Metoprolol ER Succinate 25mg Tabs

Manufacturer DR.REDDY'S LABORATORIES, INC. 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-adrenergic blocker (beta-1 selective)
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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 high blood pressure, reduce chest pain (angina), and improve symptoms of heart failure. The 'ER' means extended-release, so you usually take it 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 precisely. Take your medication with or immediately after a meal to help your body absorb it. Swallow the tablet whole, without chewing or crushing 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 maintain the quality and effectiveness of your medication, store it at room temperature in a dry place, away from the bathroom. Protect it from heat sources, such as radiators or heaters, to prevent degradation.

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 your medication exactly as prescribed, usually once daily, preferably with food or consistently without food.
  • Do not crush, chew, or break the extended-release tablet; swallow it whole.
  • Do not stop taking this medication suddenly, as it can worsen your condition (especially if you have heart disease). Your doctor will tell you how to slowly reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly at home as advised 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 (low in sodium and saturated fats), exercise regularly, and manage stress to support heart health.
  • If you have diabetes, monitor your blood sugar closely, as metoprolol can mask signs of low blood sugar.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 25 mg once daily for hypertension or heart failure (NYHA Class II-IV); 100 mg once daily for angina. Titrate as needed.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

hypertension: Initial 25-100 mg once daily; maintenance 25-400 mg once daily.
anginaPectoris: Initial 100 mg once daily; maintenance 100-400 mg once daily.
heartFailure: Initial 12.5-25 mg once daily (for NYHA Class II-IV stable chronic heart failure); double dose every 2 weeks to target 200 mg once daily, as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (6-17 years): Initial 1 mg/kg once daily (max 50 mg); titrate to max 2 mg/kg (max 200 mg) once daily. Not established for heart failure.
Adolescent: Hypertension (6-17 years): Initial 1 mg/kg once daily (max 50 mg); titrate to max 2 mg/kg (max 200 mg) once daily. Not established for heart failure.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically needed.
Moderate: No dosage adjustment typically needed.
Severe: No dosage adjustment typically needed.
Dialysis: Metoprolol is not significantly removed by hemodialysis. No supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor closely.
Moderate: Consider dosage reduction, especially in patients with cirrhosis or severe hepatic impairment, due to reduced metabolism.
Severe: Significant dosage reduction may be necessary. Monitor closely for adverse effects.

Pharmacology

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Mechanism of Action

Metoprolol is a cardioselective beta-1 adrenergic receptor blocker. It selectively blocks beta-1 receptors, primarily located in the heart, reducing heart rate, myocardial contractility, and cardiac output. It also reduces renin release from the kidneys. At higher doses, it may also block beta-2 adrenergic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30-40% (due to extensive first-pass metabolism), but the ER formulation provides sustained release.
Tmax: 6-12 hours (for extended-release formulation)
FoodEffect: Food increases the bioavailability of metoprolol. It is recommended to take Metoprolol ER Succinate consistently with food or on an empty stomach.

Distribution:

Vd: 3.2-5.6 L/kg
ProteinBinding: Approximately 10-12%
CnssPenetration: Limited, but can cross the blood-brain barrier and cause CNS effects.

Elimination:

HalfLife: 3-7 hours (for extended-release formulation, effective half-life is longer due to sustained release)
Clearance: Approximately 1 L/min
ExcretionRoute: Renal (approximately 95% as metabolites, 5% as unchanged drug)
Unchanged: Approximately 5%
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Pharmacodynamics

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

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 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. 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 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, 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 or wheezing
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • New or worsening chest pain
  • Extreme tiredness or weakness
  • 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

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. 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 tasks 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. 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 risk is higher in people with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions, consult your doctor.

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

Stopping the Medication
Do not stop taking this medication abruptly, as this may 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 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 difficult 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. Consult your doctor if you have any concerns.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. You may be at risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult your doctor, as epinephrine may be less effective while taking this medication.

Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking while taking this medication.

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 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)
  • 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. Treatment may involve atropine for bradycardia, vasopressors for hypotension, glucagon, and supportive care.

