Drug Interactions between lithium and Seroquel

Alcohol can increase the nervous system side effects of lithium such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with lithium. Do not use more than the recommended dose of lithium, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. Talk to your doctor or pharmacist if you have any questions or concerns.

Grapefruit or grapefruit juice should not be consumed during treatment with QUEtiapine. Grapefruit juice can significantly increase the blood levels and effects of QUEtiapine, which can increase the risk and/or severity of side effects including drowsiness; dry mouth; constipation; increased appetite; weight gain; increased blood sugar and cholesterol or triglyceride levels; cognitive and motor impairment; involuntary muscle movements involving the face, tongue, or other parts of the body; difficulty swallowing; and seizures. Consuming grapefruit juice together with QUEtiapine may also increase the risk of two potentially life-threatening, but uncommon conditions: serotonin syndrome and a change in the electrical activity of your heart called QT prolongation. Immediate medical attention is required if you experience symptoms of either condition such as: nausea, vomiting, and diarrhea; agitation; confusion; fast or irregular heartbeat; sweating; flushing; seizures; hallucinations; blood pressure changes; shaking, stiff muscles, or muscle twitching; dizziness; high body temperature; loss of coordination; lightheadedness; and/or fainting. You might be more susceptible to QT prolongation if you have heart problems, uncontrolled hypothyroidism, or electrolyte disturbances (for example, magnesium or potassium loss due to severe or prolonged diarrhea or vomiting). It is best to avoid or limit the consumption of alcohol, as it can increase drowsiness or other nervous system side effects of QUEtiapine. Extended-release formulations of QUEtiapine should be taken without food or with a light meal. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Using caffeine together with lithium may increase the effects of caffeine. Contact your doctor if you experience nausea, vomiting, diarrhea, drowsiness, muscle weakness, tremor, lack of coordination, blurred vision, or ringing in your ears. If your doctor does prescribe these medications together, you may need a dose adjustment or special test to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Some atypical antipsychotic agents can prolong the QTc interval of the electrocardiogram in a dose-dependent manner. Electrolyte disturbances such as hypokalemia and hypomagnesemia may augment the prolongation effect of these agents on the QT interval and should be corrected prior to institution of therapy. In addition, patients who experience frequent, severe, or prolonged diarrhea may be subject to electrolyte losses and should be followed closely and managed accordingly during therapy with these agents. Atypical antipsychotic agents should be avoided in patients with a history of cardiac arrhythmias or other conditions that may increase the risk of torsade de pointes and/or sudden death, including bradycardia; hypokalemia or hypomagnesemia; and congenital long QT syndrome.

The use of neuroleptic agents is contraindicated in patients with acute alcohol intoxication exhibiting depressed vital signs. The central nervous system depressant effects of neuroleptic agents may be additive with those of alcohol. Severe respiratory depression and respiratory arrest may occur. Therapy with neuroleptic agents should be administered cautiously in patients who might be prone to acute alcohol intake.

Antipsychotics can lower the seizure threshold and trigger seizures in a dose-dependent manner. Seizures have been reported in patients receiving antipsychotic therapy and may occur in epileptic patients even with maintenance of routine anticonvulsant treatment. Therapy with antipsychotics should be administered cautiously in patients with a history of seizures or other predisposing factors, such as head trauma, CNS abnormalities, and alcoholism. High dosages should be avoided if possible.

The use of neuroleptic agents is contraindicated in comatose patients and patients with severe central nervous system depression. Neuroleptic agents may potentiate the CNS and respiratory depression in these patients.

