Quetiapine ER 300mg Tablets
WARNING: There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children younger than 10 years of age. Talk with the doctor. @ COMMON USES: It is used to treat bipolar disorder. It is used to treat schizophrenia.It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Atypical Antipsychotic
Pharmacologic Class
Dibenzothiazepine derivative; Serotonin-Dopamine Antagonist (SDA)
Pregnancy Category
Category C
FDA Approved
May 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quetiapine ER is an extended-release medication used to treat certain mental health conditions like schizophrenia, bipolar disorder (mania and depression), and as an add-on treatment for major depression. It works by affecting certain natural chemicals in the brain. The extended-release form means you take it once a day, and it releases the medicine slowly over time.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication whole, without chewing, breaking, or crushing it.
Unless your doctor advises otherwise, take your medication in the evening.
Take your medication on an empty stomach or with a light meal.
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Important Warnings and Precautions
Avoid consuming alcohol while taking this medication.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Do not stop taking your medication suddenly without consulting your doctor, as this may increase your risk of withdrawal symptoms. If you need to stop taking your medication, your doctor will advise you on how to gradually discontinue it.
General Health Tips
Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration.
Monitoring Your Health
Have your blood work and eye exams done as scheduled by your doctor.
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Monitor your blood sugar levels as directed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist if you have questions about the best way to dispose of your medication.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
If you are unsure what to do if you miss a dose, consult with your doctor.
If it has been more than 7 days since your last dose, consult with your doctor for guidance on how to restart your medication.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication whole, without chewing, breaking, or crushing it.
Unless your doctor advises otherwise, take your medication in the evening.
Take your medication on an empty stomach or with a light meal.
Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Important Warnings and Precautions
Avoid consuming alcohol while taking this medication.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Do not stop taking your medication suddenly without consulting your doctor, as this may increase your risk of withdrawal symptoms. If you need to stop taking your medication, your doctor will advise you on how to gradually discontinue it.
General Health Tips
Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.
Be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration.
Monitoring Your Health
Have your blood work and eye exams done as scheduled by your doctor.
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.
Monitor your blood sugar levels as directed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult with your pharmacist if you have questions about the best way to dispose of your medication.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
If you are unsure what to do if you miss a dose, consult with your doctor.
If it has been more than 7 days since your last dose, consult with your doctor for guidance on how to restart your medication.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the evening.
- Swallow tablets whole; do not chew, crush, or split them.
- May be taken with or without food, but consistency is key. Taking with a light meal may improve absorption.
- Avoid alcohol and other CNS depressants, as they can increase drowsiness.
- Be cautious when driving or operating machinery until you know how the medication affects you, due to potential dizziness or drowsiness.
- Stand up slowly to avoid dizziness from orthostatic hypotension.
- Monitor for weight gain and discuss healthy lifestyle choices (diet, exercise) with your doctor.
- Report any unusual muscle movements, fever, or changes in vision immediately.
Available Forms & Alternatives
Available Strengths:
- Quetiapine 200mg Tablets
- Quetiapine 100mg Tablets
- Quetiapine 25mg Tablets
- Quetiapine 400mg Tablets
- Quetiapine 300mg Tablets
- Quetiapine 50mg Tablets
- Quetiapine 50mg Tablets
- Quetiapine ER 400mg Tablets
- Quetiapine ER 200mg Tablets
- Quetiapine ER 300mg Tablets
- Quetiapine ER 150mg Tablets
- Quetiapine ER 400mg Tablets
- Quetiapine ER 400mg Tablets
- Quetiapine 50mg ER Tablets
- Quetiapine 50mg ER Tablets
- Quetiapine ER 200mg Tablets
- Quetiapine 150mg ER Tablets
- Quetiapine 150mg Tablets
- Quetiapine ER 300mg Tablets
- Quetiapine ER 150mg Tablets
- Quetiapine 200mg ER Tablets
- Quetiapine ER 300mg Tablets
- Quetiapine 400mg ER Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication, typically once daily in the evening.
Dose Range:
50 - 800 mg
Condition-Specific Dosing:
schizophrenia:
Initial: 300 mg on Day 1, then 600 mg on Day 2. Target: 400-800 mg/day. Max: 800 mg/day.
bipolarMania:
Initial: 300 mg on Day 1, then 600 mg on Day 2. Target: 400-800 mg/day. Max: 800 mg/day.
bipolarDepression:
Initial: 50 mg on Day 1, then 100 mg on Day 2, 200 mg on Day 3, 300 mg on Day 4. Target: 300 mg/day. Max: 300 mg/day.
adjunctiveTreatmentOfMDD:
Initial: 50 mg on Day 1 and 2. Target: 150-300 mg/day. Max: 300 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for ER formulation. Immediate-release (IR) is used for specific indications in adolescents (e.g., schizophrenia, bipolar mania).
