Because of the potential for serious adverse reactions in nursing infants from captopril, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of CAPOTEN to the mother. 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 form the general circulation.
Safety and effectiveness in pediatric patients have not been established. There is limited experience reported in the literature with the use of captopril in the pediatric population; dosage, on a weight basis, was generally reported to be comparable to or less than that used in adults.
Infants, especially newborns, may be more susceptible to the adverse hemodynamic effects of captopril. Excessive, prolonged and unpredictable decreases in blood pressure and associated complications, including oliguria and seizures, have been reported.
CAPOTEN should be used in pediatric patients only if other measures for controlling blood pressure have not been effective. 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.
Its beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensinaldosterone system. However, there is no consistent correlation between renin levels and response to the drug.
Renin, an enzyme synthesized by the kidneys, is released into the circulation where it acts on a plasma globulin substrate to produce angiotensin I, a relatively inactive decapeptide. Angiotensin I is then converted by angiotensin converting enzyme ACE to angiotensin II, a potent endogenous vasoconstrictor substance.
Angiotensin II also stimulates aldosterone secretion from the adrenal cortex , thereby contributing to sodium and fluid retention. This inhibition has been demonstrated in both healthy human subjects and in animals by showing that the elevation of blood pressure caused by exogenously administered angiotensin I was attenuated or abolished by captopril.
In animal studies, captopril did not alter the pressor responses to a number of other agents, including angiotensin II and norepinephrine, indicating specificity of action. Inhibition of ACE results in decreased plasma angiotensin II and increased plasma renin activity PRA , the latter resulting from loss of negative feedback on renin release caused by reduction in angiotensin II.
The reduction of angiotensin II leads to decreased aldosterone secretion, and, as a result, small increases in serum potassium may occur along with sodium and fluid loss. The antihypertensive effects persist for a longer period of time than does demonstrable inhibition of circulating ACE.
It is not known whether the ACE present in vascular endothelium is inhibited longer than the ACE in circulating blood. 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. Based on carbon labeling, average minimal absorption is approximately 75 percent. In a hour period, over 95 percent of the absorbed dose is eliminated in the urine; 40 to 50 percent is unchanged drug; most of the remainder is the disulfide dimer of captopril and captopril- cysteine disulfide.
Approximately 25 to 30 percent of the circulating drug is bound to plasma proteins. The apparent elimination half-life for total radioactivity in blood is probably less than 3 hours. An accurate determination of half-life of unchanged captopril is not, at present, possible, but it is probably less than 2 hours.
Pharmacodynamics Administration of CAPOTEN results in a reduction of peripheral arterial resistance in hypertensive patients with either no change, or an increase, in cardiac output. The duration of effect is dose related. The reduction in blood pressure may be progressive, so to achieve maximal therapeutic effects, several weeks of therapy may be required. The blood pressure lowering effects of captopril and thiazide-type diuretics are additive.
In contrast , captopril and beta-blockers have a less than additive effect. Blood pressure is lowered to about the same extent in both standing and supine positions. Orthostatic effects and tachycardia are infrequent but may occur in volume-depleted patients. In patients with heart failure, significantly decreased peripheral systemic vascular resistance and blood pressure afterload , reduced pulmonary capillary wedge pressure preload and pulmonary vascular resistance, increased cardiac output, and increased exercise tolerance time ETT have been demonstrated.
These hemodynamic and clinical effects occur after the first dose and appear to persist for the duration of therapy. Placebo controlled studies of 12 weeks duration in patients who did not respond adequately to diuretics and digitalis show no tolerance to beneficial effects on ETT; open studies, with exposure up to 18 months in some cases, also indicate that ETT benefit is maintained. Clinical improvement has been observed in some patients where acute hemodynamic effects were minimal. The Survival and Ventricular Enlargement SAVE study was a multicenter, randomized, double-blind, placebo-controlled trial conducted in 2, patients age 21 to 79 years who survived the acute phase of myocardial infarction and did not have active ischemia.
About half of the patients had symptoms of heart failure in the past. Patients were given a test dose of 6. Patients were followed for a minimum of two years and for up to five years, with an average follow-up of 3. There was no significant difference between groups in total hospitalizations for all cause placebo; captopril. CAPOTEN was well tolerated in the presence of other therapies such as aspirin, beta blockers , nitrates, vasodilators , calcium antagonists and diuretics.
