Aricog Aripiprazole Special Precautions

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Aripiprazole. The management of NMS should include: 1. Immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2. Intensive symptomatic treatment and medical monitoring; and 3. Treatment of any concomitant serious medical problems for which specific treatments are available.
Tardive Dyskinesia: If signs and symptoms of tardive dyskinesia appear in a patient on Aripiprazole, drug discontinuation should be considered. However, some patients may require treatment with Aripiprazole despite the presence of the syndrome.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia in some cases is extreme and associated with ketoacidosis or hyperosmolar coma or death in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood.
However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
General: Orthostatic Hypotension: Aripiprazole may be associated with orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. The incidences of orthostatic hypotension-associated events are very rare. Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities).
Seizure: As with other antipsychotic drugs, Aripiprazole should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer's dementia.
Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Aripiprazole for patients.
Dysphagia: Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
Suicide: The possibility of a suicide attempt is inherent in psychotic illnesses, and close supervision of high-risk patients should accompany drug therapy.
Interference with Cognitive and Motor Performance: Because Aripiprazole may have the potential to impair judgement, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Aripiprazole therapy does not affect them adversely.
Concomitant Medication: Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.
Alcohol: Patients should be advised to avoid alcohol while taking Aripiprazole.
Heat Exposure and Dehydration: Patients should be advised regarding appropriate care in avoiding overheating and dehydration.
Effects on Ability to Drive and Use Machines: Patients should be cautioned about operating hazardous machines, including motor vehicles until they are reasonably certain that aripiprazole does not affect them adversely.