Quetiapine 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 may be given to you for other reasons. Talk with the doctor.
Drug Class
Atypical Antipsychotic
Pharmacologic Class
Serotonin-Dopamine Antagonist (SDA)
Pregnancy Category
Category C
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quetiapine is a medication used to treat certain mental health conditions like schizophrenia, bipolar disorder (manic or depressive episodes), and sometimes as an add-on treatment for depression. It works by helping to balance certain natural chemicals in the brain. It can help reduce hallucinations, delusions, mood swings, and improve overall mood.
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 to you and follow the instructions precisely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
It's essential to avoid drinking 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 this medication abruptly without consulting your doctor, as this may increase the risk of withdrawal symptoms. If you need to stop taking the medication, your doctor will guide you on how to gradually taper off.
Stay hydrated by drinking plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.
Regular monitoring is crucial. 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. Also, check 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 in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe and secure location, 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. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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're unsure about what to do if you miss a dose, contact your doctor for guidance.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
It's essential to avoid drinking 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 this medication abruptly without consulting your doctor, as this may increase the risk of withdrawal symptoms. If you need to stop taking the medication, your doctor will guide you on how to gradually taper off.
Stay hydrated by drinking plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.
Regular monitoring is crucial. 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. Also, check 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 in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe and secure location, 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. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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're unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor.
- Avoid alcohol and other sedating medications, as they can increase drowsiness and dizziness.
- Be careful when driving or operating machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Get up slowly from a sitting or lying position to avoid dizziness or fainting.
- Monitor your weight and diet, as this medication can cause weight gain and changes in blood sugar and cholesterol.
- Stay hydrated, especially if experiencing dry mouth or constipation.
- Report any new or worsening symptoms, especially unusual movements, fever, muscle stiffness, or changes in mood/behavior.
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. For Schizophrenia: Initial 25 mg BID, titrate to 300-400 mg/day in 2-3 divided doses. For Bipolar Mania: Initial 50 mg BID, titrate to 400-800 mg/day in 2 divided doses. For Bipolar Depression: Initial 50 mg at bedtime, titrate to 300 mg at bedtime. For Major Depressive Disorder (adjunctive): Initial 50 mg at bedtime, titrate to 150-300 mg at bedtime.
Dose Range:
25 - 800 mg
Condition-Specific Dosing:
Schizophrenia:
300-800 mg/day, usually divided BID or TID for IR, once daily for XR.
Bipolar Mania:
400-800 mg/day, usually divided BID or once daily for XR.
Bipolar Depression:
300 mg once daily at bedtime (IR or XR).
Major Depressive Disorder (adjunctive):
150-300 mg once daily at bedtime (IR or XR).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 10 years. For Schizophrenia (13-17 years): Initial 25 mg BID, titrate to 400-800 mg/day. For Bipolar Mania (10-17 years): Initial 25 mg BID, titrate to 400-600 mg/day.
Adolescent:
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 dose adjustment generally needed.
Moderate:
No dose adjustment generally needed.
Severe:
No dose adjustment generally needed.
Dialysis:
Not significantly removed by dialysis; no specific adjustment beyond general renal impairment guidance.
Hepatic Impairment:
Mild:
Consider lower starting dose and slower titration.
Moderate:
Consider lower starting dose (e.g., 25 mg/day) and slower titration.
Severe:
Start with 25 mg/day and titrate slowly with caution, monitoring for adverse effects. Clearance is reduced by approximately 30% in severe hepatic impairment.
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 high affinity for histamine H1 receptors and adrenergic alpha1 and alpha2 receptors, contributing to its sedative and orthostatic hypotensive effects, respectively. It has low affinity for muscarinic cholinergic receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (extensive first-pass metabolism)
Tmax:
1.5 hours (IR), 6 hours (XR)
FoodEffect:
Food increases Cmax and AUC by 25% and 15% respectively for IR. For XR, food increases Cmax and AUC by 45% and 20% respectively.