Some atypical antipsychotic agents can prolong the QTc interval of the electrocardiogram in a dose-dependent manner. Electrolyte disturbances such as hypokalemia and hypomagnesemia may augment the prolongation effect of these agents on the QT interval and should be corrected prior to institution of therapy. In addition, patients who experience frequent, severe, or prolonged diarrhea may be subject to electrolyte losses and should be followed closely and managed accordingly during therapy with these agents. Atypical antipsychotic agents should be avoided in patients with a history of cardiac arrhythmias or other conditions that may increase the risk of torsade de pointes and/or sudden death, including bradycardia; hypokalemia or hypomagnesemia; and congenital long QT syndrome.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials; these trials did not show increased risk in patients older than 24 years and risk was reduced in patients 65 years and older. Adult and pediatric patients with major depressive disorder may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressants; this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders; such disorders are the strongest predictors of suicide. Patients of all ages treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of drug therapy, and at times of dose changes. Family members/caregivers should be advised to monitor for changes in behavior and to notify the health care provider. Changing the therapeutic regimen (including discontinuing the medication) should be considered in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Lithium should generally not be given to patients with significant cardiovascular disease since the risk of lithium toxicity is high in these patients. Additionally, there have been postmarketing reports of a possible association between lithium therapy and the unmasking of Brugada Syndrome, a disorder characterized by abnormal EKG findings and a risk of sudden death. Lithium should be avoided in patients with this diagnosis or suspicion of it, or that have risk factors, which include unexplained syncope, family history of this syndrome, or family history of unexplained sudden death before the age of 45 years.
Therapy with lithium should be administered with extreme caution in patients with preexisting cardiac disease. Consultation with a cardiologist is highly recommended and cardiac monitoring should be completed before and during treatment.

Antipsychotics can lower the seizure threshold and trigger seizures in a dose-dependent manner. Seizures have been reported in patients receiving antipsychotic therapy and may occur in epileptic patients even with maintenance of routine anticonvulsant treatment. Therapy with antipsychotics should be administered cautiously in patients with a history of seizures or other predisposing factors, such as head trauma, CNS abnormalities, and alcoholism. High dosages should be avoided if possible.

Lithium reduces the ability of the kidney to concentrate urine and produces a mild diabetes insipidus and polyuria. Therefore, patients with preexisting dehydration are more prone to lithium retention and toxicity. Therapy with lithium should be administered cautiously in dehydrated patients and may need to be discontinued until improvement in hydration status. Careful monitoring of lithium levels are recommended. Patients with sweating, diarrhea or concomitant infection with fever may need a temporary reduction or cessation of medication.

Antipsychotic drugs are not approved for the treatment of patients with dementia-related psychosis. Older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; although the causes were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. A causal relationship with antipsychotic use has not been established. In controlled trials in older patients with dementia-related psychosis, patients randomized to risperidone, aripiprazole, and olanzapine had higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, compared to patients treated with placebo.

Antipsychotic drugs are not approved for the treatment of patients with dementia-related psychosis. Older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; although the causes were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. A causal relationship with antipsychotic use has not been established. In controlled trials in older patients with dementia-related psychosis, patients randomized to risperidone, aripiprazole, and olanzapine had higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, compared to patients treated with placebo.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials; these trials did not show increased risk in patients older than 24 years and risk was reduced in patients 65 years and older. Adult and pediatric patients with major depressive disorder may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressants; this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders; such disorders are the strongest predictors of suicide. Patients of all ages treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of drug therapy, and at times of dose changes. Family members/caregivers should be advised to monitor for changes in behavior and to notify the health care provider. Changing the therapeutic regimen (including discontinuing the medication) should be considered in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Some atypical antipsychotic agents can prolong the QTc interval of the electrocardiogram in a dose-dependent manner. Electrolyte disturbances such as hypokalemia and hypomagnesemia may augment the prolongation effect of these agents on the QT interval and should be corrected prior to institution of therapy. In addition, patients who experience frequent, severe, or prolonged diarrhea may be subject to electrolyte losses and should be followed closely and managed accordingly during therapy with these agents. Atypical antipsychotic agents should be avoided in patients with a history of cardiac arrhythmias or other conditions that may increase the risk of torsade de pointes and/or sudden death, including bradycardia; hypokalemia or hypomagnesemia; and congenital long QT syndrome.

Lithium reduces the ability of the kidney to concentrate urine and produces a mild diabetes insipidus and polyuria. Therefore, patients with preexisting dehydration are more prone to lithium retention and toxicity. Therapy with lithium should be administered cautiously in dehydrated patients and may need to be discontinued until improvement in hydration status. Careful monitoring of lithium levels are recommended. Patients with sweating, diarrhea or concomitant infection with fever may need a temporary reduction or cessation of medication.

