Quetiapine is used to treat schizophrenia in adults and children who are at least 13 years old. It is also used alone or with with divalproex or lithium 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).

In addition, quetiapine is used with other medications to prevent episodes of depression in patients with bipolar disorder.

Quetiapine extended release is also used alone to treat manic episodes in children at least 10 years old with bipolar disorder.

Quetiapine extended release is used in combination with antidepressant medications to treat major depressive disorder in adults.

Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers.

Quetiapine belongs to class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting quetiapine. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Quetiapine may increase the risk of death in older adults with mental health problems related to dementia.

Take quetiapine as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take quetiapine with or without food, but take it the same way each time.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood may need to be checked on a regular basis, and you may need other medical tests.

Your blood pressure may need to be checked often.

Do not stop using quetiapine suddenly, your condition may get worse, or you could have unpleasant symptoms (such as trouble sleeping, nausea and vomiting). Ask your doctor before stopping the medicine.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use quetiapine.

Store at room temperature away from moisture and heat.

You should not use quetiapine if you are allergic to it.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

To make sure quetiapine is safe for you, tell your doctor if you have ever had:

• a nervous system reaction associated with antipsychotic medication use;

• heart disease, a heart attack or stroke;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• high or low blood pressure;

• low white blood cell (WBC) counts;

• abnormal thyroid tests or prolactin levels;

• an enlarged prostate, constipation or urination problems;

• a seizure;

• glaucoma or cataracts;

• diabetes (in you or a family member);

• high cholesterol or triglycerides; or

• liver disease.

Quetiapine may increase the risk of death in older adults with mental health problems related to dementia.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

It may be harder for you to get pregnant while you are using quetiapine.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of quetiapine on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

You should know that you may gain weight while you are taking this medication. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet and exercising. You and your doctor should check your weight regularly while you are taking quetiapine.

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

Do not drink alcohol. Dangerous side effects could occur.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how quetiapine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are taking quetiapine.

Get emergency medical help if you have signs of an allergic reaction to quetiapine: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of quetiapine can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Quetiapine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• breast swelling and tenderness, nipple discharge, impotence, missed menstrual periods;

• trouble swallowing, severe constipation;

• painful or difficult urination;

• high blood pressure, fast, slow or uneven heart rate;

• a light-headed feeling, sudden numbness or weakness, severe headache;

• blurred vision, eye pain or redness, seeing halos around lights;

• a seizure, feeling unusually hot or cold;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• underactive thyroid - tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough.

Common quetiapine side effects may include:

• speech problems;

• dizziness, drowsiness, tiredness;

• feeling like you might pass out;

• lack of energy;

• fast heartbeats;

• increased appetite, weight gain;

• upset stomach, vomiting, constipation;

• stomach pain, nausea;

• abnormal liver function tests, sore throat;

• stuffy nose, dry mouth; or

• difficulty moving.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Quetiapine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat overactive bladder;

• medicine to treat Parkinson's disease; or

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with quetiapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to quetiapine.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

It typically takes several weeks for this medicine to fully kick in.

Let your doctor know if you experience any severe or unusual side effects.

For quetiapine to work properly, it should be taken every day.

Don’t stop taking this medicine without first talking to your physician.

Your dosage will be based on your medical condition, the formulation you use, and other factors.

Typically, doctors prefer to start patients on a low dose of quetiapine and gradually increase it.

Missing a dose of quetiapine can increase your chances of having a relapse in symptoms. Try not to miss any doses.

Quetiapine is sometimes used “off-label” to treat other medical conditions, including:

• Generalized anxiety disorder (GAD)
• Obsessive compulsive disorder (OCD)
• Psychosis associated with Parkinson’s disease or dementia
• Other mental health conditions

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