SEROquel XR

Name: SEROquel XR

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Reviewed on 11/4/2016 References Reference: FDA Prescribing Information

Dosing & Uses

Dosage Forms & Strengths

tablet, immediate release

  • 25mg
  • 50mg
  • 100mg
  • 200mg
  • 300mg
  • 400mg

tablet, extended release

  • 50mg
  • 150mg
  • 200mg
  • 300mg
  • 400mg

Schizophrenia

Immediate release

  • Day 1: 50 mg/day PO divided q12hr
  • Days 2-3: Dose increased daily in increments of 25-50 mg q8-12hr to 300-400 mg by day 4; further adjustments can be made in increments of 25-50 mg q12hr at intervals ≥2 days 
  • Dosage range: 150-750 mg/day

Extended release

  • Day 1: 300 mg/day PO; subsequently, may be increased by up to 300 mg/day at intervals ≥1 day 
  • Maintenance (monotherapy): 400-800 mg/day
  • Patients who have discontinued therapy for >1 week should have their dose retitrated following initiation of therapy; patients may reinitiate at their previous maintenance dose if discontinued therapy <1 week

Bipolar I Disorder, Mania

Administered as monotherapy or as adjunct to lithium or divalproex

Immediate release

  • Day 1: 100 mg/day PO divided q12hr
  • Day 2: 200 mg/day PO divided q12hr
  • Day 3: 300 mg/day PO divided q12hr
  • Day 4: 400 mg/day PO divided q12hr
  • Further dosage adjustments, up to 800 mg/day by day 6, should be in increments ≤200 mg/day
  • Dosage range: 400-800 mg/day; not to exceed 800 mg/day

Extended release

  • Day 1: 300 mg PO once daily
  • Day 2: 600 mg PO once daily
  • Maintenance (day 3 onward): 400-800 mg/day PO

Bipolar Disorder, Depressive Episodes

Either immediate-release or extended-release tablets may be given; dosage titrated upward over 4 days

Day 1: 50 mg PO at bedtime

Day 2: 100 mg PO at bedtime

Day 3: 200 mg PO at bedtime

Maintenance (day 4 onward): 300 mg PO at bedtime

Bipolar I Disorder, Maintenance

Administered as adjunct to lithium or divalproex

Immediate release: 400-800 mg/day PO divided q12hr

Extended release: 400-800 mg/day PO in single dose

Generally, in maintenance phase, patients continue to receive same dosage on which they were stabilized

Major Depressive Disorder

Extended-release formulation administered as adjunct to antidepressants

Days 1 and 2: 50 mg PO in evening

Day 3: May be increased to 150 mg PO in evening

Dosage range: 150-300 mg/day

Alcohol Dependence (Off-label)

25-50 mg PO at bedtime; may be titrated; not to exceed 300 mg

Insomnia (Off-label)

Usually, 25 mg/day PO at bedtime initially

Administration

Preferably, take in evening without food or with light meal

Switching from immediate release to extended release

  • Convert to extended release tablets at equivalent immediate release total daily dose; administer once daily; individual adjustments may be necessary

Dosage Forms & Strengths

tablet, immediate release

  • 25mg
  • 50mg
  • 100mg
  • 200mg
  • 300mg
  • 400mg

tablet, extended release

  • 50mg
  • 150mg
  • 200mg
  • 300mg
  • 400mg

Schizophrenia

<12 years

  • Safety and efficacy not established

>12 years (monotherapy, immediate release)

  • Day 1: 50 mg/day PO divided q12hr
  • Day 2: 100 mg/day PO divided q12hr
  • Day 3: 200 mg/day PO divided q12hr
  • Day 4: 300 mg/day PO divided q12hr
  • Day 5: 400 mg/day PO divided q12hr; further adjustments should be in increments ≤100 mg/day
  • Dosage range: 400-800 mg/day
  • Depending on response and tolerance, daily dose may be divided q8hr

>12 years (monotherapy, extended release)

  • Day 1: 50 mg/day PO once daily
  • Day 2: 100 mg/day PO once daily
  • Day 3: 200 mg/day PO once daily
  • Day 4: 300 mg/day PO once daily
  • Day 5: 400 mg/day PO once daily; further adjustments should be in increments ≤100 mg/day

Bipolar I Disorder, Mania

<10 years

  • Safety and efficacy not established

>10 years (monotherapy, immediate release)

  • Day 1: 50 mg/day PO divided q12hr
  • Day 2: 100 mg/day PO divided q12hr
  • Day 3: 200 mg/day PO divided q12hr
  • Day 4: 300 mg/day PO divided q12hr
  • Day 5: 400 mg/day PO divided q12hr; further adjustments should be in increments ≤100 mg/day
  • Dosage range: 400-600 mg/day
  • Depending on response and tolerance, daily dose may be divided q8hr

>10 years (monotherapy, extended release)

  • Day 1: 50 mg/day PO once daily
  • Day 2: 100 mg/day PO once daily
  • Day 3: 200 mg/day PO once daily
  • Day 4: 300 mg/day PO once daily
  • Day 5: 400 mg/day PO once daily; further adjustments should be in increments ≤100 mg/day
  • Dosage range: 400-600 mg once daily

Not approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)

Schizophrenia, Bipolar Disorder

Immediate release: 50-200 mg/day PO; may be increased by 25-50 mg/day

Extended release: 50 mg/day PO; may be increased by 50 mg/day

Psychosis, Agitation Related to Alzheimer Dementia (Off-label)

12.5-50 mg/day PO initially; may be gradually increased as tolerated; not to exceed 200-300 mg/day

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Uses of Seroquel XR

Seroquel XR is a prescription medication used to treat certain mental disorders such as schizophrenia, bipolar disorder, and depressive episodes associated with bipolar disorder. Seroquel XR also can be given with other medications to treat depression.

