Ramipril 2.5mg Capsules

Manufacturer LUPIN Active Ingredient Ramipril(RA mi pril) Pronunciation RA mi pril
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It is used to help heart function after a heart attack.It is used to lower the chance of heart attack, stroke, and death in some people.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Category D/X
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FDA Approved
Feb 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ramipril is a medication used to treat high blood pressure and heart failure. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. It can also help protect your heart and kidneys.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Swallow the medication whole; do not chew or crush it.
If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce or into apple juice, but be sure not to chew.
Alternatively, you can sprinkle the capsule contents into a glass of water.
If needed, you can prepare a dose ahead of time and store the mixture at room temperature for up to 24 hours or in the refrigerator for up to 48 hours.

Storing and Disposing of Your Medication

To ensure your medication remains effective and safe:

Store your medication at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Continue to follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Avoid potassium-rich salt substitutes unless advised by your doctor.
  • Do not stop taking ramipril suddenly without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 2.5 mg orally once daily. Heart Failure Post-MI: Initial 2.5 mg orally twice daily.
Dose Range: 1.25 - 20 mg

Condition-Specific Dosing:

Hypertension: Initial 2.5 mg once daily; maintenance 2.5-20 mg/day in 1-2 divided doses.
Heart Failure Post-MI: Initial 2.5 mg twice daily; titrate to target 5 mg twice daily.
Reduction in CV events: Initial 2.5 mg once daily; titrate to target 10 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, generally not recommended)
Adolescent: Not established (limited data, generally not recommended)
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 60 mL/min: No adjustment needed.
Moderate: CrCl 30-60 mL/min: Initial 1.25 mg once daily; max 5 mg/day.
Severe: CrCl < 30 mL/min: Initial 1.25 mg once daily; max 2.5 mg/day.
Dialysis: Initial 1.25 mg once daily; max 2.5 mg/day. Administer after dialysis session.

Hepatic Impairment:

Mild: Initial 1.25 mg once daily; titrate cautiously.
Moderate: Initial 1.25 mg once daily; titrate cautiously. Monitor closely.
Severe: Not recommended due to lack of data and potential for increased ramiprilat levels.

Pharmacology

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Mechanism of Action

Ramipril is a prodrug that is hydrolyzed in the liver to its active metabolite, ramiprilat. Ramiprilat inhibits the angiotensin-converting enzyme (ACE), which is responsible for the conversion of angiotensin I to the potent vasoconstrictor angiotensin II. This inhibition leads to decreased plasma angiotensin II, resulting in decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and increased bradykinin levels (a vasodilator). These actions collectively lead to a reduction in blood pressure and beneficial effects in heart failure.
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Pharmacokinetics

Absorption:

Bioavailability: 28% (ramipril), 44% (ramiprilat from ramipril)
Tmax: Ramipril: 1 hour; Ramiprilat: 2-4 hours
FoodEffect: Food does not significantly affect absorption, but may delay Tmax.

Distribution:

Vd: Not available (extensive tissue distribution)
ProteinBinding: Ramipril: ~73%; Ramiprilat: ~56%
CnssPenetration: Limited

Elimination:

HalfLife: Ramipril: 1-2 hours; Ramiprilat: 13-17 hours (effective half-life due to slow dissociation from ACE)
Clearance: Primarily renal clearance of ramiprilat and its inactive metabolites.
ExcretionRoute: Renal (approximately 60% of dose), Fecal (approximately 40% of dose)
Unchanged: Less than 2% (ramipril)
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Pharmacodynamics

OnsetOfAction: 1-2 hours
PeakEffect: 3-6 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue ramipril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Persistent cough
Severe stomach pain
Severe nausea or vomiting
Liver problems, which can be life-threatening. Seek medical help immediately if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

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 unusual symptoms, contact your doctor or seek medical help:

Dizziness or headache
Cough
* Fatigue or weakness

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

  • Sudden swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Difficulty breathing or swallowing.
  • Severe dizziness or fainting.
  • Persistent dry cough that is bothersome.
  • Signs of high potassium, such as muscle weakness, slow or irregular heartbeat.
  • Signs of kidney problems, such as decreased urination or swelling in the ankles/feet.
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of angioedema, a severe and potentially life-threatening reaction characterized by swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Current or recent use of telmisartan or another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Use of a medication containing sacubitril within the last 36 hours.
Breast-feeding, as this medication is not recommended during breast-feeding.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine the safety of taking this medication with your existing treatments and health status. Never start, stop, or adjust the dose of any medication without consulting your doctor.
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Precautions & Cautions

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

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure and having regular blood tests. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Additionally, if you are on a low-sodium or sodium-free diet, discuss this with your doctor.

