Quetiapine Fumarate

Quetiapine Fumarate is an FDA-approved antipsychotic medication used to treat schizophrenia, bipolar disorder, and sudden episodes of mania or depression linked to bipolar disorder. It works by rebalancing neurotransmitters in the brain, particularly dopamine and serotonin, to improve mood, thinking, and behavior. Quetiapine has different strengths and is available in two forms: oral and extended-release oral tablets. It is recommended for use in adults, elderly patients, adolescents, and children above ten years of age. Consult a licensed healthcare provider before using this medication for safe and efficient use.

Quetiapine Fumarate is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and sudden episodes of mania or depression linked to bipolar disorder. The active ingredient, quetiapine, works by rebalancing neurotransmitters in the brain, particularly dopamine and serotonin, to improve mood, thinking, and behavior.

Quetiapine Fumarate is available in two forms: oral tablets and extended-release oral tablets. The strengths of oral tablets include 25 milligrams (mg), 50 mg, 150 mg, 300 mg, 100 mg, 200 mg & 400 mg, while extended-release tablets are available in 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg strengths. This medication is taken orally, typically twice or thrice daily, with or without food. It is suitable for adults and geriatric patients but not recommended for children under ten years of age. It helps manage symptoms by slowing down nerve signals, which can reduce hallucinations, delusions, and mood swings.

Common side effects of Quetiapine Fumarate include drowsiness, dizziness, dry mouth, constipation, and weight gain. Following safety guidelines and consulting with a healthcare provider before starting this medication is important. Precautions include monitoring for side effects, avoiding alcohol, and not operating heavy machinery if drowsiness occurs. In case of a missed dose, take it as soon as remembered unless it is close to the next dose. For an overdose, seek immediate medical assistance. Store Quetiapine at room temperature, away from light, heat, and moisture, and keep it out of reach of children and pets. Always consult your physician for personalized advice & adjustments to your dosage.

It is used to treat:

• Bipolar disorder
• Schizophrenia
• Sudden episodes of mania or depression linked to bipolar disorder

It comes in the following forms and strengths:

Form: Oral tablet, extended-release

Strengths: 150 mg, 50 mg, 200 mg, 300 mg & 400 mg

Form: Oral tablet, immediate-release

Strengths: 50 mg, 25 mg, 150 mg, 200 mg, 100 mg, 300 mg & 400 mg 

What Are the Recommended Dosage of Quetiapine Fumarate?

Dosage for Schizophrenia

For Adults

Immediate-release Tablets:

• Initial Dosage:
  • Day 1: 25 mg twice daily.
  • Days 2 and 3: Increase by 25–50 mg, taken 2-3 times daily.
  • Day 4: 300–400 mg daily in divided doses.
• Maintenance Dosage: 400-800 mg daily, taken in divided doses.
• Maximum Dosage: 800 mg daily, taken in divided doses.

Extended-release Tablets:

• Initial Dosage: On day 1, you should take 300 mg daily. Increase by no more than 300 mg twice daily.
• Maintenance Dosage: 400-800 mg daily
• Maximum Dosage: 800 mg daily

For Geriatric Patients

• Initial Dosage: 50 mg daily
• Maintenance Dosage: Gradually increase by 50 mg daily
• Maximum Dosage: Lower total daily dose to reduce the risk of unwanted side effects.

For Pediatric Patients

• Initial Dosage:
  • Day 1: 25 mg twice daily.
  • Day 2: 100 mg per day.
  • Day 3: 200 mg per day.
  • Day 4: 300 mg per day.
  • Day 5: 400 mg per day in divided doses.
• Maintenance Dosage: 400-800 mg daily in divided doses.
• Maximum Dosage: 800 mg

Dosage for Bipolar I Disorder (Manic/ Mixed Episodes)

For Adults

Immediate-release tablets:

• Initial Dosage:
  • Day 1: 100 mg per day in divided doses.
  • Day 2: 200 mg per day.
  • Day 3: 300 mg per day.
  • Day 4: 400 mg per day.
• Maintenance Dosage: 400-800 mg per day in divided doses.
• Maximum Dosage: 800 mg per day in divided doses.

