There may be a slightly increased risk of serious, possibly fatal side effects (e.g., pneumonia, heart failure) when this medication is used in older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

This medication is used to treat certain mental/mood conditions (such as schizophrenia, depression, bipolar disorder). Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain.

This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.

Read the Medication Guide provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth without food or with a light meal, usually once daily in the evening or as directed by your doctor. Dosage is based on your medical condition and response to treatment. To reduce the dizziness and lightheadedness that may occur when you first start to take this drug, your doctor will direct you to start taking it at a low dose and gradually increase the dose. Your doctor may direct you to start by taking the immediate-release form of this drug, then switch you to the sustained-release form when you are regularly taking the same dose.

Swallow the medication whole. Do not break, crush, or chew the medication. Doing so can destroy the long action of the drug and may increase side effects.

Use this medication regularly in order to get the most benefit from it. It may take several weeks to notice the full benefit of this drug. To help you remember, use it at the same time each day. If you stop taking quetiapine for more than 1 week, tell your doctor before you start taking it again. You may need to start at a low dose and gradually increase the dose again.

Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as trouble sleeping, nausea, diarrhea, irritability) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Tell your doctor if your condition persists or worsens.

Drowsiness, dizziness, stomach pain/upset, weight gain, or dry mouth may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Quetiapine may cause drowsiness and dizziness. This can increase your risk of falls. This is more likely to occur in the first few days after starting/restarting the drug or after your dose increases. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, slow/shuffling walk, unusually fast/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., increased anxiety, depression, rare thoughts of suicide), difficulty swallowing, drooling, muscle stiffness/spasm, restlessness, shakiness (tremor), swelling arms/legs/feet.

Quetiapine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, vision changes.

Quetiapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms, or legs).

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.

This drug may infrequently cause a serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). Seek immediate medical attention if you develop some of the following symptoms: muscle stiffness, high fever, increased sweating, fast heartbeat, mental/mood changes, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking quetiapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: Alzheimer's disease, low blood pressure, disease of the blood vessels in the brain (e.g., stroke), blood disorders (e.g., leukopenia, neutropenia), a severe loss of body water (dehydration), certain eye problems (cataracts), liver disease, seizures, severe reaction to antipsychotic medication (neuroleptic malignant syndrome-NMS), trouble swallowing, thyroid problems.

Also tell your doctor or pharmacist if you or a family member has a history of any of the following conditions: diabetes, heart disease (e.g., chest pain, heart attack, heart failure, irregular heartbeat), high blood cholesterol/triglyceride levels, high blood pressure, obesity.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This drug may cause significant weight gain and may also cause your blood cholesterol (or triglyceride) levels to rise. These effects may increase your risk for developing heart disease, especially if you also have diabetes. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar such as unusual increased thirst/urination or vision changes. If you already have diabetes, be sure to check your blood sugar level regularly.

This drug can make you more likely to get heat stroke. Avoid activities that may cause you to overheat (e.g., strenuous work, exercising in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids, dress lightly, and stay in cool/air-conditioned areas.

Caution is advised when using this drug in older adults because they may be more sensitive to its effects, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: sibutramine.

If you are currently using this medication, tell your doctor or pharmacist before starting quetiapine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., belladonna alkaloids, benztropine, scopolamine), drugs that affect dopamine (e.g., bromocriptine, levodopa, cabergoline), drugs for treating high blood pressure (e.g., alpha blockers such as prazosin, calcium channel blockers such as diltiazem, "water pills"/diuretics such as hydrochlorothiazide), drugs affecting liver enzymes that remove quetiapine from your body (e.g., thioridazine, azole antifungals such as fluconazole/ketoconazole/itraconazole, barbiturates such as phenobarbital, glucocorticoids such as dexamethasone, macrolide antibiotics such as erythromycin, rifamycins such as rifabutin/rifampin, certain anti-seizure drugs such as carbamazepine/phenytoin), drugs for thyroid disease (e.g., thyroxine).

Also report the use of drugs that might increase seizure risk when combined with quetiapine such as bupropion, isoniazid (INH), other antipsychotics (e.g., chlorpromazine), tramadol, theophylline, and tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, loss of consciousness.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., fasting blood sugar, weight, blood pressure, blood cholesterol/triglyceride levels, eye exams) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2009 Copyright(c) 2009 First DataBank, Inc.