Seroquel XR

Generic name: Quetiapine fumarate, extended-release

What is Seroquel XR?

Seroquel XR is an antipsychotic medication prescribed for the treatment of schizophrenia. It is also used to treat symptoms of depression in patients with bipolar disorder. Seroquel XR may be given alone or in combination with lithium or divalproex to treat other symptoms (e.g., mania) associated with bipolar I disorder and is used only in combination with lithium and divalproex for the management of bipolar I disorder.

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

Seroquel XR is not approved for use in children.

Antidepressants have increased the risk of suicidal thoughts and actions in children and teenagers. All patients 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 their physician.

Seroquel XR may increase the risk of death when used to treat mental problems caused by dementia in elderly patients and therefore should not be used in these patients. Most of the deaths were linked to heart problems or infection. Patients at risk of seizures or conditions that lower seizure threshold (e.g., Alzheimer's dementia) should use Seroquel XR cautiously.

Seroquel XR may cause tardive dyskinesia, a potentially irreversible condition characterized by uncontrollable muscle spasms and twitches in the face and body. Older adults, especially women, appear to be at greater risk.

Seroquel XR may cause neuroleptic malignant syndrome (NMS), a serious, and potentially fatal, reaction to the drug. Call your doctor immediately if you develop muscle stiffness, confusion, irregular or rapid heartbeat, excessive sweating, and high fever. Be especially wary if you have a history of heart attack, heart disease, heart failure, circulation problems, or irregular heartbeat.

Certain antipsychotic drugs, including Seroquel XR, are associated with an increased risk of developing high blood sugar, which on rare occasions has led to coma or death. See your doctor right away if you develop signs of high blood sugar, including dry mouth, unusual thirst, increased urination, and tiredness. If you have diabetes or have a high risk of developing it, see your doctor regularly for blood sugar testing. Since patients being treated with Seroquel XR may experience changes or elevations in their cholesterol and triglyceride levels, your doctor may monitor these. Some instances of weight gain have also been reported.

Your doctor may also give you periodic eye exams to monitor for possible risk of cataracts.

In certain patients, elevated levels of the hormone prolactin have been reported. There is limited data available to determine the significance of this risk.

Seroquel XR may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if this happens.

Do not drink alcohol while you are using Seroquel XR.

Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke, dizziness, or fainting may occur.

Seroquel XR should be used with particular caution in patients with known cardiovascular disease (history of heart attack or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions that would predispose patients to decreased blood pressure (dehydration, low blood volume, and treatment with blood pressure medications).

Do not suddenly stop taking Seroquel XR without first talking with your doctor. You may have an increased risk of side effects. If you need to stop Seroquel XR or add a new medicine, your doctor will gradually lower your dose

Rarely, Seroquel XR may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills, especially if you have low white blood cell counts.

Who should not take Seroquel XR?

Do not take Seroquel XR if you are allergic to the medication or any of its ingredients.

What should I tell my doctor before I take the first dose of Seroquel XR?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Seroquel XR. Also, talk to your doctor about your complete medical history, especially if you have liver, kidney or heart disease, high or low blood pressure, heart rhythm problems, high cholesterol, a history of heart attack or stroke, breast cancer, a thyroid disorder, seizures, epilepsy, Alzheimer's disease, dementia or mood problems, suicidal thoughts, obesity, history of alcohol or substance abuse, thyroid problems, cataracts, narrow-angle glaucoma, blood problems, a history of neuroleptic malignant syndrome, a personal or family history of diabetes, or trouble swallowing.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Schizophrenia

Adults: The recommended starting dose of Seroquel XR is 300 milligrams (mg) a day, preferably taken in the evening. The effective dose range is 400 mg to 800 mg daily depending on how you respond and tolerate the drug. Dose increases can be made at 1-day intervals at increments of up to 300 mg per day. Individual dosage adjustments may be necessary. The safety of doses higher than 800 mg daily have not been studied in clinical trials.

Bipolar Depression

Adults: The recommended starting dose is 50 mg administered once daily in the evening. Doses may be increased on consecutive days as follows: 100 mg per day on Day 2, 200 mg per day on Day 3, and 300 mg per day on Day 4.

Bipolar Mania (given alone or with lithium or divalproex)

Adults: The recommended starting dose is 300 mg administered once daily in the evening. Doses may be increased on consecutive days as follows: 600 mg per day on Day 2 and adjusted between 400 mg and 800 mg beginning Day 3, depending on how you respond and tolerate the drug.

Management of Bipolar Disorder (given with lithium or divalproex)

Adults: Your doctor will prescribe the appropriate dose to manage your bipolar I disorder. Often, it may be the dose used to treat and stabilize your symptoms.

How should I take Seroquel XR?

Seroquel XR sustained-release tablets are best taken in the evening. Take Seroquel XR by mouth on an empty stomach or with a light meal (approximately 300 calories).

Continue with the medication even if you start to feel better; do not skip any doses.

Do not suddenly stop taking Seroquel XR without first contacting your doctor. You may have an increased risk of experiencing side effects.

What should I avoid while taking Seroquel XR?

Seroquel XR tends to cause drowsiness, especially at the start of therapy, and can impair your judgment, thinking, and motor skills. Until you are certain how the drug affects you, use caution when operating machinery or driving a car.

Avoid exposure to extreme heat, strenuous exercise, and dehydration.

Avoid drinking alcohol while taking Seroquel XR. The drug increases the effects of alcohol.

When you first start treatment, avoid sitting up or standing up too quickly, especially in the morning. Seroquel XR may cause dizziness, lightheadedness, or fainting due to a decrease in blood pressure. Alcohol, hot weather, exercise, or fever may increase these effects. Sit or lie down at the first sign of any of these effects.

Rarely, Seroquel XR may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

What are possible food and drug interactions associated with Seroquel XR?

If Seroquel XR is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Seroquel XR with the following: alcohol, barbiturates such as phenobarbital, carbamazepine, cimetidine, divalproex, erythromycin, fluconazole, itraconazole, ketoconazole, levodopa, lorazepam, phenytoin, rifampin, steroids such as hydrocortisone and prednisone, and thioridazine.

What are the possible side effects of Seroquel XR?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: constipation, dizziness, drowsiness, dry mouth, stomach upset, lightheadedness, weight gain, confusion, fainting, fever, chills, sore throat, increased saliva production or drooling, increased sweating, memory loss, menstrual changes, muscle pain, allergic reactions

Seek immediate medical attention if you experience allergic reactions such as rash, hives, itching, difficulty breathing, or swelling of the mouth, face, lips, or tongue.

Can I receive Seroquel XR if I am pregnant or breastfeeding?

The effects of Seroquel XR during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

Seroquel XR should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

What should I do if I miss a dose of Seroquel XR?

Take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once. If you miss taking Seroquel XR for longer than 1 week, contact your doctor.

How should I store Seroquel XR?

Store at room temperature away from heat, moisture, and light. Do not store in the bathroom.