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

Manufacturer

  • Astrazeneca

Seroquel XR and Pregnancy

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

Seroquel XR Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 

Other Requirements

  • Store Seroquel XR at 25ºC (77ºF).
  • Keep Seroquel XR and all medicines out of the reach of children.

Seroquel XR Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Chills
  • cold sweats
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sleepiness or unusual drowsiness
Less common
  • Black, tarry stools
  • blurred vision
  • changes in patterns and rhythms of speech
  • chest pain
  • cough
  • drooling
  • fever, muscle aches, or sore throat
  • inability to move the eyes
  • inability to sit still
  • increased blinking or spasms of the eyelid
  • lip smacking or puckering
  • loss of balance control
  • mask-like face
  • need to keep moving
  • painful or difficult urination
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • shuffling walk
  • slowed movements
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • sticking out of the tongue
  • stiffness of the arms or legs
  • sweating
  • swelling of the face, arms, hands, feet, or lower legs
  • swollen glands
  • trembling and shaking of the hands and fingers
  • trouble with breathing, speaking, or swallowing
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
Rare
  • Dry, puffy skin
  • fast, pounding, or irregular heartbeat
  • loss of appetite
  • menstrual changes
  • tiredness
  • unusual secretion of milk (in females)
  • weight gain
Incidence not known
  • Aching or discomfort in the lower legs or sensation of crawling in the legs
  • painful or prolonged erection of the penis
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash, hives, or itching
  • tightness in the chest
  • tingling of the hands or feet
  • unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • headache
Less common
  • Abnormal vision
  • acid or sour stomach
  • belching
  • decreased appetite
  • decreased strength and energy
  • headache
  • heartburn
  • increased appetite
  • increased muscle tone
  • increased sweating
  • increased weight
  • indigestion
  • sneezing
  • stomach discomfort, upset, or pain
  • stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take Seroquel XR?

For all patients taking this medicine:

  • Tell all of your health care providers that you take Seroquel XR. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Avoid drinking alcohol while taking Seroquel XR.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • Cataracts may rarely happen.
  • Have an eye exam as you have been told by your doctor.
  • High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
  • Check your blood sugar as you have been told by your doctor.
  • Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Dizziness, sleepiness, and feeling less stable may happen with this medicine. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
  • If you are 65 or older, use Seroquel XR with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Taking Seroquel XR in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.

Children:

  • Use with care in children. Talk with the doctor.
  • High blood pressure has happened in children and teenagers. Have your child's blood pressure checked as you have been told by your child's doctor.

Indications and Usage for Seroquel XR

Schizophrenia

Seroquel XR is indicated for the treatment of schizophrenia. The efficacy of Seroquel XR in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1)].

Bipolar Disorder

Seroquel XR is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of Seroquel XR in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 – 17 years) with manic episodes associated with bipolar I disorder treated with SEROQUEL [see Clinical Studies (14.2)].

Seroquel XR is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of Seroquel XR was established in one 8-week trial in adults with bipolar I or II disorder and supported by two 8-week trials in adults with bipolar I or II disorder treated with SEROQUEL [see Clinical Studies (14.2)].

Seroquel XR is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with SEROQUEL. The effectiveness of monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].

Adjunctive Treatment of Major Depressive Disorder (MDD)

Seroquel XR is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of Seroquel XR as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3)].

Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder

Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide)

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Seroquel XR and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Seroquel XR. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Seroquel XR.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Seroquel XR is not approved for elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

Suicidal Thoughts and Behaviors

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.2)].

Neuroleptic Malignant Syndrome (NMS)

Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see Warnings and Precautions (5.4)].

Hyperglycemia and Diabetes Mellitus

Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)].

Hyperlipidemia

Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)].

Weight Gain

Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)].

Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls) especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions (5.7)].

Increased Blood Pressure in Children and Adolescents

Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment [see Warnings and Precautions (5.9)].

Leukopenia/Neutropenia

Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking Seroquel XR [see Warnings and Precautions (5.10)].

Interference with Cognitive and Motor Performance

Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely [see Warnings and Precautions (5.16)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.17)].

Concomitant Medication

As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs [see Drug Interactions (7.1)].

Pregnancy and Nursing

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Seroquel XR [see Use in Specific Populations (8.1 and 8.3)].

Need for Comprehensive Treatment Program

Seroquel XR is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of Seroquel XR have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.4)_RefID_567fa960-84b4-47a8-84f3-04a3ac7c2].

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