Extended-release tablets:

• Initial Dosage:
  • Day 1: 300 mg once daily.
  • Day 2: 600 mg once daily.
  • Day 3: 400-800 mg once daily
• Maintenance Dosage: 400-800 mg once daily.
• Maximum Dosage: 800 mg once daily.

For Geriatric Patients

• Initial Dosage: 50 mg daily.
• Maintenance Dosage: Increase by 50 mg daily, slower rate.
• Maximum Dosage: Lower total daily dose to reduce the risk of unwanted side effects.

For Pediatric Patients

Immediate-release Tablets:

• Initial Dosage:
  • Day 1: 25 mg twice daily.
  • Day 2: 100 mg daily
  • Day 3: 200 mg daily.
  • Day 4: 300 mg daily.
  • Day 5: 400 mg daily in divided doses.
• Maintenance dose: 400-600 mg daily in divided doses
• Maximum dose: 600 mg in divided doses

Extended-release Tablets:

• Initial Dosage:
  • Day 1: 50 mg once daily.
  • Day 2: 100 mg once daily.
  • Day 3: 200 mg once daily.
  • Day 4: 300 mg once daily.
  • Day 5: 400 mg once daily.
• Maintenance dose: 400-600 once daily
• Maximum dose: 600 mg once daily

For Bipolar Disorder (Depressive Episodes)

For Adults

Immediate-release tablets:

• Initial Dosage:
  • Day 1: 50 mg daily at bedtime.
  • Day 2: 100 mg daily.
  • Day 3: 200 mg daily.
  • Day 4: 300 mg daily.
• Maintenance Dosage: 300 mg daily at bedtime.
• Maximum Dosage: 300 mg daily at bedtime.

Extended-release Tablets:

• Initial Dosage:
  • Day 1: 50 milligrams (mg) once daily at bedtime.
  • Day 2: 100 mg once daily.
  • Day 3: 200 mg once daily.
  • Day 4: 300 mg once daily.
• Maintenance Dosage: 300 mg once daily.
• Maximum Dosage: 300 mg once daily.

For Geriatric Patients

• Initial Dosage: 50 mg daily.
• Maintenance Dosage: Increase by 50 mg daily, slower rate.
• Maximum Dosage: Lower total daily dose to reduce side effects.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Before using this medication, carefully read and follow the directions for use given in the patient information leaflet that came along with the prescription label or provided by your healthcare provider each time you start taking the medication and each time you get a refill. If you do not understand any part of the leaflet or if you have any questions, contact your doctor.
• You should take this medication twice or thrice daily orally by mouth, exactly as your doctor has directed, with or without food. For treating depression associated with bipolar disorder, you should take this medication orally by mouth, usually once at bedtime.
• Swallow the Quetiapine Fumarate tablet as a whole. Do not crush, chew, or break it. However, if you are experiencing difficulty swallowing the immediate-release tablets, you can crush or cut them, but you cannot crush or cut the extended-release tablets.
• The quetiapine dose depends on your medical condition, response to treatment, or other medications you may be taking. Tell your doctor about all the medicines you may be taking or planning to take, including all prescription, non-prescription, over-the-counter, and herbal or vitamin supplements.
• Your doctor may ask you to take certain blood tests and visit your doctor regularly.
• This medication may cause false results on a drug-screening urine test. Tell your doctor and laboratory staff that you use Quetiapine.
• To prevent the risk of developing unwanted side effects, your medical provider may suggest that you take this medication at a low dose initially and gradually increase your dosage.
• To get the most benefit from your medication, you should maintain consistency in dosage and try to take it simultaneously daily.
• You should not take this medication more or less than prescribed, in large quantities, or more frequently. Doing so will not improve your health condition any faster, but your risk of unwanted side effects will be higher.
• You should continue taking this medication even if you feel well. You should not stop taking this medication abruptly without consulting your doctor, as certain conditions may become worse when the medication is stopped suddenly. You may experience irritability, trouble sleeping, nausea, diarrhea, and headache. If you plan to discontinue the medication, your doctor may help you taper off the medication by gradually decreasing the medication dose.
• Report any new or worsening symptoms to your doctor immediately. Let your doctor know if your condition does not improve or worsen.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Quetiapine Fumarate is an atypical antipsychotic drug that primarily affects the balance of neurotransmitters in the brain, particularly dopamine and serotonin. By binding to these receptors, Quetiapine helps to rebalance these chemicals, improving mood, thinking, and behavior. It has a calming effect on the brain, slowing down nerve signals, which is beneficial in treating conditions like schizophrenia and bipolar disorder. For schizophrenia, it can reduce symptoms such as hallucinations and delusions, while in bipolar disorder, it helps manage both manic and depressive episodes.

