Quetiapine ER 200mg 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 affinity for alpha1-adrenergic, alpha2-adrenergic, and histamine H1 receptors, which may contribute to some of its side effects (e.g., orthostasis, sedation). It has low affinity for muscarinic cholinergic receptors.

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 changes in menstrual cycle
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, 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 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, 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. Describe the allergic reaction you experienced, including the 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 numerous medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.

Please note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions. Therefore, it is vital to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have or have had in the past.

To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions.

Important Warnings and Cautions for Patients Taking This Medication

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

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, rise slowly from a sitting or lying down position, and exercise caution 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 for signs of high blood sugar, such as confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them 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, these 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 of infection, such as fever, chills, or sore throat.
A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Seek emergency medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.

Additional Safety Considerations

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, particularly when this medication is taken with other medications that slow gastrointestinal movement. If you have concerns, discuss them with your doctor.
Older adults (65 years and older) should use this medication with caution, as they 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.

Pregnancy, Fertility, and Breastfeeding

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 potential 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.

Special Considerations for Children

When prescribing 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.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, protease inhibitors)

• QT prolonging drugs (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine)
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines)
• Dopamine agonists (e.g., levodopa, bromocriptine) - may antagonize effects
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates) - significantly decrease quetiapine levels

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil)
• Anticholinergic drugs (additive effects)
• Antihypertensives (additive hypotensive effects)

• Not specifically identified as minor, but general caution with drugs affecting electrolyte balance (hypokalemia, hypomagnesemia) due to QT risk.

• Sedation/Somnolence
• Orthostatic Hypotension (dizziness, lightheadedness upon standing)
• Extrapyramidal Symptoms (EPS) - e.g., akathisia, dystonia, parkinsonism
• Tardive Dyskinesia (involuntary movements, especially of face and mouth)
• Metabolic changes (increased thirst, urination, hunger, fatigue)
• Neuroleptic Malignant Syndrome (fever, muscle rigidity, altered mental status, autonomic instability)
• Cataracts (blurred vision, vision changes)
• Suicidal ideation/behavior (especially in young adults)
• Changes in mood or behavior

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 and its active metabolite are excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for quetiapine, and any potential adverse effects on the breastfed infant from quetiapine or from the underlying maternal condition. Monitor infants for sedation, irritability, poor feeding, and weight gain.

Quetiapine ER is not approved for pediatric patients. Safety and effectiveness have not been established. Immediate-release quetiapine is approved for schizophrenia (13-17 years) and bipolar mania (10-17 years). Use in children and adolescents carries a Black Box Warning for increased risk of suicidality.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for this indication. Elderly patients may be more susceptible to orthostatic hypotension and other adverse effects. Consider lower starting doses and slower titration, and monitor closely.

• Quetiapine ER should be taken once daily, preferably in the evening, without food or with a light meal (approx. 300 calories) to optimize absorption and minimize food effects.
• 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.
• Titration is crucial to minimize side effects like orthostatic hypotension and sedation. Patients should be advised to stand up slowly.
• Monitor for metabolic side effects (weight gain, dyslipidemia, hyperglycemia) regularly, as these are common with atypical antipsychotics.
• Be aware of the Black Box Warning regarding increased mortality in elderly patients with dementia-related psychosis and increased suicidality in children, adolescents, and young adults.
• Strong CYP3A4 inhibitors are contraindicated, and strong CYP3A4 inducers require significant dose adjustments or alternative therapy.
• Quetiapine has a relatively low risk of EPS compared to some other antipsychotics, but it can still occur, especially at higher doses or during rapid titration.
• Consider the anticholinergic burden when co-prescribing with other anticholinergic medications.

• Other atypical antipsychotics (e.g., aripiprazole, olanzapine, risperidone, ziprasidone, lurasidone, cariprazine, brexpiprazole)
• Typical antipsychotics (e.g., haloperidol, chlorpromazine) - generally less preferred due to higher EPS risk
• Mood stabilizers (e.g., lithium, valproate, lamotrigine) for bipolar disorder
• Antidepressants (e.g., SSRIs, SNRIs) for MDD (as monotherapy or in combination)
• Electroconvulsive Therapy (ECT)
• Psychotherapy (e.g., CBT, family therapy)

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 overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.