Ramipril 1.25mg Capsules

Manufacturer AUROBINDO 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; Heart Failure Agent; Cardiovascular Risk Reduction Agent
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Not available (FDA advises against use in pregnancy due to fetal toxicity)
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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, heart failure, and to reduce the risk of heart attacks or strokes. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure.
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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 to feel better.

Swallowing Your Medication

Swallow your medication whole; do not chew or crush it.
If you have trouble swallowing the capsule, you can sprinkle the contents on applesauce or in apple juice. However, do not chew the mixture.
Alternatively, you can sprinkle the contents of the capsule into a glass of water.
If needed, you can mix a dose ahead of time and store it at room temperature for up to 24 hours or in the refrigerator for up to 48 hours.

Staying Hydrated

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe 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, and consider participating in a drug take-back program in your area.

Missing a Dose

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

  • Take medication exactly as prescribed, usually once or twice daily.
  • Do not stop taking ramipril without consulting your doctor, even if you feel well.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Limit alcohol intake as it can increase the blood pressure lowering effect.
  • Maintain a healthy diet (low sodium), regular exercise, and manage stress to support blood pressure control.
  • Report any swelling of the face, lips, tongue, or throat immediately to your doctor or seek emergency care.

Dosing & Administration

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Adult Dosing

Standard Dose: 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; target 5 mg twice daily. Cardiovascular Risk Reduction: Initial 2.5 mg once daily; target 10 mg once 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. May start with 1.25 mg in patients on diuretics or with renal impairment.
Heart Failure Post-MI: Initial 2.5 mg twice daily; titrate up to 5 mg twice daily as tolerated.
Cardiovascular Risk Reduction: Initial 2.5 mg once daily for 1 week, then 5 mg once daily for 3 weeks, then increase as tolerated to a target of 10 mg once daily.
Stable Coronary Artery Disease: Initial 2.5 mg once daily; target 10 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Limited data; generally not recommended as first-line. Dosing typically 0.07 mg/kg once daily, max 5 mg/day. Close monitoring required.
Adolescent: Limited data; generally not recommended as first-line. Dosing typically 0.07 mg/kg once daily, max 5 mg/day. Close monitoring required.
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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. Ramiprilat is poorly dialyzable.

Hepatic Impairment:

Mild: Initial 1.25 mg once daily; titrate cautiously. Max 2.5 mg/day.
Moderate: Initial 1.25 mg once daily; titrate cautiously. Max 2.5 mg/day.
Severe: Use with caution; consider lower initial dose and slower titration. Max 2.5 mg/day.

Pharmacology

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Mechanism of Action

Ramipril is a prodrug that is metabolized to ramiprilat, its active metabolite. Ramiprilat inhibits angiotensin-converting enzyme (ACE), which prevents the conversion of angiotensin I to angiotensin II. This leads to decreased vasoconstriction, reduced aldosterone secretion (resulting in decreased sodium and water retention), and potentiation of bradykinin (leading to vasodilation). These effects result in reduced peripheral vascular resistance, decreased blood pressure, and reduced cardiac preload and afterload.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not available (extensive tissue distribution)
ProteinBinding: Approximately 73% (ramipril), 56% (ramiprilat)
CnssPenetration: Limited

Elimination:

HalfLife: 13-17 hours (effective half-life of ramiprilat, due to slow dissociation from ACE binding sites)
Clearance: Primarily renal
ExcretionRoute: Renal (approximately 60% as ramiprilat and its metabolites), Fecal (approximately 40%)
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

FETAL TOXICITY: 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 indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

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, contact your doctor for guidance:

Dizziness or headache
Cough
* Fatigue or weakness

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:

  • Swelling of the face, lips, tongue, or throat (angioedema) - seek emergency medical attention.
  • Severe dizziness or fainting (hypotension).
  • Persistent dry cough.
  • Yellowing of skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Signs of infection like fever or sore throat (rare, but could indicate low white blood cell count).
  • Signs of high potassium, such as unusual tiredness, weakness, muscle cramps, nausea, diarrhea, or irregular heartbeat.
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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 you experienced, including any symptoms that occurred.
If you have 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.
If you are currently taking a medication containing aliskiren and have diabetes or kidney problems.
If you are taking telmisartan or another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
If you have taken a medication containing sacubitril within the last 36 hours.
If you are breastfeeding. Please note that you should not breastfeed while taking this medication.

