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Uses
Side effects
Interactions
Precautions
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
GEODON is indicated as an oral formulation for the: Treatment of schizophrenia.
- Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in adult patients with schizophrenia. Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder.
- Adults: Efficacy was established in two 3-week trials in adult patients with manic or mixed episodes. Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.
- Adults: Efficacy was established in one maintenance trial in adult patients. GEODON as an intramuscular injection is indicated for the: Acute treatment of agitation in schizophrenic patients.
- Adults: Efficacy was established in two short-term trials in agitated patients with schizophrenia.
Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were:
- Schizophrenia: Somnolence, respiratory tract infection.
- Manic and Mixed Episodes Associated with Bipolar Disorder: Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting.
- Intramuscular administration (≥5% and at least twice the lowest intramuscular ziprasidone group): Headache, nausea, somnolence.
- Ziprasidone should not be used in combination with other drugs that have demonstrated QT prolongation.
- The absorption of ziprasidone is increased up to two-fold in the presence of food.
- The full prescribing information contains additional drug interactions.
- QT Interval Prolongation: GEODON use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation.
- Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with Ziprasidone exposure. DRESS is sometimes fatal. Discontinue Geodon if DRESS is suspected.
- Tardive Dyskinesia: May develop acutely or chronically.
- Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
- Hyperglycemia and Diabetes Mellitus (DM): Monitor all patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with DM risk factors should undergo blood glucose testing before and during treatment.
- Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
- Weight Gain: Weight gain has been reported. Monitor weight gain.
- Rash: Discontinue in patients who develop a rash without an identified cause.
- Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease.
- Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Geodon at the first sign of a decline in WBC in the absence of other causative factors.
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Potential for Cognitive and Motor impairment: Patients should use caution when operating machinery.
- Suicide: Closely supervise high-risk patients.
