Ramipril 10mg Capsules

Ramipril is a prodrug that is hydrolyzed to its active metabolite, ramiprilat. 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 reabsorption and increased potassium retention), and increased bradykinin levels (a potent vasodilator). These actions result in reduced peripheral vascular resistance, decreased blood pressure, and improved cardiac output.

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. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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)

Note that liver problems have been reported with similar medications, and in some cases, have been fatal.

Other Possible Side Effects

Most people experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness or headache
Cough
* Fatigue or weakness

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

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

It is crucial 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. Be sure to describe the allergic reaction you experienced, including any 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.
If you are taking a medication containing aliskiren, especially if you have diabetes or kidney problems.
Current or prior use of telmisartan.
Use of 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. Note that you should not breastfeed while taking this medication.

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 tasks 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 instructed 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.

Infection Risk
This medication, similar to captopril, may cause a decrease in white blood cell count, increasing the risk of infection. This risk is higher in individuals with kidney problems, particularly those with other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.

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 or 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. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions 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.

• 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

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• 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., everolimus, sirolimus, temsirolimus) - increased risk of angioedema
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema
• Dual blockade of the Renin-Angiotensin System (RAS) with ARBs or aliskiren - increased risk of hypotension, hyperkalemia, and renal impairment

• Other antihypertensives (additive hypotensive effect)
• Diuretics (initial excessive hypotension)
• Insulin and oral hypoglycemic agents (increased risk of hypoglycemia)
• Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
• Corticosteroids (may reduce antihypertensive effect)

• Alcohol (additive hypotensive effect)
• Antacids (may decrease absorption, separate administration)

• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing)
• Symptoms of hypotension (dizziness, lightheadedness, fainting)
• Persistent dry cough
• Symptoms of hyperkalemia (muscle weakness, fatigue, paresthesias, bradycardia, irregular heartbeat)
• Signs of liver dysfunction (jaundice, dark urine, abdominal pain)
• Symptoms of neutropenia (fever, sore throat, signs of infection)

CONTRAINDICATED. Ramipril can cause injury and death to the developing fetus. If pregnancy is detected, discontinue ramipril as soon as possible.

Use with caution. Ramipril and its metabolites are excreted in breast milk in very low amounts. The risk to the infant is considered low, but monitor for hypotension, hyperkalemia, and renal function.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

Start with lower doses (e.g., 1.25 mg once daily) and titrate cautiously, as elderly patients may have reduced renal function and be more sensitive to the hypotensive effects. Monitor renal function and potassium levels closely.

• Ramipril is a prodrug; its active metabolite, ramiprilat, is responsible for its therapeutic effects.
• A persistent dry cough is a common side effect of ACE inhibitors, occurring in 5-20% of patients. If bothersome, an alternative class (e.g., ARB) may be considered.
• 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.
• Hyperkalemia risk is increased in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics, potassium supplements, or NSAIDs.
• First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
• Ramipril is effective for cardiovascular risk reduction beyond just blood pressure lowering, particularly in patients with high cardiovascular risk (e.g., history of MI, stroke, or diabetes with at least one other CV risk factor).

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

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.