Common Side Effects of Quetiapine Fumarate:

Similar to other medications, Quetiapine may cause side effects in some people. These side effects are not severe and go away within a couple of days as your body adjusts to the medication. The common side effects of Quetiapine Fumarate are as follows:

• Drowsiness and sedation
• Dry mouth
• Dizziness
• Weight gain
• Constipation
• Increased appetite
• Fatigue
• Headache
• Nausea
• Sore throat

Mild Side Effects of Quetiapine Fumarate:

Given below is a detailed overview of the mild side effects of Quetiapine Fumarate:

• Mild skin rash or itching
• Blurred vision
• Indigestion or stomach discomfort
• Mild weakness
• Runny or stuffy nose
• Changes in menstrual periods
• Mild swelling of hands, feet, or ankles
• Increased sweating
• Mild sleep disturbances
• Mild tremors

Serious Side Effects of Quetiapine Fumarate:

In rare cases, Quetiapine may cause severe side effects that require immediate medical attention and may become life-threatening if they are not treated promptly. It’s important to note that not everyone experiences these side effects, and many people use Quetiapine without significant problems. However, patients should be monitored carefully, especially when starting the medication or changing dosage. You should report any symptoms that are concerning to a healthcare provider immediately. Serious side effects caused by Quetiapine are as follows:

• Neuroleptic malignant syndrome. Its symptoms may include muscle stiffness, irregular heartbeat, and confusion.
• Tardive dyskinesia. Its symptoms may include uncontrollable movements, especially of the face and tongue.
• Diabetes and hyperglycemia. Its symptoms may include increased thirst, frequent urination, and extreme hunger.
• QT prolongation. Its symptoms may include irregular heartbeat and fainting
• Orthostatic hypotension. Its symptoms may include fainting when standing up or dizziness.
• Increased risk of stroke in geriatric patients with dementia
• Severe allergic reaction. Its symptoms may include rash, itching, swelling, severe dizziness, or trouble breathing.
• Priapism. Symptoms may include prolonged and painful erection.
• Leukopenia, neutropenia, and agranulocytosis. Its symptoms may include an increased risk of infections.
• Cataracts. Its symptoms may include vision changes
• Hyperthyroidism. Its symptoms may include fatigue, weight gain, cold intolerance
• Hyperprolactinemia. Its symptoms may include breast enlargement, milk production, menstrual changes
• Severe liver problems. Its symptoms may include yellowing of skin/eyes, dark urine, and persistent nausea.
• Suicidal thoughts or behaviors

[Note: This list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

• Geriatric patients with dementia have a higher risk of severe, possibly fatal side effects such as heart failure, stroke, pneumonia, and rapid/irregular heartbeat. This medication is not indicated for use in the treatment of dementia-related behavior problems. Discuss the potential risks & benefits of this medication with your doctor, as well as regarding other effective and safer treatments for dementia-related behavior problems.
• Antipsychotic medications, including Quetiapine, can help in preventing suicidal thoughts and behavior and provide other benefits. However, certain studies have suggested that in some cases, patients experience worsening depression, suicidal thoughts/attempts, or other mental/mood symptoms.
• Immediately call your doctor if you experience worsening depression, panic attacks, severe restlessness, impulsive actions, trouble sleeping, usual behavior changes, or other mental/mood changes. Careful monitoring is essential, especially when a new drug to treat depression is started, or dosage adjustment is made.
• This medication is not approved for use in pediatric patients less than ten years of age.