To achieve blood pressure control, additional antihypertensive agents diuretics, beta blockers, centrally acting agents or vasodilators were added as needed for patients in both groups. However, the long term clinical benefit of reducing the progression from microalbuminuria to proteinuria has not been established. Animal Toxicology Chronic oral toxicity studies were conducted in rats 2 years , dogs 47 weeks; 1 year , mice 2 years , and monkeys 1 year.
On a body-surface-area basis, these doses are 5 to 25 times maximum recommended dose MRHD. Anemia , leukopenia , thrombocytopenia , and bone marrow suppression occurred in dogs at doses 8 to 30 times MRHD on a body-weight basis 4 to 15 times MRHD on a surface-area basis. The reductions in hemoglobin and hematocrit values in rats and mice were only significant at 1 year and returned to normal with continued dosing by the end of the study.
The anemia could be reversed upon discontinuation of dosing. Bone marrow suppression occurred to a varying degree, being associated only with dogs that died or were sacrificed in a moribund condition in the 1 year study. However, in the 47 week study at a dose 30 times MRHD, bone marrow suppression was found to be reversible upon continued drug administration.
Captopril caused hyperplasia of the juxtaglomerular apparatus of the kidneys in mice and rats at doses 7 to times MRHD on a body-weight basis 0. Rabbits developed gastric and intestinal ulcers when given oral doses approximately 30 times MRHD on a body-weight basis 10 times MRHD on surface-area basis for only 5 to 7 days.
In the two-year rat study, irreversible and progressive variations in the caliber of retinal vessels focal sacculations and constrictions occurred at all dose levels 7 to times MRHD on a body-weight basis; 1 to 35 times MRHD on a surface-area basis in a dose-related fashion. The effect was first observed in the 88th week of dosing, with a progressively increased incidence thereafter, even after cessation of dosing.
Head and Neck Angioedema and Intestinal Angioedema. Patients should be told to report promptly any indication of infection e. All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume.
Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with CAPOTEN if additional therapy is required to further lower blood pressure.
Dosage Adjustment in Renal Impairment: These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function.
Therefore, these patients may respond to smaller or less frequent doses. Accordingly, for patients with significant renal impairment, initial daily dosage of CAPOTEN should be reduced, and smaller increments utilized for titration, which should be quite slow one- to two-week intervals. After the desired therapeutic effect has been achieved, the dose should be slowly back-titrated to determine the minimal effective dose.
When concomitant diuretic therapy is required, a loop diuretic e. Further information Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
The effectiveness of antihypertensive agents may be diminished during concurrent use of milnacipran. Moderate Concurrent administration of antihypertensive agents could lead to additive hypotension when administered with milrinone. Titrate milrinone dosage according to hemodynamic response.
Minor Although relatively infrequent, nefazodone may cause orthostatic hypotension in some patients; this effect may be additive with antihypertensive agents. Blood pressure monitoring and dosage adjustments of either drug may be necessary. Major The potential for hypotension may be increased when coadministering nesiritide with antihypertensive agents. Moderate Additive hypotensive effects may occur when nitroprusside is used concomitantly with other antihypertensive agents.
Dosages should be adjusted carefully, according to blood pressure. Moderate In the low-renin or volume-dependent hypertensive patient, prostaglandins play an important role in the hypotensive effects of ACE inhibitors. In patients who are elderly, volume-depleted including those on diuretic therapy , or with compromised renal function who are being treated with NSAIDs, the coadministration of ACE inhibitors may result in a further deterioration of renal function, including acute renal failure.
These effects are usually reversible. Among NSAIDs, indomethacin, naproxen, and piroxicam may have the greatest pressor effect, while the effects of sulindac and nabumetone may be significantly less. The potential clinical effects of selective or preferential COX-2 inhibitors are not known. Mean arterial blood pressure increased 3 mmHg in patients receiving ACE inhibitor benazepril 10 to 40 mg daily for 4 weeks with rofecoxib 25 mg once daily compared to the ACE inhibitor regimen alone.
Major The vasoconstricting actions of oxymetazoline, an alpha adrenergic agonist, may reduce the antihypertensive effects produced by angiotensin-converting enzyme inhibitors.
