Inderal 60mg 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
C
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FDA Approved
Jun 1967
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Propranolol is a medication called a 'beta-blocker'. It works by relaxing blood vessels and slowing down your heart rate, which helps lower blood pressure, reduce chest pain (angina), prevent migraines, and control certain types of tremors or irregular heartbeats. It can also be used for anxiety.
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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 prescription 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.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

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, follow these steps:

Take the missed dose as soon as you remember.
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

  • Take exactly as prescribed, do not stop abruptly without consulting your doctor.
  • Monitor your blood pressure and heart rate regularly if advised by your doctor.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Limit alcohol consumption as it can increase propranolol levels.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • If you have diabetes, monitor your blood sugar closely as propranolol can mask signs of low blood sugar.
  • Avoid over-the-counter cold and allergy medications containing decongestants without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For hypertension, 80 mg/day in 2 divided doses or as a single daily dose (extended-release). For angina, 80-320 mg/day in 2-4 divided doses. For migraine prophylaxis, 80-240 mg/day in divided doses or as a single daily dose (extended-release).
Dose Range: 20 - 640 mg

Condition-Specific Dosing:

hypertension: Initial: 40 mg twice daily or 80 mg once daily (extended-release). Maintenance: 120-240 mg/day.
angina_pectoris: Initial: 80 mg/day in 2-4 divided doses. Maintenance: 160-320 mg/day.
migraine_prophylaxis: Initial: 80 mg/day in divided doses or as a single daily dose (extended-release). Maintenance: 160-240 mg/day.
essential_tremor: Initial: 40 mg twice daily. Maintenance: 120-320 mg/day.
arrhythmias: 10-30 mg 3-4 times daily (immediate-release).
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Infant: Not established for routine use; specific indications (e.g., infantile hemangioma) have specialized dosing.
Child: Hypertension: Initial 0.5 mg/kg/day in 2 divided doses; titrate up to 2 mg/kg/day. Max 4 mg/kg/day or 60 mg/day. Arrhythmias: 0.5-1 mg/kg/day in 3-4 divided doses; max 2 mg/kg/day.
Adolescent: Dosing similar to adult for specific indications, adjusted by weight/response.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution. Consider lower initial doses and careful titration, especially if CrCl < 10 mL/min, due to potential accumulation of active metabolites.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed after dialysis. Use with caution in ESRD.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Reduce initial dose by 50% or more. Titrate carefully based on clinical response and heart rate. Monitor for increased adverse effects.
Severe: Significant dose reduction required (e.g., 75% reduction). Use with extreme caution due to extensive hepatic metabolism. Monitor closely for signs of toxicity.

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, decreased myocardial contractility, decreased cardiac output, and reduced blood pressure. It also inhibits renin release from the kidneys. Its anti-migraine effect is thought to be due 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% (highly variable due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (immediate-release); 6 hours (extended-release)
FoodEffect: Food increases bioavailability and reduces peak plasma concentrations (for extended-release), leading to more consistent absorption.

Distribution:

Vd: 3.9 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes (lipophilic, readily crosses blood-brain barrier)

Elimination:

HalfLife: 3-6 hours (immediate-release); 8-11 hours (extended-release)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes (oral)
PeakEffect: 1-1.5 hours (immediate-release); 6 hours (extended-release)
DurationOfAction: 6-12 hours (immediate-release); 24 hours (extended-release)

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Patients with coronary artery disease, especially those with ischemic heart disease, should be warned against abrupt discontinuation of propranolol therapy. Severe exacerbation of angina pectoris, myocardial infarction, and ventricular arrhythmias have occurred following abrupt cessation of therapy. When discontinuing chronically administered propranolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly 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 pectoris should be taken. 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 or seek immediate 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 blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or sweating
Signs of lupus, such as:
+ A rash on the cheeks or other body parts
+ Easy sunburning
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Severe dizziness or fainting
New or worsening chest pain
Slow or irregular heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Confusion or hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Depression or other mood changes
Unusual burning, numbness, or tingling sensations
Feeling cold in the arms or legs
Changes in skin color (pale, blue, gray, purple, or red)
Changes in eyesight
Unexplained bruising or bleeding
Fever, chills, or sore throat
Difficulty getting or maintaining an erection
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, such as 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 do not experience significant side effects, but some may occur. If you notice any of the following side effects, 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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (less than 50 beats per minute)
  • Difficulty breathing, wheezing, or shortness of breath
  • Swelling in your ankles or feet, sudden weight gain (signs of heart failure)
  • New or worsening chest pain (if stopping the medication)
  • Unusual fatigue or weakness
  • Coldness, numbness, or tingling in hands or feet
  • Signs of depression (mood changes, loss of interest)
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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 you experienced, including any symptoms that occurred.
Certain heart-related conditions, including:
+ Abnormal heart rhythms, such as heart block or sick-sinus syndrome
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to your arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
* Respiratory conditions, 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 medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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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.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Regularly monitor your blood pressure and heart rate as instructed by your doctor. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this medication.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, consult with your doctor, as this medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia. This is particularly concerning for individuals with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, consult with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

Do not abruptly stop taking this medication, as this can lead to worsening chest pain or even a heart attack, especially if you have pre-existing heart disease. To minimize the risk of side effects, your doctor will guide you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, seek medical attention immediately.

This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have hyperthyroidism and suddenly stop taking this medication, your condition may worsen and become life-threatening. Consult with your doctor to discuss the potential risks.

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

If you have a history of severe allergic reactions, inform your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult with your doctor, as this medication may reduce the effectiveness of epinephrine.

