Victus Special Precautions



Amherst Lab


Full Prescribing Info
Special Precautions
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Quetiapine is not approved for the treatment of patients with Dementia-Related Psychosis.
Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive quetiapine or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond 24 years old; there was a reduction in risk with antidepressants compared to placebo in adults ≥ 65 years old. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Quetiapine is not approved for use in pediatric patients < 10 years old.
General: Screening Patients for Bipolar Disorder: Bipolar disorder may initially present as a major depressive episode. Treating a major depressive episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Adequately screen patients with depressive symptoms if they are at risk for bipolar disorder before starting antidepressant treatment. Include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) during such screening. It should be noted that quetiapine is approved for use in treating adult bipolar depression.
Body Temperature Regulation: Appropriate care is advised when prescribing quetiapine to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant drugs with anticholinergic activity, or being subject to dehydration.
Withdrawal: Acute withdrawal symptoms such as nausea, vomiting and insomnia have rarely been reported, after abrupt cessation of atypical antipsychotic drugs including quetiapine. Gradual withdrawal is advised.
Cardiovascular Effects: Orthostatic Hypotension: Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its α1-adrenergic antagonist properties.
Quetiapine should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions which would predispose patients to hypotension (dehydration, hypovolemia and treatment with antihypertensive drugs). The risk of hypotension and syncope may be minimized by limiting the initial dose to 25 mg two times a day. If hypotension occurs during titration to the target dose, a return to the previous dose in the titration schedule is appropriate.
Increases in Blood Pressure in Children and Adolescents: Placebo-controlled trials in children and adolescents with schizophrenia or bipolar mania showed increases at any time in systolic blood pressure (≥ 20 mmHg) of 15.2% for quetiapine and 5.5% for placebo. The incidence of increases at any time in diastolic blood pressure (≥10 mmHg) was 40.6% for quetiapine and 24.5% for placebo. It is recommended that blood pressure in children and adolescents should be measured at the beginning of, and periodically during treatment.
QT Prolongation: Post marketing cases reported QT prolongation in patients who overdosed on quetiapine (see Overdosage), in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval (see Interactions).
Quetiapine should be avoided in circumstances that may increase the risk of occurrence of torsades de pointes and/or sudden death including (1) a history of cardiac arrhythmias such as bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong QTc interval; and (4) presence of congenital prolongation of the QT interval.
Exercise caution when quetiapine is prescribed in patients with increased risk of QT prolongation (e.g., cardiovascular disease, family history of QT prolongation, the elderly, congestive heart failure and heart hypertrophy).
Endocrine and Metabolic Effects: Cholesterol and Triglyceride Elevations: Very common cases of elevations in serum triglyceride levels (≥ 2.258 mmol/L on at least one occasion), elevations in total cholesterol (predominantly LDL cholesterol; ≥ 6.2064 mmol/L on at least one occasion), and decreases in HDL cholesterol (< 1.025 mmol/L males; < 1.282 mmol/L females at any time) have been observed during treatment with quetiapine. Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using quetiapine is recommended.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia and occasional reports of diabetes have been seen with quetiapine use. Patients who are at risk for developing diabetes (e.g., obesity and a family history of diabetes) should have appropriate clinical monitoring of blood sugar. Any patient who develops manifestations of hyperglycemia (e.g., polydipsia, polyuria, polyphagia, and weakness) during atypical antipsychotic therapy should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued. However, some patients required continuation of anti-diabetic treatment despite discontinuation.
Weight Gain: Increases in weight have been observed with quetiapine use. Patients receiving quetiapine should receive regular monitoring of weight.
Hyperprolactinemia: Like other drugs that antagonize dopamine D2 receptors, quetiapine elevates prolactin levels in some patients and the elevation may persist during chronic administration. Hyperprolactinemia, regardless of etiology, may suppress hypothalamic gonadotropin-releasing hormone (GnRH), resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.
Hypothyroidism: Clinical trials with quetiapine demonstrated dose-related decreases in thyroid hormone levels. The reduction in total and free thyroxine (T4) of approximately 20% at the higher end of the therapeutic dose range was maximal in the first 6 weeks of treatment and maintained without adaptation or progression during more chronic therapy. In nearly all cases, cessation of quetiapine treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment. Both thyroid-stimulating hormone (TSH) and free T4, in addition to clinical assessment, should be measured as baseline and at follow-up.
