Quetiapine 400mg 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
Antipsychotic
Pharmacologic Class
Atypical Antipsychotic; Dibenzothiazepine derivative
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, and depression. It works by helping to balance certain natural chemicals in the brain. It can help reduce symptoms like hallucinations, delusions, mood swings, and severe sadness. It's important to take it exactly as prescribed, as it often requires a gradual increase in dose.
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 better.
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 slow your reactions, consult with your doctor. Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of experiencing withdrawal symptoms. If you need to stop taking the medication, your doctor will advise you on how to gradually discontinue it.
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 when engaging in physical activity, and drink plenty of fluids to prevent dehydration. As directed by your doctor, have your blood work checked and undergo eye exams.
This medication may affect certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication. Monitor your blood sugar levels as instructed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe 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. 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 better.
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 slow your reactions, consult with your doctor. Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of experiencing withdrawal symptoms. If you need to stop taking the medication, your doctor will advise you on how to gradually discontinue it.
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 when engaging in physical activity, and drink plenty of fluids to prevent dehydration. As directed by your doctor, have your blood work checked and undergo eye exams.
This medication may affect certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication. Monitor your blood sugar levels as instructed by your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe 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. 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
- Avoid alcohol and other CNS depressants, as they can increase drowsiness and dizziness.
- Be cautious when driving or operating machinery until you know how the medication affects you, especially at the start of treatment.
- Stand up slowly from a sitting or lying position to avoid dizziness or fainting due to orthostatic hypotension.
- Monitor your weight and diet, as weight gain can be a common side effect. Regular exercise and a balanced diet are recommended.
- Report any new or worsening symptoms, especially changes in mood or behavior, to your doctor.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
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:
Highly variable, titrated based on indication and patient response. For schizophrenia, initial 25 mg BID, titrate to 300-400 mg/day in 2-3 divided doses. For bipolar mania, initial 100 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 MDD adjunctive, initial 50 mg at bedtime, titrate to 150-300 mg at bedtime.
Dose Range:
25 - 800 mg
Condition-Specific Dosing:
schizophrenia:
Initial 25 mg BID, titrate to 300-400 mg/day (max 800 mg/day)
bipolar_mania:
Initial 100 mg BID, titrate to 400-800 mg/day
bipolar_depression:
Initial 50 mg at bedtime, titrate to 300 mg at bedtime
major_depressive_disorder_adjunctive:
Initial 50 mg at bedtime, titrate to 150-300 mg at bedtime
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for children <10 years for bipolar mania, <13 years for schizophrenia)
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 dosage adjustment generally needed.
Moderate:
No dosage adjustment generally needed.
Severe:
No dosage adjustment generally needed.
Dialysis:
Not significantly removed by dialysis; no specific adjustment needed beyond general renal impairment guidelines.
Hepatic Impairment:
Mild:
Consider lower initial dose (e.g., 25 mg/day) and slower titration.
Moderate:
Consider lower initial dose (e.g., 25 mg/day) and slower titration.
Severe:
Consider lower initial dose (e.g., 25 mg/day) and slower titration.
Pharmacology
Mechanism of Action
Quetiapine is an atypical antipsychotic with a broad receptor binding profile. It acts as an antagonist at serotonin 5-HT2A receptors and dopamine D1 and D2 receptors. Its antipsychotic activity is thought to be mediated through a combination of D2 and 5-HT2A antagonism. It also has antagonism at histamine H1 receptors (contributing to sedation), alpha1-adrenergic receptors (contributing to orthostatic hypotension), and muscarinic M1 receptors (contributing to anticholinergic effects).
Pharmacokinetics
Absorption:
Bioavailability:
Not available (well absorbed)
Tmax:
1.5 hours (immediate-release); 6 hours (extended-release)
FoodEffect:
Food increases Cmax and AUC by approximately 15% and 20% respectively for IR tablets. For XR tablets, food increases Cmax by 45% and AUC by 20%.
Distribution:
Vd:
10 Âą 4 L/kg
ProteinBinding:
Approximately 83%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6-7 hours (quetiapine); 12 hours (norquetiapine)
Clearance:
Not available
ExcretionRoute:
Urine (73%), Feces (20%)
Unchanged:
Less than 1% (urine)
Pharmacodynamics
OnsetOfAction:
Within hours for sedation; Antipsychotic effects may take days to weeks.
PeakEffect:
Not precisely defined for therapeutic effect; peak plasma concentration at Tmax.
