Ramipril

Treatment of hypertension to reduce BP, as part of broader cardiovascular-risk management; may be used alone or with thiazide diuretics. BP goals and preferred-drug rankings require current disease-specific guideline assessment, not the older JNC reference retained in the label.

Risk reduction for MI, stroke and cardiovascular death: age ≥55 with coronary disease, prior stroke, peripheral vascular disease, or diabetes plus≥1 additional risk factor (hypertension, elevated total cholesterol, low HDL, smoking or documented microalbuminuria). Can supplement other needed risk treatments. Post-MI indication is clinically stable patients with congestive-heart-failure signs within the first few days after acute MI, reducing death/failure hospitalization and progression. No automatic pediatric, kidney-protection-alone or all-heart-failure indication inferred.

Usually swallow whole. May open onto about 4 oz applesauce or mix in 4 oz (120 mL) water or apple juice; consume the entire mixture to receive full dose. Specified mixtures may be stored≤24 hours at room temperature or≤48 hours refrigerated. Food does not materially reduce extent of absorption. No patient-led switch from another ACE inhibitor, pediatric dose or universal missed-dose doubling supplied.

Hypersensitivity to ramipril/product or another ACE inhibitor, including prior ACE-inhibitor angioedema. Current highlights additionally name hereditary or idiopathic angioedema; the full section 4 uses the narrower hypersensitivity/previous-ACE wording, so both safety restrictions are retained. Neprilysin-inhibitor combination is contraindicated: no ramipril within 36 hours before or after switching sacubitril/valsartan. Aliskiren combination is contraindicated in diabetes; avoid it with GFR <60 mL/min/1.73m² under warnings.

Drugs acting directly on the renin-angiotensin system can injure or kill the developing fetus. When pregnancy is detected, discontinue ramipril as soon as possible. Later pregnancy exposure can cause oligohydramnios, fetal/neonatal renal failure and other severe outcomes; the first-trimester evidence limitations do not authorize use.

Reported effects include cough, dizziness, headache, fatigue, GI complaints and hypotension; post-MI rates differ from hypertension trials. Serious reports include angioedema, kidney/liver injury, marrow disorders and severe skin reactions; postmarketing frequencies/causality may be uncertain. Overdose most likely causes marked hypotension: emergency/Poison Help (1-800-222-1222) and professional volume/hemodynamic support. Adult hemodialytic removal is not established. The retained label’s claim that angiotensin II is essentially unavailable is historical and is not repeated as a current availability or treatment rule.

Sacubitril/neprilysin inhibition: contraindicated combination and 36-hour separation; mTOR inhibitors such as temsirolimus also raise angioedema concern. Avoid routine ACE/ARB/aliskiren dual blockade; aliskiren-diabetes contraindication and GFR <60avoidance are distinct. Potassium supplements, potassium-sparing diuretics and potassium salt substitutes can cause hyperkalemia; monitor.

Diuretics/volume depletion increase hypotension; clinician-directed lower initial dose or diuretic adjustment may be needed. NSAIDs/COX-2 inhibitors can reduce BP benefit and worsen renal function, especially in older, depleted or renally impaired patients. Lithium levels/toxicity may increase, particularly with diuretics: frequent lithium monitoring. Injectable gold can cause flushing/nausea/vomiting/hypotension. Rare hypoglycemia reports with insulin/oral glucose-lowering medicines have uncertain causality; assess symptoms clinically.

Use indication-specific renal reduction in dosage; PK study units indexed to 1.73m² are distinct from estimated CrCl dosing section units. Renal-artery stenosis and severe HF increase acute renal-risk concerns. Liver impairment slows activation to ramiprilat and increases parent levels; no formal validated hepatic dose table for hypertensive patients is supplied. Do not interpret metabolism changes as proof of safety in advanced disease.

Pediatric efficacy/safety are unestablished. In-utero-exposed neonates require observation for hypotension, oliguria and hyperkalemia, with specialist perfusion/renal support if needed. Older adult sensitivity and ramiprilat exposure may be greater; review renal function, volume and medications rather than use an invented age-only dose.

Avoid pregnancy exposure; discuss alternatives before conception and discontinue promptly if pregnant. Monitor exposed fetus/neonate according to specialist guidance because oligohydramnios may appear after injury. A single 10 mg maternal dose produced undetectable milk levels, but multiple-dose concentrations are unpredictable; the selected full label says do not use in nursing mothers. No single-dose observation is presented as general breastfeeding safety.

Hepatic ester cleavage produces active ramiprilat, which inhibits ACE, lowering angiotensin II formation and aldosterone secretion. Reduced vasoconstriction lowers BP; reduced aldosterone contributes to potassium increase. ACE also metabolizes bradykinin, relevant to cough/angioedema. Mean monotherapy BP response was smaller in Black patients in label studies; this does not remove all clinical benefit or determine an individual dose.

Oral parent peak about 1 hour, ramiprilat 2–4 hours; food slows absorption rate without materially changing extent. Parent/metabolite handling includes hepatic activation and urine/fecal elimination. Repeated 5–10 mg doses yield ramiprilat therapeutic-range half-life about 13–17 hours; a >50 hour terminal phase reflects ACE binding/dissociation and does not contribute to accumulation. Renal impairment increases ramiprilat exposure; do not infer extra dialysis doses or an exact universal hepatic conversion formula.

Check baseline renal function, potassium, BP/volume status and all medicines; reassess after starting, titration, diuretic/NSAID changes or dehydration. High-riskHF starts need close follow-up for first 2 weeks and after dose increases; renal-artery stenosis requires early renal monitoring. Consider WBC with collagen-vascular disease, particularly renal impairment; liver symptoms warrant prompt testing/review. No universal creatinine-rise cutoff or fixed all-patient laboratory interval invented.

Report planned/detected pregnancy and avoid nursing under selected labeling. Stop and seek immediate evaluation for angioedema, difficulty breathing or fainting; fever/sore throat can indicate neutropenia. Vomiting, diarrhea, excessive sweating or poor intake can worsen hypotension and needs review. Do not use potassium salt substitutes/supplements or start NSAIDs/RAS drugs without clinician review. Take exact regimen and approved capsule mixture if needed; never independently bridge the sacubitril 36-hour separation.

1.25 mg capsule

Yellow opaque capsule, 54 328 printed on cap/body; white/off-white powder.

Package

Bottle of 100, NDC 0054-0106-25.

Status

Prescription oral ANDA077900 product; full PI revised May 2026, no current-stock inference.

Selected strengths

1.25, 2.5, 5 and 10 mg oral hard-gelatin capsules.

2.5 mg

Orange opaque, 54 794; bottle of 100 NDC 0054-0107-25.

5 mg

Red opaque, 54 145; bottle of 100 NDC 0054-0108-25.

10 mg

Blue opaque, 54 602; bottle of 100 NDC 0054-0109-25.

Scope

Other capsule/tablet manufacturers and combination products need exact labeling; no injectable ramipril or invented scored-capsule division.

Store at 20–25°C; dispense tight, light-resistant, child-resistant container. Approved applesauce/water/apple-juice mixtures may be kept≤24 hours room temperature or≤48 hours refrigerated, then discard unneeded mixture. Consume the complete mixture; do not extrapolate this stability to other vehicles or enteral-tube preparations.