Seroquel Information and Uses

Seroquel

Seroquel Overview

Seroquel (generic: quetiapine) is a prescription medication used to treat schizophrenia and bipolar disorder in adults and children aged 10 years and older.

Seroquel belongs to a group of drugs called antisychotics. The exact way it works is unclear, but it is proposed to regulate certain chemicals in the brain.

This medication comes in tablet form and is usually taken 2-3 times daily with or without food.

Common side effects of Seroquel are sleepiness, dizziness, and dry mouth.

This medication may cause drowsiness. Do not drive or operate heavy machinery until you know how Seroquel affects you.

Uses of Seroquel

Seroquel is a prescription medication used to treat schizophrenia and bipolar disorder in adults and children aged 10 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Seroquel

Seroquel may cause serious side effects, including:

Risk of death in the elderly with dementia
Risk of suicidal thoughts or actions
High blood sugar (hyperglycemia)
High fat levels in your blood (increased cholesterol and triglycerides)
Weight gain

These serious side effects are described below:

Risk of death in the elderly with dementia: Medicines like Seroquel can increase the risk of death in elderly people who have memory loss (dementia). Seroquel is not approved for treating psychosis in the elderly with dementia.
Risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions)

High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
- Build up of acid in your blood due to ketones (ketoacidosis)
- Coma
- Death

Increases in blood sugar can happen in some people who take Seroquel. Extremely high blood sugar can lead to coma or death.

High fat levels in your blood (increased cholesterol and triglycerides): High fat levels may happen in people treated with Seroquel. You may not have any symptoms, so your doctor may decide to check your cholesterol and triglycerides during your treatment with Seroquel.
Increase in weight (weight gain): Weight gain is common in people who take Seroquel so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Other possible serious side effects of Seroquel are:

Neuroleptic malignant syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including Seroquel. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have some or all of these symptoms:
high fever
excessive sweating
rigid muscles
confusion
changes in your breathing, heartbeat, and blood pressure
Tardive dyskinesia: Tell your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Seroquel. Tardive dyskinesia may also start after you stop taking Seroquel.
Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.
Increases in blood pressure: reported in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before starting Seroquel and during therapy.
Low white blood cell count
Cataracts
Seizures
Abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.
Increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.
Increases in liver enzymes: Your healthcare provider may do blood tests to check your liver enzyme levels.
Long lasting and painful erection
Difficulty swallowing

Common possible side effects with Seroquel include:

Adults:

drowsiness
dry mouth
dizziness
weakness
weight gain
abdominal pain
constipation
sore throat
sluggishness
upset stomach
weight gain
a sudden drop in blood pressure upon standing
abnormal liver tests

Children and Adolescents:

drowsiness
fatigue
nausea
dry mouth
weight gain
dizziness
increased appetite
vomiting
rapid heart rate

These are not all the possible side effects of Seroquel. For more information, ask your healthcare provider or pharmacist.

Seroquel Interactions

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 medicines 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.

Seroquel Precautions

Do not drive, operate machinery, or do other dangerous activities until you know how Seroquel affects you. Seroquel may make you drowsy.
Avoid getting over-heated or dehydrated.
Do not over-exercise.
In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water.
Do not drink alcohol while taking Seroquel. It may make some side effects of Seroquel worse.

Seroquel Food Interactions

Grapefruit and grapefruit juice may interact with Seroquel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Inform MD

Before taking Seroquel, tell your healthcare provider if you have or have had:

diabetes or high blood sugar in you or your family: your healthcare provider should check your blood sugar before you start Seroquel and also during therapy.
high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL- cholesterol
low or high blood pressure
low white blood cell count
cataracts
seizures
abnormal thyroid tests
high prolactin levels
heart problems
liver problems
any other medical condition
pregnancy or plans to become pregnant. It is not known if Seroquel will harm your unborn baby.
breastfeeding or plans to breastfeed. Seroquel can pass into your breast milk. You and your healthcare provider should decide if you will take Seroquel or breastfeed. You should not do both.

Seroquel and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Seroquel will harm your unborn baby.

Seroquel and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. Seroquel may be excreted in your breast milk. It is not known if it will harm your nursing baby.

Seroquel Usage

Take Seroquel exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
Take Seroquel by mouth, with or without food.
If you feel you need to stop Seroquel, talk with your healthcare provider first. If you suddenly stop taking Seroquel, you may experience side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
If you take too much Seroquel, call your healthcare provider or poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

Seroquel Dosage

Take Seroquel exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Seroquel must be individualized.

Schizophrenia

Adults

Dose Selection— Seroquel should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg - 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for Seroquel would not be achieved for approximately 1-2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg - 50 mg divided twice daily are recommended. Most efficacy data with Seroquel were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.

Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of Seroquel. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day - 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

Maintenance Treatment—The effectiveness of Seroquel for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with Seroquel should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Adolescents (13-17 years)

Dose Selection—Seroquel should be administered twice daily. However, based on response and tolerability Seroquel may be administered three times daily where needed.

The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the dose should be adjusted within the recommended dose range of 400 mg/day to 800 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day. Efficacy was demonstrated with Seroquel at both 400 mg and 800 mg; however, no additional benefit was seen in the 800 mg group.

Bipolar Disorder

Adults

Acute Treatment of Manic Episodes in Bipolar I Disorder

Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), Seroquel should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.

Acute Treatment of Depressive Episodes in Bipolar Disorder

Dose Selection—Seroquel should be administered once daily at bedtime to reach 300 mg/day by Day 4.

In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with Seroquel at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.

Maintenance Treatment of Bipolar I Disorder

Maintenance of efficacy in bipolar I disorder was demonstrated with Seroquel (administered 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.

Children and Adolescents (10 to 17 years)

Acute Treatment of Manic Episodes in Bipolar I Disorder

Dose Selection—Seroquel should be administered twice daily. However, based on response and tolerability Seroquel may be administered three times daily where needed.

The total daily dose for the initial five days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3), 300 mg (Day 4) and 400 mg (Day 5). After Day 5, the dose should be adjusted within the recommended dose range of 400 to 600 mg/day based on response and tolerability. Dosage adjustments should be in increments of no greater than 100 mg/day. Efficacy was demonstrated with Seroquel at both 400 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.

Maintenance Treatment of Bipolar I Disorder

The effectiveness of Seroquel for longer than 3 weeks has not been evaluated in controlled clinical trials of children and adolescents. While there is no body of evidence available to answer the question of how long the patient treated with Seroquel should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Dosing in Special Populations

Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions. When indicated, dose escalation should be performed with caution in these patients.

Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day – 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

Reinitiation of Treatment in Patients Previously Discontinued

Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off Seroquel, titration of Seroquel is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off Seroquel for more than one week, the initial titration schedule should be followed.

Switching from Antipsychotics

There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to Seroquel, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate Seroquel therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.

Seroquel Overdose

If you take too much Seroquel, call your healthcare provider or poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

Forms of Seroquel

Seroquel tablets are available in the following strengths: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.

Active ingredient: quetiapine fumarate

Inactive ingredients: povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain red and yellow ferric oxide. The 100 mg and 400 mg tablets contain only yellow ferric oxide.

Other Requirements

Store Seroquel at room temperature, between 59°F to 86°F (15°C to 30°C).
Keep Seroquel and all medicines out of the reach of children.

Seroquel FDA Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SEROQUEL (quetiapine) is not approved for the treatment of patients with dementia-related psychosis.

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL is not approved for use in patients under ten years of age