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
  • Bronchospasm (difficulty breathing)
  • Hypoglycemia (low blood sugar)
  • Seizures
  • Cardiac arrest

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve IV fluids, atropine, glucagon, vasopressors, or other supportive measures.

Drug Interactions

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Contraindicated Interactions

  • Fingolimod (risk of severe bradycardia)
  • Thioridazine (increased thioridazine levels, QT prolongation)
  • Cimetidine (significant increase in propranolol levels)
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Major Interactions

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem - risk of severe bradycardia, AV block, heart failure)
  • Other beta-blockers (additive effects)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered first)
  • Digoxin (additive bradycardia)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • MAO inhibitors (risk of hypertensive crisis)
  • Alpha-1 blockers (e.g., prazosin - risk of first-dose hypotension)
  • Ergot alkaloids (increased peripheral vasoconstriction)
  • Phenytoin, phenobarbital, rifampin (decreased propranolol levels)
  • Fluvoxamine, fluoxetine, paroxetine, quinidine (increased propranolol levels)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Sympathomimetics (e.g., epinephrine, norepinephrine - risk of hypertension and bradycardia)
  • Lidocaine (increased lidocaine levels)
  • Alcohol (increased propranolol levels)
  • Warfarin (potential for altered INR, though less common)
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Minor Interactions

  • Antacids (may decrease propranolol absorption)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension/angina.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).

Timing: Prior to initiation (especially in patients with cardiac history)

Renal Function (SCr, BUN)

Rationale: To assess baseline kidney function, especially in patients with pre-existing renal impairment.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, as propranolol is extensively metabolized by the liver.

Timing: Prior to initiation

Blood Glucose (in diabetics)

Rationale: Propranolol can mask symptoms of hypoglycemia and prolong hypoglycemic episodes.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly to quarterly)

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

Action Threshold: Persistent hypotension (e.g., SBP <90 mmHg) or inadequate BP control

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly to quarterly)

Target: Typically >50-60 bpm at rest (unless specific indication for lower HR)

Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia

Symptoms of Heart Failure

Frequency: Regularly (patient self-monitoring and clinical assessment)

Target: Absence of new or worsening symptoms (e.g., dyspnea, edema, weight gain)

Action Threshold: Development or worsening of heart failure symptoms

Blood Glucose (in diabetics)

Frequency: Regularly (patient self-monitoring)

Target: Individualized glycemic targets

Action Threshold: Frequent or severe hypoglycemic episodes

Renal/Liver Function

Frequency: Periodically, especially in patients with pre-existing impairment or on long-term therapy (e.g., annually or as clinically indicated)

Target: Within normal limits or stable baseline

Action Threshold: Significant worsening of renal or liver function

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Symptom Monitoring

  • Bradycardia (slow pulse)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, weakness
  • Cold extremities
  • Bronchospasm (wheezing, shortness of breath)
  • Worsening heart failure (swelling, weight gain, increased shortness of breath)
  • Masked hypoglycemia symptoms (in diabetics)
  • Depression, sleep disturbances
  • Sexual dysfunction

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. It crosses the placenta and has been associated with fetal/neonatal bradycardia, hypoglycemia, and intrauterine growth restriction. Close monitoring of the neonate for signs of beta-blockade is recommended.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided if possible due to potential for fetal effects, though not definitively linked to major malformations.
Second Trimester: Risk of fetal growth restriction and neonatal complications (bradycardia, hypoglycemia) increases with prolonged exposure.
Third Trimester: Highest risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Neonates should be monitored for at least 24-48 hours after birth.
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Lactation

Propranolol is excreted into breast milk in small amounts (Lactation Risk L3 - Moderately Safe). While generally considered compatible with breastfeeding, monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding, hypoglycemia), especially in premature or very young infants.

Infant Risk: Low to moderate. Potential for bradycardia, hypotension, and hypoglycemia in the infant, though typically minimal with usual maternal doses. Observe infant for adverse effects.
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Pediatric Use

Use with caution and careful dose titration. Dosing is weight-based and varies by indication. Neonates and infants are particularly sensitive to the effects of beta-blockade. Not recommended for routine use in neonates/infants except for specific conditions like infantile hemangioma, where specialized protocols exist.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to beta-blockade, potential for reduced renal/hepatic function, and increased risk of adverse effects (e.g., bradycardia, hypotension, CNS effects). Monitor closely for orthostatic hypotension and falls.

Clinical Information

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Clinical Pearls

  • Always taper propranolol gradually over 1-2 weeks when discontinuing, especially in patients with coronary artery disease, to avoid rebound angina, MI, or arrhythmias.
  • Propranolol is highly lipophilic, leading to significant CNS penetration, which can cause side effects like fatigue, depression, and sleep disturbances.
  • It is a non-selective beta-blocker, meaning it blocks both beta-1 and beta-2 receptors. This makes it contraindicated or used with extreme caution in patients with asthma, COPD, or severe peripheral artery disease due to the risk of bronchospasm and vasoconstriction.
  • Can mask signs of hypoglycemia (e.g., tremor, palpitations) in diabetic patients, making only sweating a reliable indicator.
  • Often used off-label for performance anxiety due to its ability to reduce physical symptoms like tremor and palpitations.
  • Food increases the bioavailability of propranolol, so consistent administration with food is recommended, especially for extended-release formulations, to ensure consistent absorption.
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Alternative Therapies

  • Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
  • Calcium channel blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • 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: $15 - $50 per 30 tablets (60mg immediate-release generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.