Seroquel

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.

Seroquel and Seroquel XR are the brand names available for quetiapine in the US.

Tell your healthcare provider about all the medicines that you take or recently have taken including prescription medicines, nonprescription medicines, herbal supplements and vitamins.

Seroquel and other medicines may affect each other causing serious side effects. Seroquel may affect the way other medicines work, and other medicines may affect how Seroquel works.

Especially tell your healthcare provider if you take or plan to take medication for:

• depression
• high blood pressure
• Parkinson's disease
• trouble sleeping
• abnormal heart beats or rhythm

Also tell your healthcare provider if you take or plan to take any of these medicines:

• phenytoin, divalproex or carbamazepine (for epilepsy)
• barbiturates (to help you sleep)
• rifampin (for tuberculosis)
• glucocorticoids (steroids for inflammation)
• thioridazine (an antipsychotic)
• ketoconazole, fluconazole or itraconazole (for fungal infections)
• erythromycin (an antibiotic)
• protease inhibitors (for HIV)

This is not a complete list of medicines that can affect or be affected by Seroquel. Your doctor can tell you if it is safe to take Seroquel with your other medicines. Do not start or stop any medicines while taking Seroquel without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Tell your healthcare provider if you are having a urine drug screen because Seroquel may affect your test results. Tell those giving the test that you are taking Seroquel.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• side effects

The recommended dose range of Seroquel for the treatment of schizophrenia and bipolar mania is 400-800mg/day.

The recommended dose of Seroquel for bipolar depression is 300 mg/day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

In the U.S.

• SEROquel
• SEROquel XR

Available Dosage Forms:

• Tablet
• Tablet, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Quetiapine

This section provides information on the proper use of a number of products that contain quetiapine. It may not be specific to Seroquel. Please read with care.

Take this medicine exactly as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Quetiapine tablets may be taken with or without food on a full or empty stomach. However, if your doctor tells you to take it a certain way, take it as directed.

Swallow the extended-release tablets whole. Do not break, crush, or chew it. It is best to take this medicine without food or with a light meal (approximately 300 calories).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For treatment of depression with bipolar disorder:
    • Adults—At first, 50 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by the doctor.
  • For treatment of mania with bipolar disorder:
    • Adults—At first, 300 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children 10 to 17 years—At first, 50 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
    • Children younger than 10 years—Use and dose must be determined by the doctor.
  • For treatment of major depressive disorder (MDD):
    • Adults—At first, 50 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by the doctor.
  • For treatment of schizophrenia:
    • Adults—At first, 300 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children 13 to 17 years—At first, 50 mg once a day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children younger than 13 years—Use and dose must be determined by the doctor.
• For oral dosage form (tablets):
  • For treatment of depression with bipolar disorder:
    • Adults—At first, 50 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
    • Children—Use and dose must be determined by the doctor.
  • For treatment of mania with bipolar disorder:
    • Adults—At first, 50 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children 10 to 17 years—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.
    • Children younger than 10 years—Use and dose must be determined by the doctor.
  • For treatment of schizophrenia:
    • Adults—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 750 mg per day.
    • Children 13 to 17 years—At first, 25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children younger than 13 years—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Controlled Substance

Seroquel is not a controlled substance.

Abuse

Seroquel has not been systematically studied, in animals or humans, for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of Seroquel, e.g., development of tolerance, increases in dose, drug-seeking behavior.

Never take Seroquel in larger amounts, or for longer than recommended by your doctor. High doses or long-term use can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Stop using Seroquel and call your doctor at once if you have the following symptoms: very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, uncontrolled muscle movements, feeling light-headed, blurred vision, eye pain, increased thirst and urination, excessive hunger, fruity breath odor, weakness, nausea and vomiting.

Some young people have thoughts about suicide when first taking Seroquel. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Seroquel is not approved for use in psychotic conditions related to dementia. Quetiapine may increase the risk of death in older adults with dementia-related conditions.

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• mask-like appearance of the face, trouble swallowing, problems with speech;

• a light-headed feeling, like you might pass out;

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

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

• low blood cell counts - sudden weakness or ill feeling, fever, chills, cold or flu symptoms, cough, sore throat, red or swollen gums, painful mouth sores, skin sores, trouble breathing.

Common Seroquel side effects may include:

• trouble with movement;

• dizziness, weakness;

• increased appetite, weight gain;

• sore throat;

• dry mouth; or

• nausea, vomiting, stomach pain, constipation.

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.

Common side effects of Seroquel include: asthenia, constipation, dizziness, drowsiness, headache, increased serum cholesterol, increased serum triglycerides, increased thyroid stimulating hormone level, and xerostomia. Other side effects include: abdominal pain, dyspepsia, increased serum alanine aminotransferase, orthostatic hypotension, pharyngitis, weight gain, and tachycardia. See below for a comprehensive list of adverse effects.

• Seroquel may be used in the treatment of schizophrenia in adults and children over the age of 13 years.
• Seroquel may also be used to treat bipolar disorder in adults and children over the age of 10.
• Its ability to also calm and make people sleepy means it may be used in addition to antidepressants or to treat other conditions (off-label uses include anxiety disorder).
• Seroquel is available as a generic under the name of quetiapine.