Inderal 20mg Tablets

Manufacturer WYETH Active Ingredient Propranolol Tablets(proe PRAN oh lole) Pronunciation proe PRAN oh lole
It is used to treat high blood pressure.It is used to treat chest pain or pressure. It is used to help certain heart problems.It is used to prevent migraine headaches.It is used to treat tremor (essential).It is used after a heart attack to help prevent future heart attacks and lengthen life.It is used to treat pheochromocytoma. It is used to treat certain types of abnormal heartbeats.
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Drug Class
Antihypertensive; Antiarrhythmic; Antianginal; Migraine Prophylaxis
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Pharmacologic Class
Non-selective Beta-Adrenergic Blocker
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Pregnancy Category
Category C
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FDA Approved
Nov 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a type of medicine called a beta-blocker. It works by blocking certain natural chemicals in your body, like adrenaline, from affecting your heart and blood vessels. This helps to slow down your heart rate, relax your blood vessels, and lower your blood pressure. It's used for conditions like high blood pressure, chest pain (angina), irregular heartbeats, preventing migraines, and reducing tremors.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance.

Continuing Your Medication Regimen

Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as directed.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature, avoiding freezing temperatures.
Protect the medication from heat, cold, and light sources.
Keep the container lid tightly closed when not in use.

What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Do not stop taking this medication suddenly, especially if you have heart disease. Your doctor will tell you how to slowly reduce the dose.
  • Take your medication exactly as prescribed, at the same time each day.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the effects of propranolol.
  • Avoid activities requiring alertness until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • If you are diabetic, monitor your blood sugar closely, as propranolol can mask signs of low blood sugar.
  • Maintain a healthy diet, regular exercise, and manage stress to support overall cardiovascular health.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. E.g., Hypertension: Initial 40 mg twice daily; Angina: 80-320 mg/day in 2-4 divided doses; Migraine Prophylaxis: Initial 80 mg/day in divided doses, usual effective range 160-240 mg/day.
Dose Range: 20 - 640 mg

Condition-Specific Dosing:

Hypertension: Initial 40 mg twice daily, may increase to 120-240 mg/day.
Angina Pectoris: 80-320 mg/day in 2-4 divided doses.
Migraine Prophylaxis: Initial 80 mg/day in divided doses, usual effective range 160-240 mg/day.
Essential Tremor: Initial 40 mg twice daily, usual effective range 120-320 mg/day.
Hypertrophic Subaortic Stenosis: 20-40 mg three or four times daily.
Pheochromocytoma (adjunct): 60 mg/day in divided doses for 3 days prior to surgery, or 30 mg/day in divided doses for non-operable tumors.
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Pediatric Dosing

Neonatal: Not established for general use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Infant: Not established for general use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Child: Dosing varies widely by indication (e.g., hypertension, arrhythmias, migraine prophylaxis). Typically 0.5-1 mg/kg/day divided every 6-12 hours, titrated based on response and tolerability. Max 2-4 mg/kg/day or 60 mg/day.
Adolescent: Similar to adult dosing for some indications, or weight-based dosing as for children.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed.
Moderate: No adjustment typically needed.
Severe: Consider dose reduction (e.g., 50%) if CrCl < 10 mL/min, or if clinical response suggests accumulation.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed after dialysis, but monitor for exaggerated effects.

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Consider dose reduction (e.g., 50%) and monitor closely due to reduced metabolism.
Severe: Significant dose reduction (e.g., 75%) is often required due to extensive hepatic metabolism. Monitor closely for exaggerated effects.

