Quetiapine 150mg Tablets

Manufacturer RISING PHARMACEUTICALS Active Ingredient Quetiapine Tablets(kwe TYE a peen) Pronunciation kwe TYE a peen
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.
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Drug Class
Antipsychotic
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Pharmacologic Class
Atypical Antipsychotic; Dibenzothiazepine derivative
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Pregnancy Category
Category C
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Quetiapine is a medication used to treat certain mental health conditions like schizophrenia, bipolar disorder (which causes extreme mood swings), and sometimes depression when other treatments haven't worked well enough. It works by helping to balance certain natural chemicals in the brain. It can make you feel sleepy, especially when you first start taking it.
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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 closely. 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 slow your reactions, consult with your doctor. Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of withdrawal symptoms. If you need to stop taking the medication, your doctor will advise you on how to gradually discontinue it.

Additional Precautions

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. As directed by your doctor, have your blood work checked and undergo regular eye exams.

Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. Also, monitor your blood sugar levels as instructed by your doctor.

Storing and Disposing of Your Medication

Store the 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.

Missing 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 extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications, as they can increase drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Monitor your weight and diet, as weight gain is a common side effect.
  • Stay hydrated to help with dry mouth and constipation.
  • Get up slowly from a sitting or lying position to avoid dizziness from low blood pressure.
  • Inform your doctor about all medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: For Quetiapine 150mg Tablets (often extended-release, XR): 150 mg once daily at bedtime for Major Depressive Disorder (adjunctive) or Bipolar Depression. For other indications, 150mg may be a titration step or part of a higher daily dose.
Dose Range: 25 - 800 mg

Condition-Specific Dosing:

schizophrenia: Initial 25-50 mg BID/TID (IR) or 300 mg once daily (XR), titrate to 300-800 mg/day.
bipolar_mania: Initial 50 mg BID (IR) or 300 mg once daily (XR), titrate to 400-800 mg/day.
bipolar_depression: Initial 50 mg QHS (IR/XR), titrate to 300 mg QHS.
major_depressive_disorder_adjunctive: Initial 50 mg QHS (IR/XR), titrate to 150-300 mg QHS.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 10 years. For adolescents (10-17 years) with Schizophrenia or Bipolar Mania: Initial 25 mg BID (IR) or 50 mg QHS (XR), titrate to 400-800 mg/day.
Adolescent: For Schizophrenia (13-17 years): Initial 25 mg BID (IR), titrate to 400-800 mg/day. For Bipolar Mania (10-17 years): Initial 25 mg BID (IR), titrate to 400-600 mg/day. XR formulations have similar dosing guidelines.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically required.
Moderate: No dosage adjustment typically required.
Severe: Consider starting with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly.
Dialysis: No specific recommendations; use with caution and titrate slowly from a low dose.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Start with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly, monitoring for adverse effects.
Severe: Start with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly, monitoring for adverse effects.

Pharmacology

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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 moderate affinity for serotonin 5-HT1A and muscarinic M1 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Not explicitly stated as a percentage, but well-absorbed. Food increases Cmax and AUC by approximately 25% for IR and 15-25% for XR.
Tmax: Immediate-release (IR): ~1.5 hours; Extended-release (XR): ~6 hours.
FoodEffect: Food increases Cmax and AUC for both IR and XR formulations. XR should be taken without food or with a light meal (less than 500 calories).

Distribution:

Vd: 10 Âą 4 L/kg
ProteinBinding: ~83%
CnssPenetration: Yes

Elimination:

HalfLife: Quetiapine: ~6-7 hours; Norquetiapine: ~10-12 hours.
Clearance: Not readily available as a single rate, but primarily hepatic.
ExcretionRoute: Urine (73%), Feces (20%)
Unchanged: <1% (urine)
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Pharmacodynamics

OnsetOfAction: Sedation: within 1 hour; Antipsychotic effects: days to weeks.
PeakEffect: Antipsychotic effects: several weeks.
DurationOfAction: 24 hours (especially for XR formulation).

