Metoprolol ER Succinate 100mg Tabs

Manufacturer DR.REDDY'S Active Ingredient Metoprolol Extended-Release Tablets(me toe PROE lole) Pronunciation me toe PROE lole
It is used to treat high blood pressure.It is used to treat some types of chest pain (angina).It is used in certain people to lower the risk of death and having to go to the hospital because of heart failure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Antianginal, Heart Failure Agent
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Pharmacologic Class
Beta-1 Selective Adrenergic Blocker
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Pregnancy Category
C
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FDA Approved
Apr 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metoprolol ER Succinate is a type of medicine called a beta-blocker. It works by slowing down your heart rate and relaxing blood vessels, which helps to lower your blood pressure, reduce chest pain (angina), and improve symptoms of heart failure. The 'ER' means extended-release, so it works slowly over 24 hours and is usually taken once a day.
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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. Take your medication with or immediately after a meal to help your body absorb it properly. Swallow the tablet whole - do not chew or crush it. If needed, you can break the tablet in half, but be sure not to chew or crush it.

It's essential to continue taking your medication as directed 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 side effects.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Protect it from heat sources, such as radiators or heaters. This will help prevent degradation of the medication and ensure it remains potent.

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one. Sticking to your regular dosing schedule will help you stay on track and get the most benefit from your medication.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning with food or immediately after a meal.
  • Swallow the tablet whole; do not crush, chew, or break it.
  • Do not stop taking this medication suddenly, especially if you have heart disease. Your doctor will tell you how to slowly reduce the dose over time.
  • Monitor your blood pressure and heart rate regularly at home as instructed by your doctor.
  • Avoid activities that require alertness until you know how the medication affects you, as it can cause dizziness or lightheadedness.
  • Limit alcohol consumption, as it can increase the effects of metoprolol.
  • Maintain a healthy diet, regular exercise, and manage stress to support cardiovascular health.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 25-100 mg once daily; Angina: 100 mg once daily; Heart Failure: 25 mg once daily (NYHA Class II) or 12.5 mg once daily (NYHA Class III-IV), titrated slowly
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

hypertension: Initial 25-100 mg once daily, may increase weekly up to 400 mg/day.
anginaPectoris: Initial 100 mg once daily, may increase weekly up to 400 mg/day.
heartFailure: Initial 12.5 mg or 25 mg once daily, double dose every 2 weeks to maximum 200 mg/day as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (â‰Ĩ6 years): Initial 1 mg/kg once daily (max 50 mg), titrate to max 2 mg/kg or 200 mg/day.
Adolescent: Hypertension (â‰Ĩ6 years): Initial 1 mg/kg once daily (max 50 mg), titrate to max 2 mg/kg or 200 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: Not significantly removed by hemodialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment, monitor response.
Moderate: Consider dose reduction, monitor closely.
Severe: Significant dose reduction may be required due to reduced metabolism and increased bioavailability. Monitor closely.

Pharmacology

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Mechanism of Action

Metoprolol is a cardioselective beta-1 adrenergic receptor blocker. It competitively blocks beta-1 receptors, primarily located in the heart, reducing heart rate, myocardial contractility, and cardiac output. This leads to a decrease in blood pressure. It also reduces renin release from the kidneys. At higher doses, its beta-1 selectivity diminishes, and it can block beta-2 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (due to first-pass metabolism), ER formulation provides sustained release.
Tmax: 6-12 hours (for ER formulation)
FoodEffect: Food increases bioavailability by 20-40%.

Distribution:

Vd: 5.5 L/kg
ProteinBinding: 10-12%
CnssPenetration: Limited

Elimination:

HalfLife: 3-7 hours (terminal half-life for ER formulation)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 5% (renal)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour (ER formulation)
PeakEffect: 6-12 hours (ER formulation)
DurationOfAction: 24 hours (ER formulation)

Safety & Warnings

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BLACK BOX WARNING

Ischemic Heart Disease: Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate, 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, metoprolol succinate 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 metoprolol succinate 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 experience any of the following symptoms, contact your doctor or seek immediate medical attention:

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 blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Depression
Severe dizziness or fainting
New or worsening chest pain
New or worsening abnormal heartbeat
Slow heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs

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 or any other symptoms that bother you or do not go away, contact your doctor:

Feeling dizzy, tired, or weak
Diarrhea
Upset stomach
Vomiting

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 (e.g., less than 50 beats per minute)
  • Shortness of breath, especially with exertion or lying down
  • Swelling in your ankles, feet, or legs
  • Unusual weight gain
  • Chest pain or discomfort that worsens after stopping the medication
  • Coldness, numbness, or tingling in your hands or feet
  • Symptoms of depression (e.g., persistent sadness, 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. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:

Medications (prescription, over-the-counter, natural products, and vitamins)
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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. This will help ensure your safety and prevent any potential interactions with other treatments.

