Seroquel XR Sustained-Release Tablets are an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Seroquel XR Sustained-Release Tablets are not approved to treat mental problems caused by dementia.
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Seroquel XR Sustained-Release Tablets outweigh the risks.
Family and caregivers must closely watch patients who take Seroquel XR Sustained-Release Tablets. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Seroquel XR Sustained-Release Tablets are used for:
Treating schizophrenia and bipolar disorder. It is also used to treat depression. It may also be used for other conditions as determined by your doctor.
Seroquel XR Sustained-Release Tablets are an atypical antipsychotic. Exactly how it works is not known. It affects certain receptors in the brain. This may help to improve symptoms associated with schizophrenia.
Do NOT use Seroquel XR Sustained-Release Tablets if:
- you are allergic to any ingredient in Seroquel XR Sustained-Release Tablets
Before using Seroquel XR Sustained-Release Tablets:
Some medical conditions may interact with Seroquel XR Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems, suicidal thoughts or attempts, or diabetes
- if you drink alcohol or have a history of alcohol or substance abuse
- if you have Alzheimer disease, dementia, or trouble swallowing
- if you are dehydrated or are very overweight
- if you have a history of heart problems (eg, heart attack, heart failure, irregular heartbeat), stroke, blood vessel problems, high blood cholesterol levels, or high or low blood pressure
- if you have history of blood problems (eg, low white blood cells), liver problems, thyroid problems, cataracts, narrow-angle glaucoma, seizures, neuroleptic malignant syndrome (NMS), high blood prolactin levels, or breast cancer
Some MEDICINES MAY INTERACT with Seroquel XR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased
- Anticholinergics (eg, scopolamine), azole antifungals (eg, ketoconazole), divalproex, fluvoxamine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Seroquel XR Sustained-Release Tablets's side effects
- Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), phenytoin, rifampin, or thioridazine because they may decrease Seroquel XR Sustained-Release Tablets's effectiveness
- Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Seroquel XR Sustained-Release Table
How to use Seroquel XR Sustained-Release Tablets:
Use Seroquel XR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Seroquel XR Sustained-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Seroquel XR Sustained-Release Tablets refilled.
- Seroquel XR Sustained-Release Tablets are best taken in the evening. Take it by mouth on an empty stomach or with a light meal.
- Swallow Seroquel XR Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
- Continue to take Seroquel XR Sustained-Release Tablets even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Seroquel XR Sustained-Release Tablets without first talking with your doctor. You may have an increased risk of side effects. If you need to stop Seroquel XR Sustained-Release Tablets or add a new medicine, your doctor will gradually lower your dose.
- If you miss a dose of Seroquel XR Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking Seroquel XR Sustained-Release Tablets for longer than 1 week, contact your doctor.
Important safety information:
- Seroquel XR Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Seroquel XR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Talk with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Seroquel XR Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Seroquel XR Sustained-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. This may be more likely to occur when you start to take Seroquel XR Sustained-Release Tablets, and also if your dose increases. To prevent these effects, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Limit the amount of alcohol you drink while you are using Seroquel XR Sustained-Release Tablets. Check with your doctor if you have any questions.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke, dizziness, or fainting may occur.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Seroquel XR Sustained-Release Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Seroquel XR Sustained-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Seroquel XR Sustained-Release Tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Seroquel XR Sustained-Release Tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Seroquel XR Sustained-Release Tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Some patients who take Seroquel XR Sustained-Release Tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Seroquel XR Sustained-Release Tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, chewing movements, mouth puckering, puffing of cheeks, tongue sticking out) while taking Seroquel XR Sustained-Release Tablets.
- Rarely, Seroquel XR Sustained-Release Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Seroquel XR Sustained-Release Tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breast or decreased sexual ability in men missed menstrual period or nipple discharge in women. Contact your doctor right away if any of these symptoms occur.
- Lab tests, including complete blood cell counts, blood sugar or cholesterol levels, liver function, or eye exams, may be performed while you use Seroquel XR Sustained-Release Tablets. You may also receive regular weight checks while you use Seroquel XR Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Seroquel XR Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
- Seroquel XR Sustained-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. Increased blood pressure has been reported in CHILDREN and TEENAGERS who use Seroquel XR Sustained-Release Tablets.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Seroquel XR Sustained-Release Tablets while you are pregnant. It is not known if Seroquel XR Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Seroquel XR Sustained-Release Tablets.
Possible side effects of Seroquel XR Sustained-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; dry mouth; increased appetite; lightheadedness; stomach upset; stuffy nose; tiredness; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, stiffness, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hallucination, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); numbness or tingling; persistent, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, legs, or feet; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sleeping; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, jerking or twisting, twitching of the face or tongue); vision changes.