Quetaz Special Precautions

Suicide/suicidal thoughts or clinical worsening: Depression in bipolar disorder is associated with an increased risk of suicidal thoughts, self-harm and suicide. Physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to be a greater risk of suicidal thoughts or suicide attempts, should receive careful monitoring during treatment. A meta-analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behavior and to seek medical advice immediately if these symptoms present.
Tardive Dyskinesia: If signs and symptoms of tardive dyskinesia (a syndrome of potentially, irreversible, involuntary, dyskinetic movement) appear, dose reduction or discontinuation of quetiapine should be considered.
Neuroleptic Malignant Syndrome: Neuroleptic Malignant Syndrome has been associated with antipsychotic treatment, including quetiapine. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatinine phosphokinase. In such an event, quetiapine should be discontinued and appropriate medical treatment given.
Hyperglycemia: Hyperglycemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases. In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilized antipsychotic agent including quetiapine, 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. Weight should be monitored regularly.
Orthostatic hypotension: Quetiapine treatment has been associated with orthostatic hypotension and related dizziness which, like somnolence has onset usually during the initial dose-titration period. This could increase the occurrence of accidental injury (fall), especially in the elderly population. Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Dose reduction or more gradual titration should be considered if orthostatic hypotension occurs, especially in patients with underlying cardiovascular disease.
Cardiomyopathy and Myocarditis: Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established. Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis.
Ocular Effects: The development of cataracts in association with quetiapine was observed in animal studies. Lens changes also have been reported in some patients receiving long-term quetiapine therapy, although a causal relationship has not been established.
Seizures: Seizures occurred in 0.6% of patients receiving quetiapine in controlled clinical trials. Use with caution when treating patients with a history of seizures.
Somnolence and Dizziness: Quetiapine treatment has been associated with somnolence and related symptoms, such as sedation.
Endocrine effect: Dose-related decrease in total and free thyroxine (T₄) of approximately 20% were observed in patients receiving quetiapine dosage at the higher end of the therapeutic dosage range during clinical studies. Increase in TSH were observed in about 0.4% or 12% of patients receiving quetiapine alone or in conjunction with lithium or divalproex sodium, respectively. In patients receiving quetiapine monotherapy, thyroid replacement therapy was necessary in some patients who experienced increase in TSH.
Weight: Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilized antipsychotic guideline.
Lipids: Increases in LDL and total cholesterol have been observed in clinical trials with quetiapine. Lipid changes should be managed as clinically appropriate.
Hepatic Effects: Asymptomatic, transit, and reversible increases in serum transaminases, principally ALT, have been reported in patients receiving quetiapine; these changes usually occurred within the first 3 weeks and resolved despite continued quetiapine therapy.
Anticholinergic (muscarinic) effects: Norquetiapine, an active metabolite of quetiapine, has moderate to strong affinity for several muscarinic receptor subtypes. Quetiapine should be used with caution in patients receiving medications having anticholinergic (muscarinic) effects. Quetiapine should be used with caution in patients with a current diagnosis or prior history of related disease with cholinergic effect such as urinary retention, priapism, clinically significant prostatic hypertrophy, intestinal obstruction or related conditions, increased intraocular pressure or narrow angle glaucoma.
Extrapyramidal symptoms: Quetiapine is associated with an increased incidence of extrapyramidal symptoms (EPS).
Dysphagia: Dysphagia has been reported with quetiapine. Quetiapine should be used with caution in patients at risk for aspiration pneumonia.
Withdrawal: Acute withdrawal symptoms such as insomnia, nausea, vomiting, dizziness, and irritability have been described after abrupt cessation of quetiapine.
Use in the Elderly: Elderly patients with dementia-related psychosis: Quetiapine is not approved for the treatment of dementia-related psychosis an increased risk of cardiovascular adverse events has been seen in randomized placebo controlled trials with some atypical antipsychotics. The mechanism for this increased risk is not known.