Quetiapine 150mg ER Tablets

Quetiapine is an atypical antipsychotic with a broad receptor binding profile. Its antipsychotic activity is primarily mediated through antagonism of dopamine D2 and serotonin 5-HT2A receptors. It also exhibits antagonism at histamine H1 receptors (contributing to sedation) and alpha1-adrenergic receptors (contributing to orthostatic hypotension). It has partial agonist activity at 5-HT1A receptors and antagonism at 5-HT2C receptors. 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low thyroid levels, including:
+ Constipation
+ Sensitivity to cold
+ Memory problems or mood changes
+ Burning, numbness, or tingling sensations that are not normal
Severe dizziness or fainting
Chest pain or pressure, rapid or irregular heartbeat
Difficulty controlling body movements, twitching, balance problems, or trouble swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Drooling or 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 (especially in people with diabetes or older adults, particularly older women)

If you experience any of the following symptoms, contact your doctor right away:
Trouble controlling body movements
Problems with your tongue, face, mouth, or jaw, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals 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 or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitability
Difficulty sleeping
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, contact 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 your medications and health conditions with your doctor. Please inform your doctor and pharmacist about:

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 medical conditions or concerns.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all 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 or 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 your 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 medication, which can increase your risk of infection. In rare cases, these infections can be life-threatening. Inform your doctor if you have a history of low white blood cell count, and seek medical attention immediately if you experience 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 stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, or excessive sweating.
This medication may cause dizziness, drowsiness, and impaired balance, which can increase your risk of falls and related injuries.
Constipation is a common side effect, and in rare cases, bowel obstruction may occur. 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 life-threatening. This medication is not approved for treating mental health conditions related to dementia.
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, protease inhibitors, nefazodone) - concomitant use is contraindicated due to significant increase in quetiapine exposure.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, barbiturates) - may significantly decrease quetiapine plasma levels, requiring dose adjustment.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, thioridazine, moxifloxacin) - increased risk of QT prolongation and arrhythmias.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive sedative effects.
• Antihypertensives - additive hypotensive effects.

• Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem) - may increase quetiapine levels, requiring dose reduction.
• Moderate CYP3A4 inducers (e.g., efavirenz) - may decrease quetiapine levels.
• Anticholinergic drugs - additive anticholinergic effects (e.g., urinary retention, constipation, dry mouth, blurred vision).

• Not available

• Sedation/Drowsiness
• Dizziness/Lightheadedness (especially upon standing)
• Dry mouth
• Constipation
• Blurred vision
• Weight gain
• Increased thirst/urination (signs of hyperglycemia)
• Muscle stiffness/tremor/restlessness (EPS)
• Involuntary movements (TD)
• Fever, muscle rigidity, altered mental status, autonomic instability (Neuroleptic Malignant Syndrome)
• Sore throat, fever, signs of infection (agranulocytosis/neutropenia)
• Chest pain, palpitations, fainting (cardiac issues)
• Suicidal thoughts or behaviors

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.

Excreted into human breast milk. L3 (Moderately Safe). The amount of quetiapine in breast milk is relatively low. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Quetiapine ER is not approved for use in pediatric patients for schizophrenia or bipolar disorder. For MDD, it is not approved as monotherapy or adjunctive therapy in pediatric patients. There is a Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults treated with antidepressants.

Increased risk of mortality in elderly patients with dementia-related psychosis (Black Box Warning). Not approved for this indication. Elderly patients may be more sensitive to the anticholinergic, orthostatic hypotensive, and sedative effects. Start with lower doses (e.g., 50 mg/day) and titrate more slowly. Monitor closely for adverse effects.

• Quetiapine ER should be taken once daily, preferably in the evening, without food or with a light meal (less than 500 calories) to ensure consistent absorption.
• Do not crush, chew, or break the extended-release tablets, as this will alter the release profile and may lead to rapid absorption and increased side effects.
• Patients should be advised about the risk of orthostatic hypotension, especially during initial titration, and instructed to rise slowly.
• Monitor for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) regularly, as these are common with atypical antipsychotics.
• Sedation is a common side effect, especially at the beginning of treatment. Taking the dose at bedtime can help manage this.
• The active metabolite, norquetiapine, contributes to the antidepressant effects, particularly relevant in bipolar depression and adjunctive MDD.
• Strong CYP3A4 inhibitors (e.g., ketoconazole) are contraindicated due to significant increases in quetiapine levels, while strong inducers (e.g., carbamazepine) can significantly decrease levels, requiring dose adjustments.

• 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 MDD, often in combination with an atypical antipsychotic for treatment-resistant depression)
• Electroconvulsive Therapy (ECT) for severe or treatment-resistant conditions

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 or take someone else's medication. 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 amount, and the time it occurred.