Quetiapine ER 150mg Tablets

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 and alpha1-adrenergic receptors, and moderate affinity for alpha2-adrenergic receptors. It has low affinity for muscarinic M1 receptors. The active metabolite, norquetiapine, has high affinity for the norepinephrine transporter (NET) and partial agonist activity at the 5-HT1A receptor.

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, or trouble swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Drooling
Seizures
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem
Difficulty urinating
Flu-like symptoms
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Tardive dyskinesia, a severe muscle problem that may cause involuntary movements, particularly in people with diabetes or 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

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, 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.
All your health problems, including any pre-existing conditions.

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

Important Warnings and Cautions for Patients Taking This Medication

Informing Your Healthcare Providers
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Safety Precautions
To ensure your safety, avoid driving and performing tasks that require alertness until you understand how this medication affects you. When rising from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Potential Side Effects
Although rare, cataracts may occur. Additionally, 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.

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, inform your doctor, as these may be indicative of high blood sugar.

Infection Risk
Drugs like this one may cause a decrease in white blood cell count, increasing the risk of infection. In rare cases, these infections can be fatal. If you have a history of low white blood cell count, inform your doctor. Seek medical attention immediately if you experience symptoms such as fever, chills, or sore throat, which may indicate an infection.

Neuroleptic Malignant Syndrome (NMS)
A rare but potentially life-threatening condition called NMS may occur. Seek medical attention immediately if you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.

Dizziness and Falling Risk
This medication may cause dizziness, drowsiness, and instability, which can increase 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. Although rare, bowel blockage can occur, and in some cases, it has been fatal, particularly 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 an increased 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 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.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, nelfinavir, indinavir, saquinavir, atazanavir, telithromycin, voriconazole, posaconazole, grapefruit juice) - concomitant use is contraindicated due to significant increase in quetiapine exposure.

• CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates, St. John's Wort) - may require significant dose increase of quetiapine or alternative antipsychotic.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, thioridazine, moxifloxacin) - increased risk of QTc prolongation and arrhythmias.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives) - additive CNS depression.
• Antihypertensives - additive hypotensive effects.
• Anticholinergic agents - additive anticholinergic effects (e.g., urinary retention, constipation, dry mouth).

• Dopaminergic agonists (e.g., levodopa) - quetiapine may antagonize effects.
• Thiazide diuretics - may exacerbate hyperglycemia.
• Lithium - increased risk of neurotoxicity (rare, but reported).

• Not specifically categorized as minor, but general caution with any drug affecting CNS or metabolism.

• Sedation/Somnolence
• Dizziness/Orthostatic Hypotension
• Dry mouth
• Constipation
• Weight gain
• Extrapyramidal symptoms (e.g., tremor, akathisia, dystonia, tardive dyskinesia)
• Neuroleptic Malignant Syndrome (NMS) symptoms (e.g., fever, muscle rigidity, altered mental status, autonomic instability)
• Hyperglycemia symptoms (e.g., polydipsia, polyuria, polyphagia, weakness)
• Cardiac symptoms (e.g., palpitations, syncope)
• Suicidal ideation/behavior (especially in young adults)
• Changes in mood or behavior
• Cataract formation (rare, but reported in animal studies; periodic eye exams may be considered)

Category C. 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 is excreted into human milk. 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 monitoring for sedation and developmental milestones is recommended.

Not approved for use in pediatric patients under 10 years of age for bipolar mania, under 13 years of age for schizophrenia, or under 18 years of age for bipolar depression or adjunctive MDD. Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.

Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Use with caution due to increased susceptibility to orthostatic hypotension, sedation, and anticholinergic effects. Consider lower starting doses and slower titration.

• Quetiapine ER should be taken without food or with a light meal (approx. 300 calories) to avoid significant increases in drug exposure.
• Due to the risk of orthostatic hypotension, patients should be advised to stand up slowly, especially during initial titration.
• Metabolic monitoring (weight, glucose, lipids) is crucial due to the risk of metabolic syndrome.
• Patients should be educated about the signs of NMS and tardive dyskinesia and instructed to seek immediate medical attention if these occur.
• Avoid abrupt discontinuation, as this can lead to withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability).
• The 150mg strength is often used as a maintenance dose or as part of a titration schedule, particularly for bipolar depression or adjunctive MDD.
• Consider the sedating effects when advising patients about driving or operating machinery, especially at the start of treatment or with dose changes.

• Other atypical antipsychotics (e.g., aripiprazole, olanzapine, risperidone, ziprasidone, lurasidone, cariprazine, brexpiprazole)
• Mood stabilizers (e.g., lithium, valproate, lamotrigine) for bipolar disorder
• Antidepressants (e.g., SSRIs, SNRIs) for major depressive disorder (often in combination with an antipsychotic for adjunctive MDD)
• Electroconvulsive therapy (ECT) for severe or treatment-resistant mood disorders or schizophrenia
• Psychotherapy (e.g., CBT, family therapy)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.