Captopril (captopril)

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Captopril is administered orally as tablets. Captopril is also commercially available in fixed-combination tablets containing captopril and hydrochlorothiazide; see the full prescribing information for administration of this combination product.

The manufacturer recommends that the drug be taken 1 hour before meals to ensure maximum absorption.

Store tablets at 20-25degreesC in tightly closed bottles protected from moisture.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to the drug or to another ACE inhibitor (e.g., those who experienced angioedema during therapy with another ACE inhibitor).

*Use in combination with aliskiren in patients with diabetes.

*Use in combination with a neprilysin inhibitor (e.g., sacubitril). Captopril should not be administered within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effect of captopril is rash, which occurs in about 4-7% of patients (depending on renal function and dosage) and is usually maculopapular and rarely urticarial. Pruritis without rash occurs in about 2% of patients. Eosinophilia and/or positive antinuclear antibody (ANA) titers have been reported in 7-10% of patients with captopril-induced rash.

Tachycardia, chest pain, and palpitations have each occurred in about 1% of patients receiving captopril. Flushing, pallor, angina pectoris, myocardial infarction (MI), Raynaud's phenomenon, and congestive heart failure have been reported rarely.

Proteinuria has been reported in about 1% of patients receiving captopril, and renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency have been reported rarely.

Dysgeusia has been reported in about 2-4% of patients (depending on renal function and dosage), which is reversible and usually self-limited (2-3 months) with continued drug administration.

Cough has been reported in about 0.5-2% of patients receiving captopril. The cough generally is persistent and nonproductive and reversible following discontinuance of the drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Although there is limited clinical experience with captopril in pediatric patients, safety and efficacy of the drug have not been established; however, pediatric dosage was reported to be comparable or less than the dosage used in adults when calculated on the basis of body weight. Infants, especially neonates, may have increased susceptibility to captopril-induced adverse hemodynamic effects. Excessive, prolonged, and unpredictable decreases in blood pressure and associated complications (e.g., oliguria, seizures) have been reported in pediatric patients receiving the drug. The manufacturer states that captopril should be used in pediatric patients only when other measures for controlling blood pressure have not been effective.

Fetal and neonatal morbidity and mortality have been reported in several dozen cases of women who were receiving ACE inhibitors during pregnancy. Once pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. Hypotension, reversible or irreversible renal failure, anuria, skull hypoplasia, and/or death were reported in neonates whose mothers received ACE inhibitors during the second and third trimesters of pregnancy. Other adverse effects associated with such use included oligohydramnios, presumably due to decreased renal function in the fetus, prematurity, and patent ductus arteriosus; however, it is not known if these effects were associated with ACE inhibition or underlying maternal disease. Oligohydramnios has been associated with contractures of the limbs, craniofacial deformities, hypoplasia of the lungs, and intrauterine growth retardation.

Although these adverse effects do not appear related to first trimester exposure, every effort should be made to discontinue captopril therapy as soon as possible in any woman who becomes pregnant while receiving the drug, regardless of the period of gestation. In addition, all women of childbearing potential who are receiving an ACE inhibitor should be advised to report pregnancy to their clinician as soon as possible. Rarely (probably less frequently than once in every 1000 pregnancies), no adequate alternative can be identified; in such rare cases, the woman should be informed of the potential hazard to the fetus and serial ultrasound examinations should be performed to assess the intra-amniotic environment. If oligohydramnios is present, captopril therapy should be discontinued, unless use of the drug is considered life-saving for the woman. Contraction stress testing (CST), a nonstress test (NST), or biophysical profiling may be performed, if appropriate, depending on the period of gestation. However, both clinicians and patients should realize that oligohydramnios may not become apparent until after irreversible fetal injury already has occurred.

Infants exposed in utero to ACE inhibitors should be observed closely for hypotension, oliguria, and hyperkalemia. If oliguria occurs, supportive measures (e.g., administration of fluids and pressor agents) to correct hypotension and renal perfusion should be considered. Exchange transfusion or dialysis may be required to reverse hypotension and/or substitute for impaired renal function. Although captopril may be removed by hemodialysis in adults, it is not known if the drug is removed from circulation of neonates or older children by hemodialysis. Peritoneal dialysis is not effective in enhancing the elimination of captopril, and it is not known whether the drug may be removed by exchange transfusion.

Reproduction studies in hamsters and rats using 150 and 625 times the maximum human dosage, respectively, of captopril have not revealed evidence of teratogenic effects. However, the drug was associated with a low incidence of craniofacial malformations in rabbits when given at dosages 0.8-70 times the maximum human dosage. Reduction in neonatal survival occurred in the offspring of rats receiving captopril dosages 400 times the usual human dosage continuously during gestation and lactation.

Captopril is distributed into human milk in concentrations about 1% of those in maternal blood. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

The manufacturer provides no specific dosage recommendations in geriatric patients.

Pharmacokinetics of captopril have not been studied in geriatric patients.