Generic Name: quetiapine (kwe TYE a peen)Brand Names: Seroquel, Seroquel XR
Quetiapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Quetiapine is used to treat schizophrenia in adults and children who are at least 13 years old.
Quetiapine is used to treat bipolar disorder (manic depression) in adults and children who are at least 10 years old.
Quetiapine is also used together with antidepressant medications to treat major depressive disorder in adults.Extended-release quetiapine (Seroquel XR) is for use only in adults and should not given to anyone younger than 18 years old.
Quetiapine may also be used for other purposes not listed in this medication guide.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.Call your doctor at once if you have any new or worsening symptoms 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.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take quetiapine:
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
a history of low white blood cell (WBC) counts;
a thyroid disorder;
seizures or epilepsy;
high cholesterol or triglycerides;
a personal or family history of diabetes; or
Quetiapine may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking quetiapine.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.FDA pregnancy category C. It is not known whether quetiapine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether quetiapine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give quetiapine to a child without a doctor's advice. Extended-release quetiapine (Seroquel XR) is for use only in adults and should not given to anyone younger than 18 years old.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.Take each dose with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.
To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.Store quetiapine tablets at room temperature away from moisture and heat.
See also: Quetiapine dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.Avoid drinking alcohol, which can increase some of the side effects of quetiapine.
Call your doctor at once if you have any new or worsening symptoms 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.Other serious side effects include:
fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
jerky muscle movements you cannot control;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips;
increased thirst, frequent urination, excessive hunger, or weakness;
feeling like you might pass out; or
urinating less than usual or not at all.
Less serious side effects may include:
dizziness, drowsiness, or weakness;
dry mouth, runny nose, sore throat;
nausea, vomiting, stomach pain, constipation;
blurred vision, headache, anxiety, agitation;
breast swelling or discharge;
missed menstrual periods; or
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.
Usual Adult Dose for Schizophrenia:
Immediate-release tablets:Initial Dose: 25 mg orally twice a day.The dosage may be increased in increments of 25 to 50 mg two times a day or three times a day on the second and third days (as tolerated). By the fourth day a dosage range of 300 mg to 400 mg daily (divided into 2 or 3 doses a day) may be achieved. Additional dosage adjustments (increases or decreases) of 25 to 50 mg twice a day may be made, as needed. However, at least 2 days should pass between the additional dosage adjustments.Efficacy in schizophrenia has been reported with doses ranging from 150 to 750 mg/day. Maximum clinical effect has been reported at 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.Extended-release tablets:Initial dose: 300 mg orally once daily without food or with a light meal.Maintenance dose: 400 to 800 mg orally once daily depending on response and tolerance.Maximum dose: Doses above 800 mg daily have not been studied.The dosage of the extended-release tablets may be increased in increments of up to 300 mg daily at intervals as short as 1 day.The efficacy of quetiapine in long-term use (over 6 weeks) has not been studied in clinical trials. Patients who respond favorably to quetiapine may be continued on the lowest dose which is effective in maintaining their remission. Patients should be periodically reassessed to determine their need for maintenance treatment.
Usual Adult Dose for Bipolar Disorder:
Immediate-release tablets:Mania associated with bipolar I disorder as monotherapy or as adjunct therapy to lithium or divalproex:Initial Dose: 50 mg orally twice a dayThe dose may be increased to 200 mg orally twice daily on day 4 in increments of up to 50 mg twice daily. Further dosage adjustments up to 800 mg per day by day 6 should be in increments of no greater than 200 mg/day. Data has been reported to indicate that the majority of patients responded between 400 mg per day to 800 mg per day. The safety of doses above 800 mg per day has not been evaluated in clinical trials.Immediate-release tablets:Depressive episodes associated with bipolar disorder:Initial dose: 50 mg orally once a dayThe dose may be increased to reach 300 mg orally once a day by day 4. Some patients may require a further increase to 600 mg once a day by increasing the daily dose to 400 mg on day 5 and 600 mg on day 8 of treatment. Efficacy was demonstrated in this patient population at both 300 mg and 600 mg per day. However, no additional benefit was observed in patients receiving 600 mg per day as compared to those patients receiving 300 mg per day.Extended-release tablets:Bipolar Depression:(Depressive Episodes Associated with Bipolar Disorder)Usual dose for Acute Treatment: administer orally once daily in the evening starting with 50 mg per day and increasing doses to reach 300 mg per day by day 4.Recommended Dosing Schedule: Day 1 - 50 mg, Day 2 - 100, mg, Day 3 - 200 mg, & Day 4 - 300 mgBipolar Mania:Usual dose for Acute Monotherapy or Adjunct Therapy (with lithium or divalproex): administer orally once daily in the evening starting with 300 mg on day 1, 600 mg on day 2, and adjust between 400 mg and 800 mg per day thereafter depending on the clinical response and tolerance of the individual patient.Bipolar Maintenance:Continue treatment at the dosage required to maintain symptom remission.While there is no body of evidence available to specifically address how long patients should remain on quetiapine extended-release tablets, maintenance of efficacy in Bipolar I Disorder has been demonstrated with quetiapine (administered orally twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Usual Adult Dose for Depression:
As adjunctive therapy to antidepressants for use in the treatment of major depressive disorder:Extended-release tablets:Initial dose: 50 mg orally once daily in the eveningOn day 3, the dose can be increased to 150 mg once daily in the evening.Range: 150 mg to 300 mg orally daily. Doses above 300 mg have not been studied.
Usual Geriatric Dose for Schizophrenia:
Immediate-release tablets:Initial Dose: 25 mg orally once a day.The dose may be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.Efficacy in schizophrenia has been reported with doses ranging from 150 to 750 mg/day. Maximum clinical effect has been reported at 300 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.Extended-release tablets:When an effective immediate-release dose has been reached (above 200 mg), the patient may be switched to the extended-release formulation at an equivalent dose.The efficacy of quetiapine in long-term use (over 6 weeks) has not been studied in clinical trials. Patients who respond favorably to quetiapine may be continued on the lowest dose which is effective in maintaining their remission. Patients should be periodically reassessed to determine their need for maintenance treatment.
Usual Geriatric Dose for Bipolar Disorder:
Extended-release tablets:Initial dose: 50 mg/dayThe dose can be increased in increments of 50 mg/day depending on the response and tolerance of the individual patient.
Before taking quetiapine, tell your doctor if you are taking any of the following medicines:
erythromycin (E-Mycin, E.E.S, Ery-Tab);
rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
steroids (prednisone and others);
an antifungal medication such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);
medicine for depression or mental illness, such as fluoxetine (Prozac), haloperidol (Haldol), imipramine (Tofranil), or risperidone (Risperdal);
a medication to treat high blood pressure or a heart condition; or
seizure medication such as carbamazepine (Tegretol), divalproex (Depakote), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), or valproate (Depakene).
This list is not complete and there may be other drugs that can interact with quetiapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.