Safety & Warnings

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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. Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of quetiapine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Quetiapine is not approved for use in pediatric patients less than 10 years of age.
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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
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, puffing cheeks, mouth puckering, or chewing, contact your doctor immediately.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, 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
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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Uncontrolled muscle movements (e.g., lip smacking, tongue thrusting, grimacing, tremors)
  • Fever, stiff muscles, confusion, sweating, fast or irregular heartbeat (signs of Neuroleptic Malignant Syndrome)
  • Sore throat, fever, chills, or other signs of infection (may indicate low white blood cell count)
  • Increased thirst, frequent urination, increased hunger (signs of high blood sugar)
  • Changes in vision or eye pain
  • New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, or suicidal thoughts/behavior.
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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 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 have or have had.

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
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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

To minimize the risk of accidents, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs.

Potential Side Effects and Risks

Although rare, cataracts may occur in patients taking this medication. Additionally, there is a risk of developing high blood sugar or diabetes, high cholesterol, and weight gain, which may increase the likelihood of heart and brain blood vessel disease.

Monitoring for High Blood Sugar

If you experience symptoms such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, notify your doctor, as these may be indicative of high blood sugar.

Risk of Infection

Drugs like this one may cause a decrease in white blood cell count, leading to a higher risk of infection. In rare cases, these infections can be fatal. Inform your doctor if you have a history of low white blood cell count. Seek immediate medical attention 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, Sleepiness, and Falls

This medication may cause dizziness, sleepiness, and impaired stability, increasing the risk of falls and subsequent injuries, such as fractures. Exercise caution to minimize this risk.

Constipation and Bowel Blockage

Constipation is a common side effect of this medication. In rare cases, bowel blockage may occur, which can be fatal, especially 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 upon discontinuation of the medication. If you have questions or concerns, discuss them with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks to you and your baby. Taking this medication during the third trimester of pregnancy may lead to side effects or withdrawal symptoms in the newborn.

Pediatric Patients

When administering this medication to children, use caution, as the risk of certain side effects may be higher in this population. 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.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Sedation
  • Tachycardia (fast heart rate)
  • Hypotension (low blood pressure)
  • Delirium
  • Coma
  • QTc prolongation
  • Arrhythmias

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive, including maintaining an open airway, ensuring adequate oxygenation and ventilation, and monitoring cardiovascular function.

Drug Interactions

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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, protease inhibitors): May significantly increase quetiapine levels, leading to increased adverse effects. Co-administration is generally not recommended.
  • Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of QTc prolongation and arrhythmias.
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids): Additive sedative effects.
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Moderate Interactions

  • CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates): May significantly decrease quetiapine levels, reducing efficacy. Dosage adjustment of quetiapine may be necessary.
  • Anticholinergic drugs: May potentiate anticholinergic side effects (e.g., dry mouth, constipation, urinary retention).
  • Antihypertensive agents: May potentiate orthostatic hypotension.
  • Dopamine agonists (e.g., levodopa): Quetiapine's D2 antagonism may counteract the effects of dopamine agonists.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Weight, 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 Triglycerides, Total Cholesterol, HDL, LDL)

Rationale: Risk of dyslipidemia.

Timing: Before initiation

Blood Pressure (Orthostatic)

Rationale: Risk of orthostatic hypotension.

Timing: Before initiation

Complete Blood Count (CBC) with differential

Rationale: Risk of neutropenia/leukopenia.

Timing: Before initiation

ECG

Rationale: Risk of QTc prolongation, especially in patients with cardiac risk factors.

Timing: Before initiation (if risk factors present)

Ophthalmologic examination (slit lamp)

Rationale: Risk of cataracts.