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 Your Condition

Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

Low Blood Sugar 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. 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, discuss them with your doctor. If you have diabetes, closely monitor your blood sugar levels.

Interactions with Other Medications

If you have high blood pressure and are taking this medication, consult 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.

Stopping the Medication

Do not stop taking this medication abruptly, as this can lead to worsened chest pain and, in some cases, heart attack, particularly if you have certain types of heart disease. To minimize the risk of side effects, your doctor will instruct 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 a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Discuss any concerns with your doctor.

Allergic Reactions

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 your doctor, as this medication may reduce the effectiveness of epinephrine. Additionally, discuss the use of alcohol with your doctor.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform 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)
  • Hypotension (very low blood pressure)
  • Cardiogenic shock
  • Bronchospasm (difficulty breathing)
  • Heart failure
  • Hypoglycemia
  • Cardiac arrest

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone, ritonavir) - may significantly increase metoprolol plasma concentrations, leading to increased beta-blockade.
  • Calcium channel blockers (e.g., verapamil, diltiazem) - increased risk of bradycardia, AV block, and hypotension.
  • Clonidine - abrupt withdrawal of clonidine while on metoprolol can lead to rebound hypertension.
  • Digoxin - increased risk of bradycardia and AV block.
  • MAO inhibitors - theoretical risk of significant hypertension or bradycardia.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce the antihypertensive effect of metoprolol.
  • Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of orthostatic hypotension.
  • Insulin and oral hypoglycemics - metoprolol may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
  • Reserpine, guanethidine - may cause additive hypotensive and bradycardic effects.
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Minor Interactions

  • Alcohol - may increase metoprolol plasma levels.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

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 cardiac rhythm and conduction, especially in patients with pre-existing cardiac conditions.

Timing: Prior to initiation (especially for heart failure)

Renal Function (BUN, Creatinine)

Rationale: To assess kidney health, though dose adjustment is generally not needed for renal impairment.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess liver health, as metoprolol is metabolized hepatically and dose adjustment may be needed in severe impairment.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly during titration, then monthly/quarterly)

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent BP outside target range, or symptomatic hypotension.

Heart Rate (HR)

Frequency: Regularly (e.g., weekly during titration, then monthly/quarterly)

Target: 50-70 bpm (or individualized target, e.g., 50-60 bpm for heart failure)

Action Threshold: HR <50 bpm or symptomatic bradycardia.

Symptoms of Heart Failure (for HF patients)

Frequency: Regularly (e.g., at each visit)

Target: Improvement or stability of symptoms (e.g., dyspnea, edema, fatigue)

Action Threshold: Worsening heart failure symptoms (e.g., increased dyspnea, weight gain, edema).

Blood Glucose (for diabetic patients)

Frequency: Regularly (as per diabetes management guidelines)

Target: Individualized glycemic targets

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

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Swelling in ankles/feet
  • Bradycardia (slow heart rate)
  • Cold hands/feet
  • Depression
  • Erectile dysfunction

Special Patient Groups

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Pregnancy

Metoprolol is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placental barrier. Neonates exposed to beta-blockers in utero may be at risk for bradycardia, hypoglycemia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly needed.
Second Trimester: May be used if benefits outweigh risks, monitor fetal growth and heart rate.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate for several days after birth.
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Lactation

Metoprolol is excreted in breast milk in small amounts. The American Academy of Pediatrics considers metoprolol to be 'compatible with breastfeeding'. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, cyanosis, hypoglycemia).

Infant Risk: Low risk, but monitor for bradycardia, hypoglycemia, and respiratory depression.
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Pediatric Use

Safety and efficacy for hypertension in children under 6 years of age have not been established. For children 6 years and older, dosing is weight-based and should be carefully titrated. Not approved for heart failure or angina in pediatric patients.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly, monitoring for adverse effects like bradycardia and hypotension.

Clinical Information

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Clinical Pearls

  • Metoprolol succinate ER is dosed once daily, while metoprolol tartrate (immediate release) is dosed multiple times a day. Ensure correct formulation is prescribed and dispensed.
  • Crucial for heart failure management (NYHA Class II-IV), but initiation requires careful, slow titration to avoid worsening symptoms.
  • Cardioselective at lower doses, meaning it primarily affects beta-1 receptors in the heart. At higher doses, its selectivity diminishes, and it can affect beta-2 receptors (e.g., in the lungs), potentially worsening bronchospasm in susceptible patients.
  • Patients should be educated on the importance of not abruptly discontinuing the medication due to the risk of rebound angina or myocardial infarction.
  • Take with food to enhance absorption and reduce GI upset.
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Alternative Therapies

  • Other beta-blockers (e.g., atenolol, bisoprolol, carvedilol, nebivolol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine, felodipine)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
  • Alpha-blockers (e.g., prazosin, doxazosin)
  • Direct vasodilators (e.g., hydralazine, minoxidil)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 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 details about the medication taken, the amount, and the time it happened.