Quetiapine (patient information)

IMPORTANT WARNING:
Use in Older Adults:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as quetiapine have an increased risk of death during treatment. If you experience any of the following symptoms, call your doctor immediately: slow or difficult speech, sudden dizziness or faintness, or weakness or numbness of an arm or leg.

Quetiapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking quetiapine. For more information visit the FDA website: http://www.fda.gov/cder

Risk of Suicidality:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as quetiapine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take quetiapine, but in some cases, a doctor may decide that quetiapine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take quetiapine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking quetiapine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with quetiapine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is this medication prescribed
Quetiapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How should this medicine be used
Quetiapine comes as a tablet to take by mouth. It is usually taken one to three times a day. Take quetiapine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take quetiapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of quetiapine and gradually increase your dose during the first week of your treatment. Ask your doctor or pharmacist if you have any questions about the amount of medication you should take each day at the beginning of your treatment

Quetiapine may help control your symptoms but will not cure your condition. Continue to take quetiapine even if you feel well. Do not stop taking quetiapine without talking to your doctor. If you suddenly stop taking quetiapine, you may experience withdrawal symptoms such as nausea, vomiting, and difficulty falling asleep or staying asleep. Your doctor will probably want to decrease your dose gradually.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow
Before taking quetiapine:


 * tell your doctor and pharmacist if you are allergic to quetiapine or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); antihistamines; barbiturates; carbamazepine (Tegretol); divalproex (Depakote);dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); erythromycin (E.E.S., E-Mycin, Erythrocin); lorazepam (Ativan); medications for anxiety, high blood pressure, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; phenobarbital (Luminal); phenytoin (Dilantin); rifampin (Rifadin, Rimactane); sedatives; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); sleeping pills; thioridazine (Mellaril); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever used street drugs or overused prescription medications and if you have or have ever had any condition that makes it difficult for you to swallow, or seizures, high cholesterol, high or low blood pressure, a heart attack, a stroke, breast cancer or thyroid, heart or liver disease. If you have ever had to stop taking a medication for mental illness because of severe side effects, be sure to tell your doctor.
 * tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking quetiapine, call your doctor. Do not breastfeed while taking quetiapine.
 * if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking quetiapine.
 * you should know that quetiapine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
 * you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking quetiapine.
 * you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking quetiapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking quetiapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
 * you should know that quetiapine may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
 * you should know that quetiapine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking quetiapine and when your dose is increased. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Be sure to drink plenty of water every day while you are taking this medication.

What should I do if I forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Mild side effects
''Quetiapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:''


 * drowsiness
 * dizziness
 * pain
 * weakness
 * dry mouth
 * indigestion
 * constipation
 * stomach pain
 * headache
 * excessive weight gain
 * sore throat

Severe side effects
''Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:''


 * fainting
 * seizures
 * changes in vision
 * uncontrollable movements of your arms, legs, tongue, face, or lips
 * painful erection of the penis that lasts for hours
 * fever
 * muscle stiffness, pain, or weakness
 * excess sweating
 * fast or irregular heartbeat
 * confusion
 * unusual bleeding or bruising
 * hives
 * rash
 * blisters
 * difficulty breathing or swallowing

Quetiapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Quetiapine has caused cataracts in laboratory animals. It is not known if quetiapine may cause cataracts in humans. You will need to have eye exams to check for cataracts at the beginning of your treatment and every six months during your treatment. Talk to your doctor about the risks of taking quetiapine.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:


 * drowsiness
 * dizziness
 * fainting
 * fast heartbeat

What other information should I know
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Seroquel®