Seroquel Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by 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.

Quetiapine is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Drugs used to treat depression can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take drugs to treat depression may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of drugs used to treat depression (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new drug to treat depression is started or when the dose is changed.

This medication is not approved for use in children under 10 years old.

Warnings:

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by 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.

Quetiapine is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Drugs used to treat depression can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take drugs to treat depression may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of drugs used to treat depression (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new drug to treat depression is started or when the dose is changed.

This medication is not approved for use in children under 10 years old.

… Show More

Uses

This medication is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (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. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.

How to use Seroquel

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using quetiapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2 or 3 times daily with or without food. For the treatment of depression associated with bipolar disorder, take this medication by mouth as directed by your doctor, usually once daily at bedtime.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as trouble sleeping, nausea, headache, diarrhea, irritability. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

Constipation, drowsiness, upset stomach, tiredness, weight gain, blurred vision, or dry mouth may occur. If any of these effects last or get worse, tell your doctor promptly.

Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: constipation with abdominal pain that doesn’t go away, nausea/vomiting that doesn’t stop, restlessness/constant need to move, shakiness (tremor), mental/mood changes (such as increased anxiety, depression, thoughts of suicide), difficulty swallowing, loss of appetite, yellowing eyes/skin, interrupted breathing during sleep, trouble urinating.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, severe dizziness.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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

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

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

Quetiapine may increase a certain natural substance (prolactin) made by your body. 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 right away.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, 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 or at www.fda.gov/medwatch.

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

Precautions

Before taking quetiapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye cataracts, liver disease, low white blood cell count (including history of low white blood cell count caused by medications), seizure disorder, trouble swallowing, thyroid problems, stomach/intestinal blockage (such as severe constipation, bowel obstruction), stomach/intestines that are not moving (such as ileus), personal or family history of diabetes, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart disease, high blood pressure, high cholesterol/triglyceride levels, breathing trouble during sleep (sleep apnea), difficulty urinating (for example, due to enlarged prostate).

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Quetiapine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using quetiapine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using quetiapine safely.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at higher risk for certain side effects while taking this medication, such as increased blood pressure or increased prolactin (see also Side Effects section). Talk with the doctor about the risks and benefits.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops symptoms such as muscle stiffness or shakiness, unusual sleepiness, or difficulty feeding. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Many drugs besides quetiapine may affect the heart rhythm (QT prolongation), including amiodarone, moxifloxacin, procainamide, quinidine, sotalol, thioridazine, among others.

Other medications can affect the removal of quetiapine from your body, which may affect how quetiapine works. Examples include azole antifungals (such as itraconazole, ketoconazole), drugs used to treat seizures (such as phenytoin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including urine tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Does Seroquel interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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.

Lab and/or medical tests (such as blood sugar, blood pressure, cholesterol levels, eye exams, weight, blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. 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. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Images

Seroquel 25 mg tablet

Color: peachShape: roundImprint: SEROQUEL 25

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Seroquel 50 mg tablet

Color: whiteShape: roundImprint: SEROQUEL 50

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Seroquel 300 mg tablet

Color: whiteShape: oblongImprint: SEROQUEL 300

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Seroquel 200 mg tablet

Color: whiteShape: roundImprint: SEROQUEL 200

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Seroquel 100 mg tablet

Color: yellowShape: roundImprint: SEROQUEL 100

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Seroquel 400 mg tablet

Color: yellowShape: oblongImprint: SEROQUEL 400

This medicine is a peach, round, film-coated, tablet imprinted with “SEROQUEL 25”.

Next

Save up to 80% on your prescriptions.

Available coupons

Save up to 80% on your prescription with WebMDRx

Drug Survey

Are you currently using Seroquel?

This survey is being conducted by the WebMD marketing sciences department.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Quetiapine (Seroquel) | NAMI: National Alliance on Mental Illness

Download PDF

Generic name: quetiapine (kwe TYE a peen)

• Oral tablet: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg
• Extended-release oral tablet: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

Brand names:

• Seroquel®
  • Oral tablet: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

• Seroquel XR®
  • Extended-release oral tablet: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What Is Quetiapine And What Does It Treat?