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 whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or modify 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
Until you understand how this medication affects you, avoid driving and other activities 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
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as recommended by your doctor, and discuss the results with them.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.

Risk of Infection
Low white blood cell counts have been associated with captopril, a similar medication. This may increase your risk of infection, particularly if you have kidney problems or other underlying health conditions. Seek immediate medical attention if you experience symptoms of infection, such as fever, chills, or sore throat.

Interactions with Over-the-Counter Products
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.

Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking while taking this medication.

Fluid Loss and Dehydration
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent fluid loss. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Effectiveness in Black Patients
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, discuss them with your doctor.

Risk of Angioedema
A severe and potentially life-threatening reaction called angioedema has been associated 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

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. 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 due to increased risk of angioedema.
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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 (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect and increase risk of renal impairment.
  • Lithium - increased serum lithium levels and toxicity.
  • ARBs (Angiotensin Receptor Blockers) - increased risk of hypotension, hyperkalemia, and renal impairment (dual blockade).
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
  • Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema.
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Moderate Interactions

  • Diuretics (thiazide, loop) - increased risk of symptomatic hypotension, especially with initial doses.
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia.
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely.
  • Tricyclic antidepressants, antipsychotics, anesthetics - increased risk of orthostatic hypotension.
  • Corticosteroids - may reduce antihypertensive effect.
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Minor Interactions

  • Alcohol - may enhance hypotensive effect.
  • Allopurinol - increased risk of hypersensitivity reactions.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation

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

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

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 changes, then periodically (e.g., monthly for first few months, then every 3-6 months)

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

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg)

Serum Creatinine (SCr) and BUN

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

Target: Stable or within acceptable limits (e.g., <30% increase from baseline)

Action Threshold: Significant increase (>30% from baseline or rapid rise), indicating potential renal impairment

Serum Potassium (K+)

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

Target: 3.5-5.0 mEq/L

Action Threshold: >5.5 mEq/L (hyperkalemia)

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Symptom Monitoring

  • Persistent dry cough
  • Swelling of face, lips, tongue, throat (angioedema)
  • Dizziness or lightheadedness (hypotension)
  • Fatigue, weakness, muscle cramps (hyperkalemia)
  • Signs of infection (e.g., fever, sore throat) due to rare neutropenia

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy, especially in the second and third trimesters, due to significant risk of fetal injury and death (e.g., fetal hypotension, anuria, renal failure, skull hypoplasia, death). Discontinue as soon as pregnancy is detected.

Trimester-Specific Risks:

First Trimester: Potential risk, though less clear than later trimesters. Advised to discontinue as soon as possible.
Second Trimester: High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
Third Trimester: High risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
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Lactation

Ramipril and its metabolites are excreted in breast milk in very low concentrations. Use with caution, especially in preterm infants or those with renal impairment. Monitor infant for hypotension and hyperkalemia. Consider alternative agents with more established safety data.

Infant Risk: Low risk, but potential for hypotension and hyperkalemia, especially in neonates/preterm infants.
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Pediatric Use

Safety and efficacy not fully established in pediatric patients. Use is generally not recommended as first-line. If used, close monitoring of blood pressure, renal function, and potassium is essential. Dosing is typically weight-based and lower than adult doses.

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Geriatric Use

Start with lower doses (e.g., 1.25 mg once daily) and titrate slowly due to potential for decreased renal function and increased sensitivity to hypotensive effects. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • The most common side effect is a persistent dry cough, which is a class effect of ACE inhibitors and usually resolves upon discontinuation.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and instructed to seek immediate medical attention if it occurs.
  • Ramipril is a prodrug; its active metabolite, ramiprilat, is responsible for its therapeutic effects.
  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
  • Monitor renal function and serum potassium regularly, especially in patients with pre-existing renal impairment, heart failure, or those taking potassium-sparing diuretics or potassium supplements.
  • Ramipril is often preferred for cardiovascular risk reduction due to evidence from the HOPE trial.
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Alternative Therapies

  • Other ACE inhibitors (e.g., lisinopril, enalapril, captopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, candesartan)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine)
  • Thiazide Diuretics (e.g., hydrochlorothiazide, chlorthalidone)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Direct Renin Inhibitors (e.g., aliskiren - limited use)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (1.25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.