Quetiapine 50mg Tablets

Quetiapine is an atypical antipsychotic with affinity for a broad range of neurotransmitter receptors. Its antipsychotic activity is thought to be mediated through a combination of dopamine D2 and serotonin 5-HT2A receptor antagonism. It also has antagonism at histamine H1 and adrenergic alpha1/alpha2 receptors, contributing to its sedative and orthostatic hypotensive effects, respectively.

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 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 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 (more common in people with diabetes, older adults, especially older females, and those taking higher doses or using the medication for an extended period)

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
+ Chewing movements

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people 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, contact your doctor or seek medical help if they bother you or persist:

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 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.
Your complete medical history, including any health problems you have or have had in the past.

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 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.

Caution with Daily Activities
Avoid driving and engaging in activities 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
Rarely, this medication may cause cataracts. Additionally, it 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, notify your doctor, as these may be signs 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 life-threatening. Inform your doctor if you have a history of low white blood cell count, and seek immediate medical attention if you experience 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 immediate medical attention if you experience 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 broken bones. Exercise caution to minimize this risk.

Constipation and Bowel Blockage
Constipation is a common side effect of this medication. In rare cases, bowel blockage may occur, which can be life-threatening 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 a higher risk of stroke, which can be fatal. This medication is not approved for treating mental health conditions related to dementia.

Pregnancy and Breastfeeding
This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor. Taking this medication during the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.

Pediatric Use
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. Children and teenagers may experience high blood pressure, so regular blood pressure checks are essential, as advised by your child's doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, protease inhibitors, nefazodone): May significantly increase quetiapine plasma concentrations, leading to increased adverse effects. Dose reduction of quetiapine by 1/6th is recommended.
• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, barbiturates, St. John's Wort): May significantly decrease quetiapine plasma concentrations, leading to loss of efficacy. Dose increase of quetiapine by 5-fold or more may be necessary, or consider alternative antipsychotic.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines): Additive CNS depression, increased sedation and psychomotor impairment.
• Antihypertensives: May potentiate orthostatic hypotension due to quetiapine's alpha1-adrenergic antagonism.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, certain antipsychotics, moxifloxacin, thioridazine): Increased risk of QT prolongation and arrhythmias, especially in susceptible patients.
• Dopamine agonists (e.g., levodopa, bromocriptine): Quetiapine may antagonize their effects.

• Anticholinergic drugs: May potentiate anticholinergic side effects (e.g., dry mouth, constipation, urinary retention).

• Sedation/Drowsiness
• Dizziness/Lightheadedness (especially upon standing)
• Dry mouth
• Constipation
• Blurred vision
• Weight gain
• Increased appetite
• Tremor
• Restlessness (akathisia)
• Muscle stiffness/rigidity
• Changes in mood or behavior (e.g., worsening depression, suicidal thoughts)
• Signs of hyperglycemia (increased thirst, urination, hunger)
• Signs of dyslipidemia
• Signs of neutropenia (fever, sore throat, infection)

Use during pregnancy should only be considered 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. 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 breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Approved for schizophrenia (13-17 years), bipolar mania (10-17 years), and bipolar depression (10-17 years). Increased risk of weight gain, dyslipidemia, and hyperglycemia compared to adults. Also, increased risk of suicidal thoughts and behaviors (Black Box Warning).

Elderly patients, particularly those with dementia-related psychosis, are at increased risk of death when treated with antipsychotics (Black Box Warning). Start with lower doses (e.g., 25 mg/day) and titrate more slowly due to increased sensitivity to adverse effects such as orthostatic hypotension, sedation, and anticholinergic effects. Monitor for falls.

• Quetiapine is highly sedating, especially at lower doses, and is often dosed at night to leverage this effect and improve adherence.
• Titration is crucial to minimize side effects like orthostatic hypotension and sedation. Patients should be advised to stand up slowly.
• Significant metabolic side effects (weight gain, dyslipidemia, hyperglycemia) are common; regular monitoring of metabolic parameters is essential.
• Risk of tardive dyskinesia and extrapyramidal symptoms, though generally lower than with first-generation antipsychotics.
• Abrupt discontinuation can lead to withdrawal symptoms (insomnia, nausea, vomiting, diarrhea, dizziness, irritability), especially with higher doses or prolonged use. Taper gradually.
• Consider the extended-release (XR) formulation for once-daily dosing and potentially smoother plasma levels, which may reduce peak-related side effects.

• Other atypical antipsychotics (e.g., Olanzapine, Risperidone, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, Brexpiprazole)
• First-generation 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 major depressive disorder (as monotherapy or adjunctive).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.