Pharmacology

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Mechanism of Action

Propranolol is a non-selective beta-adrenergic receptor blocker. It competitively blocks beta-1 (myocardial) and beta-2 (bronchial and vascular smooth muscle) adrenergic receptors. This results in decreased heart rate, myocardial contractility, and cardiac output, leading to reduced blood pressure. It also reduces renin release from the kidneys. Its antiarrhythmic effects are due to reduction of sinus rate, prolongation of AV nodal conduction, and reduction of myocardial excitability. Its migraine prophylactic effect is thought to be related to its ability to block beta-receptors in the cerebral vasculature and/or central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: 25-50% (due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (immediate release)
FoodEffect: Food increases bioavailability and reduces peak plasma concentrations, but does not significantly affect AUC. Administer consistently with or without food.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes

Elimination:

HalfLife: 3-6 hours (immediate release)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30 minutes (oral)
PeakEffect: 1-1.5 hours (oral)
DurationOfAction: 6-12 hours (immediate release)

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Do not discontinue Propranolol therapy abruptly in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease following abrupt discontinuation of beta-blocker therapy. When discontinuing chronically administered Propranolol, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina worsens or acute coronary insufficiency develops, Propranolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Propranolol therapy abruptly even in patients treated only for hypertension.
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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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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 blood sugar: dizziness, headache, feeling sleepy, weak, shaking, rapid heartbeat, confusion, hunger, or sweating
Signs of lupus: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs
Severe dizziness or fainting
New or worsening chest pain
Slow heartbeat or irregular heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or other mood changes
Abnormal burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Changes in vision
Unexplained bruising or bleeding
Fever, chills, or sore throat
Erectile dysfunction
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, characterized by red, swollen, blistered, or peeling skin; skin irritation (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor if they bother you or do not go away:

Dizziness, drowsiness, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
* Strange or vivid dreams

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • Difficulty breathing, wheezing, or new or worsening shortness of breath
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • Chest pain or discomfort (especially if you stop the medication suddenly)
  • Symptoms of depression (e.g., persistent sadness, loss of interest)
  • Coldness, numbness, or tingling in your fingers and toes
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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 heart conditions, including:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, 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
Your complete medical history

Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring and Lab Tests
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances
Discuss with your doctor before consuming alcohol. If you smoke, talk to your doctor about the potential risks. This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, especially in people with diabetes, children, and those who are fasting or have undergone surgery.

Managing Diabetes
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.

Stopping the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, particularly in individuals with certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Thyroid Conditions
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor if you have any concerns.

Interactions with Other Medications
If you have high blood pressure, consult with your doctor before taking over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Allergic Reactions
If you have a history of severe allergic reactions, discuss with your doctor the potential risks of anaphylaxis. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Hypotension (very low blood pressure)
  • Cardiogenic shock
  • Heart failure
  • Bronchospasm (difficulty breathing)
  • Hypoglycemia (low blood sugar)
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment may involve atropine for bradycardia, glucagon, intravenous fluids, vasopressors, and bronchodilators.

Drug Interactions

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Contraindicated Interactions

  • Cardiogenic shock
  • Sinus bradycardia (<45 bpm)
  • Second- or third-degree atrioventricular (AV) block
  • Sick sinus syndrome (unless a pacemaker is present)
  • Decompensated heart failure
  • Bronchial asthma or bronchospasm (including history of)
  • Severe chronic obstructive pulmonary disease (COPD)
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Major Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem): Risk of severe bradycardia, heart block, and heart failure.
  • Other beta-blockers (e.g., atenolol, metoprolol): Additive effects, increased risk of bradycardia and hypotension.
  • Clonidine: Risk of rebound hypertension upon clonidine withdrawal if propranolol is not discontinued several days prior.
  • Alpha-1 adrenergic blockers (e.g., prazosin, doxazosin): Increased risk of first-dose hypotension.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May significantly increase propranolol plasma concentrations.
  • Fingolimod: Increased risk of bradycardia and AV block.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of propranolol.
  • Insulin and oral hypoglycemics: Propranolol may mask symptoms of hypoglycemia (e.g., tachycardia, palpitations) and prolong hypoglycemic episodes.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): Antagonistic effects; may lead to hypertension and bradycardia.
  • Cimetidine, Hydralazine: May increase propranolol levels.
  • Rifampin, Phenobarbital, Phenytoin: May decrease propranolol levels.
  • Alcohol: May increase propranolol levels.
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Minor Interactions

  • Antacids (aluminum hydroxide, magnesium hydroxide): May decrease propranolol absorption (separate administration by several hours).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension or other cardiovascular indications.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and ensure HR is not excessively low before initiation; beta-blockers reduce HR.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess for pre-existing bradycardia, AV block, or other conduction abnormalities.

