Geodon ZIPRASIDONE 60 mg
1 INDICATIONS AND USAGE GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3) ] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3) ] GEODON is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of GEODON to prolong the QT interval and may consider the use of other drugs first ( 1 ) GEODON capsules are indicated for the: • treatment of schizophrenia in adults. ( 1 ) • acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. ( 1 ) • maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. ( 1 ) GEODON for injection is indicated for the: • acute treatment of agitation in schizophrenic patients in adults. ( 1 ) Schizophrenia • GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) • GEODON is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2) ]. • GEODON is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2) ] . Acute Treatment of Agitation in Schizophrenia • GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation [see Clinical Studies (14.1) ]. Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
Roerig
CAPSULE WHITE Pfizer Zdx 60
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16 HOW SUPPLIED/STORAGE AND HANDLING GEODON capsules are differentiated by capsule color/size and are imprinted in black ink with "Pfizer and ZDX [dosage strength]" or with "Pfizer" and a unique number. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied in the following strengths and package configurations: GEODON capsules Package Configuration capsule Strength (mg) NDC (National Drug Code) Imprint Bottles of 60 20 0049-0052-60 or 0049-0352-60 ZDX 20 Bottles of 60 40 0049-0054-60 or 0049-0354-60 ZDX 40 Bottles of 60 60 0049-0056-60 or 0049-0356-60 ZDX 60 Bottles of 60 80 0049-0058-60 or 0049-0358-60 ZDX 80 or GEODON capsules Package Configuration capsule Strength (mg) NDC Imprint Bottles of 60 20 0049-3960-60 396 Bottles of 60 40 0049-3970-60 397 Bottles of 60 60 0049-3980-60 398 Bottles of 60 80 0049-3990-60 399 GEODON capsules should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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