Quetiapine 25mg Tablets

Quetiapine is an atypical antipsychotic that exhibits antagonist activity at multiple neurotransmitter receptors. Its antipsychotic effect is thought to be mediated through a combination of dopamine D2 and serotonin 5-HT2A receptor antagonism. It also has antagonist activity at histamine H1 receptors (contributing to sedation), and adrenergic alpha1 and alpha2 receptors (contributing to orthostatic hypotension). It has low affinity for muscarinic cholinergic receptors.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 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 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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:

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 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.
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 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.
All your health problems, including any medical conditions or allergies.

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.

Precautions to Ensure Your Safety

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 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 your blood sugar levels and report any signs of high blood sugar to your doctor, such as:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Low white blood cell counts have been associated with this medication, which can increase the risk of infection. Inform your doctor if you have a history of low white blood cell count and seek medical attention immediately if you experience:
+ Fever
+ Chills
+ 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 cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Rapid heartbeat
+ Abnormal heartbeat
+ 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 experience severe constipation or 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 fatal. 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. Regularly monitor your child's blood pressure as advised by their doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, protease inhibitors): May significantly increase quetiapine levels, leading to increased adverse effects. Reduce quetiapine dose by 1/6.
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates): May significantly decrease quetiapine levels, leading to loss of efficacy. May need to increase quetiapine dose up to 5-fold.
• Drugs that prolong QT interval (e.g., Class IA antiarrhythmics like quinidine, procainamide; Class III antiarrhythmics like amiodarone, sotalol; antipsychotics like ziprasidone, thioridazine; moxifloxacin, methadone): Increased risk of Torsades de Pointes.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines): Additive sedative effects.
• Antihypertensives: May potentiate orthostatic hypotension due to alpha-adrenergic blockade.
• Anticholinergic drugs: May potentiate anticholinergic side effects (e.g., dry mouth, constipation, urinary retention).

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

• Sedation/Drowsiness
• Orthostatic Hypotension (dizziness upon standing)
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Weight gain
• Increased appetite
• Akathisia (restlessness)
• Dystonia (muscle spasms)
• Parkinsonism (tremor, rigidity, bradykinesia)
• Tardive Dyskinesia (involuntary movements, especially of face/mouth)
• Neuroleptic Malignant Syndrome (NMS) - fever, muscle rigidity, altered mental status, autonomic instability
• Suicidal ideation/behavior (especially in children, adolescents, young adults)
• Changes in mood or behavior
• Signs of hyperglycemia (polyuria, polydipsia, polyphagia)
• Cataracts (periodic eye exams recommended for long-term use)

Quetiapine is a Pregnancy Category C drug. 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 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.

Approved for schizophrenia in adolescents (13-17 years) and bipolar mania in children/adolescents (10-17 years). Not approved for children under 10 years. Monitor for weight gain, metabolic changes, and suicidality (Black Box Warning). Higher risk of sedation and orthostatic hypotension compared to adults.

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

• Quetiapine 25mg is often used for initial titration or off-label for insomnia due to its sedating properties, even though its primary indications require much higher doses.
• Take immediate-release quetiapine twice daily for most psychiatric indications due to its relatively short half-life.
• Orthostatic hypotension is common, especially during initial titration; advise patients to rise slowly.
• Significant weight gain and metabolic changes (hyperglycemia, dyslipidemia) are common side effects; regular monitoring is crucial.
• Avoid abrupt discontinuation, as it can lead to withdrawal symptoms (insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability).
• Patients should be advised about the risk of cataracts with long-term use and the need for periodic eye examinations.

• 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 MDD augmentation)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.