Quetiapine 200mg ER Tablets

Quetiapine is an atypical antipsychotic that exhibits antagonism at multiple 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 high affinity for histamine H1 and adrenergic alpha1/alpha2 receptors, and moderate affinity for serotonin 5-HT1A and muscarinic M1 receptors. The active metabolite, norquetiapine, has high affinity for the norepinephrine transporter (NET) and partial agonist activity at the 5-HT1A receptor, contributing 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
+ 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 disorder 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

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 notice any of the following side effects, 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
Stuffy nose

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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. Be sure to describe the allergic reaction and its symptoms.
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 ask your doctor or pharmacist if you are unsure.

This is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with 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 engaging in activities 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 the 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 may increase the risk of infection. In rare cases, 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 the 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 dementia-related mental health issues.
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. Regular blood pressure checks are essential, as recommended by your child's doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, protease inhibitors like ritonavir, indinavir, saquinavir, nelfinavir): May significantly increase quetiapine plasma concentrations, requiring dose reduction.
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates, St. John's Wort): May significantly decrease quetiapine plasma concentrations, requiring dose increase.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine): Increased risk of cardiac arrhythmias.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids): Additive sedative effects.

• Moderate CYP3A4 inhibitors/inducers: May require quetiapine dose adjustment.
• Antihypertensives: May enhance orthostatic hypotension due to alpha-1 adrenergic antagonism.
• Anticholinergic drugs: May potentiate anticholinergic side effects (e.g., dry mouth, constipation, urinary retention).

• Not available

• Orthostatic hypotension (dizziness, lightheadedness upon standing)
• Sedation/Somnolence
• Extrapyramidal Symptoms (EPS) including akathisia, dystonia, parkinsonism
• Tardive Dyskinesia (involuntary movements, especially of face and tongue)
• Neuroleptic Malignant Syndrome (NMS) (fever, muscle rigidity, altered mental status, autonomic instability)
• Suicidal ideation or worsening of depression/unusual changes in behavior (especially in children, adolescents, young adults)
• Hyperglycemia symptoms (polydipsia, polyuria, polyphagia, weakness)
• Cataracts (blurred vision, glare, difficulty with night vision - rare, but noted in animal studies)

Category C. Use 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 breast milk. The American Academy of Pediatrics considers quetiapine to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Approved for schizophrenia (adolescents 13-17 years) and bipolar mania (adolescents 10-17 years). Monitor closely for weight gain, metabolic changes (glucose, lipids), and suicidal thoughts/behaviors (Black Box Warning).

Increased risk of orthostatic hypotension, sedation, and metabolic side effects. Black Box Warning for increased mortality in elderly patients with dementia-related psychosis. Start with lower doses (e.g., 50 mg/day) and titrate more slowly due to potential for increased sensitivity and higher plasma concentrations.

• Quetiapine ER should be taken once daily, preferably in the evening, without food or with a light meal. Do not crush, chew, or break the tablets.
• Sedation is a common initial side effect; advise patients to take it at bedtime and be cautious with activities requiring alertness.
• Orthostatic hypotension is a significant risk, especially during initial titration. Advise patients to rise slowly.
• Metabolic monitoring (weight, glucose, lipids) is crucial due to the risk of weight gain, hyperglycemia, and dyslipidemia.
• The active metabolite, norquetiapine, contributes to the antidepressant effects, making it useful for bipolar depression and adjunctive MDD.
• Patients should be advised to avoid grapefruit juice as it can inhibit CYP3A4 and increase quetiapine levels.
• Withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability) can occur if discontinued abruptly; taper dose gradually.

• 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 major depressive disorder (often in combination with an antipsychotic for adjunctive MDD)

If your symptoms or health issues persist or worsen, it is 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, which is a valuable resource that provides additional information. It is crucial to read this guide carefully and review it again whenever you receive a refill of your medication. 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, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.