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SEROQUEL XR®(quetiapine fumarate) Extended-Release Tablets (十)
2016-02-26 10:31:11 来源: 作者: 【 】 浏览:16200次 评论:0
CNS) pathology.

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. There is no general agreement about specific pharmacological treatment regimens for NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored since recurrences of NMS have been reported.
5.4 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 quetiapine. 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 in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse reactions 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 (eg, 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.

Table 2: Fasting Glucose—Proportion of Patients Shifting to ≥ 126 mg/dL in short-term (≤ 12 weeks) Placebo Controlled Studies  Laboratory Analyte Category Change (At Least Once) from Baseline Treatment Arm N Patients n(%)
Fasting Glucose
 Normal to High

(<100 mg/dL to ≥ 126 mg/dL)
 Quetiapine
 2907
 71 (2.4%)
 
Placebo
 1346
 19 (1.4%)
 
Borderline to High

(≥ 100 mg/dL and <126 mg/dL) to ≥ 126 mg/dL
 Quetiapine
 572
 67 (11.7%)
 
Placebo
 279
 33 (11.8%)
Adults:

In a 24-week trial (active-controlled, 115 patients treated with SEROQUEL) designed to eva luate glycemic status with oral glucose tolerance testing of all patients, at week 24 the incidence of a treatment-emerg

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