Adolescent:
Not established for ER formulation. For IR: Schizophrenia (13-17 years): Initial 25 mg BID, titrate to 400-800 mg/day. Bipolar Mania (10-17 years): Initial 25 mg BID, titrate to 400-600 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally required.
Moderate:
No dosage adjustment generally required.
Severe:
No dosage adjustment generally required, but caution advised.
Dialysis:
Not significantly removed by dialysis. No specific adjustment, but caution.
Hepatic Impairment:
Mild:
Consider lower starting dose (e.g., 50 mg/day) and slower titration.
Moderate:
Consider lower starting dose (e.g., 50 mg/day) and slower titration.
Severe:
Consider lower starting dose (e.g., 50 mg/day) and slower titration.
Pharmacology
Mechanism of Action
Quetiapine is an atypical antipsychotic. Its antipsychotic activity is thought to be mediated through a combination of antagonism at dopamine D2 and serotonin 5-HT2A receptors. It also has antagonism at histamine H1 and adrenergic alpha1 and alpha2 receptors, which may contribute to some of its side effects (e.g., sedation, orthostatic hypotension).
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for ER, but well absorbed.
Tmax:
Approximately 6 hours (for ER formulation).
FoodEffect:
Food increases Cmax and AUC by approximately 25% and 20% respectively for ER formulation. Should be taken without food or with a light meal.
Distribution:
Vd:
Approximately 10 ± 4 L/kg.
ProteinBinding:
Approximately 83% (to plasma proteins).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7 hours (quetiapine); approximately 12 hours (norquetiapine).
Clearance:
Approximately 28 L/hour (quetiapine).
ExcretionRoute:
Mainly renal (73%) and fecal (20%).
Unchanged:
Less than 1% (quetiapine).
Pharmacodynamics
OnsetOfAction:
Within hours for sedative effects; Antipsychotic effects may take days to weeks.
PeakEffect:
Varies by indication and individual response; typically within 1-2 weeks for full therapeutic effect.
DurationOfAction:
24 hours (due to extended-release formulation and active metabolite).
Safety & Warnings
BLACK BOX WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for the treatment of patients with dementia-related psychosis. Suicidal Thoughts and Behaviors: Antidepressants increased the risk compared to placebo of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low thyroid levels, including:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Difficulty controlling body movements, twitching, balance problems, trouble swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Drooling
Seizures
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Difficulty urinating
Flu-like symptoms
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Tardive dyskinesia, a severe muscle problem that may cause involuntary movements, particularly in people with diabetes and older adults, especially older females. The risk increases with longer use or higher doses, but can also occur with short-term use or low doses. If you experience trouble controlling body movements or problems with your tongue, face, mouth, or jaw, such as tongue protrusion, cheek puffing, mouth puckering, or chewing, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitement
Sleep disturbances
Constipation
Dry mouth
Increased appetite
Weight gain
Upset stomach or vomiting
Stomach pain
Back pain
Nasal congestion
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low thyroid levels, including:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Difficulty controlling body movements, twitching, balance problems, trouble swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Drooling
Seizures
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Difficulty urinating
Flu-like symptoms
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Tardive dyskinesia, a severe muscle problem that may cause involuntary movements, particularly in people with diabetes and older adults, especially older females. The risk increases with longer use or higher doses, but can also occur with short-term use or low doses. If you experience trouble controlling body movements or problems with your tongue, face, mouth, or jaw, such as tongue protrusion, cheek puffing, mouth puckering, or chewing, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitement
Sleep disturbances
Constipation
Dry mouth
Increased appetite
Weight gain
Upset stomach or vomiting
Stomach pain
Back pain
Nasal congestion
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting upon standing
- Uncontrolled muscle movements (e.g., lip smacking, tongue protrusion, grimacing, tremor)
- High fever, stiff muscles, confusion, sweating, fast or irregular heartbeat (signs of Neuroleptic Malignant Syndrome)
- Signs of high blood sugar (increased thirst, increased urination, increased hunger, weakness)
- Signs of infection (fever, sore throat, chills)
- New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, mania, or suicidal thoughts/behaviors.
- Blurred vision or eye pain
- Difficulty urinating
- Severe constipation or abdominal pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Low levels of potassium or magnesium in your blood.
+ A history of abnormal heart rhythms, such as a prolonged QT interval on an electrocardiogram (ECG).
If you are taking any medications that can cause abnormal heart rhythms, specifically those that can prolong the QT interval. There are many medications that can have this effect, so it is crucial to ask your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems, including any medical conditions or allergies.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Low levels of potassium or magnesium in your blood.
