Seroquel XR

DRUG DESCRIPTION

SEROQUEL XR (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:

SEROQUEL XR (quetiapine fumarate)  Structural Formula Illustration

Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.

SEROQUEL XR is supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated.

Inactive ingredients for SEROQUEL XR are lactose monohydrate, microcrystalline cellulose, sodium citrate, hypromellose, and magnesium stearate. The film coating for all SEROQUEL XR tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50, 200 and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths.

Each 50 mg tablet contains 58 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 173 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate equivalent to 400 mg quetiapine.

What are the possible side effects of quetiapine (Seroquel, Seroquel XR)?

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

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...

Read All Potential Side Effects and See Pictures of Seroquel XR

What are the precautions when taking quetiapine fumarate extended-release tablets (Seroquel XR)?

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: personal or family history of diabetes, eye cataracts, high blood pressure, high cholesterol, liver disease, low white blood cell count, seizure disorder, trouble swallowing, thyroid problems.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Quetiapine may cause a...

Read All Potential Precautions of Seroquel XR


Seroquel XR Consumer (continued)

SIDE EFFECTS: Constipation, drowsiness, upset stomach, tiredness, weight gain, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor promptly.

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

Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: restlessness/constant need to move, shaking (tremor), signs of infection (such as fever, persistent sore throat), mental/mood changes (such as increased anxiety, depression, thoughts of suicide), difficulty swallowing.

Get medical help right away if any of these rare but serious side effects occur: fainting, fast/irregular heartbeat, seizure, severe dizziness.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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

This drug may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop the following: fever, muscle stiffness, severe confusion, sweating, fast/irregular heartbeat.

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 immediately.

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: 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.

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: personal or family history of diabetes, eye cataracts, high blood pressure, high cholesterol, liver disease, low white blood cell count, seizure disorder, trouble swallowing, thyroid problems.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Quetiapine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in 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 affect the heart rhythm. 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 can make you more likely to get heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs).

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Seroquel XR Patient Information Including Side Effects

Brand Names: Seroquel, Seroquel XR

Generic Name: quetiapine (Pronunciation: kwe TYE a peen)

  • What is quetiapine (Seroquel XR)?
  • What are the possible side effects of quetiapine (Seroquel XR)?
  • What is the most important information I should know about quetiapine (Seroquel XR)?
  • What should I discuss with my healthcare provider before taking quetiapine (Seroquel XR)?
  • How should I take quetiapine (Seroquel XR)?
  • What happens if I miss a dose (Seroquel XR)?
  • What happens if I overdose (Seroquel XR)?
  • What should I avoid while taking quetiapine (Seroquel XR)?
  • What other drugs will affect quetiapine (Seroquel XR)?
  • Where can I get more information?

What is quetiapine (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.

What are the possible side effects of quetiapine (Seroquel XR)?

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

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
  • weight gain.

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.

What is the most important information I should know about quetiapine (Seroquel XR)?

Quetiapine is not for use in psychotic conditions related to dementia. Quetiapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Stop using quetiapine and call your doctor at once if you have the following symptoms: fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, uncontrolled muscle movements, symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

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.

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