Quetiapine is a medication that works in the brain to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Quetiapine rebalances dopamine and serotonin to improve thinking, mood, and behavior.

Symptoms of schizophrenia include:

• Hallucinations – imagined voices or images that seem real
• Delusions – beliefs that are not true (e.g., other people are reading your thoughts)
• Disorganized thinking or trouble organizing your thoughts and making sense
• Little desire to be around other people
• Trouble speaking clearly
• Lack of motivation

Quetiapine may help some or all these symptoms.

Quetiapine is also FDA approved for the following indications:

• Acute treatment of manic episodes of bipolar disorder
• Acute treatment of depressive episodes of bipolar disorder
• Maintenance (long-term) treatment of bipolar disorder (when used alone or with lithium or valproate)
• Adjunctive treatment of major depressive disorder. This means quetiapine is used in addition to an antidepressant to help treat depression.

This medication sheet will focus primarily on schizophrenia. You can find more information about bipolar disorder and depression here.

This medication may be prescribed for other uses; ask your health care provider for more information.

What Is The Most Important Information I Should Know About Quetiapine?

Schizophrenia requires long-term treatment. Do not stop taking quetiapine, even when you feel better.

With input from you, your health care provider will assess how long you will need to take the medication.

Missing doses of quetiapine may increase your risk for a relapse in your symptoms.

Do not stop taking quetiapine or change your dose without talking with your health care provider first.

For quetiapine to work properly, it should be taken every day as ordered by your health care provider.

Are There Specific Concerns About Quetiapine And Pregnancy?

If you are planning on becoming pregnant, notify your health care provider to best manage your medications. People living with schizophrenia or certain other mental illness who wish to become pregnant face important decisions. This is a complex decision since untreated schizophrenia or other mental illness has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers.

Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization.

Caution is advised with breastfeeding since quetiapine does pass into breast milk.

What Should I Discuss With My Health Care Provider Before Taking Quetiapine?

• Symptoms of your condition that bother you the most
• If you have thoughts of suicide or harming yourself
• Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
• If you ever had muscle stiffness, shaking, tardive dyskinesia, neuroleptic malignant syndrome, or weight gain caused by a medication
• If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.
• Any psychiatric or medical problems you have, such as heart rhythm problems, long QT syndrome, heart attacks, diabetes, high cholesterol, or seizures
• If you have any of these health problems: low potassium or magnesium levels
• If you have a family history of diabetes or heart disease
• All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
• Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
• If you are pregnant, plan to become pregnant, or are breastfeeding
• If you smoke, drink alcohol, or use illegal drugs

How Should I Take Quetiapine?

Quetiapine may help control your symptoms but will not cure your condition.

It may take two to three months before you feel the full effect of quetiapine.

Quetiapine is usually taken 1, 2, or 3 times per day with or without food. The extended release should be taken without food or with a light meal (≤300 calories).

Typically, patients begin at a low dose of medication and the dose is increased slowly over several weeks.

The dose usually ranges from 100 mg to 800 mg. Only your health care provider can determine the correct dose for you.

The extended-release tablets should be swallowed whole. They should not be chewed, crushed, or broken.

Use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member a friend to remind you or check in with you to be sure you are taking your medication.

What Happens If I Miss A Dose Of Quetiapine?

It is important to take your medication everyday as directed by your health care provider. Do not miss or skip a dose.

If you miss a dose of quetiapine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What Should I Avoid While Taking Quetiapine?

Avoid drinking alcohol or using illegal drugs while you are taking quetiapine. They may decrease the benefits (e.g., worsen your confusion) and increase adverse effects (e.g., sedation) of the medication.

What Happens If I Overdose With Quetiapine?

If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of quetiapine does not exist.

What Are The Possible Side Effects Of Quetiapine?

This is not a complete list. Talk with your health care provider for more information.