Drug Interactions

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Contraindicated Interactions

  • Not applicable for drug-drug interactions, but contraindications for use include severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless permanent pacemaker in place), severe peripheral arterial circulatory disorders.
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Major Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone, ritonavir, bupropion, terbinafine, chlorpromazine, cimetidine, hydralazine): May significantly increase metoprolol plasma concentrations, leading to increased beta-blockade and risk of bradycardia/hypotension.
  • Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and hypotension. Avoid concomitant IV administration.
  • Digoxin: Additive bradycardia.
  • Clonidine: May potentiate rebound hypertension if clonidine is withdrawn abruptly while on metoprolol. If discontinuing, withdraw metoprolol first, then clonidine after several days.
  • Adrenergic-depleting drugs (e.g., reserpine, guanethidine): May have an additive effect, leading to excessive reduction of sympathetic tone (bradycardia, hypotension, syncope).
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of metoprolol.
  • Alpha-blockers (e.g., prazosin, doxazosin): May cause additive hypotensive effects, especially orthostatic hypotension.
  • Insulin and oral hypoglycemics: Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia, palpitations) and prolong hypoglycemic episodes. Monitor blood glucose closely in diabetic patients.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): Beta-blockers may blunt the bronchodilator effect of beta-agonists and may cause hypertension and bradycardia with alpha-agonists.
  • Amiodarone: Increased risk of bradycardia and AV block.
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Minor Interactions

  • Alcohol: May increase metoprolol levels slightly.
  • Rifampin: May decrease metoprolol 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 for 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 (BUN, Creatinine)

Rationale: To assess kidney function, though no dose adjustment is typically needed for renal impairment.

Timing: Prior to initiation.

Hepatic Function (ALT, AST, Bilirubin)

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

Timing: Prior to initiation.

Blood Glucose

Rationale: To establish baseline, especially in diabetic patients, as beta-blockers can mask hypoglycemia symptoms.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly during titration, then monthly or quarterly once stable)

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

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

Heart Rate (HR)

Frequency: Regularly (e.g., weekly during titration, then monthly or quarterly once stable)

Target: 50-60 bpm (resting, or individualized target)

Action Threshold: Bradycardia (<50 bpm or symptomatic), or significant increase.

Signs/Symptoms of Heart Failure

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

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 diabetics)

Frequency: Regularly (as per diabetes management guidelines)

Target: Individualized glycemic targets

Action Threshold: Frequent or severe hypoglycemic episodes.

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Symptom Monitoring

  • Bradycardia (slow pulse)
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or weakness
  • Shortness of breath or wheezing (especially in patients with asthma/COPD)
  • Cold hands and feet
  • Depression or mood changes
  • Insomnia or vivid dreams
  • Edema (swelling in ankles/feet)
  • Weight gain (in heart failure patients)
  • Masked symptoms of hypoglycemia (in diabetics)

Special Patient Groups

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Pregnancy

Metoprolol is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause fetal/neonatal bradycardia, hypoglycemia, and respiratory depression.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations. Use with caution.
Second Trimester: Potential for fetal growth restriction and neonatal complications (bradycardia, hypoglycemia).
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Monitor neonate for several days after birth.
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Lactation

Metoprolol is excreted into breast milk. The amount is generally low, and adverse effects in breastfed infants are rare but possible (e.g., bradycardia, hypoglycemia). It is rated L3 (moderately safe).

Infant Risk: Low to moderate risk. Monitor breastfed infants for signs of beta-blockade (bradycardia, lethargy, poor feeding, hypoglycemia). Consider using the lowest effective dose and monitoring the infant, especially if the mother is a poor metabolizer of CYP2D6.
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Pediatric Use

Safety and effectiveness for hypertension have been established in pediatric patients 6 to 17 years of age. Safety and effectiveness have not been established for heart failure in pediatric patients. Dosing is weight-based for hypertension. Not recommended for children under 6 years.

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Geriatric Use

No overall differences in effectiveness or safety 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 consistently with food or on an empty stomach to ensure consistent absorption.
  • Do not crush, chew, or break the extended-release tablets; they must be swallowed whole.
  • Abrupt discontinuation 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, initiation and titration must be done very slowly and carefully, starting with low doses (e.g., 12.5 mg or 25 mg once daily) and doubling every two weeks as tolerated.
  • Patients with asthma or severe COPD should generally avoid metoprolol due to potential for bronchospasm, even though it is cardioselective. If necessary, use with extreme caution and monitor respiratory function.
  • Can mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism (e.g., tachycardia).
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Alternative Therapies

  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine, nifedipine, diltiazem, verapamil)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • 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 25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand) on most formularies
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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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.