Kapspargo Sprinkle ER 200mg Caps

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
Mar 2018
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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 works by blocking certain natural chemicals in your body that affect the heart and blood vessels. This can help reduce the workload on your heart, making it beat slower and with less force. It is 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 if you have trouble swallowing pills whole.
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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 mix it with a soft food like applesauce, pudding, or yogurt. To do this, sprinkle the contents of the tablet onto the soft food and swallow the mixture within 60 minutes without chewing. Be sure to swallow the mixture right away and do not save it for later 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 medication.

Storing and Disposing of Your Medication

Keep 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 your medication exactly as prescribed, usually once daily, at the same time each day.
  • Do not stop taking this medication suddenly, as it can worsen your condition. Your doctor will tell you how to slowly reduce the dose if needed.
  • Take with food or immediately after a meal to increase absorption and reduce stomach upset.
  • If you cannot swallow the capsule whole, you can open it and sprinkle the contents on a spoonful of soft food (like applesauce, pudding, or yogurt) and swallow immediately without chewing.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium), regular exercise, and avoiding smoking and excessive alcohol consumption.
  • Be aware that this medication may cause dizziness or lightheadedness, especially when standing up quickly. Avoid driving or operating machinery until you know how it affects you.
  • If you have diabetes, be aware that this medication may mask the symptoms of low blood sugar (like a fast heartbeat).

Dosing & Administration

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Adult Dosing

Standard Dose: Dosage is individualized. For hypertension, initial 25-100 mg once daily; maintenance 100-400 mg once daily. For angina, initial 100 mg once daily; maintenance 100-400 mg once daily. For heart failure, initial 12.5-25 mg once daily, titrated slowly to target 200 mg once daily.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

Hypertension: Initial 25-100 mg once daily; maintenance 100-400 mg once daily.
Angina Pectoris: Initial 100 mg once daily; maintenance 100-400 mg once daily.
Stable Symptomatic Heart Failure (NYHA Class II-IV): Initial 12.5-25 mg once daily, titrated slowly over weeks to target 200 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For hypertension (6 years and older): Initial 0.5 mg/kg once daily (maximum 50 mg), titrated to maximum 2 mg/kg (maximum 200 mg) once daily.
Adolescent: For hypertension (6 years and older): Initial 0.5 mg/kg once daily (maximum 50 mg), titrated to maximum 2 mg/kg (maximum 200 mg) once daily.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: No dosage adjustment necessary.
Dialysis: Metoprolol is not significantly removed by hemodialysis; no dosage adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor closely.
Moderate: Consider dosage reduction, especially in patients with cirrhosis.
Severe: Significant dosage reduction may be necessary due to reduced metabolism and increased bioavailability. Start with lowest dose and titrate cautiously.

Pharmacology

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Mechanism of Action

Metoprolol is a beta-1 selective (cardioselective) adrenergic receptor blocking agent. It competitively blocks beta-1 adrenergic receptors, primarily located in the heart, reducing heart rate, cardiac contractility, and cardiac output. This leads to a reduction in blood pressure. 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)
Tmax: 6-12 hours (extended-release formulation)
FoodEffect: Food increases the bioavailability of metoprolol by 20-40%.

Distribution:

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

Elimination:

HalfLife: 3-7 hours (extended-release formulation)
Clearance: Approximately 1 L/min
ExcretionRoute: Renal
Unchanged: <5%
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

Ischemic Heart Disease: Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol 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 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

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 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, wheezing, or shortness of breath
  • Swelling in your ankles or feet
  • Unusual weight gain
  • Chest pain that worsens or occurs more frequently
  • Signs of depression (e.g., persistent sadness, loss of interest)
  • Coldness or numbness in your fingers and toes
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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 circulation to your 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 (OTC) 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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up 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 the results of 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 people with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, discuss them with your doctor.

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

Interactions with Other Medications
If you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter products that may increase blood pressure, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

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 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 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 this medication may reduce the effectiveness of epinephrine.

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)
  • Bronchospasm (difficulty breathing, wheezing)
  • Cardiac arrest
  • Cardiogenic shock
  • Heart failure
  • Nausea, vomiting
  • Hypoglycemia (low blood sugar)
  • Loss of consciousness, coma
  • Seizures

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and may include atropine for bradycardia, vasopressors for hypotension, glucagon, and bronchodilators.

