Quetiapine 200mg Tablets

Manufacturer SUN Active Ingredient Quetiapine Tablets(kwe TYE a peen) Pronunciation kwe TYE a peen
WARNING: There is a higher chance of death in older adults who take this drug for mental problems caused by dementia. Most of the deaths were linked to heart disease or infection. This drug is not approved to treat mental problems caused by dementia.Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children younger than 10 years of age. Talk with the doctor. @ COMMON USES: It is used to treat bipolar disorder. It is used to treat schizophrenia.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Atypical Antipsychotic
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Pharmacologic Class
Serotonin-dopamine antagonist (SDA)
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Pregnancy Category
Category C
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Quetiapine is a medication used to treat certain mental health conditions like schizophrenia, bipolar disorder (manic or depressive episodes), and sometimes as an add-on treatment for depression. It works by helping to balance certain natural chemicals in the brain. It can help reduce hallucinations, delusions, mood swings, and improve overall mood.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.

It's essential to avoid drinking alcohol while taking this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may slow your reactions, consult with your doctor. Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of experiencing withdrawal symptoms. If you need to stop taking the medication, your doctor will advise you on how to gradually discontinue it.

Staying Hydrated and Safe

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. Be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration.

Monitoring Your Health

Follow your doctor's instructions for getting your blood work checked and having regular eye exams. Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. Also, monitor your blood sugar levels as directed by your doctor.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
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Lifestyle & Tips

  • Avoid alcohol and other CNS depressants as they can increase drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Monitor your weight and diet, as quetiapine can cause weight gain and changes in blood sugar and cholesterol.
  • Stay hydrated to help manage dry mouth and constipation.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and formulation (immediate-release vs. extended-release)
Dose Range: 25 - 800 mg

Condition-Specific Dosing:

Schizophrenia (IR): Initial: 25 mg BID, titrate to 300-400 mg/day in 2-3 divided doses. Max: 800 mg/day.
Bipolar Mania (IR): Initial: 50 mg BID, titrate to 400-800 mg/day in 2-3 divided doses. Max: 800 mg/day.
Bipolar Depression (IR): Initial: 50 mg QHS, titrate to 300 mg QHS. Max: 300 mg/day.
Major Depressive Disorder (MDD) Augmentation (XR): Initial: 50 mg QHS, titrate to 150-300 mg QHS. Max: 300 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for general use. For Schizophrenia (13-17 years): Initial 25 mg BID, titrate to 400-800 mg/day in 2-3 divided doses. For Bipolar Mania (10-17 years): Initial 25 mg BID, titrate to 400-600 mg/day in 2-3 divided doses.
Adolescent: See 'child' for specific indications (Schizophrenia, Bipolar Mania).
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally needed.
Moderate: No dose adjustment generally needed.
Severe: No dose adjustment generally needed.
Dialysis: Not significantly removed by dialysis; no specific recommendations, but monitor for adverse effects.

Hepatic Impairment:

Mild: Consider starting with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly.
Moderate: Consider starting with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly.
Severe: Consider starting with 25 mg/day (IR) or 50 mg/day (XR) and titrate slowly.

Pharmacology

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Mechanism of Action

Quetiapine is an atypical antipsychotic with a broad receptor binding profile. It exhibits antagonism at serotonin 5-HT2A receptors and dopamine D1 and D2 receptors. Its antipsychotic activity is thought to be mediated through a combination of D2 and 5-HT2A antagonism. It also has high affinity for histamine H1 receptors and adrenergic alpha1 and alpha2 receptors, which may contribute to its sedative and orthostatic hypotensive effects, respectively. It has low affinity for muscarinic M1 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Not formally established, but rapidly absorbed.
Tmax: 1.5 hours (IR), 6 hours (XR)
FoodEffect: Food increases Cmax and AUC by 15% and 18% respectively for IR. For XR, food increases Cmax and AUC by 45% and 20% respectively.