Common side effects

Increased blood pressure, increased heart rate, drowsiness, headache, agitation, dizziness, fatigue, extrapyramidal symptoms, weight gain, cholesterol abnormalities, increased glucose, dry mouth, increased appetite, constipation

Rare/serious side effects

Quetiapine may increase the blood levels of a hormone called prolactin. Side effects of increased prolactin levels include females losing their period, production of breast milk and males losing their sex drive or possibly experiencing erectile problems. Long term (months or years) elevated prolactin levels can lead to osteoporosis, or increased risk of bone fractures.

Some people may develop muscle related side effects while taking quetiapine. The technical terms for these are “extrapyramidal symptoms” (EPS) and “tardive dyskinesia” (TD). Symptoms of EPS include restlessness, tremor, and stiffness. TD symptoms include slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements.

Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, and dehydration.

Second generation antipsychotics (SGAs) increase the risk of weight gain, high blood sugar, and high cholesterol. This is also known as metabolic syndrome. Your health care provider may ask you for a blood sample to check your cholesterol, blood sugar, and hemoglobin A1c (a measure of blood sugar over time) while you take this medication.

• Information on healthy eating and adding exercise to decrease your chances of developing metabolic syndrome may be found at the following sites:
  • http://www.helpguide.org/articles/healthy-eating/healthy-eating.htm
  • http://www.helpguide.org/home-pages/exercise-fitness.htm

SGAs have been linked with higher risk of death, strokes, and transient ischemic attacks (TIAs) in elderly people with behavior problems due to dementia.

All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heart beat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. Your doctor may order an EKG to monitor for irregular heartbeat.

Neuroleptic malignant syndrome is a rare, life threatening adverse effect of antipsychotics which occurs in <1% of patients. Symptoms include confusion, fever, extreme muscle stiffness, and sweating. If any of these symptoms occur, contact your health care provider immediately.

All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. If falls or any of these symptoms occur, contact your health care provider.

Increased blood pressure in children and adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents.

Are There Any Risks For Taking Quetiapine For Long Periods Of Time?

Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics. Medications such as quetiapine have been shown to have a lower risk of TD compared to older antipsychotics, such as Haldol (haloperidol). If you develop symptoms of TD, such as grimacing, sucking, and smacking of lips, or other movements that you cannot control, contact your health care provider immediately. All patients taking either first- or second-generation antipsychotics should have an Abnormal Involuntary Movement Scale (AIMS) completed regularly by their health care provider to monitor for TD.

Second generation antipsychotics (SGAs) increase the risk of diabetes, weight gain, high cholesterol, and high triglycerides. (See “Serious Side Effects” section for monitoring recommendations).

Cataracts: Lens change have been observed in patients with long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment.

What Other Medications May Interact With Quetiapine?

Tell your health care provider about all medications that you take, have recently taken or plan to take including prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements. This medication may affect the way other medications work, and other medications may affect how this medication works.

Quetiapine may block the effects of agents used to treat Parkinson’s disease such as levodopa/carbidopa (Sinemet®), bromocriptine, pramipexole (Mirapex®), ropinirole (Requip®), and others.

The following medications may increase the risk of heart problems when used with quetiapine:

• Antipsychotics, including chlorpromazine (Thorazine®), thioridizine (Mellaril®), iloperidone (Fanapt®), asenapine (Saphris®), paliperidone (Invega®), ziprasidone (Geodon®)
• Antiarrhymics (heart rhythm medications), including procainamide, quinidine, amiodarone (Cordarone®), dronedarone (Multaq®), sotalol (Betapace®)

The following medications may increase the levels and effects of quetiapine:

• Erythromycin (Ery-Tab®), fluconazole (Diflucan®), fluvoxamine (Luvox®), ketoconazole, ritonavir, and nefazodone.

The following medications may decrease the levels and effects of quetiapine:

• Carbamazepine (Tegretol®), phenytoin (Dilantin®), phenobarbital, and rifampin (Rifadin®).

How Long Does It Take For Quetiapine To Work?

It is especially important to tell your doctor how you feel things are going during the first few weeks after you start taking quetiapine. It will probably take several weeks to see big enough changes in your symptoms to decide if quetiapine is the right medication for you.

Antipsychotic treatment is generally needed lifelong for persons with schizophrenia. Your doctor can best discuss the duration of treatment you need based on your symptoms and illness.

