Important Safety Information
Elderly patients with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death compared to placebo. GEODON is not approved for
the treatment of patients with dementia-related psychosis.
GEODON is contraindicated in patients with a known history of QT prolongation, recent
acute myocardial infarction, or uncompensated heart failure, and should not be used
with certain other QT-prolonging drugs. GEODON has a greater capacity to prolong
the QTc interval than several antipsychotics. In some drugs, QT prolongation has
been associated with torsade de pointes, a potentially fatal arrhythmia. In many
cases this would lead to the conclusion that other drugs should be tried first.
Hypokalemia may increase the risk of QT prolongation and arrhythmia.
As with all antipsychotic medications, a rare and potentially fatal condition known
as neuroleptic malignant syndrome (NMS) has been reported with GEODON. NMS can cause
hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood
pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms
appear, immediate discontinuation, treatment, and monitoring are recommended.
Prescribing should be consistent with the need to minimize tardive dyskinesia (TD),
a potentially irreversible dose- and duration-dependent syndrome. If signs and symptoms
appear, discontinuation should be considered since TD may remit partially or completely.
Hyperglycemia-related adverse events, sometimes serious, have been reported in patients
treated with atypical antipsychotics. There have been few reports of hyperglycemia
or diabetes in patients treated with GEODON, and it is not known if GEODON is associated
with these events. Patients treated with an atypical antipsychotic should be monitored
for symptoms of hyperglycemia.
Precautions include the risk of rash, orthostatic hypotension, and seizures.
In short-term schizophrenia trials, the most commonly observed adverse events associated
with GEODON at an incidence of ≥5% and at least twice the rate of placebo were somnolence
and respiratory tract infection.
The most common adverse events associated with GEODON in bipolar mania were somnolence,
extrapyramidal symptoms, dizziness, akathisia, and abnormal vision.
In short-term schizophrenia clinical trials, 10% of GEODON-treated patients experienced
a weight gain of ≥7% of body weight vs. 4% for placebo.
In fixed-dose, pivotal studies, the most commonly observed adverse events associated
with the use of GEODON for Injection (incidence ≥5%) and observed at a rate in the
higher GEODON dose groups (10 mg, 20 mg) of at least twice that of the lowest GEODON
dose group (2 mg control) were somnolence (20%), headache (13%), and nausea (12%).
IM administration of GEODON for more than 3 consecutive days has not been studied.
Since there is no experience regarding the safety of administering GEODON for Injection
to schizophrenic patients already taking oral GEODON, the practice of coadministration
is not recommended.
GEODON for Injection has not been systematically evaluated in elderly patients or
in patients with hepatic or renal impairment. As the cyclodextrin excipient is cleared
by renal filtration, GEODON should be administered with caution to patients with
impaired renal function.