USE IN PREGNANCY
CAPOTENŽ (captopril tablets, USP) is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II.
CAPOTENŽ (captopril tablets, USP) is indicated for the following:
Hypertension: CAPOTEN (captopril tablets, USP) is indicated for the treatment of hypertension.
In using CAPOTEN, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).
CAPOTEN may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
CAPOTEN is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
Heart Failure: CAPOTEN is indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.
Left Ventricular Dysfunction After Myocardial Infarction: CAPOTEN is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.
Diabetic Nephropathy: CAPOTEN is indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. CAPOTEN decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of CAPOTEN, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).
Published Studies Related to Capoten (Captopril)
Comparison of alprazolam versus captopril in high blood pressure: a randomized controlled trial. [2011.08]
CONCLUSION: A significant association exists between the level of BP and anxiety in hypertensive ED patients. Alprazolam is as effective as captopril in lowering BP in ED patients with an initial SBP > 160 mmHg.
Assessment of liquid captopril formulations used in children. [2011.03]
OBJECTIVE: Unlicensed liquid captopril formulations are commonly used to treat children with heart disease. This study assessed the bioequivalence of two liquid preparations against a licensed tablet form... CONCLUSIONS: Unlicensed captopril formulations are not bioequivalent to the licensed tablet form, or to each other, and so cannot be assumed to behave similarly in therapeutic use. Thus formulation substitution must be done with care and may require a period of increased monitoring of the patient. There is also significant within-subject variability in performance which has clinical implications with respect to titrating to an optimum therapeutic dose.
Olive (Olea europaea) leaf extract effective in patients with stage-1
hypertension: comparison with Captopril. 
A double-blind, randomized, parallel and active-controlled clinical study was
conducted to evaluate the anti-hypertensive effect as well as the tolerability of
Olive leaf extract in comparison with Captopril in patients with stage-1
hypertension... In conclusion, Olive (Olea europaea) leaf extract, at the
dosage regimen of 500 mg twice daily, was similarly effective in lowering
systolic and diastolic blood pressures in subjects with stage-1 hypertension as
Captopril, given at its effective dose of 12.5-25 mg twice daily.
The acute administration of either amiloride or captopril does not prevent endothelial dysfunction induced by ischemia and reperfusion in the human forearm vasculature. [2010.10]
Animal studies have demonstrated the ability of both sodium-hydrogen exchange inhibitors and angiotensin-converting enzyme inhibitors to reduce infarct size and preserve postischemic ventricular function following ischemia and reperfusion (IR) injury... In humans, neither 10 mg of oral amiloride nor 50 mg of oral captopril was able to provide protection against IR-induced endothelial dysfunction in the peripheral vasculature.
Captopril and combination therapy of captopril and pentoxifylline in reducing proteinuria in diabetic nephropathy. [2010.01]
Chronic kidney disease is a worldwide health problem. Type II diabetes mellitus is now a major cause of end stage renal disease...
Clinical Trials Related to Capoten (Captopril)
Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure [Recruiting]
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed
scientifically. There are no reports in the literature and concrete enough to elucidate
important issues, especially in the field of hypertension and pregnancy.
Searches based on current evidence concentrate their focus on the diagnosis of hypertensive
disorders and treatment of these diseases maternofetais repercussions. However, the
prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia,
the most effective treatment for the control of hypertensive crisis and metabolic and
cardiovascular events after two years of termination of pregnancy require further
The main idea for developing this research came from the clinical experience with the use of
captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with
severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of
hypertensive crisis and keeping pressure levels. Following the technical standards of the
institution and during his administration, there were reports of side effects such as dry
cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved
hindering control the use of hypotensive.
Alternative therapy, clonidine began to be used in mothers with some restriction on the use
of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not
known yet is how long clonidine reduces high blood pressure and how long to leave stabilized
compared to the use of captopril.
There are no reports in the literature databases, no randomized clinical trials that prove
the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this
particular group of patients, even in comparison with other classes of antihypertensive
drugs, especially captopril, to this purpose.
The investigators' primary assumption is that clonidine has better effectiveness in
decreasing the frequency of pressure peaks when compared with captopril.
Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension [Completed]
The purpose of this study is to determine whether a larger dose of the aldosterone antagonist
spironolactone combined with an ACE inhibitor (captopril) and a beta-blocker (carvedilol) is
effective in reverse pulmonary artery remodeling in patients with pulmonary arterial
hypertension (PAH)secondary to congenital heart disease
Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation [Active, not recruiting]
RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell
PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the
side effects in patients who are undergoing bone marrow or stem cell transplantation
following chemotherapy and radiation therapy.
In Vivo Angiostatin Generation Using Tissue Plasminogen Activator and Captopril in Treating Patients With Progressive Metastatic Cancer [Active, not recruiting]
RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin.
Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue
plasminogen activator and captopril and to see how well they work in treating patients with
progressive metastatic cancer.
Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy [Active, not recruiting]
RATIONALE: Captopril is a drug that may be able to decrease side effects caused by radiation
therapy, and may improve the quality of life of patients with non-small cell lung cancer or
limited-stage small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well captopril works in decreasing
side effects and improving the quality of life in patients who have received radiation
therapy with or without chemotherapy for stage I, stage II, or stage IIIB non-small cell lung
cancer or limited-stage small cell lung cancer.