Distribution:
Vd:
10 Âą 4 L/kg
ProteinBinding:
Approximately 83%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6-7 hours (quetiapine), 10-12 hours (norquetiapine)
Clearance:
Not available (high variability)
ExcretionRoute:
Urine (73%), Feces (20%)
Unchanged:
Less than 1% (quetiapine), 5% (norquetiapine)
Pharmacodynamics
OnsetOfAction:
Within hours for sedation, days to weeks for full antipsychotic/mood-stabilizing effects.
PeakEffect:
Variable, depends on indication and individual response.
DurationOfAction:
Approximately 12 hours (IR), 24 hours (XR)
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 of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Quetiapine is not approved for use in pediatric patients except for schizophrenia and bipolar mania.
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
+ Difficulty 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, or 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 (especially in people with diabetes, older adults, and those taking higher doses or using the medication for an extended period)
If you experience any of the following symptoms, contact your doctor right away:
Trouble controlling body movements
Problems with your tongue, face, mouth, or jaw, such as:
+ Tongue sticking out
+ Puffing cheeks
+ Mouth puckering
+ Chewing movements
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitability
Difficulty sleeping
Constipation
Dry mouth
Increased appetite
Weight gain
Upset stomach or vomiting
Stomach pain
Back pain
Stuffy nose
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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
+ Difficulty 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, or 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 (especially in people with diabetes, older adults, and those taking higher doses or using the medication for an extended period)
If you experience any of the following symptoms, contact your doctor right away:
Trouble controlling body movements
Problems with your tongue, face, mouth, or jaw, such as:
+ Tongue sticking out
+ Puffing cheeks
+ Mouth puckering
+ Chewing movements
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitability
Difficulty sleeping
Constipation
Dry mouth
Increased appetite
Weight gain
Upset stomach or vomiting
Stomach pain
Back pain
Stuffy nose
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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:
- Uncontrolled muscle movements (especially of the face, tongue, or limbs) - signs of tardive dyskinesia.
- High fever, severe muscle stiffness, confusion, sweating, fast or irregular heartbeat - signs of Neuroleptic Malignant Syndrome (NMS).
- Signs of high blood sugar (increased thirst, increased urination, increased hunger, weakness).
- Signs of high cholesterol (often no symptoms, requires blood tests).
- Dizziness or fainting, especially when standing up.
- Sore throat, fever, chills, or other signs of infection (rare, but could indicate low white blood cell count).
- New or worsening suicidal thoughts or behavior, especially in young adults.
- Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing).
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 symptoms you experienced.
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, including those that may prolong the QT interval. There are many drugs 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.
Your complete medical history, including any health problems you are experiencing.
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 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 symptoms you experienced.
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, including those that may prolong the QT interval. There are many drugs 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.
Your complete medical history, including any health problems you are experiencing.
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions to Ensure Your Safety
Avoid driving or engaging in activities that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and be cautious when climbing stairs.
Potential Side Effects and Risks
Cataracts may occur rarely.
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.
Monitor your blood sugar levels and report any signs of high blood sugar to your doctor, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Low white blood cell counts have been associated with this medication, which can increase the risk of infection. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you experience:
+ Fever
+ Chills
+ Sore throat
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Call your doctor right away if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Rapid heartbeat
+ Abnormal heartbeat
+ Excessive sweating
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and related injuries.
Constipation is a common side effect, and bowel obstruction has been reported in some cases. In rare instances, bowel obstruction has been fatal, especially when combined with other medications that slow gastrointestinal movement. If you have concerns, discuss them with your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Older adults with dementia who take this medication have a higher risk of stroke, which can be fatal. This medication is not approved for treating dementia-related mental health issues.
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have concerns, discuss them with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.
Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
Pediatric Patients
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.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions to Ensure Your Safety
Avoid driving or engaging in activities that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and be cautious when climbing stairs.
