Propranolol 80mg Tablets

Manufacturer AMICI PHARMACEUTICALS 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, Essential Tremor Agent
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Pharmacologic Class
Non-selective Beta-Adrenergic Blocker
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Pregnancy 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 relaxing blood vessels and slowing your heart rate, which helps to lower high blood pressure, prevent chest pain (angina), control irregular heartbeats, and prevent migraine headaches. It can also help with tremors and anxiety.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the medication and minimize the risk of any potential complications.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from heat, cold, and light. Keep the container tightly closed to prevent moisture and other environmental factors from affecting the medication. Do not freeze your medication, as this can cause it to become less effective or even unsafe to use.

What to Do If You Miss a Dose

If you miss a dose of your medication, 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, as this can increase the risk of side effects or other complications.
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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 at home if advised by your doctor.
  • Avoid or limit alcohol consumption, as it can increase the effects of propranolol.
  • Inform your doctor or dentist that you are taking propranolol before any surgery or dental procedures.
  • If you have diabetes, be aware that propranolol can mask the signs of low blood sugar (like shakiness or a fast heartbeat). Monitor your blood sugar closely.
  • Avoid activities requiring mental alertness until you know how this medication affects you, as it can cause dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage is highly individualized based on indication and patient response. For hypertension, initial 40 mg twice daily, maintenance 120-240 mg/day in 2-3 divided doses. For angina, initial 80 mg/day in 2-4 divided doses, maintenance 160-320 mg/day. For migraine prophylaxis, initial 80 mg/day in divided doses, maintenance 160-240 mg/day.
Dose Range: 40 - 640 mg

Condition-Specific Dosing:

Hypertension: Initial 40 mg BID; maintenance 120-240 mg/day (max 640 mg/day)
Angina Pectoris: Initial 80 mg/day in 2-4 divided doses; maintenance 160-320 mg/day
Arrhythmias: 10-30 mg 3-4 times daily
Migraine Prophylaxis: Initial 80 mg/day in divided doses; maintenance 160-240 mg/day
Essential Tremor: Initial 40 mg BID; maintenance 120-320 mg/day (max 360 mg/day)
Hypertrophic Subaortic Stenosis: 20-40 mg 3-4 times daily
Pheochromocytoma (preoperative): 60 mg/day in divided doses for 3 days prior to surgery (with alpha-blocker)
Anxiety (situational): 10-40 mg as a single dose 30-60 minutes prior to event
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., infantile hemangioma) may have specialized dosing.
Infant: Not established for routine use; specific conditions (e.g., infantile hemangioma) may have specialized dosing.
Child: Hypertension: Initial 0.5-1 mg/kg/day in 2-4 divided doses; usual range 1-2 mg/kg/day (max 4 mg/kg/day or 60 mg/day). Migraine Prophylaxis: Initial 10-20 mg 2-3 times daily; usual range 20-40 mg 2-3 times daily.
Adolescent: Similar to adult dosing, individualized based on indication and response.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for exaggerated effects. Accumulation of active metabolites may occur.
Dialysis: Propranolol is not significantly removed by hemodialysis. No supplemental dose needed after dialysis. Use with caution in ESRD due to potential for accumulation of active metabolites.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Significant dose reduction required (e.g., 50% or more of usual dose). Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 75% or more of usual dose). Monitor for exaggerated effects and accumulation.

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 inhibits renin release from the kidneys. Beta-2 blockade can cause bronchoconstriction and peripheral vasoconstriction. 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: 10-60% (highly variable due to extensive first-pass metabolism)
Tmax: 1-1.5 hours (oral)
FoodEffect: Food increases bioavailability and reduces peak plasma concentrations, but overall AUC is increased. Administer consistently with or without food.

Distribution:

Vd: 4 L/kg
ProteinBinding: 90-95%
CnssPenetration: Yes (lipophilic, readily crosses blood-brain barrier)

Elimination:

HalfLife: 3-6 hours (parent drug); 8-11 hours (4-hydroxypropranolol)
Clearance: Not readily available as a single rate, but highly variable due to first-pass metabolism.
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes (oral)
PeakEffect: 1-1.5 hours (oral)
DurationOfAction: 6-12 hours (dose-dependent, can be longer with chronic use due to accumulation)

Safety & Warnings

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BLACK BOX WARNING

WARNING: ABRUPT CESSATION OF THERAPY. Exacerbation of angina pectoris and, in some cases, myocardial infarction and ventricular arrhythmia have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Therefore, 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. 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 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
Abnormal sensations, such as burning, numbness, or tingling
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
Erectile dysfunction
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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, drowsiness, tiredness, or weakness
Upset stomach or vomiting
Stomach pain or cramps
Diarrhea or constipation
Difficulty sleeping
Vivid or unusual dreams

Reporting 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.
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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 (especially if new or worsening)
  • Swelling in your ankles or feet, sudden weight gain, or unusual tiredness (signs of heart failure)
  • New or worsening chest pain
  • Severe depression or unusual mood changes
  • Coldness, numbness, or pain in your hands or feet
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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 modify the dosage of any medication without first consulting your doctor to confirm 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 know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, 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 lab 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 a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar, particularly in people with diabetes, children, and those who are fasting or have undergone surgery.

