Kapspargo Sprinkle ER 100mg 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
Feb 2018
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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 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. The 'Sprinkle' means you can open the capsule and sprinkle the beads 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 to you 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 in advance or store it for future use.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. If you have a feeding tube, you can still use this medication - follow the instructions provided by your healthcare provider. After administering the medication through the feeding tube, be sure to flush the tube.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Protect it from heat.

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 dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, do not stop abruptly.
  • Monitor blood pressure and heart rate regularly at home.
  • Maintain a healthy diet (low sodium, low fat).
  • Engage in regular physical activity as advised by your doctor.
  • Limit alcohol intake.
  • Quit smoking.
  • Manage stress.
  • Inform all healthcare providers that you are taking this medication.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 25-100 mg once daily; Angina: Initial 100 mg once daily; Heart Failure: Initial 25 mg once daily (NYHA Class II) or 12.5 mg once daily (NYHA Class III/IV), titrated slowly.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

hypertension: Initial 25-100 mg once daily, maintenance 25-400 mg once daily.
anginaPectoris: Initial 100 mg once daily, maintenance 100-400 mg once daily.
heartFailure: Initial 12.5-25 mg once daily, titrated slowly over weeks to months to target 200 mg once daily as tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (6 years and older): Initial 1 mg/kg once daily (max 50 mg), titrated to max 2 mg/kg (max 200 mg) once daily.
Adolescent: Hypertension: Initial 1 mg/kg once daily (max 50 mg), titrated to max 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: Not significantly removed by hemodialysis; no supplemental dose needed.

Hepatic Impairment:

Mild: No specific adjustment, monitor for increased effects.
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 selectively blocks beta-1 receptors, primarily located in the heart, reducing heart rate, myocardial contractility, and cardiac output. It also reduces renin release from the kidneys. At higher doses, it can also block beta-2 receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (due to first-pass metabolism), but can vary significantly (30-70%).
Tmax: Extended-release: 6-12 hours
FoodEffect: Food increases the bioavailability of metoprolol by 20-40%.

Distribution:

Vd: Approximately 5.6 L/kg
ProteinBinding: Approximately 10-12%
CnssPenetration: Limited (lipophilicity is moderate, less than propranolol)

Elimination:

HalfLife: Extended-release: 5-9 hours (variable, influenced by CYP2D6 polymorphism)
Clearance: Hepatic clearance, approximately 1 L/min
ExcretionRoute: Renal (primarily metabolites, small amount of unchanged drug)
Unchanged: Approximately 3-10% (unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: Extended-release: Within hours (for blood pressure reduction)
PeakEffect: Extended-release: 6-12 hours
DurationOfAction: 24 hours (due to extended-release 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 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. 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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Depression
Severe dizziness or fainting
New or worsening chest pain
New or worsening abnormal heartbeat
Slow heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Feeling dizzy, tired, or weak
Diarrhea
Upset stomach
Vomiting

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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 (e.g., less than 50 beats per minute)
  • New or worsening shortness of breath
  • Swelling in your hands, ankles, or feet
  • Unusual weight gain
  • Severe fatigue or weakness
  • Coldness or numbness in fingers and toes
  • Symptoms of depression (e.g., persistent sadness, loss of interest)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain heart conditions, such as:
+ Abnormal heart rhythms (heart block or sick-sinus syndrome)
+ Heart failure (a weakened heart)
+ Low blood pressure
+ Poor blood circulation to the arms or legs
+ Shock caused by heart problems
+ A slow heartbeat
Respiratory issues, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD) or other breathing problems

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, natural products, and 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 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
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.

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 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.

Overactive Thyroid
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. Consult your doctor for guidance.