The risk for lithium toxicity may be increased in patients with diarrhea and excessive sweating. Dehydration and sodium depletion may occur in these patients leading to lithium retention and toxicity. The use of lithium may need to be reduced or suspended until the condition resolves. Supplemental fluid and salt may need to be administered. Monitoring serum lithium levels is recommended.

Lithium reduces the ability of the kidney to concentrate urine and produces a mild diabetes insipidus and polyuria. Therefore, patients with preexisting dehydration are more prone to lithium retention and toxicity. Therapy with lithium should be administered cautiously in dehydrated patients and may need to be discontinued until improvement in hydration status. Careful monitoring of lithium levels are recommended. Patients with sweating, diarrhea or concomitant infection with fever may need a temporary reduction or cessation of medication.

The risk for lithium toxicity may be increased in patients with diarrhea and excessive sweating. Dehydration and sodium depletion may occur in these patients leading to lithium retention and toxicity. The use of lithium may need to be reduced or suspended until the condition resolves. Supplemental fluid and salt may need to be administered. Monitoring serum lithium levels is recommended.

Lithium reduces the ability of the kidney to concentrate urine and produces a mild diabetes insipidus and polyuria. Therefore, patients with preexisting dehydration are more prone to lithium retention and toxicity. Therapy with lithium should be administered cautiously in dehydrated patients and may need to be discontinued until improvement in hydration status. Careful monitoring of lithium levels are recommended. Patients with sweating, diarrhea or concomitant infection with fever may need a temporary reduction or cessation of medication.

Some atypical antipsychotic agents can prolong the QTc interval of the electrocardiogram in a dose-dependent manner. Electrolyte disturbances such as hypokalemia and hypomagnesemia may augment the prolongation effect of these agents on the QT interval and should be corrected prior to institution of therapy. In addition, patients who experience frequent, severe, or prolonged diarrhea may be subject to electrolyte losses and should be followed closely and managed accordingly during therapy with these agents. Atypical antipsychotic agents should be avoided in patients with a history of cardiac arrhythmias or other conditions that may increase the risk of torsade de pointes and/or sudden death, including bradycardia; hypokalemia or hypomagnesemia; and congenital long QT syndrome.

Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therapy with lithium should be administered cautiously in patients with preexisting sodium depletion as the risk of lithium toxicity is increased. Lower dosages may be required. Patients should maintain a normal diet, including salt, and an adequate fluid intake. Monitoring lithium serum concentrations is recommended.

The use of lithium has been associated with hypothyroidism in 5% to 15% of patient as it blocks the release of thyroxine (T4) and triiodothyronine (T3) mediated by thyrotropin. Therapy with lithium should be administered cautiously in patients with preexisting hypothyroidism. Careful monitoring of the thyroid function is recommended and supplemental thyroid treatment may be required.

Some atypical antipsychotic agents can prolong the QTc interval of the electrocardiogram in a dose-dependent manner. Electrolyte disturbances such as hypokalemia and hypomagnesemia may augment the prolongation effect of these agents on the QT interval and should be corrected prior to institution of therapy. In addition, patients who experience frequent, severe, or prolonged diarrhea may be subject to electrolyte losses and should be followed closely and managed accordingly during therapy with these agents. Atypical antipsychotic agents should be avoided in patients with a history of cardiac arrhythmias or other conditions that may increase the risk of torsade de pointes and/or sudden death, including bradycardia; hypokalemia or hypomagnesemia; and congenital long QT syndrome.

The central dopaminergic blocking effects of neuroleptic agents may precipitate or aggravate a potentially fatal symptom complex known as neuroleptic malignant syndrome (NMS). NMS is observed most frequently when high-potency agents like haloperidol are administered intramuscularly, but may occur with any neuroleptic agent given for any length of time. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria, and acute renal failure. Neuroleptic agents should not be given to patients with active NMS and should be immediately discontinued if currently being administered in such patients. In patients with a history of NMS, introduction or reintroduction of neuroleptic agents should be carefully considered, since NMS may recur.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with the use of antipsychotic drugs. The diagnostic evaluation is complicated and the management requires immediate discontinuation of the antipsychotic therapy and intensive symptomatic treatment and medical monitoring. If a patient that has recovered from NMS requires antipsychotic drug treatment again, the reintroduction of therapy should be carefully considered as NMS recurrences have been reported.