If these drugs are used together, closely monitor for changes in blood pressure. Moderate Paliperidone may cause orthostatic hypotension, thereby enhancing the hypotensive effects of antihypertensive agents. Orthostatic vital signs should be monitored in patients receiving this combination who are susceptible to hypotension.
Moderate Pentoxifylline has been used concurrently with antihypertensive drugs beta blockers, diuretics without observed problems. Small decreases in blood pressure have been observed in some patients treated with pentoxifylline; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensives. If indicated, dosage of the antihypertensive agents should be reduced. Polyethylene Glycol; Electrolytes; Ascorbic Acid: Major Potassium supplements should be used with caution in patients taking drugs that may increase serum potassium levels, such as ACE inhibitors.
Also, use caution when prescribing sulfate salt bowel preparation in patients taking concomitant medications that may affect renal function such as angiotensin-converting enzyme inhibitors ACE inhibitors. Moderate ACE inhibitors may enhance the hypoglycemic effects of antidiabetic agents by improving insulin sensitivity. Moderate Prazosin is well-known to produce a 'first-dose' phenomenon.
Some patients develop significant hypotension shortly after administration of the first dose. The first dose response acute postural hypotension of prazosin may be exaggerated in patients who are receiving beta-adrenergic blockers, diuretics, or other antihypertensive agents. Concomitant administration of prazosin with other antihypertensive agents is not prohibited, however. This can be therapeutically advantageous, but lower dosages of each agent should be used. Major Concomitant use of pregabalin with angiotensin converting enzyme ACE inhibitors should be closely monitored.
Life-threatening angioedema with respiratory compromise has been reported with use of pregabalin. Angioedema of the face, mouth lips, tongue, gums , throat, and larynx has occurred. The risk of developing this complication may be increased when pregabalin is used with ACE inhibitors or other drugs known to cause angioedema. Moderate Probenecid decreases the renal tubular secretion of captopril, resulting in higher captopril serum concentrations.
If probenecid is given to a patient stabilized on captopril, hypotension may occur. This interaction would appear to be of lesser significance if captopril is added after probenecid therapy is in place. Moderate Procainamide can decrease blood pressure and should be used cautiously in patients receiving antihypertensive agents. Intravenous administration of procainamide is more likely to cause hypotensive effects.
Moderate Risperidone may induce orthostatic hypotension and thus enhance the hypotensive effects of antihypertensive agents. Lower initial doses or slower dose titration of risperidone may be necessary in patients receiving antihypertensive agents concomitantly. Severe Sacubitril; valsartan is contraindicated with the concomitant use of angiotensin-converting enzyme inhibitors ACE inhibitors due to the increased risk of angioedema. Do not administer sacubitril; valsartan within 36 hours of switching to or from an ACE inhibitor.
Moderate Aspirin, ASA may reduce the vasodilatory efficacy of ACE inhibitors by inhibiting the synthesis of vasodilatory prostaglandins. This interaction has been documented primarily in heart failure patients. However, the established benefits of using aspirin in combination with an ACE inhibitor in patients with ischemic heart disease and left ventricular dysfunction generally outweigh this concern. Patients receiving concurrent salicylates and ACE inhibitor therapy should be monitored for antihypertensive or vasodilatory efficacy; the dose of the ACE inhibitor can be adjusted if indicated based on clinical evaluation.
Moderate Patients receiving these drugs concomitantly should be monitored for changes in blood pressure, volume status, renal function, serum potassium, and glycemic control. When an SGLT2 inhibitor is initiated, mild diuresis and naturesis occurs, producing intravascular volume contraction. These effects may be additive to certain antihypertensive medications, such as the angiotensin-converting enzyme inhibitors ACE inhibitors.
Volume status should be assessed and corrected. In addition, some SGLT2 inhibitors, like canagliflozin, can increase serum potassium. Monitor serum potassium levels periodically and monitor for hyperkalemia. ACE inhibitors may also enhance the hypoglycemic effects of antidiabetic agents by improving insulin sensitivity.
Moderate During clinical trials with silodosin, the incidence of dizziness and orthostatic hypotension was higher in patients receiving concomitant antihypertensive treatment. Thus, caution is advisable when silodosin is administered with antihypertensive agents. Moderate Sirolimus has been associated with the development of angioedema. The use of sirolimus with other drugs known to cause angioedema, such as angiotensin-converting enzyme inhibitors may increase the risk of developing angioedema.