What Are the FDA Boxed Warning for Quetiapine Fumarate?

There is a boxed warning for Quetiapine Fumarate issued by the FDA due to the potential key warnings:

• Increased mortality in geriatric patients with dementia-associated psychosis.
• Suicidal thoughts & behaviors in children, adolescents, and young patients aged 24 and under
• Metabolic changes, including hyperglycemia, dyslipidemia, weight gain
• Neuroleptic malignant syndrome (NMS)
• Tardive dyskinesia

• Before taking Quetiapine Fumarate, tell your doctor or healthcare provider if you have an allergy to Quetiapine, any of its components, or any other allergies. This medication contains certain inactive ingredients that may cause severe allergic reactions or other problems. Contact your pharmacist or healthcare provider for the complete list of ingredients.
• Before starting to take this medication, share your complete medical and family history with your doctor, especially if you have any of the following conditions:
  • Difficulty urinating
  • Eye cataracts
  • Heart disease
  • High blood pressure
  • High cholesterol
  • Liver disease
  • Low white blood cells
  • Personal or family history of diabetes mellitus
  • Seizure disorder
  • Stomach/intestinal problems
  • Substance use disorder
  • Trouble swallowing
  • Thyroid problems
• This medication may cause drowsiness, dizziness, or blur your vision temporarily. Consuming alcohol or marijuana may make you more dizzy. You should not drive, operate heavy machinery, or engage in activities that require alertness & clear vision unless you can do it safely. Contact your doctor if you use marijuana.
• This medication may cause a condition known as QT prolongation, which affects the heart rhythm. This condition can rarely cause severe rapid or irregular heartbeat & other symptoms that require prompt medical attention.
• Your risk of developing QT prolongation is higher if you have certain medical attention or if you are taking other medications that may cause this condition.
• Before taking this medication, tell your doctor about all the medications you are currently taking or planning to take, including all prescription, non-prescription, over-the-counter, and herbal or vitamin supplements. Also, tell them about all your medical conditions, particularly heart-related conditions.
• Low potassium/ magnesium levels in the blood can also increase your risk of QT prolongation. This risk may be higher if you use certain medications, such as diuretics, or have certain conditions, such as diarrhea, vomiting, or severe sweating.
• This medication may make you sweat less, making you more susceptible to heat stroke. Do not do things that make you overheat. When the weather is hot, you should consume lots of fluids and dress lightly. Call your doctor if you have a persistent or high fever, mental/mood changes, dizziness, or headache.
• Before having surgery, including a dental procedure, tell your doctor, surgeon, or dentist about all the medications you are using.
• While taking this medication, children may be at a higher risk of certain side effects, such as increased prolactin or increased blood pressure. Call your doctor to discuss the potential risks & benefits.
• Geriatric patients may be at a greater risk of developing certain side effects of this medication, such as dizziness, drowsiness, QT prolongation, and lightheadedness. These symptoms may increase the risk of falling.
• This medication should only be needed during pregnancy when it is clearly needed. If you are pregnant, suspect pregnancy, or planning to get pregnant, tell your doctor immediately.
• Since untreated mood/mental problems, including bipolar disorder, depression, and schizophrenia, can be a serious condition, you should not stop taking this medication abruptly without consulting your doctor.
• Quetiapine passes into your breastmilk and may cause harm to the nursing infant. Let your doctor know immediately if your baby develops muscle stiffness, unusual sleepiness, or difficulty feeding. Before using Quetiapine while breastfeeding, consult your doctor.