Lithium is primarily eliminated by the kidneys and should generally not be administered to patients with significant renal dysfunction. Additionally, morphological changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic lithium therapy, although the association has not been clearly established. Kidney function should be assessed in patients prior to starting therapy, during and thereafter and routine urinalysis and renal function tests are recommended. Progressive or sudden changes in renal function indicate the need for reevaluation of treatment. Monitoring lithium serum levels is also recommended.

The use of neuroleptic agents is contraindicated in comatose patients and patients with severe central nervous system depression. Neuroleptic agents may potentiate the CNS and respiratory depression in these patients.

Lithium should generally not be given to patients with significant cardiovascular disease since the risk of lithium toxicity is high in these patients. Additionally, there have been postmarketing reports of a possible association between lithium therapy and the unmasking of Brugada Syndrome, a disorder characterized by abnormal EKG findings and a risk of sudden death. Lithium should be avoided in patients with this diagnosis or suspicion of it, or that have risk factors, which include unexplained syncope, family history of this syndrome, or family history of unexplained sudden death before the age of 45 years.
Therapy with lithium should be administered with extreme caution in patients with preexisting cardiac disease. Consultation with a cardiologist is highly recommended and cardiac monitoring should be completed before and during treatment.

Lithium should generally not be given to patients with significant cardiovascular disease since the risk of lithium toxicity is high in these patients. Additionally, there have been postmarketing reports of a possible association between lithium therapy and the unmasking of Brugada Syndrome, a disorder characterized by abnormal EKG findings and a risk of sudden death. Lithium should be avoided in patients with this diagnosis or suspicion of it, or that have risk factors, which include unexplained syncope, family history of this syndrome, or family history of unexplained sudden death before the age of 45 years.
Therapy with lithium should be administered with extreme caution in patients with preexisting cardiac disease. Consultation with a cardiologist is highly recommended and cardiac monitoring should be completed before and during treatment.

Antipsychotic and neuroleptic drugs can lower the seizure threshold and trigger seizures in a dose-dependent manner. This risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold. Therapy with these drugs should be administered cautiously in patients with a history of seizures or other predisposing factors, such as head trauma, CNS abnormalities, and alcoholism.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Antipsychotic drugs can elevate serum prolactin concentrations, and this elevation persists during chronic administration. This should be considered if therapy will be prescribed in patients with previously detected breast cancer as one-third of human breast cancers are prolactin-dependent in vitro. Associated disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported. Appropriate laboratory testing and follow-up is advised.

The chronic use of neuroleptic agents can cause persistent elevations in prolactin levels due to antagonism of dopamine D2 receptors. Based on in vitro data, approximately one-third of human breast cancers are thought to be prolactin-dependent. The clinical significance of this observation with respect to long-term neuroleptic therapy is unknown. Chronic administration of neuroleptic drugs has been associated with mammary tumorigenesis in rodent studies but not in human clinical or epidemiologic studies. Until further data are available, therapy with neuroleptic agents should be administered cautiously in patients with a previously detected breast cancer. Caution is also advised in patients with preexisting hyperprolactinemia. Hyperprolactinemia may suppress hypothalamic gonadotrophin 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. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds; however, the clinical significance of elevated serum prolactin levels is unknown for most patients. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male patients.

Prolonged use of quetiapine was associated with the development of cataracts in dogs. Lens changes have also been observed in humans during chronic treatment with quetiapine, but a causal relationship has not been established. Long-term therapy with quetiapine should be administered cautiously in patients with a history of cataracts. Examination of the lens by slit lamp exam or other appropriately sensitive methods is recommended at initiation of treatment or shortly thereafter and at 6-month intervals during chronic treatment.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported with the use of atypical antipsychotic agents. Patients with diabetes should be monitored for worsening control of blood glucose when treated with these agents. It is recommended that patients with risk factors for diabetes mellitus starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment, and periodically thereafter. 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 treatment with these agents was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the atypical antipsychotic drug.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Esophageal dysmotility and aspiration have been associated with the use of antipsychotic drugs. These drugs should be administered cautiously in patients at risk for aspiration pneumonia.

