Ramipril 1.25mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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.
Before Using This Medicine
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.
Precautions & 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.
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
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.
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.
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.
Minor Interactions
- Alcohol - may enhance hypotensive effect.
- Allopurinol - increased risk of hypersensitivity reactions.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and assess efficacy.
Timing: Prior to initiation
Rationale: To assess renal function, as ramipril is renally eliminated and can affect renal perfusion.
Timing: Prior to initiation
Rationale: To assess baseline potassium levels, as ramipril can cause hyperkalemia.
Timing: Prior to initiation
Routine Monitoring
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)
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
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)
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
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:
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.
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.
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
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.
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)