Metoprolol ER Succinate 50mg 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 you usually take it only 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 feeling well. 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 quality and effectiveness of your medication, store it at room temperature in a dry place, away from the bathroom. Protect the medication from heat, as this can affect its potency.

What to Do If You Miss a Dose

If you miss a dose, skip it and take your next dose at the scheduled time. Do not take two doses at the same time or take extra doses to make up for the missed one. This will help you stay on track with your medication regimen and minimize the risk of any potential side effects.
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Lifestyle & Tips

  • Take the tablet whole; do not crush, chew, or break it.
  • Take with food or immediately after a meal to increase absorption and reduce stomach upset.
  • Take at the same time each day.
  • Do not stop taking this medication suddenly, as it can worsen your condition. Your doctor will tell you how to slowly reduce the dose if needed.
  • Limit alcohol consumption, as it can increase the effects of metoprolol.
  • Maintain a healthy diet (low sodium, low fat).
  • Engage in regular physical activity as advised by your doctor.
  • Monitor your blood pressure and heart rate at home as instructed.
  • Avoid activities requiring mental alertness until you know how the medication affects you, as it can cause dizziness or fatigue.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 25-100 mg once daily. Angina: 100-400 mg once daily. Heart Failure: Initial 12.5-25 mg once daily, titrate up to 200 mg once daily.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; limited data for hypertension in adolescents (0.2-1 mg/kg/day, max 50 mg/day initially)
Adolescent: Hypertension: Initial 0.2-1 mg/kg once daily (max 50 mg/day), titrate up to 2 mg/kg (max 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 adjustment needed
Moderate: Consider dose reduction, monitor closely
Severe: Significant dose reduction may be required due to reduced metabolism; monitor closely for adverse effects

Pharmacology

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Mechanism of Action

Metoprolol is a beta-1 selective (cardioselective) adrenergic receptor blocking agent. It competitively blocks beta-1 adrenergic 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 and decreases sympathetic outflow from the central nervous system. At higher doses, it may also block beta-2 adrenergic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: 30-50% (due to first-pass metabolism)
Tmax: 6-12 hours (for ER succinate)
FoodEffect: Food increases bioavailability by 20-40%

Distribution:

Vd: 5.6 L/kg
ProteinBinding: 10-12%
CnssPenetration: Limited

Elimination:

HalfLife: 3-7 hours
Clearance: Not available
ExcretionRoute: Renal (95% as metabolites, 5% unchanged)
Unchanged: 5%
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6-12 hours
DurationOfAction: 24 hours

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, 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 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 therapy abruptly even in patients treated only for hypertension.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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, 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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, 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 or worsening shortness of breath
  • Swelling in your ankles, feet, or hands
  • 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)
  • Signs of low blood sugar (in diabetics, though metoprolol can mask typical symptoms like rapid heartbeat)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, 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 weak heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, including:
+ Asthma
+ Other breathing problems, such as chronic obstructive pulmonary disease (COPD)

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have

It is vital to verify that it is safe to take this medication with all 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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying 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 directed by your doctor.

Interference with Lab Tests
This medication may affect certain laboratory tests. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication.

Risk of Low Blood Sugar
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.

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

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.

Discontinuing the Medication
Do not stop taking this medication abruptly, as this may lead to worsened 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 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 this with your doctor.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. 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.

Alcohol Consumption
Before consuming alcohol, discuss the potential risks with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need 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
  • Loss of consciousness
  • 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 atropine for bradycardia, glucagon, vasopressors for hypotension, and bronchodilators for bronchospasm.

Drug Interactions

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Major Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone, ritonavir, bupropion, terbinafine, duloxetine): May significantly increase metoprolol plasma concentrations, leading to increased beta-blockade and risk of bradycardia/hypotension.
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and heart failure.
  • Clonidine: May potentiate rebound hypertension upon abrupt withdrawal of clonidine.
  • Digitalis glycosides (e.g., digoxin): Increased risk of bradycardia and AV block.
  • Other antihypertensives: Additive hypotensive effects.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of metoprolol.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): May cause hypertension and bradycardia.
  • Insulin and oral hypoglycemics: Beta-blockers may mask symptoms of hypoglycemia (e.g., tremor, tachycardia) and prolong hypoglycemic episodes.
  • Rifampin: May decrease metoprolol plasma concentrations.
  • Alcohol: May increase metoprolol plasma levels.
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Minor Interactions

  • Antacids: May decrease metoprolol absorption (separate administration).

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 for bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm and conduction, especially in patients with pre-existing cardiac conditions or heart failure.

Timing: Prior to initiation (especially for heart failure)

Renal Function (SCr, BUN)

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

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess baseline hepatic function, as metoprolol is metabolized by the liver 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 or as clinically indicated

Target: Individualized, e.g., <130/80 mmHg for hypertension

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

Heart Rate (HR)

Frequency: Regularly, e.g., weekly during titration, then monthly or as clinically indicated

Target: 50-60 bpm (resting) or as tolerated

Action Threshold: Bradycardia (<45-50 bpm or symptomatic), significant decrease from baseline

Symptoms of Heart Failure (for HF patients)

Frequency: Regularly, especially during titration

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 plan

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes (due to masked symptoms)

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Shortness of breath
  • Edema (swelling)
  • Weight gain (for heart failure patients)
  • Cold hands/feet
  • Depression
  • Insomnia

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Metoprolol crosses the placenta. Neonates exposed to beta-blockers in utero may experience bradycardia, hypoglycemia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations.
Second Trimester: Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Monitor neonate for 48-72 hours after birth.
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Lactation

L3 (Moderately Safe). Metoprolol is excreted in breast milk in small amounts. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding, hypoglycemia). Consider using the lowest effective dose.

Infant Risk: Low risk of adverse effects in healthy, full-term infants. Higher risk in preterm or infants with underlying conditions.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients for all indications. Limited data for hypertension in adolescents. Use with caution and close monitoring, typically not a first-line agent.

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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 ER succinate should be taken once daily, preferably with food or immediately after a meal, to ensure consistent absorption and reduce GI upset.
  • Do not crush, chew, or break the extended-release tablets; they must be swallowed whole to maintain their extended-release properties.
  • Abrupt discontinuation of metoprolol can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with ischemic heart disease. Taper dose gradually over 1-2 weeks.
  • In heart failure, metoprolol ER succinate (Toprol-XL) is one of the three beta-blockers proven to reduce mortality (along with carvedilol and bisoprolol). Dosing for heart failure starts very low and is titrated slowly over weeks to months.
  • Beta-blockers can mask the signs of hypoglycemia (e.g., tremor, palpitations) in diabetic patients, except for sweating. Monitor blood glucose closely.
  • Patients with asthma or severe COPD should generally avoid non-selective beta-blockers. While metoprolol is beta-1 selective, high doses can lose selectivity and cause bronchospasm. Use with caution in patients with reactive airway disease.
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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, Diltiazem, Verapamil)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
  • Loop Diuretics (e.g., Furosemide, Torsemide) - primarily for fluid overload in HF
  • Alpha-1 Blockers (e.g., Prazosin, Terazosin)
  • Direct Vasodilators (e.g., Hydralazine, Minoxidil)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (50mg generic)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 this medication, don't 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.