Kapspargo Sprinkle ER 50mg Capsules

Manufacturer RANBAXY LABORATORIES Active Ingredient Metoprolol Extended-Release Capsules(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
Oct 2020
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Kapspargo Sprinkle ER is a type of medicine called a beta-blocker. It works by slowing down your heart rate and relaxing blood vessels, which helps lower your blood pressure and reduce the strain on your heart. It's used to treat high blood pressure, chest pain (angina), and heart failure. The 'Sprinkle ER' means it's an extended-release capsule that can be opened and sprinkled on soft food for easier swallowing.
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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 with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew or crush it.

If you have difficulty swallowing the tablet whole, you can sprinkle the contents onto a soft food like applesauce, pudding, or yogurt. If you do this, be sure to swallow the mixture within 60 minutes of mixing, without chewing. Do not prepare a dose ahead of time or store it for future use.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. If you have a feeding tube, you can still use this medication - follow the instructions provided by your healthcare provider and flush the feeding tube after administering the dose.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from heat. Do not store it in a bathroom.

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 a missed dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking this medication suddenly, especially if you have heart disease, as it can worsen your condition. Your doctor will guide you on how to slowly reduce the dose if needed.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Maintain a healthy diet (low in sodium and saturated fats).
  • Engage in regular physical activity as recommended by your doctor.
  • Limit alcohol intake.
  • Avoid smoking.
  • Report any new or worsening symptoms to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, typically 25-100 mg once daily, up to 400 mg/day
Dose Range: 25 - 400 mg

Condition-Specific Dosing:

hypertension: 25-100 mg once daily, may increase weekly up to 400 mg/day
anginaPectoris: 100 mg once daily, may increase weekly up to 400 mg/day
heartFailure: Initial 25 mg once daily (NYHA Class II) or 12.5 mg once daily (NYHA Class III/IV) for 2 weeks, then double dose every 2 weeks up to 200 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (6 years and older): Initial 0.2 mg/kg (max 10 mg) once daily; titrate up to 2 mg/kg (max 200 mg) once daily. Kapspargo specifically approved for pediatric hypertension.
Adolescent: Hypertension: Initial 0.2 mg/kg (max 10 mg) once daily; titrate up to 2 mg/kg (max 200 mg) once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; metoprolol is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Consider dose reduction, monitor closely
Severe: Significant dose reduction recommended (e.g., 25% of usual dose), monitor closely due to increased plasma concentrations.

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. At higher doses, it can also block beta-2 receptors. It reduces renin release from the kidneys.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (due to first-pass metabolism), but can vary (30-70%)
Tmax: 6-8 hours (for extended-release formulation)
FoodEffect: Food increases bioavailability by 20-40%. Kapspargo can be taken with or without food, or sprinkled on soft food.

Distribution:

Vd: Approximately 3.2-5.6 L/kg
ProteinBinding: Approximately 10-12%
CnssPenetration: Limited (more lipophilic than atenolol, less than propranolol)

Elimination:

HalfLife: 3-7 hours (extended-release formulation provides sustained release)
Clearance: Approximately 1 L/min
ExcretionRoute: Renal (approximately 95% of dose)
Unchanged: Less than 5% (of oral dose) in urine
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Pharmacodynamics

OnsetOfAction: Within 1 hour (for ER formulation, initial effect)
PeakEffect: 6-8 hours (for ER formulation)
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

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
+ 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Feeling dizzy, tired, or weak
Diarrhea
Upset stomach
Vomiting

Reporting Side Effects

This is not an exhaustive list of possible 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 ankles or feet, or sudden weight gain (signs of worsening heart failure)
  • Unusual fatigue or weakness
  • Coldness or numbness in your fingers and toes
  • Symptoms of depression
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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 you experienced, including any symptoms that occurred.
Certain heart conditions, including:
+ Abnormal heart rhythms, such as heart block or sick-sinus syndrome
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood flow to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory conditions, including:
+ 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 your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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Precautions & Cautions

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. 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 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 to ensure accurate test results.

Risk of Low Blood Sugar
This medication may mask symptoms of low blood sugar, such as 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, 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 or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* 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 minimize 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 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 for guidance.

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, discuss this with your doctor, as epinephrine may be less effective while taking this medication.

Alcohol Consumption
Avoid drinking alcohol while taking this medication.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome 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
  • Heart failure
  • Hypoglycemia
  • Loss of consciousness
  • Seizures

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve atropine for bradycardia, vasopressors for hypotension, glucagon, and bronchodilators for bronchospasm.

