Ramipril

Ramipril is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Ramipril is also used to improve survival after a heart attack. It may also be used in high risk patients (such as patients with heart disease/diabetes) to help prevent heart attacks and strokes. Ramipril may also be used to treat heart failure in patients who have had a recent heart attack.

Ramipril is an ACE inhibitor and works by relaxing blood vessels so that blood can flow more easily.

Ramipril may also be used to help protect the kidneys from harm due to diabetes.

Ramipril is available under the following different brand names: Altace.

Dosage Forms and Strengths

Capsules

•     1.25 mg
•     2.5 mg
•     5 mg
•     10 mg

Dosage Considerations – Should be Given as Follows:

Hypertension

•     Initial (not on diuretic): 2.5 mg orally once/day
•     Initial (with diuretic): 1.25 mg orally once/day
•     Maintenance: 2.5-20 mg/day orally once/day or divided every 12 hours

Heart Failure (Post-Myocardial Infarction)

•  Stable patients with congestive heart failure (CHF) signs within a few days of acute heart attack (myocardial infarction [MI])
•  Initial: 2.5 mg orally every 12 hours; may titrate to 5 mg orally every 12 hours; decrease to 1.25 mg every 12 hours if hypotension occurs; monitor for more than 2 hours after initial dose and reduce concomitant diuretic if hypotension occurs
• Maintenance: After 1 week, increase dose (if tolerated) to target dose of 5 mg every 12 hours

Myocardial Infarction/Stroke Prevention

• Reduce risk of heart attack (myocardial infarction [MI]), stroke, or death from cardiovascular causes in patients 55 years and older
• Initial: 2.5 mg orally once/day for 1 week, THEN 5 mg once/day for 3 weeks
• Maintenance: Increase as tolerated to 10 mg once/day; for hypertensive or recently post-MI patients, give 5 mg orally BID    
• Dosing considerations                 
  • Reduce risk of MI, stroke, or death from cardiovascular causes in patients 55 years and older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, or peripheral vascular disease, or of diabetes that is accompanied by at least 1 other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria)

Diabetic Nephropathy (Off-label)  

• Initial (not on diuretic): 2.5 mg orally once/day    
• Initial (with diuretic): 1.25 mg orally once/day    
• Maintenance: 2.5-20 mg orally once/day; daily dose may be either increased or divided twice daily if antihypertensive effect is diminished toward the end of the dosing interval

Dosing Modifications

Renal impairment    

• CrCl less than 40 mL/min and concomitant diuretic therapy: Not to exceed 5 mg/day (25% of normal dose)
• Renal/heart failure: 1.25 mg orally once/day; may increase to 1.25 mg every 12 hours and to a maximum dose of 2.5 mg every 12 hours depending on clinical response and tolerability    
• Renal failure and hypertension: 1.25 mg orally once/day initially; may titrate upward, not to exceed 5 mg/day   
• Geriatric patients: At increased risk for renal dysfunction; adjust dose to renal clearance and monitor closely

Dosing Considerations 

• Requires weeks for full effect; to start, use low dose and titrate every 1-2 weeks
• Once/day dosing may result in diminished antihypertensive effect at end of day in some patients; consider increase in dosage or dosing interval (every 12 hours)   
• If blood pressure is not adequately treated, consider adding diuretic    
• Consider ACE inhibitor in high-risk patients, even if no hypertension or congestive heart failure (CHF)    
• Abrupt discontinuance not associated with rapid increase in blood pressure    
• Pediatric: Safety and efficacy not established

Administration    

• Swallow capsule whole; can also open capsule and sprinkle contents on small amount of applesauce or mixed in 120 mL of water or apple juice; mixture can be stored for less than 24 hours at room temperature or less than 48 hours under refrigeration.

Common side effects or health problems may include:

• Cough
• Low blood pressure (hypotension)
• Headache
• Chest pain (angina pectoris)
• Dizziness
• Nausea
• Vomiting
• Dizziness on standing
• Fainting
• Spinning sensation (vertigo)
• Abnormal kidney function
• Diarrhea
• Skin swelling
• Tired feeling
• Feeling unwell (malaise)
• Stomach discomfort

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any drug before seeking medical advice from your doctor, healthcare provider or pharmacist first. To do so may result in serious consequences or side effects.

Severe interactions of ramipril include:

• aliskiren
• protein A column

Ramipril has serious interactions with at 38 different drugs.

Ramipril has moderate interactions with at least 101 different drugs.

Ramipril has mild interactions with at least 30 different drugs.

Ramipril has mild interactions with at least 65 different drugs.
This document does not contain all possible interactions from the use of this medication. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death.
• This medication contains ramipril. Do not take Altace if you are allergic to ramipril or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to drug or other ACE inhibitors
• Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (i.e., GFR less than 60 mL/min/1.73 m²)

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Ramipril?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ramipril?"

Cautions

• Anaphylactoid and related reactions (head and neck/intestinal angioedema, anaphylaxis during desensitizing treatment with Hymenoptera venom, anaphylaxis during membrane exposure with high-flux membrane dialysis, and low-density lipoprotein apheresis with dextran sulfate absorption).
• (Rare) risk of hepatic failure, which starts as cholestatic jaundice and progresses to sometimes fatal fulminant hepatic necrosis; discontinue if patient develops jaundice or marked elevations of hepatic enzymes.
• Excessive low blood pressure (hypotension) if on concomitant diuretics, hypovolemia, hyponatremia; increased risk in congestive heart failure (CHF) patients; treat by placing patient in supine position and treating with IV infusion of physiologic saline if necessary.
• Increased hypotension risk in patients undergoing surgery or during anesthesia with agents that produce hypotension; correct by volume expansion in such situations.
• Coadministration with mTOR inhibitors (e.g., temsirolimus) may increased risk for angioedema.
• African American patients may have a smaller average reduction in blood pressure than other populations.
• Changes in renal function due to blockage of renin-angiotensin-aldosterone system; severe congestive heart failure (CHF) patients are at increased risk for oliguria or progressive azotemia and (rarely) for acute renal failure or death; increase in BUN/SCr may occur in patients with unilateral or bilateral renal artery stenosis; monitor closely.
• Reduction in red blood cell and hemoglobin content with rare cases of agranulocytosis, pancytopenia and bone marrow depression reported; collagen-vascular disease (systemic lupus erythematosus [SLE], scleroderma) patients with impaired renal function are at increased risk; monitor closely.
• Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy.
• Risk of hyperkalemia, especially in patients with renal impairment, DM, concomitant use of potassium-elevating drugs.
• Reversible, persistent, nonproductive cough thought to be due to inhibition of degradation of endogenous bradykinin.

Pregnancy and Lactation

• Use ramipril during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk.
• Discontinue ramipril use as soon as pregnancy detected. During the second and third trimesters of pregnancy, therapy can result in fetal injury (e.g., hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure) and death.
• Ramipril is possibly excreted in breast milk; nursing is not recommended.