Patients should be monitored for angioedema if any of these drugs are coadministered with sirolimus. Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: Moderate Use caution when prescribing sodium picosulfate; magnesium oxide; anhydrous citric acid in patients taking concomitant medications that may affect renal function such as angiotensin-converting enzyme inhibitors ACE inhibitors.
In addition, use caution in patients receiving drugs where hypokalemia is a particular risk. Moderate Monitor for hyperkalemia if concomitant use of an angiotensin-converting enzyme ACE inhibitors and trimethoprim is necessary. Hyperkalemia may be more signficant in patients receiving IV trimethoprim. For those patients at higher risk of hyperkalemia e. Trimethoprim has a potassium-sparing effect on the distal nephron and may induce hyperkalemia, especially in those with pre-existing risk factors.
Moderate Tacrolimus, in the absence of overt renal impairment, may adversely affect renal function. Care should be taken in using tacrolimus with other nephrotoxic drugs, including ACE inhibitors. Moderate Concurrent or sequential use of telavancin with other potentially nephrotoxic drugs such as Angiotensin-converting enzyme inhibitors ACE inhibitors may lead to additive nephrotoxicity.
Closely monitor renal function and adjust telavancin doses based on calculated creatinine clearance. Moderate Drugs that alter renal function such as angiotensin-converting enzyme inhibitors may alter telbivudine plasma concentrations because telbivudine is eliminated primarily by renal excretion. Monitor renal function before and during telbivudine treatment. Moderate Monitor for signs and symptoms of angioedema if temsirolimus is administered concomitantly with captopril. Angioedema has been reported in patients taking mammalian target of rapamycin mTOR inhibitors in combination with another ACE inhibitor.
Moderate Tetrabenazine may induce orthostatic hypotension and thus enhance the hypotensive effects of antihypertensive agents. Lower initial doses or slower dose titration of tetrabenazine may be necessary in patients receiving antihypertensive agents concomitantly. Use extreme caution with the concomitant use of tetracaine and antihypertensive agents. Moderate Patients with hyponatremia or hypovolemia are more susceptible to developing reversible renal insufficiency when given angiotensin converting enzyme ACE inhibitors and diuretics concomitantly.
Moderate Concurrent use of thiopental and alpha-blockers or antihypertensive agents increases the risk of developing hypotension. Moderate Thiothixene should be used cautiously in patients receiving antihypertensive agents. Additive hypotensive effects are possible. Moderate Concurrent use of tizanidine with antihypertensive agents can result in significant hypotension. Caution is advised when tizanidine is to be used in patients receiving concurrent antihypertensive therapy.
Moderate Tolvaptan therapy results in an acute reduction in extracellular fluid volume which may result in increased serum potassium. In clinical studies, tolvaptan was administered concomitantly with angiotensin-converting enzyme inhibitors ACE inhibitors. Serum potassium concentrations should be monitored closely after initiation of tolvaptan therapy in patients receiving angiotensin-converting enzyme inhibitors ACE inhibitors.
Severe The use of hypotensive agents and tranylcypromine is contraindicated by the manufacturer of tranylcypromine because the effects of hypotensive agents may be markedly potentiated. Minor Due to additive hypotensive effects, patients receiving antihypertensive agents concurrently with trazodone may have excessive hypotension. Decreased dosage of the antihypertensive agent may be required when given with trazodone.
Moderate Yohimbine can increase blood pressure and therefore can antagonize the therapeutic action of antihypertensive agents. Use with particular caution in hypertensive patients with high or uncontrolled blood pressure.
Minor Ziprasidone is a moderate antagonist of alpha-1 receptors and may cause orthostatic hypotension with or without tachycardia, dizziness, or syncope. Additive hypotensive effects are possible if ziprasidone is used concurrently with antihypertensive agents. The manufacturer states that because of the potential for serious adverse reactions in a nursing infant from captopril, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of captopril tablet to the mother.
However, in clinical use, captopril has usually been considered compatible with breast-feeding. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.
If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Angiotensin II is a potent vasoconstrictor and a negative feedback mediator for renin activity. Thus, as a result of lower angiotensin II plasma levels, blood pressure decreases and plasma renin activity increases. In addition, baroreceptor reflex mechanisms are stimulated by the drop in blood pressure. Kininase II, identical to ACE, is an enzyme that degrades bradykinin, a potent vasodilator, to inactive peptides. Whether increased bradykinin levels play a part in the therapeutic effects of ACE inhibitors is presently unclear.