Timing: Before initiation (if risk factors present or long-term use anticipated)

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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 changes)

Target: FPG <100 mg/dL, HbA1c <5.7%

Action Threshold: FPG â‰Ĩ126 mg/dL, HbA1c â‰Ĩ6.5%

Lipid Panel (Fasting)

Frequency: At 3 months, then annually (more frequently if risk factors or changes)

Target: Triglycerides <150 mg/dL, Total Cholesterol <200 mg/dL

Action Threshold: Significant elevations

Blood Pressure (Orthostatic)

Frequency: Weekly for first month, then monthly for 3 months, then quarterly

Target: Stable BP

Action Threshold: Significant drop in SBP (>20 mmHg) or DBP (>10 mmHg) with position change

Complete Blood Count (CBC) with differential

Frequency: Periodically, especially if patient develops signs/symptoms of infection or has history of low WBC

Target: WBC >3.0 x 10^9/L, ANC >1.5 x 10^9/L

Action Threshold: ANC <1.0 x 10^9/L (consider discontinuation)

ECG

Frequency: As clinically indicated, especially with dose increases or concomitant QT-prolonging drugs

Target: QTc <450 ms (men), <470 ms (women)

Action Threshold: QTc >500 ms or increase >60 ms from baseline

Abnormal Involuntary Movement Scale (AIMS)

Frequency: Annually (more frequently if symptoms develop)

Target: No abnormal movements

Action Threshold: Development of tardive dyskinesia symptoms

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Symptom Monitoring

  • Sedation/Drowsiness
  • Dizziness/Lightheadedness (especially upon standing)
  • Dry mouth
  • Constipation
  • Blurred vision
  • Tremor
  • Restlessness (akathisia)
  • Muscle stiffness/rigidity
  • Difficulty swallowing
  • Changes in mood or behavior (e.g., worsening depression, suicidal thoughts)
  • Signs of infection (fever, sore throat) - indicative of neutropenia
  • Unusual thirst or urination (hyperglycemia)
  • Changes in vision (cataracts)

Special Patient Groups

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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 no clear evidence of increased major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Risk of extrapyramidal symptoms (e.g., tremor, hypertonia, hypotonia, somnolence, agitation, respiratory distress, feeding disorder) and/or withdrawal symptoms in neonates.
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Lactation

Quetiapine is excreted into human milk. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor the infant for sedation, irritability, poor feeding, and developmental milestones.

Infant Risk: L3 (Moderately Safe) - Monitor infant for adverse effects.
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Pediatric Use

Not approved for children under 10 years of age. Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Monitor for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) which may be more pronounced than in adults.

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Geriatric Use

Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Increased risk of orthostatic hypotension, falls, and metabolic side effects. Start with lower doses and titrate slowly. More susceptible to anticholinergic effects and tardive dyskinesia.

Clinical Information

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Clinical Pearls

  • Quetiapine is highly sedating, especially at lower doses and upon initiation. Taking it at bedtime can help manage this side effect and improve sleep.
  • The extended-release (XR) formulation is designed for once-daily dosing and may have a lower incidence of orthostatic hypotension and sedation compared to immediate-release (IR) due to slower absorption.
  • Metabolic monitoring (weight, glucose, lipids) is crucial due to the significant risk of metabolic syndrome.
  • Orthostatic hypotension is common, particularly during initial titration. Advise patients to rise slowly.
  • Risk of cataracts with long-term use; regular eye exams may be recommended.
  • Tapering off quetiapine is recommended to avoid withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability).
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Alternative Therapies

  • Other atypical antipsychotics (e.g., Olanzapine, Risperidone, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine)
  • Mood stabilizers (e.g., Lithium, Valproate, Lamotrigine) for bipolar disorder
  • Antidepressants (e.g., SSRIs, SNRIs) for major depressive disorder (often used in combination with an antipsychotic for adjunctive treatment)
  • ECT (Electroconvulsive Therapy) for severe mood disorders or schizophrenia
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 150mg IR/XR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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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. When you receive this medication, you will also get a Medication Guide, which is a detailed patient information sheet. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, do not hesitate 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. Be prepared to provide information about the overdose, including the medication taken, the amount, and the time it occurred.