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Ramipril

Class
Antihypertensives
Subclass
Angiotensin-converting enzyme inhibitors
Substance name
Ramipril
Brand names
Altace®
Common formulations
Capsule
Dosage and administration
Adults patients
HF in patients with myocardial infarction
•
Start at: 2.5 mg PO BID for 1 week
•
Maintenance: 5 mg PO BID
Reduce starting dose to 1.25 mg BID if hypotension occurs. Titrate to maintenance dose every 3 weeks as tolerated.
Hypertension
•
Start at: 2.5 mg PO daily
•
Maintenance: 2.5-20 mg PO daily, in 1-2 divided doses
•
Maximum: 20 mg per day
Diabetic nephropathy • Off-label
•
2.5-10 mg PO daily, in 1-2 divided doses
HFrEF • Off-label
•
Start at: 1.25-2.5 mg PO daily
•
Maintenance: 10 mg PO daily
Ischemia with no obstructive arteries • Off-label
•
2.5-10 mg PO daily
Myocardial infarction • Off-label
•
Start at: 2.5 mg PO BID
•
Maintenance: 5 mg PO BID
Proteinuria in patients with CKD • Off-label
•
Maintenance: 2.5-10 mg PO daily, in 1-2 divided doses
•
Maximum: 20 mg per day
Indications for use
Labeled indications
Adults
•
Treatment of HF in patients with myocardial infarction
•
Treatment of hypertension
•
Prevention of cardiovascular events (in patients ≥ 55 years) with high cardiovascular risk
Off-label indications
Adults
•
Treatment of diabetic nephropathy
•
Treatment of HFrEF
•
Treatment of ischemia with no obstructive arteries
•
Treatment of myocardial infarction
•
Treatment of proteinuria in patients with CKD
Safety risks
Boxed warnings
Fetal toxicity
•
Do not use in pregnant patients. Discontinue ramipril as soon as possible when pregnancy is detected.
Contraindications
Hypersensitivity to ramipril or its components or other ACEis
Concomitant use of aliskiren in patients with diabetes
Concomitant use of neprilysin inhibitors
•
Do not use ramipril with or within 36 hours of switching to or from neprilysin inhibitors.
Concomitant use of other ACEis or ARBs
Warnings and precautions
ACE inhibitor-associated cough
•
Maintain a high level of suspicion, as ACEis can cause persistent nonproductive cough.
ACE inhibitor-induced angioedema
•
Use caution in all patients, recognizing that patients patients taking mTOR inhibitors and Black people have a higher risk of developing angioedema. Discontinue ramipril if angioedema develops.
Agranulocytosis, decreased blood neutrophil count
•
Use caution in patients with renal impairment, especially in patients with a collagen vascular disease, such as SLE or scleroderma.
Anaphylactoid reactions
•
Use caution in patients on hemodialysis with high-flux membranes, desensitizing treatment with hymenoptera venom, or LDL apheresis with dextran sulfate absorption.
Cholestatic jaundice, hepatic necrosis
•
Maintain a high level of suspicion, as ACEis have been associated with an increased risk for these adverse events. Discontinue ramipril if jaundice or marked elevations of liver enzymes develops.
Hypotension
•
Use caution in patients with volume or salt depletion, such as with prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting, as well as in patients undergoing surgery or during anesthesia with agents producing hypotension.
Increased serum potassium
•
Use caution in patients with renal impairment, diabetes mellitus, or taking drugs increasing serum potassium levels. Monitor serum potassium levels periodically.
Renal failure
•
Use caution in patients with pre-existing renal impairment, severe congestive HF, unilateral or bilateral renal artery stenosis.
Specific populations
Renal impairment
CrCl ≥ 40 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 40 mL/min
•
Reduce dose by 75%. Monitor renal function. Monitor serum potassium. Monitor complete blood count.
Renal replacement therapy
Continuous renal replacement
•
Start at a dose of 2.5 mg. Maximal dose of 7.5 mg. Titrate slowly. Monitor for hypotension and anaphylactoid reactions.
Intermittent hemodialysis
•
Administer the dose after dialysis session. Start at a dose of 1.25 mg. Maximal dose of 5 mg. Monitor for hypotension and anaphylactoid reactions.
Peritoneal dialysis
•
Start at a dose of 1.25 mg. Maximal dose of 5 mg.
Hepatic impairment
Any severity
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans. Discontinue ramipril when pregnancy is detected.
•
Use of RAAS inhibitors during the second and third trimesters can cause reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, and skeletal deformations, including skull hypoplasia, hypotension, and death.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Hypotension, cough
Common 1-10%
•
↑ serum creatinine, ↑ serum potassium, orthostatic hypotension, angina pectoris, asthenia, belching, diarrhea, dizziness, fatigue, headache, nausea, syncope, vertigo, vomiting
Uncommon < 1%
•
Agranulocytosis, ↓ blood neutrophil count, angioedema, photosensitivity of skin, Stevens-Johnson syndrome
Unknown frequency
•
Acute liver failure, acute pancreatitis, hepatic necrosis, anaphylactoid reactions, cholestasis, DRESS syndrome, renal failure, ↓ WBC count, ↓ platelet count, ↓ serum sodium, eosinophilic pneumonia, erythema multiforme, hearing loss, hemolytic anemia, ↑ blood eosinophil count, ↑ liver enzymes, jaundice, onycholysis, pancytopenia, purpura, abdominal pain, anxiety, arthralgia, constipation, loss of appetite, depression, dry mouth, dysgeusia, dyspepsia, dysphagia, dyspnea, erectile dysfunction, fever, gynecomastia, ↑ serum uric acid, ↑ blood glucose, ↓ blood glucose, hallucinations, urinary retention, insomnia, itching, myalgia, palpitations, paresthesia, skin rash, somnolence, tinnitus, weight gain, toxic epidermal necrolysis, tremor, urticaria, vasculitis
Interactions
Drug(s)
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