Potential Side Effects and Risks
Cataracts may occur rarely.
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.
Monitor your blood sugar levels and report any signs of high blood sugar to your doctor, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Low white blood cell counts have been associated with this medication, which can increase the risk of infection. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you experience:
+ Fever
+ Chills
+ Sore throat
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Call your doctor right away if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Rapid heartbeat
+ Abnormal heartbeat
+ Excessive sweating
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and related injuries.
Constipation is a common side effect, and bowel obstruction has been reported in some cases. In rare instances, bowel obstruction has been fatal, especially when combined with other medications that slow gastrointestinal movement. If you have concerns, discuss them with your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Older adults with dementia who take this medication have a higher risk of stroke, which can be fatal. This medication is not approved for treating dementia-related mental health issues.
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have concerns, discuss them with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.
Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.
Pediatric Patients
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:
- Extreme drowsiness
- Sedation
- Tachycardia (fast heart rate)
- Hypotension (low blood pressure)
- Delirium
- Coma
- QT prolongation
- Arrhythmias
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining airway, oxygenation, and ventilation, and monitoring cardiovascular function.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, protease inhibitors like ritonavir, indinavir, saquinavir, nelfinavir): May significantly increase quetiapine levels, leading to increased adverse effects. Co-administration is generally not recommended.
- Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates, St. John's Wort): May significantly decrease quetiapine levels, reducing efficacy. Dose adjustments or alternative agents may be necessary.
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of cardiac arrhythmias.
Moderate Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines): Additive CNS depression.
- Antihypertensives: Additive hypotensive effects due to alpha1-adrenergic blockade.
- Dopamine agonists (e.g., levodopa, bromocriptine): Quetiapine's D2 antagonism may counteract their effects.
- Anticholinergic drugs: Potential for additive anticholinergic effects (e.g., constipation, dry mouth, urinary retention).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Weight/BMI
Rationale: Risk of weight gain and metabolic syndrome.
Timing: Before initiation
Fasting Glucose/HbA1c
Rationale: Risk of hyperglycemia and new-onset diabetes.
Timing: Before initiation
Lipid Panel (Fasting)
Rationale: Risk of dyslipidemia.
Timing: Before initiation
Blood Pressure
Rationale: Risk of orthostatic hypotension.
Timing: Before initiation (supine and standing)
ECG
Rationale: Consider if patient has cardiac risk factors or history of arrhythmias, or if co-administering QT-prolonging drugs.
Timing: Before initiation
Complete Blood Count (CBC)
Rationale: Rare risk of neutropenia/agranulocytosis.
Timing: Before initiation
Thyroid Function Tests (TFTs)
Rationale: Rare risk of thyroid abnormalities.
Timing: Before initiation
Ophthalmologic Exam (Slit Lamp)
Rationale: Risk of cataract formation (less common with quetiapine than some other antipsychotics, but still recommended by some guidelines).
Timing: Before initiation
Routine Monitoring
Weight/BMI
Frequency: Monthly for first few months, then quarterly.
Target: Maintain healthy range.
Action Threshold: Significant weight gain (e.g., >5% baseline) warrants intervention.
Fasting Glucose/HbA1c
Frequency: At 3 months, then annually (or more frequently if risk factors/abnormalities).
Target: Fasting glucose <100 mg/dL, HbA1c <5.7%.
Action Threshold: Pre-diabetes or diabetes levels warrant intervention/referral.
Lipid Panel (Fasting)
Frequency: At 3 months, then annually (or more frequently if risk factors/abnormalities).
Target: LDL <100 mg/dL, HDL >40 mg/dL (men), >50 mg/dL (women), Triglycerides <150 mg/dL.
Action Threshold: Dyslipidemia warrants intervention/referral.
Blood Pressure
Frequency: Weekly for first few weeks, then monthly.
Target: Normotensive.
Action Threshold: Persistent orthostatic hypotension or hypertension warrants intervention.