• Hallucinations, disorganized thinking, and delusions may improve in the first 1-2 weeks
• Sometimes these symptoms do not completely go away
• Motivation and desire to be around other people can take at least 1-2 weeks to improve
• Symptoms continue to get better the longer you take quetiapine
• It may take 2-3 months before you get the full benefit of quetiapine

Summary of FDA Black Box Warnings

Increased mortality in elderly patients with dementia related psychosis

• Both first generation (typical) and second generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia related psychosis.
• Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g., sudden cardiac death) or infection (e.g., pneumonia).
• Antipsychotics are not indicated for the treatment of dementia related psychosis.

Suicidal thoughts or actions in children and adults

• Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
• Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking medications. This risk may persist until significant remission occurs.
• Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional.
• All patients being treated with this medication for depression should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

Provided by

(January 2023)

©2022 The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). AAPP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.

This information is being provided as a community outreach effort of the American Association of Psychiatric Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The American Association of Psychiatric Pharmacists disclaims any and all liability alleged as a result of the information provided herein.

Volgograd Psychotherapy Center, Psychotherapist, Psychologist

International non-proprietary name: quetiapine

Chemical name: bis[2-(2-[4-(dibenzo[b,f] [1,4]- tiapine-11- yl)piperazin-1-yl] ethoxy)ethanol] fumarate

Dosage form: coated tablets

Composition

Active ingredient:

tablet 25 mg: contains quetiapine fumar ata 28.78 mg equivalent to 25 mg of quetiapine free base;

100 mg tablet: contains 115.13 mg quetiapine fumarate, equivalent to 100 mg quetiapine free base;

tablet 200 mg: contains 230. 26 mg quetiapine fumarate, equivalent to 200 mg quetiapine free base.

Excipients: povidone, calcium dihydrogen phosphate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate.

Coating contains red iron oxide (25 mg tablets), yellow iron oxide (25 and 100 mg tablets), titanium dioxide, hypromellose, polyethylene glycol 400.

Description:

25 mg tablet: round, biconvex, coated, pink;

100mg tablet: round, biconvex, film-coated, yellow;

200 mg tablet: round, biconvex, coated, white, engraved on one side Seroquel 25, Seroquel WO, Seroquel 200, respectively.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antipsychotic agent (neuroleptic)

Pharmacodynamics

Mechanism of action

Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin (5HT2) receptors than for brain dopamine D1 and D2 receptors. Quetiapine also has a higher affinity for histamine and a1-adrenergic receptors and less for a2-adrenergic receptors. No significant affinity of quetiapine for cholinergic muscarinic and benzodiazepine receptors was found. In standard tests, quetiapine exhibits antipsychotic activity.

Pharmacodynamic effects

The results of the study of extrapyramidal symptoms (EPS) in animals revealed that quetiapine causes mild catalepsy at a dose that effectively blocks dopamine D2 receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10 dopaminergic neurons in comparison with A9 nigrostriatal neurons involved in motor function.

Clinical efficacy

In clinical trials (using Seroquel at a dose of 75-750 mg / day), there was no difference between the use of Seroquel and placebo in the incidence of extrapyramidal symptoms and in the concomitant use of anti cholinergic drugs.

Seroquel does not cause a prolonged increase in plasma prolactin concentration. Numerous fixed-dose studies have found no difference in prolactin levels between Seroquel and placebo.

Seroquel has been shown to be effective in the treatment of both positive and negative symptoms of schizophrenia in clinical studies. The effect of quetiapine on 5HT2 and D2 receptors lasts up to 12 hours after taking the drug.

Pharmacokinetics

When administered orally, quetiapine is well absorbed from the gastrointestinal tract and extensively metabolized in the liver. The main metabolites in plasma do not have a pronounced pharmacological activity.

Food intake does not significantly affect the bioavailability of quetiapine. The half-life is about 7 hours. Approximately 83% of quetiapine binds to plasma proteins.

The pharmacokinetics of quetiapine is linear, there are no differences in pharmacokinetic parameters in men and women.

