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-1-piperazinyl)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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
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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) 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.
Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). Seroquel XR is not approved for treating these patients.
Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Families and caregivers should watch patients daily and report these symptoms immediately to the physician. Seroquel XR is not approved for patients under the age of 18 years.
* High blood sugar and diabetes have been reported with Seroquel XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, ask your doctor about checking your blood sugar before starting Seroquel XR and regularly throughout treatment. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening
* Increases in cholesterol and triglycerides, and weight gain have been reported with Seroquel XR
* A rare, but potentially fatal, side effect reported with Seroquel XR and medicines like it is neuroleptic malignant syndrome (NMS). Tell your doctor if you have very high fever; rigid muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness because treatment should be stopped if you have NMS
* Another serious side effect reported with Seroquel XR and medicines like it is tardive dyskinesia (TD)—uncontrollable movements of the face, tongue, or other parts of the body. TD may become permanent, and the risk of TD is believed to increase as the length of time on and the amount of these medications increase. While TD can develop in patients taking low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if treatment is stopped
* Before starting treatment, tell your doctor if you have high prolactin levels or have a history of, or are at risk for, seizures or a low white blood cell (WBC) count. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter
* During treatment, tell your doctor if you feel dizzy or lightheaded upon standing, or if you have trouble swallowing
* Suicidal thoughts or actions may occur; tell your doctor if you have thoughts about death or suicide
* Since drowsiness has been reported with Seroquel XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid drinking alcohol while taking Seroquel XR because Seroquel XR increases the effects of alcohol. Avoid becoming overheated or dehydrated while taking Seroquel XR
* Common side effects: The most common side effects are drowsiness, dry mouth, increases in cholesterol and triglycerides, constipation, upset stomach, dizziness, a sudden drop in blood pressure upon standing, weight gain, increased hunger, tiredness, increases in blood sugar, difficulty speaking, and stuffy nose
This is not a complete summary of safety information. Please discuss the full Prescribing Information Adobe PDF with your health care provider.
Indications
Seroquel XR is a once-daily tablet approved to treat acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or when added to lithium or divalproex; long-term maintenance of bipolar disorder when added to lithium or divalproex; and schizophrenia.
AstraZeneca announced today that once-daily SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.
Following this new indication, SEROQUEL and SEROQUEL XR are the only agents approved in the European Union to treat all phases of bipolar disorder – acute depressive episodes, acute manic episodes and maintenance treatment to prevent recurrence of any mood event in bipolar disorder.
AstraZeneca will now move forward with obtaining local approvals with the Member States that take part in the Mutual Recognition Procedure.