Quetiapine Fumarate is contraindicated for use in patients who have:

• A known hypersensitivity to Quetiapine or any of the ingredients present in the medication
• Electrolyte imbalance
• Heart problems
• History of arrhythmias
• Low blood pressure
• Seizures

• If you miss a dose of Quetiapine, it may not work as well. For it to function properly, a certain amount of medication needs to be in your body at all times.
• If you have missed a dose of Quetiapine Fumarate, you should take it as soon as you remember.
• However, if it is almost time for your next dose, you may omit the missed dose and continue taking your medications according to your regular dosing schedule.
• Do not take double or extra doses to compensate for the missed dose.
• You can set a reminder on your phone to prevent missing doses further.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

If you suspect an overdose, you should immediately seek medical assistance. Symptoms of Quetiapine overdose may include drowsiness, sleepiness, dizziness, fainting, and rapid heartbeat. If someone is experiencing severe side effects such as difficulty breathing, passing out, or seizures, you should call a doctor, 911, or the poison control helpline. You can also head to the nearest emergency room.

[Note: If you consumed more than the recommended dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

• You should keep Quetiapine Fumarate at a controlled room temperature, away from direct light, excess heat, and moisture.
• You can store the medication in its original container tightly closed in a dark, cool & dry place.
• Keep all medications, including Quetiapine Fumarate, in a safe place away from the sight and reach of children and pets.
• Do not keep medications that are outdated or no longer needed. Discard them safely.
• Do not pour them down the drain, flush them down the toilet, or throw them into the household garbage bin.
• You should dispose of unwanted medications in such a way that prevents children, animals, and others from consuming them.
• Consult your pharmacist, healthcare provider, or local waste disposal company to learn more about the proper ways to eliminate unwanted medications.

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

Certain medications may interact with Quetiapine Fumarate and affect its effectiveness. The list of interactions below is incomplete; consult your healthcare provider, physician, or pharmacist to determine potential drug interactions based on your specific medication regimen.

• Antiarrhythmic agents
• Anticholinergic medications
• Antidepressants
• Antifungal agents
• Antihistamines
• Antihypertensive drugs
• Barbiturates
• Benzodiazepines
• Carbamazepine
• Cimetidine
• Corticosteroids
• CYP3A4 inducers
• CYP3A4 inhibitors
• Dopamine agonists
• Levodopa
• Lithium
• Methadone
• Phenytoin
• Thioridazine
• Valproic acid
• Verapamil

What Are the Other Quetiapine Fumarate Interactions?

Before starting to take this medication, tell your doctor about all the medications you are taking or planning to take alongside Quetiapine. This includes all prescription, non-prescription, over-the-counter drugs, and herbal or vitamin supplements. Interaction of Quetiapine Fumarate with supplements, herbs, foods, and beverages may vary in severity and effect. It can interact with:

• Grapefruit or grapefruit juice
• Caffeine
• Alcohol
• High-fat meals

[Note: This isn’t a complete list, and there could be other drugs that interact with Quetiapine Fumarate. Tell your doctor about any prescription, over-the-counter medicines, and herbal products.]

People look for alternative medicines to Quetiapine when it does not suit them, or they do not get the desired results from this medication. There are various effective substitute medicines available in the market. Given below is the list of alternative medicines to Quetiapine based on the intent of usage:

Atypical Antipsychotics:

• Risperdal (risperidone)
• Zyprexa (olanzapine)
• Abilify (aripiprazole)
• Geodon (ziprasidone)
• Invega (paliperidone)
• Latuda (lurasidone)
• Rexulti (brexpiprazole)
• Vraylar (cariprazine)

Mood Stabilizers:

• Lithobid (lithium)
• Depakene (valproic acid)
• Lamictal (lamotrigine)
• Tegretol (carbamazepine)
• Trileptal (oxcarbazepine)

Antidepressants:

• Prozac (fluoxetine)
• Zoloft (sertraline)
• Paxil (paroxetine)

[Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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