This medication can cause a decrease in white blood cell count, which may increase your risk of infection. This is more likely to occur in individuals with kidney problems, especially those with other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or a sore throat, contact your doctor immediately.

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, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Discuss your alcohol consumption with your doctor before drinking. In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

It is crucial to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. If you have questions or concerns, consult your doctor.

A rare but potentially life-threatening reaction called angioedema can occur with this medication. The risk of angioedema may be higher in Black patients.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Bradycardia (slow heart rate)
  • Electrolyte disturbances (e.g., hyperkalemia)
  • Renal failure
  • Shock

What to Do:

Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. Treatment is supportive, including IV fluids for hypotension, and monitoring of vital signs and electrolytes.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or moderate-to-severe renal impairment)
  • Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of last dose of sacubitril/valsartan
  • Angiotensin Receptor Blockers (ARBs) - generally not recommended for dual blockade
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
  • Potassium supplements - increased risk of hyperkalemia
  • NSAIDs (Nonsteroidal Anti-inflammatory Drugs) - may reduce antihypertensive effect and increase risk of renal impairment
  • Lithium - increased serum lithium levels and toxicity
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
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Moderate Interactions

  • Diuretics (thiazide, loop) - increased risk of symptomatic hypotension (especially first dose)
  • Other antihypertensives - additive hypotensive effects
  • Insulin and oral hypoglycemics - increased risk of hypoglycemia
  • Trimethoprim - increased risk of hyperkalemia
  • Cyclosporine - increased risk of hyperkalemia and renal dysfunction
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Minor Interactions

  • Allopurinol - increased risk of hypersensitivity reactions
  • Corticosteroids - may reduce antihypertensive effect

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)

Rationale: To assess baseline renal function, as ramipril is renally eliminated and can affect renal function.

Timing: Prior to initiation

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ramipril can cause hyperkalemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments and during maintenance therapy.

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg) warrants dose adjustment or re-evaluation.

Serum Creatinine (Cr) and BUN

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Stable, within normal limits or acceptable baseline variation.

Action Threshold: Significant increase (e.g., >30% from baseline or Cr >2.5 mg/dL) warrants dose reduction or discontinuation.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with renal impairment or on potassium-sparing diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: K+ >5.5 mEq/L warrants dose reduction or discontinuation.

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Symptom Monitoring

  • Persistent dry cough
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue
  • Muscle weakness or irregular heartbeat (signs of hyperkalemia)
  • Signs of infection (fever, sore throat) due to rare neutropenia

Special Patient Groups

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Pregnancy

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks, though data are less conclusive than for later trimesters.

Trimester-Specific Risks:

First Trimester: Potential for major congenital malformations (cardiovascular, CNS) has been suggested in some studies, but data are conflicting. Generally, use is avoided.
Second Trimester: Fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death.
Third Trimester: Fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death. Neonatal hypotension, hyperkalemia, and renal failure.
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Lactation

Not recommended. Ramipril and its active metabolite ramiprilat are excreted into breast milk in small amounts. Due to the potential for serious adverse effects in the nursing infant (e.g., hypotension, hyperkalemia), an alternative medication with a better safety profile during lactation should be considered.

Infant Risk: Low to moderate risk of adverse effects (e.g., hypotension, hyperkalemia, renal effects) in the infant. Monitor infant for signs of hypotension or hyperkalemia.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended. If used, close monitoring of blood pressure, renal function, and electrolytes is essential.

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Geriatric Use

Lower initial doses (e.g., 1.25 mg once daily) are recommended due to potential for decreased renal function and increased sensitivity to hypotensive effects. Titrate dose cautiously based on response and tolerability. Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • Ramipril is a prodrug; its active metabolite, ramiprilat, is responsible for its therapeutic effects.
  • A common side effect is a persistent, dry cough, which is a class effect of ACE inhibitors and often leads to discontinuation. If cough is intolerable, an ARB may be considered as an alternative.
  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, dialysis). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and advised to seek immediate medical attention if it occurs. It can occur at any time during therapy.
  • Hyperkalemia is a risk, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements. Regular monitoring of serum potassium is crucial.
  • Ramipril is often used for its cardiovascular protective effects beyond just blood pressure lowering, particularly in patients with high cardiovascular risk, heart failure, or post-MI.
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Alternative Therapies

  • Other ACE inhibitors (e.g., lisinopril, enalapril, perindopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, candesartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine, nifedipine)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
  • Beta-blockers (e.g., metoprolol, carvedilol)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (generic 2.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.