Kapspargo Sprinkle ER 25mg 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
Feb 2020
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Kapspargo Sprinkle ER is a medication that helps to lower your blood pressure and heart rate. It can also help with chest pain (angina) and improve symptoms of heart failure. It works by relaxing blood vessels and making your heart beat more slowly and with less force. The 'Sprinkle ER' means it's an extended-release capsule that can be opened and sprinkled on soft food if you have trouble swallowing pills whole.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. 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 in advance or store it for later use.

Continue taking this 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 team and flush the feeding tube after administering the dose.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, away from bathrooms and heat sources.

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 your medication exactly as prescribed, usually once daily.
  • Do not stop taking this medication suddenly without talking to your doctor, as it can worsen your condition.
  • Monitor your blood pressure and heart rate regularly at home if advised by your doctor.
  • Maintain a healthy diet (low in sodium, saturated fats), engage in regular physical activity, and manage stress.
  • Limit alcohol intake as it can increase the effects of the medication.
  • Avoid smoking, as it can worsen heart conditions.
  • Inform your doctor or dentist that you are taking this medication before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage is individualized. Typically initiated at 25-100 mg once daily for hypertension/angina, or 12.5-25 mg once daily for heart failure, titrated weekly/bi-weekly.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

Hypertension: Initial: 25-100 mg once daily. Maintenance: 25-400 mg once daily.
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 dose (e.g., 200 mg once daily) as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension/angina. Limited data for heart failure, generally not recommended.
Adolescent: Not established for hypertension/angina. Limited data for heart failure, generally not recommended.
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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 (e.g., 50%) may be necessary due to reduced metabolism. Monitor closely for adverse effects.

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 in the heart, leading to decreased heart rate, myocardial contractility, and cardiac output. This results in reduced blood pressure and myocardial oxygen demand. At higher doses, it can also block beta-2 adrenergic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (variable, due to first-pass metabolism)
Tmax: 6-8 hours (for extended-release formulation)
FoodEffect: Food increases the bioavailability of metoprolol by 20-40%.

Distribution:

Vd: 5.6 L/kg
ProteinBinding: 10-12%
CnssPenetration: Limited (lipophilicity is moderate)

Elimination:

HalfLife: 3-7 hours (for extended-release, effective half-life is longer due to sustained release)
Clearance: Variable, dependent on hepatic blood flow and enzyme activity
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <5% (in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6-12 hours (for extended-release)
DurationOfAction: 24 hours (for extended-release)

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 extended-release, 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 extended-release administration should be reinstated 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 extended-release 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. While many people may not experience any side effects or only mild 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 (signs of low blood pressure)
  • Very slow heart rate (less than 50 beats per minute)
  • Difficulty breathing, wheezing, or new/worsening shortness of breath
  • Swelling in your ankles, feet, or legs, or sudden weight gain (signs of worsening heart failure)
  • Unusual fatigue or weakness
  • Coldness or numbness in your fingers and toes
  • Symptoms of depression (mood changes, loss of interest)
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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 you experienced, including the symptoms that occurred.
Certain heart-related conditions, such as:
+ Heart block or sick-sinus syndrome (types of abnormal heartbeats)
+ Heart failure (a weak heart)
+ Low blood pressure
+ Poor blood flow to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory conditions, including:
+ Asthma
+ Other breathing problems, such as COPD (chronic obstructive pulmonary disease)

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or 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. Do not initiate, stop, or modify the dose of any medication without first consulting your doctor.
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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. 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 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 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 stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Thyroid Conditions
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Discuss 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 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.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Hypotension (very low blood pressure)
  • Cardiogenic shock (heart failure leading to inadequate blood flow)
  • Bronchospasm (difficulty breathing, wheezing)
  • Cardiac arrest
  • Hypoglycemia (low blood sugar)
  • Loss of consciousness, seizures

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Do not induce vomiting unless instructed by a healthcare professional.

