiden PJ, et al.J Clin Psychiatry 2003;64:580-588.

Please review the full product information or package insert before prescribing.