Seroquel XR

Seroquel XR is a prescription medication used to treat certain mental disorders such as schizophrenia, bipolar disorder, and depressive episodes associated with bipolar disorder. Seroquel XR also can be given with other medications to treat depression.

Seroquel XR belongs to a group of drugs called antipsychotics. The exact way it works is unclear, but it is proposed to regulate certain chemicals in the brain.

This medication comes as an extended-release tablet form and is usually taken once daily. Take without food or with a light meal (approx. 300 calories).

Common side effects of Seroquel XR are sleepiness, dizziness, and dry mouth. This medication may cause drowsiness. Do not drive or operate heavy machinery until you know how Seroquel XR affects you.

Seroquel XR is a prescription medication used to treat certain mental disorders such as schizophrenia, bipolar disorder, and depressive episodes associated with bipolar disorder. Seroquel XR also can be given with other medications to treat depression.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astrazeneca

Serious side effects have been reported with Seroquel XR including: Also see “Seroquel XR Precautions” section.

• Neuroleptic malignant syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including Seroquel XR. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have some or all of these symptoms:
• Tardive dyskinesia: Tell your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Seroquel XR. Tardive dyskinesia may also start after you stop taking Seroquel XR.
• Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.
• Increases in blood pressure: reported in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before starting Seroquel XR and during therapy. Seroquel XR is not approved for patients under 18 years of age.
• Low white blood cell count
• Cataracts
• Seizures
• Abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.
• Increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.
• Increases in liver enzymes: Your healthcare provider may do blood tests to check your liver enzyme levels.
• Long lasting and painful erection
• Difficulty swallowing
• high fever
• excessive sweating
• rigid muscles
• confusion
• changes in your breathing, heartbeat, and blood pressure

Common possible side effects with Seroquel XR include:

• drowsiness
• dry mouth
• constipation
• dizziness
• increased appetite
• upset stomach
• weight gain
• fatigue
• disturbance in speech and language
• stuffy nose

These are not all the possible side effects of Seroquel XR. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, nonprescription medicines, herbal supplements and vitamins.

Seroquel XR and other medicines may affect each other causing serious side effects. Seroquel XR may affect the way other medicines work, and other medicines may affect how Seroquel XR works.

Especially tell your healthcare provider if you take or plan to take medicines for:

• depression
• high blood pressure
• Parkinson's disease
• trouble sleeping
• abnormal heart beats or rhythm

Also tell your healthcare provider if you take or plan to take any of these medicines:

• phenytoin, divalproex or carbamazepine (for epilepsy)
• barbiturates (to help you sleep)
• rifampin (for tuberculosis)
• glucocorticoids (steroids for inflammation)
• thioridazine (an antipsychotic)
• ketoconazole, fluconazole or itraconazole (for fungal infections)
• erythromycin (an antibiotic)
• protease inhibitors (for HIV)

This is not a complete list of medicines that can affect or be affected by Seroquel XR. Your doctor can tell you if it is safe to take Seroquel XR with your other medicines. Do not start or stop any medicines while taking Seroquel XR without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider if you are having a urine drug screen because Seroquel XR may affect your test results. Tell those giving the test that you are taking Seroquel XR.

Seroquel XR may cause serious side effects, including:

1.  Risk of death in the elderly with dementia

2.  Risk of suicidal thoughts or actions

3.  High blood sugar (hyperglycemia)

4.  High fat levels in your blood (increased cholesterol and triglycerides)

5.  Weight gain

These serious side effects are described below:

1.  Risk of death in the elderly with dementia: Medicines like Seroquel XR can increase the risk of death in elderly people who have memory loss (dementia). Seroquel XR is not approved for treating psychosis in the elderly with dementia.

2.  Risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

• Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
• Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.
• How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Talk to your, or your family member’s, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines.
• all treatment choices for depression or other serious mental illness.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to your healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

3.  High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:

• Build up of acid in your blood due to ketones (ketoacidosis)
• Coma
• Death

Increases in blood sugar can happen in some people who take Seroquel XR. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start Seroquel XR and during therapy.

Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking Seroquel XR:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity

4.  High fat levels in your blood (increased cholesterol and triglycerides): High fat levels may happen in people treated with Seroquel XR. You may not have any symptoms, so your doctor may decide to check your cholesterol and triglycerides during your treatment with Seroquel XR.

5.  Increase in weight (weight gain): Weight gain is common in people who take Seroquel XR so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Do not drive, operate machinery, or do other dangerous activities until you know how Seroquel XR affects you. Seroquel XR may make you drowsy.

• Avoid getting overheated or dehydrated.
• Do not drink alcohol while taking Seroquel XR. It may make some side effects of Seroquel XR worse.
• Do not over-exercise.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun. Do not wear too much or heavy clothing.
• Drink plenty of water.

Grapefruit and grapefruit juice may interact with Seroquel XR and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Seroquel XR, tell your healthcare provider if you have or have had:

• diabetes or high blood sugar in you or your family: your healthcare provider should check your blood sugar before you start Seroquel XR and also during therapy
• high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL- cholesterol
• low or high blood pressure
• low white blood cell count
• cataracts
• seizures
• abnormal thyroid tests
• high prolactin levels
• heart problems
• liver problems
• any other medical condition
• pregnancy or plans to become pregnant. It is not known if Seroquel XR will harm your unborn baby
• breastfeeding or plans to breastfeed

Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, nonprescription medicines, herbal supplements and vitamins.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Seroquel XR will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Seroquel XR can pass into your breast milk. You and your healthcare provider should decide if you will take Seroquel XR or breastfeed. You should not do both.

• Take Seroquel XR exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
• Take Seroquel XR by mouth, with a light meal or without food.
• Seroquel XR tablets should be swallowed whole and not split, chewed or crushed.
• If you feel you need to stop Seroquel XR, talk with your healthcare provider first.

If you suddenly stop taking Seroquel XR, you may experience side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.

If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• side effects

The recommended dose range of Seroquel XR for the treatment of schizophrenia in adults and adolescents is 400-800mg/day.

The recommended dose range of Seroquel XR for the treatment of Bipolar I disorder (manic or mixed) in adults is 400-800mg/day.

The recommended dose range of Seroquel XR for the treatment of Bipolar I disorder (manic) in children and adolescents is 400-600 mg/day.

The recommended dose of Seroquel XR for bipolar depression is 300 mg/day.

The recommended dose range of Seroquel XR in combination with other medications to treat Major Depressive Disorder in adults is 150-300 mg/day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Seroquel XR at 25ºC (77ºF).
• Keep Seroquel XR and all medicines out of the reach of children.

WARNING: 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. Analyses of seventeen 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 antipsychotic 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. Seroquel XR 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 Seroquel XR 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 age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. 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. Seroquel XR is not approved for use in pediatric patients.