Ramipril 5mg Capsules

Ramipril is a prodrug that is hydrolyzed in the liver to its active metabolite, ramiprilat. Ramiprilat is an angiotensin-converting enzyme (ACE) inhibitor. It inhibits ACE, an enzyme responsible for converting angiotensin I to angiotensin II. This inhibition leads to decreased levels of angiotensin II, a potent vasoconstrictor, and decreased aldosterone secretion. Reduced angiotensin II results in vasodilation, decreased peripheral vascular resistance, and reduced blood pressure. It also reduces aldosterone-mediated sodium and water reabsorption, leading to decreased blood volume. Additionally, ACE inhibition prevents the degradation of bradykinin, a potent vasodilator, which may contribute to the antihypertensive effect and some side effects like cough and angioedema.

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. Watch for signs such as:
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dizziness or headache
Cough
* Feeling tired or weak

This is not an exhaustive list of possible 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.

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. 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, particularly if you have diabetes or kidney problems.
Current or prior use of 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, as 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 with your existing treatments and health status. 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 know how this medication affects you, avoid driving and other activities that require you to be alert. 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
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.

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 medical attention immediately 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 Heat-Related Illness
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.

• Aliskiren (in patients with diabetes mellitus or renal impairment [GFR < 60 mL/min/1.73 m²])
• Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of switching from/to an ACE inhibitor due to increased risk of angioedema.

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia.
• Potassium supplements - increased risk of hyperkalemia.
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib) - may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly or volume-depleted patients.
• Lithium - increased serum lithium levels and lithium toxicity.
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema (see contraindicated).

• Diuretics (thiazide, loop) - increased risk of symptomatic hypotension, especially with initial doses.
• Other antihypertensives - additive hypotensive effects.
• Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely.
• Insulin and oral hypoglycemic agents - increased risk of hypoglycemia, especially at initiation of ACE inhibitor therapy.
• Trimethoprim/sulfamethoxazole (Bactrim) - increased risk of hyperkalemia.

• Alcohol - may enhance hypotensive effect.

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Persistent dry cough (common ACE inhibitor side effect)
• Swelling of face, lips, tongue, throat, or extremities (angioedema - medical emergency)
• Difficulty breathing or swallowing (angioedema)
• Signs of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, bradycardia)
• Signs of infection (e.g., fever, sore throat - rare, but indicative of neutropenia)

CONTRAINDICATED in the second and third trimesters of pregnancy due to significant risk of fetal injury and death (e.g., fetal hypotension, anuria, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential, though less established, risks.

Ramipril and its metabolites are excreted in human milk in very low concentrations. The risk to a breastfed infant is considered low, but caution is advised, especially with preterm or neonates. Monitor infant for hypotension, hyperkalemia, and renal effects. Consider alternative agents with more established safety profiles during lactation, especially for neonates.

Safety and efficacy have not been established in pediatric patients <16 years of age. Use is generally not recommended. If used in children 6-16 years for hypertension, careful titration and monitoring are required due to potential for dose-dependent adverse effects.

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses (e.g., 1.25 mg once daily) and titrate cautiously, especially considering potential for age-related decline in renal function and increased sensitivity to hypotensive effects. Monitor renal function and potassium 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 up to 20% of patients, and often leads to discontinuation. If bothersome, an ARB may be considered as an alternative.
• Angioedema is a rare but life-threatening side effect. Patients should be educated on symptoms and to seek immediate medical attention if it occurs.
• Risk of hyperkalemia is increased with concomitant use of potassium-sparing diuretics, potassium supplements, NSAIDs, or in patients with renal impairment or diabetes.
• First-dose hypotension can occur, especially in volume-depleted patients (e.g., those on diuretics). Consider discontinuing diuretics 2-3 days prior to initiating ramipril, or starting with a very low dose and monitoring closely.
• Renal function and serum potassium should be monitored regularly, especially at initiation and after dose changes.

• Other ACE inhibitors (e.g., lisinopril, enalapril, captopril)
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, candesartan) - often used if ACE inhibitor cough or angioedema occurs.
• Beta-blockers (e.g., metoprolol, carvedilol)
• Calcium Channel Blockers (e.g., amlodipine, diltiazem)
• Thiazide diuretics (e.g., hydrochlorothiazide)
• Direct Renin Inhibitors (e.g., aliskiren - limited use due to safety concerns)

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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.