DurationOfAction:
Approximately 12 hours (IR, requiring BID dosing); 24 hours (XR, once daily dosing)
Confidence:
High
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. 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 medical attention immediately:
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
A severe muscle problem called tardive dyskinesia, which may cause:
+ Trouble controlling body movements
+ Problems with the tongue, face, mouth, or jaw, such as tongue protrusion, puffing cheeks, mouth puckering, or chewing
The risk of developing tardive dyskinesia is higher in people with diabetes, older adults, especially older females, and those taking higher doses or using the medication for an extended period. However, it can also occur after short-term use with low doses.
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
Sleep disturbances
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, 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 medical attention immediately:
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
A severe muscle problem called tardive dyskinesia, which may cause:
+ Trouble controlling body movements
+ Problems with the tongue, face, mouth, or jaw, such as tongue protrusion, puffing cheeks, mouth puckering, or chewing
The risk of developing tardive dyskinesia is higher in people with diabetes, older adults, especially older females, and those taking higher doses or using the medication for an extended period. However, it can also occur after short-term use with low doses.
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
Sleep disturbances
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, 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
- Uncontrolled muscle movements (e.g., lip smacking, grimacing, tongue protrusion, tremors)
- 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)
- Sore throat, fever, chills, or other signs of infection (may indicate low white blood cell count)
- Changes in vision or eye pain
- Thoughts of self-harm or suicide
- Severe allergic reaction (rash, itching, swelling, severe dizziness, trouble 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 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, including those that may 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 of your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
Your complete medical history, including any health problems you have or have had in the past.
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 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, including those that may 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 of your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
Your complete medical history, including any health problems you have or have had in the past.
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 Avoid Adverse Effects
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 exercise caution 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 for signs of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them to your doctor.
Low white blood cell counts have been associated with this medication, which can increase the risk of infection. In rare cases, infections can be fatal. Inform your doctor if you have a history of low white blood cell count and seek medical attention immediately if you experience symptoms of infection, such as fever, chills, or sore throat.
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Seek medical help immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and subsequent injuries, such as fractures.
Constipation is a common side effect, and in rare cases, bowel obstruction may occur. In some instances, bowel obstruction has been fatal, particularly when this medication is taken with other drugs 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 Considerations
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 Avoid Adverse Effects
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 exercise caution 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 for signs of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them to your doctor.
Low white blood cell counts have been associated with this medication, which can increase the risk of infection. In rare cases, infections can be fatal. Inform your doctor if you have a history of low white blood cell count and seek medical attention immediately if you experience symptoms of infection, such as fever, chills, or sore throat.
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Seek medical help immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.
This medication may cause dizziness, drowsiness, and impaired balance, which can increase the risk of falls and subsequent injuries, such as fractures.
Constipation is a common side effect, and in rare cases, bowel obstruction may occur. In some instances, bowel obstruction has been fatal, particularly when this medication is taken with other drugs 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 Considerations
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
- QTc prolongation
- Arrhythmias
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 and vital signs. Gastric lavage and activated charcoal may be considered if performed soon after ingestion.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, nelfinavir) - concomitant use is not recommended due to significant increase in quetiapine exposure.
Major Interactions
- CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates, St. John's Wort): May significantly decrease quetiapine plasma concentrations, requiring dose increase of quetiapine.
- Drugs that prolong QT interval (e.g., Class IA antiarrhythmics like quinidine, procainamide; Class III antiarrhythmics like amiodarone, sotalol; antipsychotics like ziprasidone, thioridazine; moxifloxacin, methadone): Increased risk of QTc prolongation and torsades de pointes.
- CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics): Additive CNS depression, increased sedation and respiratory depression.
- Anticholinergic drugs (e.g., benztropine, tricyclic antidepressants): Increased risk of anticholinergic side effects (e.g., urinary retention, constipation, dry mouth, blurred vision).
Moderate Interactions
- Antihypertensives: Additive hypotensive effects due to alpha1-adrenergic blockade.
- Dopamine agonists (e.g., levodopa, bromocriptine): Quetiapine may antagonize their effects.