Gastrointestinal Effects: Antiemetic Effect: Consistent with its dopamine antagonist effects, quetiapine may have an antiemetic effect. Such an effect may mask signs of toxicity due to overdosage of other drugs, or may mask symptoms of disease such as brain tumor or intestinal obstruction.
Dysphagia and Aspiration Pneumonia: The use of antipsychotic drugs has been associated with esophageal dysmotility and aspiration. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Quetiapine and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
Genitourinary Effects: Priapism: Rare cases of priapism have been reported with antipsychotic use, such as quetiapine. This adverse reaction did not appear to be dose-dependent and did not correlate with the duration of treatment. Severe priapism may require surgical intervention.
Hematologic Effects: Leukopenia, Neutropenia and Agranulocytosis: There have been reports of leukopenia/neutropenia (including severe neutropenia) and agranulocytosis temporally related to atypical antipsychotic agents, including quetiapine.
Possible risk factors for leukopenia/neutropenia include pre-existing low white cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue quetiapine at the first sign of a decline in WBC in the absence of other causative factors.
Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1000/mm3) should discontinue quetiapine and have their WBC followed until recovery.
Venous Thromboembolism: Venous thromboembolism (VTE), including fatal pulmonary embolism, has been reported with antipsychotic agents, including quetiapine. When prescribing quetiapine, all potential risk factors for VTE should be identified and preventive measures undertaken.
Hepatic/Pancreatic Effects: Transaminase Elevations: There have been reports of asymptomatic, transient and reversible elevations in serum transaminases (primarily alanine transaminase or ALT).
Pancreatitis: Pancreatitis has been reported with the use of quetiapine. Many patients had risk factors which were known to be associated with pancreatitis such as increased triglycerides, gallstones, and alcohol consumption.
Neurologic and Psychiatric Effects: Cerebrovascular Adverse Reactions (including stroke) in Elderly Patients with Dementia-Related Psychosis: In placebo-controlled trials with antipsychotic drugs in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. Quetiapine is not approved for the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome: Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported rarely in patients receiving antipsychotic agents, including quetiapine. 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.
Reintroduction of drug therapy should be carefully considered if a patient requires antipsychotic therapy following recovery from NMS. The patient should be carefully monitored since recurrences of NMS have been reported.
Tardive Dyskinesia: Antipsychotic agents including quetiapine may be associated with tardive dyskinesia, a syndrome of potentially irreversible, involuntary and dyskinetic movements. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
Chronic antipsychotic treatment should generally be reserved for patients (1) who suffer from a chronic illness that is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.
If signs and symptoms of tardive dyskinesia appear in a patient on quetiapine, drug discontinuation should be considered. However, some patients may require treatment with quetiapine despite the presence of the syndrome.
Potential for Cognitive and Motor Impairment: Since quetiapine has the potential to impair judgment, thinking or motor skills, patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery until they are reasonably certain that quetiapine therapy does not affect them adversely. Somnolence may lead to falls.
Suicide: The possibility of a suicide attempt is inherent in bipolar disorder and schizophrenia; close supervision of high risk patients should accompany drug therapy. Prescriptions for quetiapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Seizures: As with other antipsychotic agents, caution is recommended when treating patients with a history of seizures or with conditions that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of ≥65 years old.
Ophthalmologic Effects: Cataracts: Lens changes have been reported in patients during long-term quetiapine therapy. Examination of the lens by slit lamp exam is recommended at initiation of treatment or shortly thereafter, and at six month intervals during chronic treatment.
Use in Children (< 18 years old): The safety and efficacy of quetiapine has only been established for schizophrenia in adolescents 13 to 17 years old and for bipolar mania in children and adolescents 10 to 17 years old.
The safety and efficacy of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. The safety and efficacy of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients < 18 years old.
The safety and efficacy of quetiapine in pediatric patients < 10 years old with bipolar mania has not been established.
The safety and efficacy of quetiapine in pediatric patients < 18 years old with bipolar depression has not been established.
Adverse reactions observed in children and adolescents during clinical trials were generally similar to those in adults with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. Orthostatic hypotension occurred more frequently in adults compared to children and adolescents.
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