Patients with fever may have a lower tolerance to lithium due to increased fluid and sodium loss. Lithium dosage may need to be reduced or suspended in such patients. Monitoring lithium serum levels is recommended.

Antipsychotic and neuroleptic drugs can lower the seizure threshold and trigger seizures in a dose-dependent manner. This risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold. Therapy with these drugs should be administered cautiously in patients with a history of seizures or other predisposing factors, such as head trauma, CNS abnormalities, and alcoholism.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Atypical antipsychotic drugs have been associated with undesirable alterations in lipid levels. While all agents in the class have been shown to produce some changes, each drug has its own specific risk profile. Before or soon after initiation of antipsychotic medications, a fasting lipid profile should be obtained at baseline and monitored periodically during treatment.

According to the manufacturer, patients treated with quetiapine in 3- to 6-week placebo-controlled trials had increases in cholesterol and triglyceride of 11% and 17%, respectively, compared to slight decreases in the placebo group. Patients with preexisting hyperlipidemia may require closer monitoring during quetiapine therapy, and adjustments made accordingly in their lipid-lowering regimen.

Antipsychotic drugs can elevate serum prolactin concentrations, and this elevation persists during chronic administration. This should be considered if therapy will be prescribed in patients with previously detected breast cancer as one-third of human breast cancers are prolactin-dependent in vitro. Associated disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported. Appropriate laboratory testing and follow-up is advised.

The chronic use of neuroleptic agents can cause persistent elevations in prolactin levels due to antagonism of dopamine D2 receptors. Based on in vitro data, approximately one-third of human breast cancers are thought to be prolactin-dependent. The clinical significance of this observation with respect to long-term neuroleptic therapy is unknown. Chronic administration of neuroleptic drugs has been associated with mammary tumorigenesis in rodent studies but not in human clinical or epidemiologic studies. Until further data are available, therapy with neuroleptic agents should be administered cautiously in patients with a previously detected breast cancer. Caution is also advised in patients with preexisting hyperprolactinemia. Hyperprolactinemia may suppress hypothalamic gonadotrophin 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. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds; however, the clinical significance of elevated serum prolactin levels is unknown for most patients. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male patients.

The use of quetiapine may be associated with in increase systolic and diastolic blood pressure in children and adolescents. During the 26 week open-label clinical trial, one child with a reported history of hypertension experienced a hypertensive crisis. Blood pressure in children and adolescents should be measured at the beginning of, and periodically during treatment with quetiapine.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

Most neuroleptic agents are extensively metabolized by the liver. The plasma concentrations of these agents may be increased and the half-lives prolonged in patients with impaired hepatic function. Therapy with neuroleptic agents should be administered cautiously in patients with significant liver disease. Lower initial dosages and slower titration may be appropriate.

The use of quetiapine may be associated with transient, asymptomatic elevations in serum transaminase. During a series of 3- to 6-week clinical trials, 6% of patients exposed to quetiapine experienced ALT (SGPT) elevations greater than three times the upper limit of normal, compared to 1% in the placebo group. Liver enzymes tended to increase within the first 3 weeks of therapy and return to baseline with continued treatment. Therapy with quetiapine should be administered cautiously in patients with signs and symptoms of hepatic impairment. Periodic assessment of serum transaminases should be performed in patients with significant hepatic disease.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

Cases of leukopenia, neutropenia, and agranulocytosis have been reported with the use of atypical antipsychotic agents. Patients with preexisting low white blood cell count may be at increased risk. Therapy with these agents should be administered cautiously in patients with a history of, or predisposition to, decreased white blood cell or neutrophil counts. Clinical monitoring of hematopoietic function is recommended. At the first sign of a clinically significant decline in white blood cells, discontinuation of atypical antipsychotic therapy should be considered in the absence of other causative factors, and the patient closely monitored for fever or other signs and symptoms of infection.

