Zipradon

• Do not use in patients with a known history of QT prolongation
• Do not use in patients with recent acute myocardial infarction
• Do not use in patients with uncompensated heart failure
• Do not use in combination with other drugs that have demonstrated QT prolongation
• Do not use in patients with known hypersensitivity to ziprasidone

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 Zipradon group): Headache, nausea, somnolence.

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack).

QT Interval Prolongation: Zipradon 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.

Severe Cutaneous Adverse Reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome has been reported with Zipradon exposure. DRESS and other Severe Cutaneous Adverse Reactions (SCAR) are sometimes fatal. Discontinue Zipradon if DRESS or SCAR are 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 Zipradon 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.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.