Drug Interactions

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Contraindicated Interactions

  • MAO inhibitors (non-selective, due to potential for hypertensive crisis if used with indirect-acting sympathomimetics)
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) - concomitant use should be avoided or require significant dose reduction of metoprolol due to increased metoprolol exposure and risk of bradycardia/hypotension.
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Major Interactions

  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and hypotension. Avoid concomitant IV administration.
  • Clonidine: May potentiate rebound hypertension upon clonidine withdrawal. Discontinue metoprolol several days before gradual withdrawal of clonidine.
  • Digoxin: Additive bradycardia.
  • Other beta-blockers (including ophthalmic): Additive systemic effects.
  • Reserpine, Guanethidine, Alpha-methyldopa: Additive hypotensive and bradycardic effects.
  • Prazosin, Terazosin, Doxazosin (alpha-1 blockers): Increased risk of first-dose hypotension.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of metoprolol.
  • Rifampin: May decrease metoprolol plasma concentrations (CYP2D6 induction).
  • Cimetidine: May increase metoprolol plasma concentrations (CYP2D6 inhibition).
  • Oral contraceptives: May increase metoprolol plasma concentrations.
  • Alcohol: May increase metoprolol plasma concentrations and enhance hypotensive effects.
  • Insulin and oral hypoglycemics: Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
  • Lidocaine: Metoprolol may reduce lidocaine clearance, increasing lidocaine levels and toxicity risk.
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Minor Interactions

  • Not specifically listed as minor, but general caution with other drugs affecting heart rate or blood pressure.

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

Timing: Prior to initiation, especially in heart failure patients

Renal Function (SCr, BUN)

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

Timing: Prior to initiation

Hepatic Function (ALT, AST, Bilirubin)

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

Timing: Prior to initiation

Blood Glucose (for diabetic patients)

Rationale: Beta-blockers can mask symptoms of hypoglycemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

Target: Individualized based on condition (e.g., <130/80 mmHg for hypertension)

Action Threshold: Persistent hypotension (e.g., SBP <90 mmHg) or inadequate BP control.

Heart Rate (HR)

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

Target: Typically 50-60 bpm at rest (unless target for specific condition differs)

Action Threshold: Bradycardia (<45-50 bpm) or symptomatic bradycardia.

Symptoms of Heart Failure/Angina

Frequency: Ongoing clinical assessment at each visit

Target: Improvement or stability of symptoms

Action Threshold: Worsening dyspnea, edema, weight gain, chest pain.

Blood Glucose (for diabetic patients)

Frequency: Regularly, as per diabetes management guidelines

Target: Individualized

Action Threshold: Frequent hypoglycemic episodes or difficulty recognizing hypoglycemia.

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue, lethargy
  • Shortness of breath, wheezing (especially in patients with reactive airway disease)
  • Peripheral edema, weight gain (signs of worsening heart failure)
  • Cold extremities
  • Depression, sleep disturbances
  • Masked symptoms of hypoglycemia (e.g., sweating, hunger, confusion may still be present, but tachycardia may be absent)

Special Patient Groups

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Pregnancy

Metoprolol is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers may cause bradycardia, hypoglycemia, and respiratory depression in the neonate. Monitor neonates for these effects.

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, especially if used close to delivery.
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Lactation

Metoprolol is excreted in breast milk. The amount is small, and adverse effects in breastfed infants are unlikely but possible. Monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding). L3 (Moderately Safe).

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and hypoglycemia. Use with caution, especially in preterm or unstable infants.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for hypertension or angina. For heart failure, limited data exist, and it is generally not recommended as first-line therapy. Use in children should be under specialist supervision.

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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 closely for adverse effects such as bradycardia and hypotension.

Clinical Information

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Clinical Pearls

  • Kapspargo Sprinkle ER capsules can be opened and the beads sprinkled on a spoonful of soft food (e.g., applesauce, pudding, yogurt) and swallowed immediately without chewing. Do not crush or chew the beads.
  • Always take metoprolol succinate extended-release consistently with food or on an empty stomach, but ideally with food to enhance absorption and reduce GI upset.
  • This is an extended-release formulation, designed for once-daily dosing. Do not substitute with immediate-release metoprolol tartrate on a milligram-for-milligram basis.
  • Patients with asthma or COPD should use metoprolol with extreme caution, as even beta-1 selective agents can cause bronchospasm at higher doses or in susceptible individuals.
  • Diabetic patients should be advised that beta-blockers can mask symptoms of hypoglycemia, particularly tachycardia. Other symptoms like sweating may still be present.
  • Patients should be educated on the importance of not abruptly discontinuing the medication due to the risk of rebound hypertension, angina exacerbation, or myocardial infarction.
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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., Valsartan, Losartan)
  • Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Diltiazem, Verapamil)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Alpha-1 Blockers (e.g., Prazosin, Terazosin)
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Cost & Coverage

Average Cost: Varies, typically $100-$300+ per 30 capsules (25mg)
Generic Available: Yes
Insurance Coverage: Brand-name Kapspargo may be Tier 2 or 3. Generic metoprolol succinate ER is typically Tier 1.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.