pharmacopeia
GET
/api/v1/drug/ramipril

Boxed warning

FETAL TOXICITY See full prescribing information for complete boxed warning • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).

2D structure
(2S,3aS,6aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]pyrrole-2-carboxylic acid
SMILES CCOC(=O)[C@H](CCC1=CC=CC=C1)N[C@@H](C)C(=O)N2[C@H]3CCC[C@H]3C[C@H]2C(=O)O
InChIKey HDACQVRGBOVJII-JBDAPHQKSA-N

Mechanism of action

Sourced from openFDA

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-converting Enzyme

Indications

Sourced from openFDA
  • 1. INDICATIONS AND USAGE • Ramipril capsules USP are indicated for the treatment of hypertension.ICD-10: I10

Contraindications

Sourced from openFDA
  • 4. CONTRAINDICATIONS Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema.( 4 ).contraindicated

Dosage & administration

Sourced from openFDA

2. DOSAGE AND ADMINISTRATION • Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust dosage according to blood pressure response after 2–4 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 ( 2.1 ). • 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. Increase dose as tolerated toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart ( 2.3 ). • Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations ( 2.5 ). 2.1 Hypertension The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with ramipril alone, a diuretic can be added. 2.3 Heart Failure Post-Myocardial Infarction For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ramipril is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily.

Warnings & precautions

Sourced from openFDA

5. WARNINGS AND PRECAUTIONS ACE inhibitor use has been associated with the following: • Angioedema, with increased risk in patients with a prior history ( 5.1 ) • Hypotension and hyperkalemia ( 5.5 , 5.8 ) • Renal impairment: monitor renal function during therapy ( 5.3 ) • Increased risk of renal impairment when combined with another blocker of the renin-angiotensin-aldosterone system ( 5.7 ) • Rare cholestatic jaundice and hepatic failure ( 5.2 ) • Rare neutropenia and agranulocytosis ( 5.4 ) 5.1 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 ramipril) may be subject to a variety of adverse reactions, some of them serious. Angioedema Head and Neck Angioedema: Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue treatment with ramipril and institute appropriate therapy immediately.

Adverse reactions

Sourced from openFDA

6. ADVERSE REACTIONS The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension Ramipril has been evaluated for safety in over 4000 patients with hypertension; of these, 1230 patients were studied in U.S. controlled trials, and 1107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ramipril and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ramipril in placebo-controlled trials were: headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2.0%), but only the last one was more common in ramipril patients than in patients given placebo. Generally the side effects were mild and transient, and there was no relation to total dosage within the range of 1.25 mg–20 mg. Discontinuation of therapy because of a side effect was required in approximately 3% of U.S. patients treated with ramipril.

Use in specific populations

Sourced from openFDA

8. USE IN SPECIFIC POPULATIONS • Pregnancy: Discontinue drug if pregnancy is detected ( 5.6 , 8.1 ). • Nursing mothers: Ramipril use is not recommended in nursing mothers ( 8.3 ). 8.1 Pregnancy Pregnancy Category D 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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue ramipril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Following oral administration of ramipril, peak plasma concentrations (C max ) of ramipril are reached within 1 hour. The extent of absorption is at least 50% to 60%, and is not significantly influenced by the presence of food in the gastrointestinal tract, although the rate of absorption is reduced.

Overdosage

Sourced from openFDA

10. OVERDOSAGE Single oral doses of ramipril in rats and mice of 10 g/kg to 11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Laboratory determinations of serum levels of ramipril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of ramipril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of ramipril and its metabolites. Similarly, it is not known which, if any, of these substances can be effectively removed from the body by hemodialysis. Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of ramipril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities.

Approval history

Sourced from openFDA
  • Jun 9, 2008ANDAANDA077626Lupin
  • Jun 18, 2008ANDAANDA078745Chartwell Molecular
  • Jun 18, 2008ANDAANDA077900Hikma
  • Jun 20, 2008ANDAANDA079116Corepharma
  • Sep 2, 2008ANDAANDA078832Zydus Pharms Usa
  • Jun 8, 2011ANDAANDA091604Aurobindo Pharma Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
121,241 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea8,2296.8%
  2. 2Fatigue8,0176.6%
  3. 3Nausea7,4606.2%
  4. 4Diarrhoea7,0465.8%
  5. 5Off Label Use6,6735.5%
  6. 6Dizziness6,6575.5%
  7. 7Drug Ineffective6,4265.3%
  8. 8Vomiting6,1795.1%
  9. 9Pain5,7884.8%
  10. 10Headache5,5084.5%
  11. 11Acute Kidney Injury5,3664.4%
  12. 12General Physical Health Deterioration5,2614.3%
  13. 13Asthenia5,1454.2%
  14. 14Arthralgia5,0564.2%
  15. 15Malaise5,0504.2%

Literature

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Recent PubMed references pinned to Ramipril as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 203 ClinicalTrials.gov registrations naming Ramipril as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Ramipril work?
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.
What is Ramipril used for?
According to FDA labeling, Ramipril carries indications including: 1. INDICATIONS AND USAGE • Ramipril capsules USP are indicated for the treatment of hypertension.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ramipril?
Ramipril is classified as ACE inhibitors, plain, Angiotensin Converting Enzyme Inhibitor, Angiotensin-converting Enzyme Inhibitors, Decreased Blood Pressure, Decreased Bradykinin Degradation, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.
What are the brand names for Ramipril?
Ramipril is marketed under brand names including Altace, Vostally.
What are the contraindications for Ramipril?
Ramipril labeling lists contraindications including: 4. CONTRAINDICATIONS Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema.( 4 ).. Always consult the full prescribing information and a clinician.
Note. Data for ramipril is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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