The average clearance of quetiapine in elderly patients is 30-50% less than in patients aged 18 to 65 years.

Mean plasma clearance of quetiapine is less than approximately 25% in patients with severe renal insufficiency (creatinine clearance less than 30 ml/min/1.73 m2) and in patients with liver damage (stabilized alcoholic cirrhosis), but individual clearance values ​​are within the limits corresponding to healthy people.

Approximately 73% of quetiapine is excreted in the urine and 21% in the faeces. Less than 5% of quetiapine is not metabolized and is excreted unchanged by the kidneys or faeces

CYP3A4 has been identified as a key enzyme in quetiapine metabolism mediated by cytochrome P450.

In a study of the pharmacokinetics of quetiapine at various dosages, the administration of quetiapine before ketoconazole or simultaneously with ketoconazole resulted in an increase, on average, in the maximum concentration (Cmax) and area under the concentration-time curve (AUC) of quetiapine by 235% and 522 %, respectively, and also led to a decrease in the clearance of quetiapine, on average, by 84%. The half-life of quetiapine increased, but the mean time to reach maximum concentration (tmax) did not change.

Quetiapine and some of its metabolites have weak inhibitory activity against cytochrome P450 enzymes 1A2, 2C9, 2C19, 2D6 and 3A4, but only at a concentration 10-50 times higher than the concentration observed at the commonly used effective dosage of 300-450 mg/day

Based on in vitro results, co-administration of quetiapine with other drugs should not be expected to result in clinically significant inhibition of cytochrome P450 mediated metabolism of other drugs.

INDICATIONS

For the treatment of acute and chronic psychoses, including schizophrenia.

For the treatment of manic episodes in the pattern of bipolar disorder.

CONTRAINDICATIONS

Hypersensitivity to any of the components of the drug.

PREGNANCY AND LACTATION

The safety and efficacy of Seroquel in pregnant women have not been established. Therefore, Seroquel should only be used during pregnancy if the expected benefit justifies the potential risk.

The degree of excretion of quetiapine in human milk is not known. Women should be advised to avoid breastfeeding while taking Seroquel.

DOSAGE AND ADMINISTRATION

Seroquel is administered orally 2 times a day, regardless of food intake.

Adults

Treatment of acute and chronic psychosis, including schizophrenia

The daily dose for the first 4 days of therapy is: 1st day – 50 mg; Day 3 – 300 mg. Starting on day 4, the dose should be adjusted to the effective dosage, usually in the range of 300 to 450 mg/day. Depending on the clinical effect and individual patient tolerance, the dose may vary from 150 to 750 mg / day.

Treatment of manic episodes in the structure of bipolar disorder

Seroquel is used as monotherapy or as adjuvant therapy for mood stabilization.

The daily dose for the first 4 days of therapy is: 1st day – 100 mg, 2nd day – 200 mg, 3rd day – 300 mg, 4th day – 400 mg. In the future, by the 6th day of therapy, the daily dose of the drug can be increased to 800 mg. An increase in the daily dose should not exceed 200 mg per day.

Depending on the clinical effect and individual tolerance, the dose may vary from 200 to 800 mg / day. Usually an effective dose is from 400 to 800 mg / day.

For the treatment of schizophrenia, the maximum recommended daily dose of Seroquel is 750 mg, for the treatment of manic episodes in the structure of bipolar disorder, the maximum recommended daily dose of Seroquel is 800 mg / day.

Elderly

In elderly patients, the initial dose of Seroquel is 25 mg/day. The dose should be increased daily by 25-50 mg until an effective dose is reached, which is likely to be less than in younger patients.

Patients with renal and hepatic insufficiency

In patients with renal or hepatic insufficiency it is recommended to start Seroquel therapy with 25 mg/day. It is recommended to increase the dose daily by 25-50 mg until an effective dose is reached.

Children and adolescents

The safety and efficacy of Seroquel have not been studied in children and adolescents.