+ A history of abnormal heart rhythms, such as a prolonged QT interval on an electrocardiogram (ECG).
If you are taking any medications that can cause abnormal heart rhythms, specifically those that can prolong the QT interval. There are many medications that can have this effect, so it is crucial to ask your doctor or pharmacist if you are unsure.
This list is not exhaustive, and it is vital to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems, including any medical conditions or allergies.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Potential Side Effects
Although rare, cataracts may occur. Additionally, this medication may increase the risk of developing high blood sugar, diabetes, high cholesterol, and weight gain, which can contribute to heart and brain blood vessel disease.
Monitoring for High Blood Sugar
If you experience symptoms of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, notify your doctor promptly.
Infection Risk
Drugs like this one may cause low white blood cell counts, increasing the risk of infection. In rare cases, these infections can be fatal. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you exhibit signs of infection, such as fever, chills, or sore throat.
Neuroleptic Malignant Syndrome (NMS)
A rare but potentially life-threatening condition called NMS may occur. Contact your doctor immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.
Dizziness and Falling Risk
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and subsequent injuries, such as fractures.
Constipation and Bowel Blockage
Constipation is a common side effect of this medication. Although rare, bowel blockage can occur, and in some cases, it has been fatal, particularly when combined with other medications that slow gastrointestinal movement. If you have concerns, discuss them with your doctor.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, older adults with dementia who take medications like this one have a higher risk of stroke, which can be fatal. This medication is not approved for treating dementia-related mental health issues.
Pregnancy and Fertility
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions, consult your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
Pediatric Use
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. High blood pressure has been reported in children and teenagers taking this medication. Regularly monitor your child's blood pressure as advised by their doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Potential Side Effects
Although rare, cataracts may occur. Additionally, this medication may increase the risk of developing high blood sugar, diabetes, high cholesterol, and weight gain, which can contribute to heart and brain blood vessel disease.
Monitoring for High Blood Sugar
If you experience symptoms of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, notify your doctor promptly.
Infection Risk
Drugs like this one may cause low white blood cell counts, increasing the risk of infection. In rare cases, these infections can be fatal. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you exhibit signs of infection, such as fever, chills, or sore throat.
Neuroleptic Malignant Syndrome (NMS)
A rare but potentially life-threatening condition called NMS may occur. Contact your doctor immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.
Dizziness and Falling Risk
This medication may cause dizziness, drowsiness, and impaired balance, increasing the risk of falls and subsequent injuries, such as fractures.
Constipation and Bowel Blockage
Constipation is a common side effect of this medication. Although rare, bowel blockage can occur, and in some cases, it has been fatal, particularly when combined with other medications that slow gastrointestinal movement. If you have concerns, discuss them with your doctor.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, older adults with dementia who take medications like this one have a higher risk of stroke, which can be fatal. This medication is not approved for treating dementia-related mental health issues.
Pregnancy and Fertility
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have questions, consult your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
Pediatric Use
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. High blood pressure has been reported in children and teenagers taking this medication. Regularly monitor your child's blood pressure as advised by their doctor.
Overdose Information
Overdose Symptoms:
- Excessive sedation
- Drowsiness
- Tachycardia (fast heart rate)
- Hypotension (low blood pressure)
- Delirium
- Coma
- QT prolongation
- Seizures
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining an open airway, ensuring adequate oxygenation and ventilation, and monitoring cardiovascular function.
Drug Interactions
Major Interactions
Moderate Interactions
- CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates)
- Antihypertensives (additive hypotensive effects)
- Anticholinergic drugs (additive anticholinergic effects)
- Dopamine agonists (potential antagonism)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Weight and BMI
Rationale: Risk of weight gain.
Timing: Before initiation
Fasting Plasma Glucose (FPG) or HbA1c
Rationale: Risk of hyperglycemia and diabetes.
Timing: Before initiation
Lipid Panel (Fasting)
Rationale: Risk of dyslipidemia.
Timing: Before initiation
Blood Pressure (BP)
Rationale: Risk of orthostatic hypotension.
Timing: Before initiation
Electrocardiogram (ECG)
Rationale: Risk of QT prolongation, especially in patients with cardiac risk factors.
Timing: Before initiation (consider if risk factors present)
Complete Blood Count (CBC) with differential
Rationale: Risk of neutropenia/agranulocytosis.
Timing: Before initiation (consider if risk factors present)
Routine Monitoring
Weight and BMI
Frequency: Monthly for first few months, then quarterly.
Target: Maintain healthy range; monitor for significant increase.
Action Threshold: Significant weight gain (e.g., >5% baseline) warrants intervention.