Allergic Reactions
If you have a history of severe allergic reactions, discuss this with your doctor, as 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, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

Alcohol Consumption
Avoid consuming alcohol 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
  • Loss of consciousness
  • Seizures
  • Cardiac arrest

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • MAO inhibitors (non-selective, due to potential for hypertensive crisis if used with other sympathomimetics, though direct interaction with metoprolol is less clear)
  • Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, propafenone, ritonavir) in patients who are extensive metabolizers, leading to significantly increased metoprolol levels and risk of toxicity.
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Major Interactions

  • Verapamil, Diltiazem (increased risk of bradycardia, AV block, hypotension, heart failure exacerbation)
  • Clonidine (potential for rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first)
  • Digoxin (additive bradycardia)
  • Other beta-blockers (additive effects)
  • Reserpine, Guanethidine (additive hypotensive and bradycardic effects)
  • Fingolimod (severe bradycardia and heart block)
  • Strong CYP2D6 inhibitors (e.g., bupropion, duloxetine, terbinafine) - significant increase in metoprolol exposure.
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Moderate Interactions

  • NSAIDs (may reduce antihypertensive effect of metoprolol)
  • Rifampin (decreased metoprolol levels due to enzyme induction)
  • Cimetidine (increased metoprolol levels due to enzyme inhibition)
  • Hydralazine (increased metoprolol levels)
  • Alcohol (may increase metoprolol levels)
  • Insulin and oral hypoglycemics (beta-blockers may mask symptoms of hypoglycemia and prolong hypoglycemic episodes)
  • Epinephrine (paradoxical hypertension and bradycardia)
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Minor Interactions

  • Antacids (may slightly decrease metoprolol absorption)

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 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 health, though metoprolol is primarily hepatically metabolized, renal function is important for overall patient assessment.

Timing: Prior to initiation

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess liver health, as metoprolol is hepatically metabolized.

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: Systolic >140 mmHg or Diastolic >90 mmHg (consider dose increase); Systolic <90 mmHg or symptomatic hypotension (consider dose decrease)

Heart Rate (HR)

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

Target: 50-70 bpm (resting)

Action Threshold: <50 bpm or symptomatic bradycardia (consider dose decrease or discontinuation)

Signs/Symptoms of Heart Failure

Frequency: Regularly (especially in heart failure patients)

Target: Improvement or stability of symptoms (e.g., dyspnea, edema, fatigue)

Action Threshold: Worsening symptoms (consider dose adjustment, diuretic, or other HF therapy)

Blood Glucose (in diabetic patients)

Frequency: Regularly (as per diabetes management guidelines)

Target: Individualized

Action Threshold: Frequent or severe hypoglycemia (beta-blockers can mask symptoms)

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Swelling in ankles/feet
  • Weight gain
  • Chest pain
  • Cold hands/feet
  • Depression
  • 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. Beta-blockers can cause fetal/neonatal bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for signs of beta-blockade for 48-72 hours after birth.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless essential.
Second Trimester: Potential for fetal growth restriction, bradycardia, hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor.
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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, lethargy, poor feeding). Generally considered compatible with breastfeeding, especially with extended-release formulations 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 efficacy for hypertension established in children 6 years and older. Dosing is weight-based. Not recommended for heart failure or angina in pediatric patients. 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 slowly due to potential for decreased hepatic metabolism and increased sensitivity to hypotensive/bradycardic effects. Monitor renal function.

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.
  • Do not discontinue metoprolol abruptly, especially in patients with ischemic heart disease, due to the risk of rebound angina, myocardial infarction, or sudden death. Taper dose gradually over 1-2 weeks.
  • Use with caution in patients with bronchospastic diseases (e.g., asthma, COPD) as even beta-1 selective agents can cause bronchoconstriction at higher doses or in susceptible individuals. A beta-1 selective agent like metoprolol is preferred over non-selective beta-blockers if a beta-blocker is necessary.
  • Beta-blockers can mask symptoms of hypoglycemia (e.g., tremor, palpitations) in diabetic patients. Monitor blood glucose closely.
  • Monitor for signs of worsening heart failure, especially during initiation or dose titration in heart failure patients, as beta-blockers can initially worsen symptoms before providing long-term benefit.
  • Patients should be advised to report any symptoms of bradycardia, dizziness, or shortness of breath.
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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, verapamil, diltiazem)
  • 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: Varies widely, typically $100-$300+ per 30 capsules (Kapspargo 100mg)
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, depending on formulary.
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General Drug Facts

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