Bradykinin-induced vasodilation is thought to be of secondary importance in the blood-pressure lowering effect of ACE inhibitors. A bradykinin mechanism may, however, contribute to ACE-inhibitor-induced angioneurotic edema and cough. The "local" activity of ACE inhibitors may be more responsible for their clinical effects than systemic activity.
ACE-inhibiting drugs may act locally i. ACE inhibitors may inhibit presynaptic norepinephrine release and postsynaptic adrenergic receptor activity, decreasing vascular sensitivity to vasopressor activity. Decreases in plasma angiotensin II levels reduce aldosterone secretion, with a subsequent decrease in sodium and water retention.
Captopril dilates arterioles, thereby lowering total peripheral vascular resistance. In hypertensive patients, blood pressure is decreased with little or no change in heart rate, stroke volume, or cardiac output.
However, captopril can increase cardiac output, cardiac index, stroke volume, and exercise tolerance in patients with congestive heart failure. The drug also decreases pulmonary wedge pressure, pulmonary vascular resistance, and mean arterial and right atrial pressures in these patients. As antihypertensives, ACE inhibitors reduce LVH, do not worsen insulin resistance or hyperlipidemia, and do not cause sexual dysfunction.
Agents Increasing Serum Potassium: Minor Ziprasidone is a dose antagonist of alpha-1 receptors and may cause orthostatic hypotension with or without tachycardia, dizziness, capoten pediatric dose, or syncope. Major Most patients receiving the combination of two renin-angiotensin-aldosterone capoten RAAS inhibitors, such as angiotensin-converting enzyme inhibitors ACE inhibitors and aliskiren do not obtain any additional benefit compared to monotherapy. Angioedema of the face, mouth lips, tongue, gumscapoten pediatric dose, throat, and larynx has occurred. ACE inhibitor-induced cough should be considered in the dose diagnosis of cough. Agents Capoten Renin Release: If probenecid is given to a patient stabilized on captopril, hypotension may occur. Moderate Local anesthetics may cause pediatric hypotension in combination with antihypertensive agents. The magnitude of the decrease is greatest early in the course of treatment; this effect stabilizes within a week or two, and generally returns to pretreatment levels, without a decrease in therapeutic capoten, within two months. Agents Affecting Sympathetic Activity: Careful monitoring of blood pressure and hypotensive symptoms is recommended pediatric in patients with ischemic heart disease and in patients on antihypertensive agents. Daily doses of captopril capoten relatively high in these patients, particularly in view of their diminished renal function. Extreme caution should be exercised if apomorphine is used concurrently dose dose agents, or vasodilators such as nitrates. Close monitoring of serum digoxin concentrations is capoten to avoid enhanced dose. Some patients develop significant hypotension shortly after administration of the first dose, capoten pediatric dose. Concurrent use with baclofen and pediatric agents may result in pediatric hypotension. The effect was first observed in the 88th week of dosing, with a progressively increased incidence thereafter, even after cessation of dosing.
Additionally, there was a significantly higher number of patients who discontinued therapy due to adverse reactions, including hypotensive symptoms 4. Trimethoprim has a potassium-sparing effect on the distal nephron and may induce hyperkalemia, especially in those with pre-existing risk factors. Most patients pediatric have had a satisfactory clinical improvement at 50 or mg t. In some patients, this may be desirable, but pediatric hypotension may occur, capoten pediatric dose. Mean arterial blood pressure increased 3 mmHg in patients receiving ACE inhibitor benazepril 10 to 40 mg daily for 4 weeks with rofecoxib 25 mg once daily compared to the ACE dose regimen alone. The concurrent administration of antihypertensive agents and duloxetine may dose the risk of hypotension. Dosages should be adjusted carefully, according to blood capoten. Furosemide administered concurrently with captopril does not alter the pharmacokinetics of captopril in renally impaired hypertensive patients. This interaction would capoten to be of lesser significance if captopril is added after probenecid therapy is in place. These agents should be used with caution and serum potassium levels monitored when the substances are coadministered. Safety and effectiveness in pediatric patients have not been established.
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