Fasting Plasma Glucose (FPG) or HbA1c
Frequency: At 4 weeks, 12 weeks, then annually.
Target: FPG <100 mg/dL; HbA1c <5.7%.
Action Threshold: FPG ≥126 mg/dL or HbA1c ≥6.5% warrants further evaluation/intervention.
Lipid Panel (Fasting)
Frequency: At 12 weeks, then annually.
Target: LDL <100 mg/dL, HDL >40 mg/dL, Triglycerides <150 mg/dL.
Action Threshold: Significant dyslipidemia warrants intervention.
Blood Pressure (BP)
Frequency: At each visit, especially during titration.
Target: Normal BP; monitor for orthostatic changes.
Action Threshold: Symptomatic orthostatic hypotension or sustained hypertension.
Extrapyramidal Symptoms (EPS) / Tardive Dyskinesia (TD) assessment (e.g., AIMS)
Frequency: At each visit, or at least every 6-12 months.
Target: Absence of abnormal movements.
Action Threshold: Emergence of new or worsening EPS/TD.
Ophthalmologic exam (slit lamp)
Frequency: Every 6 months (for cataract risk, though less common with quetiapine than some other antipsychotics).
Target: No significant lens changes.
Action Threshold: Development of cataracts.
Symptom Monitoring
- Sedation/Drowsiness
- Dizziness/Orthostatic Hypotension
- Dry mouth
- Constipation
- Weight gain
- Increased appetite
- Blurred vision
- Urinary retention
- Tachycardia
- Akathisia (restlessness)
- Parkinsonism (tremor, rigidity)
- Dystonia (muscle spasms)
- Tardive Dyskinesia (involuntary movements)
- Signs of hyperglycemia (polyuria, polydipsia, polyphagia)
- Signs of neutropenia (fever, sore throat, infection)
- Suicidal ideation or worsening of depression/anxiety
- Neuroleptic Malignant Syndrome (NMS) symptoms (fever, muscle rigidity, altered mental status, autonomic instability)
- Seizures
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered Category C. Animal studies show some developmental toxicity.
Second Trimester:
Limited data.
Third Trimester:
Risk of extrapyramidal and/or withdrawal symptoms in the neonate (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).
Lactation
Quetiapine and its active metabolite are excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for quetiapine, and any potential adverse effects on the breastfed infant from quetiapine or from the underlying maternal condition. Monitor infants for sedation, irritability, poor feeding, and weight gain.
Infant Risk:
L3 (Moderate risk). Potential for sedation, poor feeding, and weight gain in the infant.
Pediatric Use
Safety and effectiveness of Quetiapine ER have not been established in pediatric patients. Immediate-release quetiapine is approved for schizophrenia in adolescents (13-17 years) and bipolar mania in children and adolescents (10-17 years). Use of ER in pediatric populations is off-label and requires careful consideration of risks vs. benefits.
Geriatric Use
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine ER is not approved for this indication. Elderly patients may be more sensitive to the effects of quetiapine, including orthostatic hypotension, sedation, and anticholinergic effects. A lower starting dose and slower titration are recommended.
Clinical Information
Clinical Pearls
- Quetiapine ER is designed for once-daily dosing, typically in the evening, to minimize daytime sedation.
- Swallow tablets whole; crushing or chewing will alter the extended-release properties and can lead to rapid drug release and increased side effects.
- Significant weight gain and metabolic changes (hyperglycemia, dyslipidemia) are common side effects; regular monitoring is crucial.
- Orthostatic hypotension is a common dose-limiting side effect, especially during initiation and dose titration. Advise patients to rise slowly.
- Risk of neutropenia/agranulocytosis, though rare, warrants monitoring of CBC if clinically indicated (e.g., signs of infection).
- Consider the active metabolite, norquetiapine, which has significant norepinephrine reuptake inhibition and may contribute to antidepressant effects and side effects like insomnia or anxiety at higher doses.
- Patients should be advised to avoid abrupt discontinuation due to potential withdrawal symptoms (e.g., insomnia, nausea, vomiting, diarrhea, dizziness, irritability).
Alternative Therapies
- Other atypical antipsychotics (e.g., Aripiprazole, Olanzapine, Risperidone, Ziprasidone, Lurasidone, Cariprazine)
- Mood stabilizers (e.g., Lithium, Valproate, Lamotrigine for bipolar disorder)
- Antidepressants (for MDD, often in combination with an antipsychotic for adjunctive treatment)
- Electroconvulsive Therapy (ECT)
- Transcranial Magnetic Stimulation (TMS)
- Psychotherapy (e.g., Cognitive Behavioral Therapy, Dialectical Behavior Therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets (300mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic); Tier 3 or Tier 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.