ECG
Frequency: As clinically indicated (e.g., if new cardiac symptoms, electrolyte imbalance, or dose escalation of QT-prolonging drugs).
Target: Normal QTc interval (<450 ms for men, <470 ms for women).
Action Threshold: QTc prolongation >500 ms or increase >60 ms from baseline warrants intervention.
Complete Blood Count (CBC)
Frequency: As clinically indicated (e.g., signs of infection, unexplained fever).
Target: Normal WBC and neutrophil counts.
Action Threshold: Neutrophil count <1.0 x 10^9/L warrants discontinuation and close monitoring.
Thyroid Function Tests (TFTs)
Frequency: Annually or as clinically indicated.
Target: Normal TSH, T3, T4.
Action Threshold: Abnormalities warrant further investigation/referral.
Movement Disorder Scales (e.g., AIMS, SAS, BARS)
Frequency: Periodically (e.g., every 6-12 months) or if new movement symptoms appear.
Target: Absence of abnormal involuntary movements.
Action Threshold: Emergence of tardive dyskinesia or other extrapyramidal symptoms warrants intervention.
Symptom Monitoring
- Sedation/Drowsiness
- Dizziness/Orthostatic Hypotension
- Dry mouth
- Constipation
- Weight gain
- Blurred vision
- Extrapyramidal symptoms (tremor, rigidity, akathisia, dystonia)
- Tardive Dyskinesia (involuntary movements, especially of face/mouth)
- Neuroleptic Malignant Syndrome (fever, muscle rigidity, altered mental status, autonomic instability)
- Suicidal ideation or worsening of depression/anxiety
- Changes in mental status or behavior
- Signs of infection (fever, sore throat) - rare, but indicates neutropenia risk
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use 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:
Potential for developmental toxicity based on animal studies; human data limited.
Second Trimester:
Limited data, generally considered similar risk to first trimester.
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 is excreted into human milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.
Infant Risk:
Low to moderate risk. Sedation and irritability have been reported in some exposed infants.
Pediatric Use
Approved for schizophrenia (13-17 years) and bipolar mania (10-17 years). Not approved for major depressive disorder or dementia-related psychosis in pediatric patients. Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Monitor for metabolic changes (weight gain, dyslipidemia, hyperglycemia) and extrapyramidal symptoms.
Geriatric Use
Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Not approved for this indication. Generally, lower starting doses and slower titration are recommended due to increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation, metabolic changes). Monitor closely for falls and cognitive changes.
Clinical Information
Clinical Pearls
- Quetiapine is highly sedating, especially at lower doses. It is often dosed at bedtime to leverage this effect and minimize daytime drowsiness.
- Orthostatic hypotension is common, particularly during initial titration. Advise patients to rise slowly.
- Metabolic monitoring (weight, glucose, lipids) is crucial due to the risk of metabolic syndrome.
- IR formulation is typically dosed BID or TID, while XR is once daily. Ensure patients understand which formulation they are taking.
- Titration is important to minimize side effects. Do not abruptly discontinue, as withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability) can occur.
- Consider the risk of cataracts with long-term use, though less common than with some other antipsychotics. Regular eye exams may be warranted.
- Quetiapine has a broad therapeutic range and can be used for various indications at different doses, from low-dose sedation/sleep aid (off-label) to high-dose antipsychotic.
Alternative Therapies
- Other atypical antipsychotics (e.g., olanzapine, risperidone, aripiprazole, ziprasidone, lurasidone, cariprazine, brexpiprazole)
- Mood stabilizers (e.g., lithium, valproate, lamotrigine) for bipolar disorder
- Antidepressants (e.g., SSRIs, SNRIs) for major depressive disorder (often in combination with an antipsychotic for augmentation)
- Conventional antipsychotics (e.g., haloperidol, chlorpromazine) for schizophrenia (less common due to higher EPS risk)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. 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, we encourage you to discuss them 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 seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.