Distribution:

Vd: 10 Âą 4 L/kg
ProteinBinding: Approximately 83%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 6-7 hours (quetiapine), 10-12 hours (norquetiapine)
Clearance: Not available
ExcretionRoute: Urine (73%), Feces (20%)
Unchanged: Less than 1% (quetiapine)
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Pharmacodynamics

OnsetOfAction: Within hours for sedation, days to weeks for full antipsychotic/mood-stabilizing effects.
PeakEffect: Varies by indication and individual response.
DurationOfAction: Approximately 12 hours (IR), 24 hours (XR)

Safety & Warnings

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BLACK BOX WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for the treatment of patients with dementia-related psychosis. Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Quetiapine is not approved for use in pediatric patients except for schizophrenia and bipolar mania.
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Side 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 (may indicate a serious bowel problem)
Urination difficulties
Flu-like symptoms
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
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 mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness, drowsiness, fatigue, or weakness
Headache
Nervousness or excitement
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 concerns or questions, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Uncontrolled muscle movements (e.g., lip smacking, chewing, tongue thrusting, tremors)
  • High fever, stiff muscles, confusion, sweating, fast or irregular heartbeat (signs of Neuroleptic Malignant Syndrome)
  • Sore throat, fever, chills, or other signs of infection (may indicate low white blood cell count)
  • Increased thirst, frequent urination, increased hunger, blurred vision (signs of high blood sugar)
  • Thoughts of self-harm or suicide, worsening depression or anxiety, agitation, panic attacks, insomnia, irritability, aggressiveness, impulsivity, restlessness, or unusual changes in behavior (especially in young adults)
  • Difficulty swallowing
  • Priapism (prolonged erection)
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Before Using This Medicine

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 and its symptoms.
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 medications 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 inform your doctor and pharmacist about:

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 pre-existing conditions.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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Precautions & Cautions

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, 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 your blood sugar levels and report any signs of high blood sugar to your doctor, such as:
+ Confusion
+ Drowsiness
+ Increased 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. In rare cases, infections can be fatal. Inform your doctor if you have a history of low white blood cell counts, 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. 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.

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.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Sedation
  • Tachycardia (fast heart rate)
  • Hypotension (low blood pressure)
  • Delirium
  • Coma
  • QT prolongation
  • Arrhythmias

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining an open airway, oxygenation, ventilation, and cardiovascular monitoring.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, nelfinavir) - concomitant use is not recommended due to significant increase in quetiapine exposure.
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Major Interactions

  • Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, barbiturates, St. John's Wort) - may significantly decrease quetiapine exposure, requiring dose increase.
  • Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, moxifloxacin, thioridazine) - increased risk of arrhythmias.
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids) - additive sedative effects.
  • Anticholinergic drugs - additive anticholinergic effects (e.g., urinary retention, constipation, dry mouth).
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Moderate Interactions

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) - may increase quetiapine exposure, consider dose reduction.
  • Antihypertensives - additive hypotensive effects.
  • Dopamine agonists (e.g., levodopa) - quetiapine may antagonize effects.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Weight and BMI

Rationale: Risk of weight gain and metabolic syndrome.

Timing: Before initiation

Fasting glucose/HbA1c

Rationale: Risk of hyperglycemia and diabetes.

Timing: Before initiation

Lipid panel (fasting)

Rationale: Risk of dyslipidemia.

Timing: Before initiation

Blood pressure

Rationale: Risk of orthostatic hypotension.

Timing: Before initiation

ECG

Rationale: Consider if patient has cardiac risk factors or history of arrhythmias, due to potential for QT prolongation.

Timing: Before initiation

Complete Blood Count (CBC)

Rationale: Rare risk of neutropenia/agranulocytosis.

Timing: Before initiation

Thyroid function tests (TSH)

Rationale: Rare risk of thyroid abnormalities.

Timing: Before initiation

Mental status and symptom assessment

Rationale: Establish baseline for therapeutic response and adverse effects.

