Quetiapine 50mg ER Tablets

Quetiapine is an atypical antipsychotic. Its mechanism of action is thought to be mediated through a combination of antagonism at dopamine D2 and serotonin 5-HT2A receptors. It also exhibits antagonism at histamine H1 receptors (contributing to sedation), adrenergic alpha1 receptors (contributing to orthostatic hypotension), and muscarinic M1 receptors (contributing to anticholinergic effects). The active metabolite, N-desalkylquetiapine (norquetiapine), has high affinity for norepinephrine transporter (NET) and partial agonist activity at 5-HT1A receptors, which may contribute to its antidepressant effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low thyroid levels, including:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Difficulty controlling body movements, twitching, balance problems, 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 changes in menstrual cycle
Tardive dyskinesia, a severe muscle disorder that may cause involuntary movements, particularly in people with diabetes or older adults, especially older women. The risk increases with longer treatment duration or higher doses, but can also occur with short-term use or low doses. If you experience trouble controlling body movements or problems with your tongue, face, mouth, or jaw, such as tongue protrusion, cheek puffing, mouth puckering, or chewing, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or 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.

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 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 of your medications, health problems, and concerns with your doctor and pharmacist. This includes:

All prescription and over-the-counter (OTC) medications.
Natural products and vitamins.
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 crucial to verify that it is safe to take this medication with all of your other medications and health conditions.

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 and performing tasks that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Potential Side Effects 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 symptoms such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath to your doctor.
Low white blood cell counts have been associated with this type of 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 immediate medical attention if you experience symptoms such as fever, chills, or sore throat.
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Seek emergency medical help 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 related injuries.
Constipation is a common side effect, and in rare cases, bowel obstruction may occur. In some 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 type of 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.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, nefazodone, protease inhibitors like indinavir, nelfinavir, ritonavir, saquinavir) due to significant increase in quetiapine exposure.

• CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates): May significantly decrease quetiapine plasma levels, requiring dose adjustment.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Increased risk of sedation and CNS depression.
• Anticholinergic drugs: Increased risk of anticholinergic adverse effects (e.g., urinary retention, constipation, dry mouth, blurred vision).
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, thioridazine, moxifloxacin): Increased risk of QT prolongation and arrhythmias.
• Antihypertensive agents: Increased risk of orthostatic hypotension.

• Dopamine agonists (e.g., levodopa): Quetiapine may antagonize their effects.
• Thiazide diuretics: May exacerbate hyperglycemia.
• Grapefruit juice: May inhibit CYP3A4, increasing quetiapine levels (avoid large amounts).

• Not available

• Sedation/Drowsiness
• Dizziness/Orthostatic Hypotension
• Dry mouth
• Constipation
• Weight gain
• Blurred vision
• Urinary retention
• Tremor
• Akathisia
• Dystonia
• Tardive dyskinesia (involuntary movements, especially of face/tongue)
• Signs of hyperglycemia (increased thirst, urination, hunger)
• Signs of hyperlipidemia
• Suicidal ideation or worsening of depression/anxiety
• Neuroleptic Malignant Syndrome (NMS) symptoms (fever, muscle rigidity, altered mental status, autonomic instability)
• Agranulocytosis/Neutropenia symptoms (fever, sore throat, infection)

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.

Quetiapine and its active metabolite are excreted into human milk. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Approved for schizophrenia (adolescents 13-17 years) and bipolar mania (children/adolescents 10-17 years). Not approved for bipolar depression or MDD augmentation in pediatric patients. Increased risk of weight gain, dyslipidemia, and elevated prolactin compared to adults. Black Box Warning regarding suicidality applies to young adults and adolescents when used for MDD augmentation.

Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Increased risk of orthostatic hypotension, falls, and anticholinergic effects. Lower starting doses and slower titration are recommended. Monitor closely for adverse effects.

• Quetiapine ER should be taken once daily, preferably in the evening, without food or with a light meal to optimize absorption and minimize sedation during the day.
• Titration is crucial to minimize side effects like orthostatic hypotension and sedation. Patients should be advised to get up slowly.
• Metabolic monitoring (weight, glucose, lipids) is essential due to the risk of metabolic syndrome associated with atypical antipsychotics.
• The 50mg ER tablet is often used as a starting dose for bipolar depression or MDD augmentation, or for very sensitive patients.
• Patients should be educated about the Black Box Warnings, especially regarding increased mortality in elderly dementia patients and suicidality risk in younger populations.
• Avoid abrupt discontinuation, as withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability) can occur. Taper gradually.

• Other atypical antipsychotics (e.g., Olanzapine, Risperidone, Aripiprazole, Lurasidone, Ziprasidone, Cariprazine)
• Mood stabilizers (e.g., Lithium, Valproate, Lamotrigine) for bipolar disorder
• Antidepressants (e.g., SSRIs, SNRIs) for MDD (often in combination with an antipsychotic for augmentation)
• Psychotherapy (e.g., CBT, DBT)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.