- Thiazide diuretics: May exacerbate hyperglycemia.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Weight/BMI
Rationale: Risk of weight gain
Timing: Before initiation
Fasting Plasma Glucose (FPG) or 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
ECG
Rationale: Consider if patient has cardiac risk factors or history of QTc prolongation
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 dysfunction
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)
Fasting Plasma Glucose (FPG) or HbA1c
Frequency: At 3 months, then annually (more frequently if risk factors or concerns)
Target: FPG <100 mg/dL, HbA1c <5.7%
Action Threshold: FPG âĨ126 mg/dL, HbA1c âĨ6.5%
Lipid Panel (Fasting)
Frequency: At 3 months, then annually (more frequently if risk factors or concerns)
Target: LDL <100 mg/dL, HDL >40 mg/dL (men), >50 mg/dL (women), Triglycerides <150 mg/dL
Action Threshold: Significant dyslipidemia
Blood Pressure
Frequency: At each visit, especially during titration
Target: Normal range
Action Threshold: Symptomatic orthostatic hypotension
Extrapyramidal Symptoms (EPS) / Tardive Dyskinesia (TD) screening (e.g., AIMS)
Frequency: Annually (more frequently for high-risk patients)
Target: Absence of symptoms
Action Threshold: Emergence of symptoms
Ophthalmologic exam (slit lamp)
Frequency: Every 6 months for first year, then annually (due to rare risk of cataracts)
Target: Normal lens
Action Threshold: Evidence of cataracts
Symptom Monitoring
- Sedation/Drowsiness
- Dizziness/Orthostatic Hypotension
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Tremor
- Akathisia
- Dystonia
- Tardive dyskinesia (involuntary movements)
- Changes in mood or behavior (e.g., worsening depression, suicidal thoughts)
- Signs of hyperglycemia (e.g., polydipsia, polyuria, polyphagia, weakness)
- Signs of neuroleptic malignant syndrome (e.g., fever, muscle rigidity, altered mental status, autonomic instability)
- Signs of agranulocytosis (e.g., fever, sore throat, infection)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered 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 no clear evidence of increased major congenital malformations.
Second Trimester:
Limited data.
Third Trimester:
Risk of extrapyramidal and/or withdrawal symptoms in neonates (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).
Lactation
Quetiapine and its active metabolite are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk). Potential for sedation, irritability, poor feeding, and developmental effects. Monitor infant for drowsiness, adequate weight gain, and developmental milestones.
Pediatric Use
Safety and efficacy not established for all indications and age groups. Increased risk of suicidal thoughts and behaviors in children and adolescents. Close monitoring for clinical worsening and suicidality is essential. Higher rates of weight gain, increased appetite, and metabolic changes (hyperglycemia, dyslipidemia) observed compared to adults.
Geriatric Use
Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Increased risk of cerebrovascular adverse events (e.g., stroke, TIA) in elderly patients with dementia. Generally, lower initial doses and slower titration are recommended due to increased sensitivity to adverse effects (e.g., orthostatic hypotension, sedation).
Clinical Information
Clinical Pearls
- Quetiapine is highly sedating, especially at lower doses and during initiation. Administering the majority of the dose at bedtime can help manage sedation and improve sleep.
- Orthostatic hypotension is common, particularly during initial titration. Advise patients to rise slowly and monitor blood pressure.
- Metabolic monitoring (weight, glucose, lipids) is crucial due to the risk of weight gain, hyperglycemia, and dyslipidemia.
- The extended-release (XR) formulation allows for once-daily dosing and may have a lower peak concentration, potentially reducing some acute side effects like orthostatic hypotension and sedation compared to IR.
- Withdrawal symptoms (e.g., insomnia, nausea, headache, diarrhea, vomiting, dizziness, irritability) can occur if discontinued abruptly, especially after prolonged use. Taper gradually.
- Consider ophthalmologic exams due to the rare risk of cataracts, especially with long-term use.
- Quetiapine has a relatively low risk of EPS compared to first-generation antipsychotics and some other atypical antipsychotics.
Alternative Therapies
- Other Atypical Antipsychotics (e.g., Olanzapine, Risperidone, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, Brexpiprazole)
- First-Generation Antipsychotics (e.g., Haloperidol, Chlorpromazine) - generally less preferred due to higher EPS risk
- Mood Stabilizers (e.g., Lithium, Valproate, Lamotrigine) for bipolar disorder
- Antidepressants (e.g., SSRIs, SNRIs) for major depressive disorder (adjunctive or monotherapy)
- Electroconvulsive Therapy (ECT)
- Psychotherapy (e.g., CBT, family therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ per 30 tablets (400mg)
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 safe use, never share your medication with others, and do not take medication prescribed to someone else. 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, consult 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 quantity, and the time it occurred.