USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, CAPOTEN should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
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CAPOTEN SUMMARY
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).
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NEWS HIGHLIGHTS
Published Studies Related to Capoten (Captopril)
Usefulness of beta blockers in high-risk patients after myocardial infarction in conjunction with captopril and/or valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] trial). [2009.07.15] Concern has been raised about combining beta blockers with angiotensin-receptor blockers in patients with heart failure. The VALsartan In Acute myocardial infarction (VALIANT) trial enrolled 14,703 patients with myocardial infarction complicated by heart failure or documented left ventricular systolic dysfunction...
Lack of interaction between the peptidomimetic substrates captopril and cephradine. [2009.03] Intestinal peptide transporters, including hPEPT1, facilitate the absorption of cephalosporins and angiotensin-converting enzyme inhibitors, and have been investigated as a means to improve oral drug absorption...
Captopril to mitigate chronic renal failure after hematopoietic stem cell transplantation: a randomized controlled trial. [2008.04.01] CONCLUSIONS: There is a trend in favor of captopril in mitigation of chronic renal failure after radiation-based HSCT.
[A comparison of the effect of oral captopril and nicardipine in hypertensive crisis] [2008.02] BACKGROUND: Hypertensive crisis is defined as a severe elevation in blood pressure (BP) without target organ injury. There are few data about the efficacy and safety of comparative oral antihypertensive drugs. AIM: To compare the efficacy and safety of oral captopril (25 mg) and nicardipine (20 mg) in hypertensive crisis... CONCLUSION: Oral captopril or nicardipine are efficacy and safe in the treatment of hypertensive crisis.
Polymorphisms of ACE2 gene are associated with essential hypertension and antihypertensive effects of Captopril in women. [2007.08] ACE2 appears to counterbalance the vasopressor effect of angiotensin I converting enzyme (ACE) in the reninangiotensin system...
Clinical Trials Related to Capoten (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
Rapid Versus Prolonged Inpatient Up-Titration of Captopril [Recruiting]
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
transplantation.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Capoten has an overall score of 1. The effectiveness score is 4 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Capoten review by 57 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | | Treatment Info |
| Condition / reason: | | High blood Pressure |
| Dosage & duration: | | 50 mg taken three times a day for the period of 8 months |
| Other conditions: | | none |
| Other drugs taken: | | Propanolol, HCTZ | | | Reported Results |
| Benefits: | | Lower blood pressure |
| Side effects: | | I developed an intractable cough, and a post nasal drip. Cough worsened daily to the point that I was unable to speak any full sentence without either a coug,h or tears coming to my eyes in an effort to not cough. |
| Comments: | | Capoten was to be taken 150 mg daily - in divided doses. Propanolol was 20 mg twice a day, and the Hydrochlorothiazide was to be 12.5 mg daily. Blood pressure baseline was 180's over 110. Resultant decrease was to 150s over 105. Stopping the Capoten relieved the cough after about 3 weeks of being off the medication. |
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Page last updated: 2009-10-20
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