Finished product reference

Ramipril

Tablet · Oral · 2.5 mg

List code
53207
Pharmacologic class
Angiotensin Converting Enzyme Inhibitor
Boxed warning

WARNING: FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as possible . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus . When pregnancy is detected, discontinue ramipril as soon as possible .

What it is and how it works

Mechanism of Action Ramipril and ramiprilat inhibit ACE in human subjects and animals. Angiotensin converting enzyme is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.

Mechanism class: Angiotensin-converting Enzyme Inhibitors

Indications

Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics . In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes . Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction . Hypertension Ramipril capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

Dosage and administration (summary)

Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust dosage according to blood pressure response after 2 to 4 weeks of treatment. The usual maintenance dose following titration is 2.5 mg to 20 mg daily as a single dose or equally divided doses . Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes: 2.5 mg once daily for 1 week, 5 mg once daily for 3 weeks, and increased as tolerated to a maintenance dose of 10 mg once daily . Heart failure post-myocardial infarction: Starting dose of 2.5 mg twice daily. If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily.

Contraindications

Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Ramipril capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril capsules within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor .

Warnings and precautions

Angioedema, increased risk in patients with a prior history Hypotension and hyperkalemia ( 5.5 , 5.8 ) Renal impairment: monitor renal function during therapy Avoid concomitant use of an ACE inhibitor and angiotensin blocker Rare cholestatic jaundice and hepatic failure Rare neutropenia and agranulocytosis Anaphylactoid and Possibly Related Reactions Presumably because drugs that act directly on the renin-angiotensin-aldosterone system (e.g., ACE inhibitors) affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving these drugs (including ramipri…

Pregnancy

Pregnancy Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Storage and supply

Ramipril Capsules USP, 1.25 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-43" in black ink and yellow opaque body printed with "1.25 mg" in black ink and are supplied as follows: NDC 68382-144-06 in bottle of 30 capsules with child-resistant closure NDC 68382-144-16 in bott…

Source: Ramipril (Ramipril) — US FDA prescribing information, 2026-06-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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