Drug Interactions

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Contraindicated Interactions

  • Diltiazem (IV)
  • Verapamil (IV)
  • Clonidine (abrupt withdrawal while on metoprolol)
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Major Interactions

  • Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, propafenone, ritonavir, bupropion, terbinafine): May significantly increase metoprolol plasma concentrations.
  • Other AV nodal blocking agents (e.g., diltiazem, verapamil, digoxin): Increased risk of bradycardia, AV block, and hypotension.
  • Clonidine: If discontinuing clonidine, metoprolol should be withdrawn several days before the gradual withdrawal of clonidine to avoid rebound hypertension.
  • Fingolimod: Increased risk of bradycardia and AV block.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen): May blunt the antihypertensive effect of beta-blockers.
  • Alpha-1 blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
  • Insulin and oral hypoglycemic agents: Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
  • Sympathomimetics (e.g., epinephrine, norepinephrine): May antagonize the effects of beta-blockers.
  • Rifampin: May decrease metoprolol plasma concentrations.
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Minor Interactions

  • Alcohol: May increase metoprolol plasma levels slightly.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia.

Timing: Prior to initiation of therapy.

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 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 metabolized in the liver and dose adjustment may be needed in severe hepatic impairment.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

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

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

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Typically 50-60 bpm at rest, unless otherwise clinically indicated.

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

Signs/Symptoms of Heart Failure Exacerbation

Frequency: Regularly, especially in patients with heart failure.

Target: N/A

Action Threshold: Worsening dyspnea, edema, weight gain, fatigue.

Signs/Symptoms of Bronchospasm

Frequency: Regularly, especially in patients with asthma/COPD.

Target: N/A

Action Threshold: Wheezing, shortness of breath, cough.

Blood Glucose (in diabetic patients)

Frequency: Regularly

Target: Individualized

Action Threshold: Unexplained hypoglycemia or hyperglycemia (beta-blockers can mask hypoglycemia symptoms).

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Fatigue
  • Dizziness
  • Shortness of breath or wheezing
  • Cold extremities
  • Swelling in ankles or feet
  • Depression
  • Insomnia
  • Sexual dysfunction

Special Patient Groups

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Pregnancy

Metoprolol is classified as Pregnancy Category C. It should be used 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. There have been reports of intrauterine growth restriction with beta-blocker use.

Trimester-Specific Risks:

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

Metoprolol is excreted into breast milk. The amount is generally considered low, but there is a potential for adverse effects in the breastfed infant, particularly in neonates or infants with impaired renal/hepatic function. The American Academy of Pediatrics considers metoprolol to be 'compatible with breastfeeding'. Monitor the infant for signs of beta-blockade (e.g., bradycardia, hypotension, lethargy, poor feeding).

Infant Risk: Low to moderate risk (L3). Monitor infant for bradycardia, hypotension, and other signs of beta-blockade.
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Pediatric Use

Metoprolol succinate extended-release is approved for the treatment of hypertension in pediatric patients 6 years of age and older. Dosing is weight-based and should be carefully titrated. Safety and effectiveness in pediatric patients younger than 6 years of age have not been established.

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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, hypotension, and dizziness, as elderly patients may be more susceptible to these effects.

Clinical Information

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Clinical Pearls

  • Kapspargo Sprinkle ER capsules can be opened and sprinkled on soft food (e.g., applesauce, pudding, yogurt) for patients who have difficulty swallowing whole capsules. The entire contents should be swallowed immediately without chewing.
  • Do NOT crush or chew the capsule or its contents if taken whole, as this will destroy the extended-release properties and lead to rapid absorption and potential toxicity.
  • Always take metoprolol succinate with food or immediately after a meal to enhance absorption and reduce the risk of gastrointestinal upset.
  • Abrupt discontinuation of metoprolol can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with ischemic heart disease. Taper the dose gradually over 1-2 weeks.
  • Metoprolol can mask the symptoms of hypoglycemia (e.g., tachycardia) in diabetic patients and hyperthyroidism (e.g., tachycardia).
  • Use with caution in patients with bronchospastic diseases (e.g., asthma, COPD) as beta-1 selectivity is not absolute, especially at higher doses.
  • Monitor for signs of worsening heart failure, especially during initiation or dose titration in patients with heart failure.
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Alternative Therapies

  • Other Beta-Blockers (e.g., Atenolol, Carvedilol, Bisoprolol, Labetalol, Propranolol)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Calcium Channel Blockers (e.g., Amlodipine, Diltiazem, Verapamil)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide)
  • Alpha-Blockers (e.g., Prazosin, Doxazosin)
  • Direct Vasodilators (e.g., Hydralazine, Minoxidil)
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Cost & Coverage

Average Cost: Check current pricing (varies significantly by pharmacy and dosage) per 30 capsules
Generic Available: Yes
Insurance Coverage: Typically Tier 1 or Tier 2 for generic metoprolol succinate ER; Kapspargo Sprinkle may be Tier 2 or 3.
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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 happened.