Timing: Before initiation

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Routine Monitoring

Weight and BMI

Frequency: Monthly for first few months, then quarterly.

Target: Maintain healthy range.

Action Threshold: Significant weight gain (e.g., >5% baseline) warrants intervention.

Fasting glucose/HbA1c

Frequency: At 3 months, then annually.

Target: Normal glucose/HbA1c levels.

Action Threshold: Elevated levels warrant intervention (e.g., lifestyle, medication change).

Lipid panel (fasting)

Frequency: At 3 months, then annually.

Target: Normal lipid levels.

Action Threshold: Elevated levels warrant intervention.

Blood pressure

Frequency: Regularly, especially during dose titration.

Target: Normal blood pressure.

Action Threshold: Significant orthostatic drop or sustained hypertension.

Extrapyramidal Symptoms (EPS) assessment (e.g., AIMS, SAS)

Frequency: Regularly, especially during dose titration and long-term.

Target: Absence of EPS.

Action Threshold: Emergence of EPS (e.g., akathisia, parkinsonism, tardive dyskinesia).

Sedation/Alertness

Frequency: Regularly, especially during dose titration.

Target: Functional level of alertness.

Action Threshold: Excessive sedation impacting daily activities.

Suicidality assessment

Frequency: Regularly, especially in children, adolescents, and young adults.

Target: Absence of suicidal ideation/behavior.

Action Threshold: Emergence or worsening of suicidal thoughts/behaviors.

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Symptom Monitoring

  • Sedation/Drowsiness
  • Dizziness/Orthostatic Hypotension
  • Dry mouth
  • Constipation
  • Weight gain
  • Increased appetite
  • Extrapyramidal symptoms (tremor, rigidity, akathisia, tardive dyskinesia)
  • Blurred vision
  • Urinary retention
  • Suicidal thoughts or behaviors (especially in young adults)
  • Signs of Neuroleptic Malignant Syndrome (NMS): fever, muscle rigidity, altered mental status, autonomic instability
  • Signs of agranulocytosis: fever, sore throat, infection

Special Patient Groups

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Pregnancy

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.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of increased major malformations.
Second Trimester: Limited data.
Third Trimester: Risk of extrapyramidal and/or withdrawal symptoms in neonates (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).
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Lactation

Quetiapine and its active metabolite are excreted into human milk. The relative infant dose (RID) is low (around 1-2%). Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.

Infant Risk: L3 (Moderately safe). Potential for sedation, irritability, and poor feeding. Use with caution and monitor infant.
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Pediatric Use

Approved for schizophrenia (13-17 years) and bipolar mania (10-17 years). Not approved for depression in pediatric patients. Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Monitor for weight gain, metabolic changes, and EPS.

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Geriatric Use

Increased risk of adverse effects, including orthostatic hypotension, sedation, and falls. Black Box Warning regarding increased mortality in elderly patients with dementia-related psychosis. Generally, lower starting doses and slower titration are recommended.

Clinical Information

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Clinical Pearls

  • Quetiapine is often chosen for patients who experience significant insomnia or anxiety due to its sedating properties.
  • The extended-release (XR) formulation can be taken once daily, which may improve adherence.
  • Titration is crucial to minimize side effects like orthostatic hypotension and sedation.
  • Metabolic monitoring (weight, glucose, lipids) is essential due to the risk of metabolic syndrome.
  • Consider the risk of cataracts with long-term use; regular eye exams are recommended by some guidelines.
  • Withdrawal symptoms (e.g., insomnia, nausea, vomiting, headache, diarrhea, dizziness, irritability) can occur if discontinued abruptly, especially after high doses or long-term use. Taper slowly.
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Alternative Therapies

  • 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 depression (often in combination with quetiapine for MDD augmentation)
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Cost & Coverage

Average Cost: $10 - $100+ per 30 tablets (generic 200mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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General Drug Facts

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, a patient fact sheet that provides crucial information. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.