Quetiapine 100mg 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 receptors and adrenergic alpha1 and alpha2 receptors, which may contribute to some of its side effects (e.g., sedation, orthostatic hypotension). It has moderate affinity for serotonin 5-HT1A receptors and muscarinic M1 receptors.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 that are not normal
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Difficulty controlling body movements, twitching, balance problems, trouble swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Drooling
Seizures
Changes in vision
Severe constipation or stomach pain, which may be signs of 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 and older adults, especially older females. The risk increases with longer use or higher doses, but can also occur after short-term use with low doses. If you experience trouble controlling body movements or problems with your tongue, face, mouth, or jaw, such as tongue sticking out, puffing cheeks, mouth puckering, or chewing, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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
Stuffy nose

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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have low levels of potassium or magnesium in your blood.
If you have a history of abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG).
If you are taking any medications that can cause abnormal heart rhythms, such as those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to ask 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. To ensure your safety, it is vital to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about any health problems you have.
Verify that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose of any medication without first consulting your doctor.

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 Avoid Adverse Effects

To minimize the risk of accidents, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When changing positions, get up slowly from sitting or lying down to reduce the risk of dizziness or fainting. Be cautious when climbing stairs.

Potential Side Effects and Risks

Rarely, cataracts may develop in patients taking this medication. Additionally, there is a risk of developing high blood sugar, diabetes, high cholesterol, and weight gain, which may increase the likelihood of heart and brain blood vessel disease. Monitor your condition and report any signs of high blood sugar, 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 reported in patients taking similar medications, which may increase 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 medical attention immediately if you experience symptoms of infection, such as fever, chills, or sore throat.

Life-Threatening Conditions

A rare but potentially life-threatening condition called neuroleptic malignant syndrome (NMS) may occur. Seek medical attention immediately if you experience any of the following symptoms: fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid heartbeat, irregular heartbeat, or excessive sweating.

Increased Risk of Falls and Injuries

This medication may cause dizziness, drowsiness, and impaired balance, which may increase the risk of falls and subsequent injuries, such as fractures. Exercise caution to minimize this risk.

Gastrointestinal Risks

Constipation is a common side effect of this medication. In rare cases, bowel obstruction 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 years or older, use this medication with caution, as you may be more susceptible to side effects. Older adults with dementia who take similar medications have a higher risk of stroke, which can be life-threatening. This medication is not approved for treating dementia-related mental health issues.

Reproductive and Pregnancy Considerations

This medication may affect fertility, but this effect is reversible when the medication is discontinued. If you have concerns, discuss them with your doctor. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to weigh 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, erythromycin, clarithromycin, protease inhibitors): Significantly increase quetiapine levels, leading to increased adverse effects. Co-administration is generally not recommended.
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates): Significantly decrease quetiapine levels, leading to loss of efficacy. Dosage adjustment of quetiapine or alternative therapy may be needed.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of cardiac arrhythmias. Use with caution.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Additive sedative effects.
• Antihypertensives: Additive hypotensive effects due to alpha1-adrenergic blockade.
• Anticholinergic drugs: Additive anticholinergic effects (e.g., constipation, dry mouth, urinary retention).
• Dopamine agonists (e.g., levodopa): Quetiapine may antagonize the effects of dopamine agonists.

• Grapefruit juice: May inhibit CYP3A4, leading to slight increase in quetiapine levels (avoid large amounts).

• Dizziness or lightheadedness (especially when standing)
• Excessive sedation or somnolence
• Unusual weight gain
• Increased thirst or urination
• Muscle stiffness or tremors
• Restlessness or agitation
• Uncontrolled movements (especially of face, tongue, or limbs)
• Fever, severe muscle stiffness, confusion, sweating, or rapid heart rate (signs of NMS)
• Sore throat, fever, or other signs of infection (potential neutropenia)
• Yellowing of skin or eyes, dark urine (potential liver issues)
• Changes in mood or behavior, suicidal thoughts (especially in young adults)

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 breast 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, poor feeding, and weight gain.

Not approved for use in children under 10 years. For adolescents (10-17 years) with schizophrenia or bipolar mania, dosing is adjusted. Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults.

Increased risk of orthostatic hypotension, sedation, and falls. Increased risk of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) and increased mortality in elderly patients with dementia-related psychosis (Black Box Warning). Start with lower doses (e.g., 25 mg/day) and titrate more slowly. Monitor closely for adverse effects.

• Quetiapine is highly sedating, especially at lower doses, and is often taken at bedtime. This can be beneficial for patients with insomnia.
• Titration is crucial to minimize side effects like orthostatic hypotension and sedation. Do not start at the full target dose.
• Metabolic monitoring (weight, glucose, lipids) is essential due to the significant risk of metabolic side effects.
• Immediate-release (IR) and extended-release (XR) formulations are not interchangeable on a milligram-for-milligram basis due to different pharmacokinetic profiles and dosing schedules.
• Patients should be advised to avoid sudden discontinuation to prevent withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability).

• Other atypical antipsychotics (e.g., Olanzapine, Risperidone, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine)
• Mood stabilizers (e.g., Lithium, Valproate, Lamotrigine) for bipolar disorder
• Antidepressants (e.g., SSRIs, SNRIs) for bipolar depression (often in combination with a mood stabilizer or antipsychotic)
• Cognitive Behavioral Therapy (CBT)
• Electroconvulsive Therapy (ECT) for severe or treatment-resistant cases

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.