SIDE EFFECTS

The most common adverse reactions associated with taking the drug were noted: drowsiness (17.5%), dizziness (10%), constipation (9%), dyspepsia (6%), orthostatic hypotension and tachycardia ( 7%), dry mouth (7%), increased activity of liver enzymes in the blood serum (6%), (including an increase in the concentration of cholesterol and triglycerides).

Taking Seroquel may be accompanied by the development of moderate asthenia, rhinitis and dyspepsia, weight gain (mainly in the first weeks of treatment).

Seroquel may cause orthostatic hypotension (accompanied by dizziness), tachycardia and, in some patients, syncope; these adverse reactions mainly occur in the initial period of dose selection (see section “Special Instructions”).

Very rare cases of priapism and seizures have been reported in patients treated with Seroquel.

In rare cases, neuroleptic malignant syndrome (hyperthermia, impaired consciousness, muscle rigidity, vegetative-vascular disorders, increased concentration of creatine phosphokinase) was observed, leukopenia and / or neutropenia were observed. There were no cases of severe neutropenia or agranulocytosis in patients taking Seroquel. With the use of Seroquel in routine practice, leukopenia and/or neutropenia resolved after discontinuation of the drug. Possible risk factors for the development of leukopenia and / or neutropenia include a decrease in the number of leukocytes before the start of therapy or a history of indications of drug-induced leukopenia and / or neutropenia. Rarely, cases of eosinophilia, the development of peripheral edema, allergic reactions, including angioedema, have been reported.

Asymptomatic cases of increased serum transferase activity (alanine and aspartic ALT and ACT, respectively) or gamma-glutamyl transpeptidase (GGT) activity have been reported in patients treated with Seroquel. During treatment with Seroquel, these changes, as a rule, were reversible.

During treatment with Seroquel, there may be a slight increase in the concentration of cholesterol and serum triglycerides.

Seroquel therapy is associated with a small dose-dependent decrease in thyroid hormone levels, in particular total T4 and free T4. The maximum decrease in total and free T4 was registered at the 2nd and 4th weeks of quetiapine therapy, without further decrease in hormone concentrations during long-term treatment. Subsequently, there were no signs of clinically significant changes in the concentration of thyroid-stimulating hormone.

In almost all cases, the concentration of total and free T4 returned to baseline after discontinuation of therapy with Seroquel, regardless of the duration of treatment. Seroquel can cause a prolongation of the QTC interval, the relationship of the use of Seroquel with a constant increase in QTC has not been identified (see section “Special Instructions”). Also, the following common (1/100) side effects were reported –

increased blood pressure, palpitations, dysarthria, pharyngitis, cough, anorexia, increased sweating. A causal relationship between these side effects and Seroquel has not been established.

Tardive dyskinesia

Long-term use of Seroquel has the potential to develop tardive dyskinesia. If symptoms of tardive dyskinesia occur, the dose should be reduced or further treatment with Seroquel discontinued.

With abrupt withdrawal of high doses of antipsychotic drugs, the following acute reactions (withdrawal syndrome) can be observed – nausea, vomiting, rarely insomnia.

Cases of exacerbation of psychotic symptoms and the appearance of involuntary movement disorders (akathisia, dystonia, dyskinesia) have been reported. In this connection, the abolition of the drug is recommended to be carried out gradually.

OVERDOSAGE

Data on Seroquel overdose are limited. Cases of taking Seroquel at a dose exceeding 20 g are described, without fatal consequences and with complete recovery, however, there are reports of extremely rare cases of overdose of Seroquel, leading to death or coma.

Symptoms: The reported symptoms were mainly due to an increase in the known pharmacological effects of the drug, such as drowsiness and excessive sedation, tachycardia and lowering of blood pressure.

Treatment: no specific antidotes for quetiapine. In cases of serious intoxication, symptomatic therapy should be considered and measures aimed at maintaining respiratory function, the cardiovascular system, ensuring adequate oxygenation and ventilation are recommended. Careful medical monitoring and observation should be continued until the patient has fully recovered.