The use of antipsychotics has been associated with events of leukopenia, neutropenia and agranulocytosis. Possible risk factors include preexisting low white blood cell count, and history of drug induced leukopenia/neutropenia. Patients with these risk factors should have complete blood count monitored frequently during the first few months of therapy. Patients should also be monitored for any signs or symptoms of infection. Treatment should be discontinued in any patient who develops a sore throat, fever, stomatitis, or other signs of infection along with a low WBC count or severe neutropenia (ANC < 1000/mm3).

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported with the use of atypical antipsychotic agents. Patients with diabetes should be monitored for worsening control of blood glucose when treated with these agents. It is recommended that patients with risk factors for diabetes mellitus starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment, and periodically thereafter. 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 treatment with these agents was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the atypical antipsychotic drug.

Weight gain has been observed with atypical antipsychotic use. While all agents in the class have been shown to produce some changes, each drug has its own specific risk profile. When treating pediatric patients with atypical antipsychotic agents, weight gain should be monitored and assessed against that expected for normal growth. Monitor weight at baseline and frequently thereafter.

The use of neuroleptic agents is associated with pseudo-parkinsonian symptoms such as akinesia, bradykinesia, tremors, pill-rolling motion, cogwheel rigidity, and postural abnormalities including stooped posture and shuffling gait. The onset is usually 1 to 2 weeks following initiation of therapy or an increase in dosage. Older neuroleptic agents such as haloperidol are more likely to induce these effects, and their use may be contraindicated in patients with Parkinson's disease or parkinsonian symptoms.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

Antipsychotic and neuroleptic drugs can lower the seizure threshold and trigger seizures in a dose-dependent manner. This risk is greatest in patients with a history of seizures or with conditions that lower the seizure threshold. Therapy with these drugs should be administered cautiously in patients with a history of seizures or other predisposing factors, such as head trauma, CNS abnormalities, and alcoholism.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

Tardive dyskinesia (TD) has occurred in patients treated with antipsychotic drugs; the syndrome consists of potentially irreversible, involuntary, dyskinetic movements. The risk appears highest in older patients (particularly older women) but it is not possible to predict which patients are likely to develop TD; whether antipsychotic drugs differ in their potential to cause TD is unknown. The risk of TD and the likelihood that it will become irreversible increase with the duration of therapy and the total cumulative dose. The syndrome can develop after relatively brief treatment periods, even at low dosages; it may also occur after discontinuation of therapy. TD may remit (partially or completely) upon discontinuation of antipsychotic therapy, although antipsychotic therapy itself may suppress (or partially suppress) signs/symptoms of TD, possibly masking the underlying process; the effect of symptomatic suppression on the long-term course of TD is unknown. In patients with preexisting drug-induced TD, initiating or increasing the dosage of antipsychotic therapy may temporarily mask the symptoms of TD but could eventually worsen the condition. In patients requiring chronic therapy, the lowest dose and shortest duration of therapy producing a satisfactory clinical response are recommended; the need for continued therapy should be reassessed periodically. If signs/symptoms of TD occur during antipsychotic therapy, discontinuation of the offending agent should be considered; however, some patients may require treatment despite the presence of TD.

Atypical antipsychotic agents with alpha-adrenergic blocking effects may cause priapism. The condition is characterized by prolonged, often painful erections lasting longer than 4 hours. If not treated promptly, priapism can cause irreversible damage to the erectile tissue. Therapy with these agents should be administered cautiously in patients with a history of priapism, conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia, thalassemia), or anatomical deformations of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease). Patients who experience an erection lasting longer than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

During clinical trials, the use of quetiapine was associated with a dose-related decrease in total and free thyroxine (T4) levels that reached approximately 20% at the higher end of the therapeutic dose range and peaked within the first 2 to 4 weeks of treatment. Generally, the changes were of no clinical significance and were reversible following discontinuation of quetiapine regardless of the duration of treatment. TBG levels were not altered in any patient, while TSH increased in 0.4% (10/2386) of patients, some of whom required thyroid replacement therapy. Therapy with quetiapine should be administered cautiously in patients with thyroid disease. Closer monitoring of thyroid function may be appropriate following initiation or cessation of quetiapine.

The use of atypical antipsychotic agents has been associated with orthostatic hypotension and syncope. Therapy with atypical antipsychotics should be administered cautiously in patients with hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with atypical antipsychotics. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.