Metoprolol ER Succinate 200mg 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-1 Selective Adrenergic Blocker
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Pregnancy Category
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 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 preserve the medication's potency and prevent any degradation.

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 schedule will help you stay on track and maintain the effectiveness of your medication.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily with or immediately following a meal.
  • Do not crush, chew, or break the extended-release tablet; swallow it whole.
  • Do not stop taking this medication suddenly, especially if you have heart disease, as it can worsen your condition. Your doctor will tell you how to slowly reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly at home if 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), engage in regular exercise, and manage stress as part of your overall treatment plan for hypertension or heart disease.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 100-200 mg once daily; Angina: 100-200 mg once daily; Heart Failure: Target dose 200 mg once daily (titrated from lower doses)
Dose Range: 25 - 400 mg

Condition-Specific Dosing:

Hypertension: Initial: 25-50 mg once daily; Maintenance: 100-200 mg once daily, max 400 mg.
Angina Pectoris: Initial: 100 mg once daily; Maintenance: 100-400 mg once daily.
Heart Failure (NYHA Class II-IV): Initial: 12.5-25 mg once daily; Titrate slowly over weeks to target 200 mg once daily as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for ER formulation; limited data for hypertension in adolescents (6-17 years) with immediate-release.
Adolescent: Not established for ER formulation.
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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 needed
Moderate: Consider dose reduction, monitor closely
Severe: Significant dose reduction (e.g., 50%) recommended due to reduced metabolism and increased bioavailability.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Approximately 50% (due to first-pass metabolism), increased by food.
Tmax: 6-12 hours (for ER formulation)
FoodEffect: Food increases the bioavailability of metoprolol by 20-40%.

Distribution:

Vd: Approximately 5.5 L/kg
ProteinBinding: Approximately 10-12%
CnssPenetration: Limited (lipophilicity is moderate, but less than propranolol)

Elimination:

HalfLife: 3-7 hours (for ER formulation, 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: Within 1 hour (for ER, initial effect)
PeakEffect: 6-12 hours (for ER)
DurationOfAction: 24 hours (for 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

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. Although 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, 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
  • New or worsening swelling in your hands, ankles, or feet
  • Unusual weight gain
  • Chest pain that is new or worsening after stopping the medication
  • Signs 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, and natural products)
Vitamins
Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in conjunction with your other treatments 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 understand 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 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.

Management of High Blood Sugar
If you have diabetes, it is crucial to 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.

Discontinuing the Medication
Do not stop taking this medication abruptly, as this may lead to worsened chest pain or even a heart attack, particularly 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 a higher 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 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 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 or call 911. For poison control, call 1-800-222-1222. Treatment may involve atropine for bradycardia, glucagon, vasopressors, and intravenous fluids.

Drug Interactions

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Major Interactions

  • Verapamil (increased risk of bradycardia, AV block, hypotension)
  • Diltiazem (increased risk of bradycardia, AV block, hypotension)
  • Clonidine (risk of rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first)
  • Fingolimod (increased risk of bradycardia)
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Moderate Interactions

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone, ritonavir, bupropion, terbinafine, cimetidine) - may increase metoprolol plasma concentrations and enhance effects.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs) - may blunt the antihypertensive effect of metoprolol.
  • Digitalis glycosides (e.g., digoxin) - increased risk of bradycardia and AV block.
  • Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - additive hypotensive effects.
  • Insulin and oral hypoglycemics - beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
  • Sympathomimetics (e.g., epinephrine, norepinephrine) - may cause paradoxical hypertension and bradycardia.
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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 heart failure patients)

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess hepatic function, as metoprolol is primarily metabolized by the liver.

Timing: Prior to initiation (especially in patients with suspected hepatic impairment)

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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 (general target for hypertension, may vary based on comorbidities)

Action Threshold: Systolic >140 mmHg or Diastolic >90 mmHg (consider dose adjustment); Systolic <90 mmHg or symptomatic hypotension (consider dose reduction/discontinuation).

Heart Rate (HR)

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

Target: 50-70 bpm (resting HR, may vary based on indication)

Action Threshold: <50 bpm or symptomatic bradycardia (consider dose reduction/discontinuation).

Symptoms of Heart Failure (e.g., dyspnea, edema, weight gain)

Frequency: Regularly, especially in heart failure patients.

Target: Improvement or stability of symptoms.

Action Threshold: Worsening heart failure symptoms (consider temporary dose reduction or discontinuation, re-evaluate treatment plan).

Glucose levels (in diabetic patients)

Frequency: Regularly, as per diabetes management guidelines.

Target: Individualized

Action Threshold: Frequent or severe hypoglycemic episodes (educate patient on masked symptoms, adjust diabetes regimen if needed).

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Swelling in ankles/feet (edema)
  • Bradycardia (slow heart rate)
  • 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 be at risk for 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, and respiratory depression. Monitor neonate for 24-48 hours after birth.
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Lactation

L3 (Moderately Safe). Metoprolol is excreted into breast milk in small amounts. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, drowsiness, hypoglycemia). Generally considered compatible with breastfeeding, especially with ER formulation due to lower peak levels.

Infant Risk: Low risk of adverse effects, but monitor for bradycardia, hypotension, and hypoglycemia.
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Pediatric Use

Safety and effectiveness of metoprolol succinate extended-release in pediatric patients have not been established. Use of immediate-release metoprolol for hypertension in children 6 years and older is established, but ER formulation is generally not recommended.

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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 or immediately following a meal to enhance absorption and reduce variability.
  • Do not crush or chew 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.
  • While cardioselective at lower doses, metoprolol can lose its beta-1 selectivity at higher doses (e.g., 200mg), potentially affecting beta-2 receptors and causing bronchospasm in susceptible patients (e.g., asthma, COPD).
  • Monitor heart rate closely, especially in patients with pre-existing bradycardia or AV block. Avoid in patients with sick sinus syndrome or second/third-degree AV block without a pacemaker.
  • Can mask symptoms of hypoglycemia in diabetic patients (e.g., tachycardia, tremors), but sweating may still occur. Use with caution in diabetics.
  • Often a preferred beta-blocker for heart failure due to its proven mortality benefit in chronic stable heart failure (NYHA Class II-IV).
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Alternative Therapies

  • Other Beta-blockers (e.g., Carvedilol, Bisoprolol, Atenolol, Labetalol)
  • ACE Inhibitors (e.g., Lisinopril, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine, Diltiazem, Verapamil)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Alpha-1 Blockers (e.g., Prazosin, Terazosin)
  • Direct Vasodilators (e.g., Hydralazine, Minoxidil)
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Cost & Coverage

Average Cost: $10 - $100+ per 30 tablets
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 for more information. 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.