Quetiapine sustained-release tabletsPronunciation
Generic Name: quetiapine (kwe-TYE-a-peen)
Brand Name: Seroquel XR
Quetiapine 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. Quetiapine 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 quetiapine sustained-release tablets outweigh the risks.
Family and caregivers must closely watch patients who take quetiapine 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.
Quetiapine sustained-release tablets are not approved for use in all children. If quetiapine sustained-release tablets are prescribed for your child, talk with the doctor to be sure that quetiapine sustained-release tablets are right for your child.
Quetiapine sustained-release tablets are used for:
Treating schizophrenia or bipolar disorder. It is also used to treat depression when used along with other medicines. It may also be used for other conditions as determined by your doctor.
Quetiapine sustained-release tablets are an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.
Do NOT use quetiapine sustained-release tablets if:
- you are allergic to any ingredient in quetiapine sustained-release tablets
- you have low blood potassium or magnesium levels
- you have a history of certain types of irregular heartbeat (eg, QT prolongation, very slow heartbeat)
- you are taking certain antiarrhythmic medicines (eg, amiodarone, procainamide, quinidine, sotalol), certain antipsychotic medicines (eg, ziprasidone), methadone, pentamidine, certain phenothiazines (eg, chlorpromazine, thioridazine), certain quinolone antibiotics (eg, moxifloxacin) or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Contact your doctor or health care provider right away if any of these apply to you.
Before using quetiapine sustained-release tablets:
Some medical conditions may interact with quetiapine 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) or other mental or mood problems, suicidal thoughts or attempts, a certain type of irregular heartbeat (prolonged QT interval), or diabetes or high blood sugar
- if you drink alcohol or have a history of alcohol or substance abuse
- if you have Alzheimer disease, dementia, poor health, or trouble swallowing, or you are very overweight
- if you are dehydrated, have low blood volume, or will be exposed to very high temperatures
- if you have a history of heart attack or other heart problems (eg, enlargement of the heart, heart failure, irregular heartbeat), stroke, blood vessel problems (eg, in the brain), high blood cholesterol or triglyceride levels, or high or low blood pressure
- if you have a history of low white blood cell levels, including low levels caused by medicine; kidney, liver, or pancreas problems; stomach or bowel problems; thyroid problems; cataracts; narrow-angle glaucoma; seizures; neuroleptic malignant syndrome (NMS); gallstones; or low blood magnesium or potassium levels
- if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
- if you take medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver
Some MEDICINES MAY INTERACT with quetiapine sustained-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for cancer, depression or other mental or mood problems, hepatitis C, high blood pressure, HIV, infections, inflammation, irregular heartbeat or other heart problems, narcotic abuse or dependence, nausea or vomiting, pain, Parkinson disease, restless legs syndrome, seizures, stomach or bowel problems, trouble sleeping), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with quetiapine sustained-release tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with quetiapine sustained-release tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if quetiapine sustained-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use quetiapine sustained-release tablets:
Use quetiapine sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Quetiapine sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get quetiapine sustained-release tablets refilled.
- Quetiapine sustained-release tablets are best taken in the evening. Take it by mouth on an empty stomach or with a light meal.
- Swallow quetiapine sustained-release tablets whole. Do not break, crush, or chew before swallowing.
- Continue to take quetiapine sustained-release tablets even if you feel well. Do not miss any doses.
- Do not suddenly stop taking quetiapine sustained-release tablets without first talking with your doctor. You may have an increased risk of side effects. If you need to stop quetiapine sustained-release tablets, your doctor will gradually lower your dose.
- If you miss a dose of quetiapine 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 quetiapine sustained-release tablets for longer than 1 week, contact your doctor before you start to take it again. Your dose may need to be adjusted.
Ask your health care provider any questions you may have about how to use quetiapine sustained-release tablets.
Important safety information:
- Quetiapine 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 quetiapine sustained-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using quetiapine sustained-release tablets.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using quetiapine sustained-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Quetiapine sustained-release tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. This may be more likely to occur when you start to take quetiapine 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.
- 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 quetiapine sustained-release tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take quetiapine 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.
- Quetiapine 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.
- Quetiapine 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.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- NMS is a possibly fatal syndrome that can be caused by quetiapine 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 quetiapine 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 quetiapine 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 quetiapine sustained-release tablets.
- Rarely, quetiapine 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 such as fever, sore throat, rash, or chills.
- Quetiapine sustained-release tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
- Tell your doctor or dentist that you take quetiapine sustained-release tablets before you receive any medical or dental care, emergency care, or surgery.
- Quetiapine sustained-release tablets may interfere with certain lab tests, including urine drug screen tests. Be sure your doctor and lab personnel know you are taking quetiapine sustained-release tablets.
- Lab tests, including complete blood cell counts, blood sugar or cholesterol levels, liver function, thyroid function, or eye exams, may be performed while you use quetiapine sustained-release tablets. You may also receive regular weight checks while you use quetiapine 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 quetiapine sustained-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
- Quetiapine 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 quetiapine sustained-release tablets.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking quetiapine sustained-release tablets while you are pregnant. Using quetiapine sustained-release tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Quetiapine sustained-release tablets are found in breast milk. Do not breast-feed while taking quetiapine sustained-release tablets.
If you stop taking quetiapine sustained-release tablets suddenly, you may have WITHDRAWAL symptoms. These may include diarrhea, dizziness, headache, irritability, nausea, trouble sleeping, or vomiting.
Possible side effects of quetiapine 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; headache; increased appetite; indigestion; light-headedness; nausea; runny or stuffy nose; sluggishness; sore throat; stomach pain or upset; tiredness; vomiting; weakness; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficult or painful urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; increased saliva production or drooling; increased sweating; memory problems; menstrual changes; muscle pain, stiffness, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); numbness, burning, or tingling; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or prolonged dizziness, light-headedness, or headache; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; suicidal thoughts or actions; swelling of the arms, hands, legs, or feet; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; unusual weakness); symptoms of high prolactin levels (eg, decreased sexual ability, enlarged breast size, missed menstrual period, nipple discharge); tremor; trouble concentrating, speaking, or swallowing; trouble sleeping; trouble walking or standing; uncontrollable or involuntary muscle movements (eg, loss of balance, twitching of the face or tongue, uncontrollable arm or leg movements); unusual bruising or bleeding; vision changes (eg, blurred vision, decreased vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; muscle pain, weakness, or cramping; seizures; severe dizziness, drowsiness, or light-headedness; uncontrolled muscle movements.Proper storage of quetiapine sustained-release tablets:
Store quetiapine sustained-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep quetiapine sustained-release tablets out of the reach of children and away from pets.
- If you have any questions about quetiapine sustained-release tablets, please talk with your doctor, pharmacist, or other health care provider.
- Quetiapine sustained-release tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take quetiapine sustained-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about quetiapine sustained-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to quetiapine sustained-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using quetiapine sustained-release tablets.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: atypical antipsychotics