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During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period.
Suicidality: The occurrence of suicidal behavior is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with Aripiprazole. Close supervision of high-risk patients should accompany antipsychotic treatment.
Cardiovascular disorders: 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), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant. Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors of VTE should be identified before and during treatment with Aripiprazole and preventive measures taken.
QT prolongation: Aripiprazole should be used with caution in patients with a family history of QT prolongation.
Tardive dyskinesia: If signs and symptoms of tardive dyskinesia appear in a patient on Aripiprazole, dose reduction or discontinuation should be considered. These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Other extrapyramidal symptoms: If signs and symptoms of other EPS appear in a patient taking Aripiprazole, dose reduction and dose clinical monitoring should be considered.
Neuroleptic Malignant Syndrome (NMS): NMS is potentially fatal symptom complex associated with antipsychotics. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including Aripiprazole, must be discontinued.
Seizure: Aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Elderly patients with dementia-related psychosis: Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis due to increased mortality and cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack).
Hyperglycemia and diabetes mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Aripiprazole. Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Patients treated with any antipsychotics, including Aripiprazole, should be observed for signs and symptoms of hyperglycemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Hypersensitivity: Hypersensitivity reactions, characterized by allergic symptoms, may occur with Aripiprazole.
Weight gain: Weight gain is commonly seen in schizophrenic and bipolar mania patients due to co-morbidities, use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe complications. When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma. If weight gain is clinically significant, dose reductions should be considered.
Dysphagia: Esophageal dysmotility and aspiration have been associated with the use of antipsychotics, including Aripiprazole.
Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Pathological gambling and other impulse control disorders: Patients experience increased urges, particularly for gambling, and the inability to control these urges while taking Aripiprazole. Other urges, reported, include: increased sexual urges, compulsive shopping, binge or compulsive eating, and other impulsive and compulsive behaviors. It is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with Aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Impulse control disorders may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges while taking Aripiprazole.
Lactase: The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorptions should not take this medicinal product.
Patients with attention deficit hyperactivity disorder (ADHD) comorbidity: Extreme caution should be taken when these medicinal products are co-administered.
Falls: Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g. elderly or debilitated patients).