Timing: Prior to initiation, especially in patients with cardiac history.

Pulmonary Function Tests (PFTs)

Rationale: To assess for underlying obstructive airway disease (e.g., asthma, COPD) due to non-selective beta-blockade.

Timing: Prior to initiation in patients with respiratory symptoms or history.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly during dose titration, then monthly or every 3-6 months once stable.

Target: Individualized based on indication (e.g., <130/80 mmHg for hypertension).

Action Threshold: Hypotension (e.g., SBP <90 mmHg or symptomatic), or uncontrolled hypertension.

Heart Rate (HR)

Frequency: Regularly, e.g., weekly during dose titration, then monthly or every 3-6 months once stable.

Target: Typically >50-60 bpm (unless specific indication for lower HR, e.g., atrial fibrillation rate control).

Action Threshold: Bradycardia (<50 bpm or symptomatic), or significant drop from baseline.

Symptoms of Bronchospasm/Dyspnea

Frequency: Continuously, especially in patients with respiratory history.

Target: Absence of new or worsening respiratory symptoms.

Action Threshold: New onset or worsening shortness of breath, wheezing, cough.

Blood Glucose (in diabetics)

Frequency: More frequently than usual, especially during dose titration.

Target: Individualized glycemic targets.

Action Threshold: Frequent or severe hypoglycemic episodes, or difficulty recognizing hypoglycemia.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Shortness of breath
  • Wheezing
  • Cold hands or feet
  • Depression
  • Sleep disturbances
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause fetal bradycardia, hypoglycemia, and growth restriction. Neonates of mothers treated with propranolol may be at increased risk for hypoglycemia, bradycardia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations. Use with caution.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia. Monitor fetal growth and heart rate.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression at birth. Monitor neonate closely for first 24-48 hours.
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Lactation

Propranolol is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding, hypoglycemia), especially in neonates or premature infants.

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Dosing must be individualized and carefully titrated based on age, weight, and indication. Children may be more sensitive to the effects of beta-blockade. Close monitoring for adverse effects (e.g., bradycardia, hypotension, hypoglycemia) is essential. Specific formulations (e.g., oral solution for infantile hemangioma) are available for very young children.

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Geriatric Use

Elderly patients may be more sensitive to the effects of propranolol, particularly bradycardia and hypotension, due to age-related decreases in renal and hepatic function, and increased prevalence of comorbidities. Initiate therapy with lower doses and titrate slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Propranolol is highly lipophilic, allowing it to cross the blood-brain barrier, which contributes to its efficacy in conditions like migraine prophylaxis, essential tremor, and anxiety.
  • It is a non-selective beta-blocker, meaning it blocks both beta-1 and beta-2 receptors. This can lead to bronchoconstriction (contraindicated in asthma/severe COPD) and masking of hypoglycemia symptoms.
  • Abrupt discontinuation, especially in patients with coronary artery disease, can lead to severe rebound effects including angina exacerbation, myocardial infarction, and arrhythmias. Always taper the dose.
  • The immediate-release formulation requires multiple daily doses, while extended-release formulations (e.g., Inderal LA, Innopran XL) allow for once-daily dosing, improving adherence.
  • Used off-label for performance anxiety ('stage fright') due to its ability to reduce physical symptoms of anxiety like palpitations and tremor.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, labetalol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • Central alpha-agonists (e.g., clonidine)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for generic 20mg x 30 tablets per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand) for most insurance plans.
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General Drug Facts

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. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.