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ZIPRASIDONE Hydrochloride Capsules (GREENSTONE LLC)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ZIPRASIDONE Hydrochloride Capsules (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death....

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1 INDICATIONS AND USAGE

Ziprasidone 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...

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2 DOSAGE AND ADMINISTRATION

2.1 Schizophrenia

Dose Selection

Ziprasidone...

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3 DOSAGE FORMS AND STRENGTHS

Ziprasidone capsules are differentiated by capsule color/size and are imprinted in black ink with "G" and a unique number. Ziprasidone capsules are supplied for oral administration in 20 mg (blue...

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4 CONTRAINDICATIONS

4.1 QT Prolongation

Because of ziprasidone's dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT...

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5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.3 Dependence

Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical...

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10 OVERDOSAGE

10.1 Human Experience

In premarketing trials involving more than 5400 patients and/or normal subjects, accidental or intentional overdosage of oral...

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11 DESCRIPTION

Ziprasidone is an atypical antipsychotic available as capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis...

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14 CLINICAL STUDIES

14.1 Schizophrenia

The efficacy of oral ziprasidone in the treatment of schizophrenia was evaluated in 5 placebo-controlled studies, 4 short-term...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Ziprasidone capsules are differentiated by capsule color/size and are imprinted in black ink with "G" and a unique number. Ziprasidone capsules are supplied for oral administration in 20...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Administration...

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This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

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