INTERACTION WITH OTHER DRUGS AND OTHER FORMS OF INTERACTION

Concomitant administration of drugs with a strong inhibitory effect on CYP3A4 (such as azole antifungals and macrolide antibiotics) may increase plasma concentrations of quetiapine. In such cases, lower doses of Seroquel should be used. Particular attention should be paid to elderly and debilitated patients. It is necessary to individually assess the risk-benefit ratio for each patient. Simultaneous administration of Seroquel with drugs that induce the liver enzyme system, such as carbamazepine, may reduce the plasma concentration of the drug, which may require an increase in the dose of Seroquel, depending on the clinical effect. In a study of the pharmacokinetics of quetiapine at various dosages, when administered before or simultaneously with carbamazepine (an inducer of liver enzymes), such simultaneous administration resulted in a significant increase in quetiapine clearance. This increase in quetiapine clearance reduced AUC by an average of 13% compared with quetiapine without carbamazepine. Simultaneous administration of Seroquel with another inducer of microsomal liver enzymes – phenytoin – also led to an increase in the clearance of quetiapine. With the simultaneous appointment of Seroquel and phenytoin (or other inducers of liver enzymes, such as barbiturates, rifampicin), an increase in the dose of Seroquel may be required. It may also be necessary to reduce the dose of Seroquel when phenytoin or carbamazepine or another inducer of the liver enzyme system is canceled or replaced with a drug that does not induce microsomal liver enzymes (for example, sodium valproate).

The pharmacokinetics of lithium preparations does not change with the simultaneous administration of Seroquel.

There were no clinically significant changes in the pharmacokinetics of valproic acid and quetiapine when divalproex sodium (sodium valproate and valproate in a 1:1 molar ratio) and Seroquel (quetiapine) were co-administered.

Quetiapine did not cause induction of hepatic enzyme systems involved in antipyrine metabolism.

The pharmacokinetics of quetiapine does not change significantly when co-administered with the antipsychotics risperidone or haloperidol. However, the simultaneous administration of Seroquel and thioridazine resulted in an increase in the clearance of quetiapine.

CYP3A4 is a key enzyme involved in the cytochrome P450-mediated metabolism of quetiapine. The pharmacokinetics of quetiapine does not change significantly with the simultaneous use of cimetidine, which is a P450 inhibitor.

The pharmacokinetics of quetiapine did not change significantly with the simultaneous administration of the antidepressant imipramine (CYP2D6 inhibitor) or fluoxetine (CYP3A4 and CYP2D6 inhibitor). However, caution is advised when Seroquel is co-administered with systemic use of strong CYP3A4 inhibitors (such as azole antifungals and macrolide antibiotics).

CNS depressants and ethanol increase the risk of side effects.

SPECIAL INSTRUCTIONS

Seroquel can cause orthostatic hypotension, especially during the initial period of dose selection (in elderly patients it is more common than in young patients).

No relationship was found between taking quetiapine and increasing the QTc interval. However, when prescribing quetiapine concomitantly with drugs that prolong the QTc interval, care must be taken, especially in the elderly.

Given that quetiapine mainly affects the central nervous system, Seroquel should be used with caution in combination with other drugs that have a depressant effect on the central nervous system or alcohol.

Seizures

There was no difference in the incidence of seizures between patients taking Seroquel or placebo. However, as with other antipsychotics, caution is advised when treating patients with a history of seizures.

Antipsychotic Malignant Syndrome

Antipsychotic Malignant Syndrome may be associated with ongoing antipsychotic treatment. Clinical manifestations of the syndrome include hyperthermia, altered mental status, muscle rigidity, instability of the autonomic nervous system, and an increase in the level of creatine phosphokinase. In such cases, Seroquel should be canceled and appropriate treatment carried out.

Acute Withdrawal Reactions

With abrupt withdrawal of high doses of antipsychotic drugs, the following acute reactions (withdrawal syndrome) may occur – nausea, vomiting, rarely insomnia.

Cases of exacerbation of psychotic symptoms and the appearance of involuntary movement disorders (akathisia, dystonia, dyskinesia) have been reported. In this connection, the abolition of the drug is recommended to be carried out gradually.

WITH CAUTION: in patients with cardiovascular and cerebrovascular disease or other conditions predisposing to hypotension, advanced age, liver failure, history of seizures.