Special Considerations
If you have diabetes, closely monitor your blood sugar levels. Do not stop taking this medication abruptly, as this can lead to worsening chest pain or even a heart attack, especially if you have certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Thyroid and Blood Pressure Considerations
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. If you have high blood pressure, consult with your doctor before using over-the-counter 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 and Epinephrine
If you have a history of severe allergic reactions, discuss with your doctor the potential risks of an even more severe reaction if you are exposed to the allergen again. 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, consult with your doctor to discuss the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Severe hypotension (very low blood pressure)
  • Cardiogenic shock
  • Heart failure
  • Bronchospasm
  • Hypoglycemia
  • 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

  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) in patients with impaired ventricular function or AV nodal conduction abnormalities (risk of severe bradycardia, heart block, heart failure)
  • MAO inhibitors (risk of hypertensive crisis)
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Major Interactions

  • Other beta-blockers (additive effects)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if propranolol is not tapered)
  • Digoxin (additive bradycardia)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
  • Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) (risk of hypertension, bradycardia)
  • Fingolimod (risk of severe bradycardia)
  • Prazosin (risk of first-dose syncope)
  • Amiodarone (risk of bradycardia, AV block, cardiac arrest)
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Phenytoin, phenobarbital, rifampin (may decrease propranolol levels)
  • Cimetidine, fluoxetine, paroxetine, quinidine (may increase propranolol levels)
  • Alcohol (may increase propranolol levels)
  • Lidocaine (propranolol may decrease lidocaine clearance)
  • Theophylline (propranolol may decrease theophylline clearance)
  • Ergot alkaloids (increased peripheral vasoconstriction)
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Minor Interactions

  • Antacids (may decrease propranolol absorption if taken concurrently)

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

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia, a common side effect.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block) that may be exacerbated by propranolol.

Timing: Prior to initiation (especially for cardiac indications)

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, although dose adjustment is generally not needed for mild-moderate impairment, severe impairment requires caution.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess hepatic function, as propranolol is extensively metabolized by the liver and dose adjustments are critical in hepatic impairment.

Timing: Prior to initiation

Blood Glucose (for diabetic patients)

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 (e.g., weekly initially, then monthly or as clinically indicated)

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

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

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: Typically >50-60 bpm (unless target bradycardia for specific arrhythmia)

Action Threshold: Bradycardia (<50 bpm or symptomatic), or inadequate control

Symptoms of Heart Failure

Frequency: At each visit

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

Action Threshold: Development or worsening of heart failure symptoms

Blood Glucose (for diabetic patients)

Frequency: Regularly (as per diabetes management guidelines)

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes

Respiratory Status (for patients with asthma/COPD)

Frequency: At each visit

Target: Absence of bronchospasm or worsening respiratory symptoms

Action Threshold: Development of wheezing, shortness of breath, or increased inhaler use

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Symptom Monitoring

  • Bradycardia (slow pulse)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, lethargy
  • Cold hands and feet
  • Bronchospasm (wheezing, shortness of breath) in susceptible individuals
  • Worsening of heart failure symptoms (e.g., swelling, weight gain, dyspnea)
  • Depression, sleep disturbances
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Propranolol is Pregnancy Category C. Use 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. Neonates of mothers treated with propranolol should be closely monitored for signs of beta-blockade for several days after birth.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed due to potential for fetal effects.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Withdrawal symptoms may occur in the neonate.
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Lactation

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

Infant Risk: Low to Moderate (L3). Potential for bradycardia, hypotension, and hypoglycemia in the infant, especially with high maternal doses or in premature/sick infants.
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Pediatric Use

Dosing is individualized based on weight and indication. Safety and efficacy for some indications (e.g., hypertension) are established. For infantile hemangioma, a specific liquid formulation (Hemangeol) is approved. Close monitoring for adverse effects, especially hypoglycemia and bradycardia, is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the effects of beta-blockers, particularly bradycardia and hypotension. Start with lower doses and titrate slowly. Renal and hepatic function should be assessed, as age-related decline in these functions can affect drug clearance.

Clinical Information

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Clinical Pearls

  • Always taper propranolol slowly over 1-2 weeks to avoid rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with coronary artery disease.
  • Propranolol is highly lipophilic, leading to significant CNS penetration, which can contribute to side effects like fatigue, depression, and sleep disturbances.
  • Non-selective beta-blockade can worsen bronchospasm in patients with asthma or COPD; use with extreme caution or avoid in these populations.
  • Can mask signs of hypoglycemia in diabetic patients, requiring careful blood glucose monitoring.
  • The 80mg tablet is a common strength for maintenance therapy across various indications, but initial dosing often starts lower (e.g., 40mg BID).
  • Food increases propranolol's bioavailability; advise patients to take it consistently with or without food to maintain stable drug levels.
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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)
  • ARBs (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • For migraine prophylaxis: Topiramate, Amitriptyline, CGRP inhibitors
  • For essential tremor: Primidone
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 80mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 details about the overdose, including the medication taken, the amount, and the time it occurred.