Drug Interactions

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Contraindicated Interactions

  • Fingolimod (severe bradycardia)
  • Cimetidine (significant increase in metoprolol levels, though often managed with dose adjustment rather than strict contraindication)
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Major Interactions

  • Other beta-blockers (additive effects, severe bradycardia/hypotension)
  • Calcium channel blockers (e.g., verapamil, diltiazem - severe bradycardia, heart block, heart failure)
  • Clonidine (rebound hypertension upon clonidine withdrawal if beta-blocker not stopped first)
  • Digoxin (additive bradycardia)
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone, ritonavir, bupropion - significantly increase metoprolol plasma concentrations)
  • MAO inhibitors (enhanced hypotensive effect)
  • Reserpine, guanethidine (additive hypotensive/bradycardic effects)
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Moderate Interactions

  • NSAIDs (may blunt antihypertensive effect)
  • Alpha-1 blockers (e.g., prazosin - increased risk of first-dose hypotension)
  • Insulin/oral hypoglycemics (may mask symptoms of hypoglycemia, prolong hypoglycemic response)
  • Sympathomimetics (e.g., epinephrine - unopposed alpha-adrenergic stimulation, hypertension, bradycardia)
  • Rifampin (decreased metoprolol levels)
  • Alcohol (may increase metoprolol levels)
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Minor Interactions

  • Antacids (may decrease absorption, separate administration)
  • Lidocaine (decreased lidocaine clearance)

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 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 (SCr, BUN)

Rationale: To assess kidney health, though metoprolol is primarily hepatically metabolized, renal function is important for overall patient assessment.

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

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

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: Hypotension (<90/60 mmHg) or uncontrolled hypertension

Heart Rate (HR)

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

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

Action Threshold: <50 bpm or symptomatic bradycardia

Symptoms of Heart Failure

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

Target: Improvement or stability

Action Threshold: Worsening dyspnea, edema, weight gain

Symptoms of Bronchospasm

Frequency: As needed, especially in patients with respiratory conditions

Target: Absence of wheezing, shortness of breath

Action Threshold: New or worsening respiratory symptoms

Blood Glucose (in diabetics)

Frequency: Regularly (as per diabetes management guidelines)

Target: Individualized

Action Threshold: Frequent or severe hypoglycemia

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Shortness of breath
  • Wheezing
  • Cold extremities
  • Depression
  • Insomnia
  • Sexual dysfunction

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 neonates 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, drowsiness, hypoglycemia). Generally considered compatible with breastfeeding, especially with low doses.

Infant Risk: Low risk of adverse effects in most breastfed infants. Monitor for bradycardia, hypotension, and hypoglycemia.
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Pediatric Use

Kapspargo Sprinkle ER is approved for hypertension in pediatric patients 6 years of age and older. Dosing is weight-based. Safety and effectiveness in pediatric patients younger than 6 years of age have not been established. Close monitoring for adverse effects is crucial.

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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 carefully due to potential for decreased hepatic/renal function and polypharmacy. Monitor for exaggerated hypotensive or bradycardic responses.

Clinical Information

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Clinical Pearls

  • Kapspargo Sprinkle ER capsules can be opened and the beads sprinkled on a tablespoon of soft food (e.g., applesauce, pudding, yogurt) and swallowed immediately without chewing. Do not crush or chew the beads.
  • Always advise patients not to abruptly discontinue metoprolol due to the risk of rebound hypertension, angina exacerbation, or myocardial infarction.
  • Metoprolol succinate (ER) is preferred over metoprolol tartrate (IR) for chronic conditions like heart failure due to its once-daily dosing and smoother blood pressure control.
  • Patients with asthma or COPD should use metoprolol with caution, as even cardioselective beta-blockers can cause bronchospasm at higher doses or in susceptible individuals.
  • Beta-blockers can mask symptoms of hypoglycemia in diabetic patients, except for sweating. Educate patients to monitor blood glucose closely.
  • Monitor for signs of depression, as beta-blockers can sometimes exacerbate or induce depressive symptoms.
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Alternative Therapies

  • Other Beta-blockers (e.g., carvedilol, bisoprolol, atenolol, nebivolol)
  • ACE Inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine, felodipine)
  • 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: $100 - $300+ per 30 capsules (Kapspargo 50mg)
Generic Available: Yes
Insurance Coverage: Generic metoprolol succinate ER is typically Tier 1 or 2. Brand-name Kapspargo Sprinkle may be Tier 2 or 3.
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.