Apalife 10/Apalife 15

Apalife 10/Apalife 15 Warnings

aripiprazole

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Warnings
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. Assessment of the relationship between atypical antipsychotics 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 in general population. Given this 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.
Pathological gambling and impulse-control problems: Patients can 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, or other urges, while being treated with Aripiprazole. It should be noted that impulse-control symptoms can be associated with underlying disorder; however, in some cases urges were reported to have stopped when the dose was reduced or the medication was discontinued. Patients who are at higher risk for impulse-control problems (e.g. personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse or other addictive behaviors) would require monitoring for new or worsening of uncontrollable urges. Impulse-control problems may results 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.
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