pharmacopeia
GET
/api/v1/drug/captopril

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue captopril tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

2D structure
(2S)-1-[(2S)-2-methyl-3-sulfanylpropanoyl]pyrrolidine-2-carboxylic acid
SMILES C[C@H](CS)C(=O)N1CCC[C@H]1C(=O)O
InChIKey FAKRSMQSSFJEIM-RQJHMYQMSA-N

Mechanism of action

Sourced from openFDA

The mechanism of action of captopril tablets have not yet been fully elucidated. Its beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system.

Angiotensin-converting Enzyme

Indications

Sourced from openFDA
  • Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).ICD-10: I10

Contraindications

Sourced from openFDA
  • Captopril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin- converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril tablets in patients with diabetes (see PRECAUTIONS: Drug Interactions).contraindicated

Dosage & administration

Sourced from openFDA

Captopril tablets should be taken one hour before meals. Dosage must be individualized. Hypertension Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting captopril tablets. The initial dose of captopril tablets is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when captopril tablets are used alone. The dose of captopril tablets in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added. The diuretic dose may be increased at one- to two-week intervals until its highest usual antihypertensive dose is reached. If captopril tablets are being started in a patient already receiving a diuretic, captopril tablets therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril tablets as noted above. If further blood pressure reduction is required, the dose of captopril tablets may be increased to 100 mg b.i.d. or t.i.d.

Warnings & precautions

Sourced from openFDA

Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including captopril tablets) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1000 solution of epinephrine should be promptly instituted. Swelling confined to the face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuation of captopril; some cases required medical therapy (see PRECAUTIONS: Information for Patients and ADVERSE REACTIONS). Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS: Drug Interactions). Intestinal Angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.

Adverse reactions

Sourced from openFDA

Reported incidences are based on clinical trials involving approximately 7000 patients. Renal About one of 100 patients developed proteinuria (see WARNINGS). Each of the following has been reported in approximately 1 to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency. Hematologic Neutropenia/agranulocytosis has occurred (see WARNINGS). Cases of anemia, thrombocytopenia, and pancytopenia have been reported. Dermatologic Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy. It is usually maculopapular, and rarely urticarial. The rash is usually mild and disappears within a few days of dosage reduction, short-term treatment with an antihistaminic agent, and/or discontinuing therapy; remission may occur even if captopril is continued. Pruritus, without rash, occurs in about 2 of 100 patients. Between 7 and 10 percent of patients with skin rash have shown an eosinophilia and/or positive ANA titers. A reversible associated pemphigoid-like lesion, and photosensitivity, have also been reported. Flushing or pallor has been reported in 2 to 5 of 1000 patients. Cardiovascular Hypotension may occur; see WARNINGS and PRECAUTIONS: Drug Interactions for discussion of hypotension with captopril therapy. Tachycardia, chest pain, and palpitations have each been observed in approximately 1 of 100 patients.

Use in specific populations

Sourced from openFDA

Pregnancy Female patients of childbearing age should be told about the consequences of exposure to captopril tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Pharmacokinetics

Sourced from openFDA
Metabolism
After oral administration of therapeutic doses of captopril tablets, rapid absorption occurs with peak blood levels at about one hour. The presence of food in the gastrointestinal tract reduces absorption by about 30 to 40 percent; captopril therefore should be given one hour before meals.

Overdosage

Sourced from openFDA

Correction of hypotension would be of primary concern. Volume expansion with an intravenous infusion of normal saline is the treatment of choice for restoration of blood pressure. While captopril may be removed from the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the circulation of neonates or children. Peritoneal dialysis is not effective for removing captopril; there is no information concerning exchange transfusion for removing captopril from the general circulation.

Approval history

Sourced from openFDA
  • Feb 13, 1996ANDAANDA074477Prinston Inc
  • Feb 13, 1996ANDAANDA074505Hikma Intl Pharms
  • May 30, 1997ANDAANDA074677Andas 5 Holding
  • Dec 29, 1997ANDAANDA074896Rising
  • Oct 28, 1998ANDAANDA074737Corepharma
  • Dec 13, 2019ANDAANDA212809Ajanta Pharma Ltd
  • Jan 27, 2023ANDAANDA214442Aiping Pharm Inc

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.
9,590 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. 1Dyspnoea6136.4%
  2. 2Drug Ineffective5956.2%
  3. 3Hypertension5345.6%
  4. 4Nausea5075.3%
  5. 5Diarrhoea4684.9%
  6. 6Pain4534.7%
  7. 7Dizziness4494.7%
  8. 8Asthenia4234.4%
  9. 9Headache3994.2%
  10. 10Vomiting3984.2%
  11. 11Fatigue3904.1%
  12. 12Pneumonia3743.9%
  13. 13Hypotension3473.6%
  14. 14Malaise3453.6%
  15. 15Fall3433.6%

Literature

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Recent PubMed references pinned to Captopril 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 84 ClinicalTrials.gov registrations naming Captopril as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Captopril. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • ACECPIC D (provisional)ClinPGx 2A

Frequently asked questions

How does Captopril work?
The mechanism of action of captopril tablets have not yet been fully elucidated. Its beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system.
What is Captopril used for?
According to FDA labeling, Captopril carries indications including: Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Captopril?
Captopril 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 contraindications for Captopril?
Captopril labeling lists contraindications including: Captopril tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin- converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril tablets in patients with diabetes (see PRECAUTIONS: Drug Interactions).. Always consult the full prescribing information and a clinician.
Note. Data for captopril 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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