Captopril Dosage

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Usual Adult Dose for Hypertension

Initial dose: 25 mg orally 2 to 3 times a day one hour before meals.
Maintenance dose: 25 to 150 mg orally 2 to 3 times a day one hour before meals.

Usual Adult Dose for Congestive Heart Failure

Initial dose: 25 mg orally 3 times a day (6.25 to 12.5 mg orally 3 times a day if volume depleted or hypotensive).
Maintenance dose: After a dose of 50 mg three times a day is reached, further increases in dosage should be delayed, where possible, for at least 2 weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 to 100 mg three times a day.
Captopril should generally be used in conjunction with a diuretic and digitalis.

Usual Adult Dose for Left Ventricular Dysfunction

Initial dose: 6.25 mg orally for one dose, then 12.5 mg orally 3 times a day.
Increasing dose: The dose is increased to 25 mg orally 3 times a day during the next several days.
Maintenance dose: The dose is increased to a target dose of 50 mg orally 3 times a day over the next several weeks as tolerated.
Therapy may be initiated as early as three days following a myocardial infarction.
Captopril may be used in patients treated with other postmyocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.

Usual Adult Dose for Diabetic Nephropathy

The recommended dose for long-term use is 25 mg orally 3 times a day.

Usual Adult Dose for Hypertensive Emergency

When prompt titration of blood pressure is indicated, continue diuretic therapy and halt current medication therapy and initiate 25 mg two or three times daily under close supervision. Increase the dose every 24 hours or less until a satisfactory response is obtained or the maximum dose is reached.

Usual Adult Dose for Cystinuria

Initial dose: 25 mg orally 2 to 3 times a day one hour before meals. Initial doses may be titrated as tolerated approximately every 1 to 2 weeks to reduce the degree of cystinuria.

Limited data have shown significant reductions in the urinary excretion of cystine after daily doses of captopril of 150 mg.

Usual Pediatric Dose for Congestive Heart Failure

Note: Dosage must be titrated according to patient response; use lowest effective dose; lower doses should be used in patients who are sodium and water depleted due to diuretic therapy.

Premature neonates and term neonates less than or equal to 7 days of age:
Initial: 0.01 mg/kg/dose every 8 to 12 hours; titrate dose

Term neonates greater than 7 days of age:
Initial: 0.05 to 0.1 mg/kg/dose every 8 to 24 hours; titrate dose upward to maximum of 0.5 mg/kg/dose given every 6 to 24 hours

Infants:
Initial: 0.15 to 0.3 mg/kg/dose; titrate dose upward to maximum of 6 mg/kg/day in 1 to 4 divided doses; usual required dose: 2.5 to 6 mg/kg/day

Children:
Initial: 0.3 to 0.5 mg/kg/dose; titrate upward to a maximum dose of 6 mg/kg/day in 2 to 4 divided doses

Older children:
Initial: 6.25 to 12.5 mg/dose every 12 to 24 hours; titrate upward to maximum of 6 mg/kg/day in 2 to 4 divided doses

Adolescents to adults:
Initial: 12.5 to 25 mg/dose given every 8 to 12 hours; increase by 25 mg/dose at 1 to 2 week intervals based on patient response
Maximum dose: 450 mg/day; usual dosage range for hypertension

Usual Pediatric Dose for Diabetic Nephropathy

Note: Dosage must be titrated according to patient response; use lowest effective dose; lower doses should be used in patients who are sodium and water depleted due to diuretic therapy.

Premature neonates and term neonates less than or equal to 7 days of age:
Initial: 0.01 mg/kg/dose every 8 to 12 hours; titrate dose

Term neonates greater than 7 days of age:
Initial: 0.05 to 0.1 mg/kg/dose every 8 to 24 hours; titrate dose upward to maximum of 0.5 mg/kg/dose given every 6 to 24 hours

Infants:
Initial: 0.15 to 0.3 mg/kg/dose; titrate dose upward to maximum of 6 mg/kg/day in 1 to 4 divided doses; usual required dose: 2.5 to 6 mg/kg/day

Children:
Initial: 0.3 to 0.5 mg/kg/dose; titrate upward to a maximum dose of 6 mg/kg/day in 2 to 4 divided doses

Older children:
Initial: 6.25 to 12.5 mg/dose every 12 to 24 hours; titrate upward to maximum of 6 mg/kg/day in 2 to 4 divided doses

Adolescents to adults:
Initial: 12.5 to 25 mg/dose given every 8 to 12 hours; increase by 25 mg/dose at 1 to 2 week intervals based on patient response
Maximum dose: 450 mg/day; usual dosage range for hypertension

Usual Pediatric Dose for Hypertension

Note: Dosage must be titrated according to patient response; use lowest effective dose; lower doses should be used in patients who are sodium and water depleted due to diuretic therapy.

Premature neonates and term neonates less than or equal to 7 days of age:
Initial: 0.01 mg/kg/dose every 8 to 12 hours; titrate dose

Term neonates greater than 7 days of age:
Initial: 0.05 to 0.1 mg/kg/dose every 8 to 24 hours; titrate dose upward to maximum of 0.5 mg/kg/dose given every 6 to 24 hours

Infants:
Initial: 0.15 to 0.3 mg/kg/dose; titrate dose upward to maximum of 6 mg/kg/day in 1 to 4 divided doses; usual required dose: 2.5 to 6 mg/kg/day

Children:
Initial: 0.3 to 0.5 mg/kg/dose; titrate upward to a maximum dose of 6 mg/kg/day in 2 to 4 divided doses

Older children:
Initial: 6.25 to 12.5 mg/dose every 12 to 24 hours; titrate upward to maximum of 6 mg/kg/day in 2 to 4 divided doses

Adolescents to adults:
Initial: 12.5 to 25 mg/dose given every 8 to 12 hours; increase by 25 mg/dose at 1 to 2 week intervals based on patient response
Maximum dose: 450 mg/day; usual dosage range for hypertension

Renal Dose Adjustments

CrCl 10 to 50 mL/min: 75% of the normal dose is recommended.
CrCl less than 10 mL/min: 50% of the normal dose is recommended.

Liver Dose Adjustments

Data not available

Dose Adjustments

If satisfactory reduction of blood pressure has not been achieved after 1-2 weeks, the dose may be increased to 50 mg two to three times a day.

The dose in hypertension usually does not exceed 50 mg three times a day. Therefore, if the blood pressure has not been satisfactorily controlled after 1-2 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 1-2 week intervals until its highest usual antihypertensive dose is reached.

If further blood pressure reduction is required, the dose of captopril may be increased to 100 mg two to three times a day and then, if necessary, to 150 mg two to three times a day (while continuing the diuretic).

For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and captopril dose promptly initiated at 25 mg two to three times a day. When necessitated by the patient's clinical condition, the daily dose may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.

Precautions

Captopril is contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

If captopril is being started in a patient already receiving a diuretic, captopril therapy should be initiated under close medical supervision.

Reversible anemia with high dosage captopril has been reported in a 7-year-old boy. A dosage reduction corrected the problem.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors. Intestinal angioedema has also been reported in patients treated with ACE inhibitors. 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.

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.

Anaphylactoid reactions have occurred in patients receiving ACE inhibitor therapy during desensitization treatment with hymenoptera venom, and in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.

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.

Neutropenia (less than 1000/mm3 ) with myeloid hypoplasia has resulted from use of captopril. About half of the neutropenic patients developed systemic or oral cavity infections or other features of the syndrome of agranulocytosis. Neutropenia is usually detected within three months after initiation of captopril. Bone marrow examinations in patients with neutropenia consistently showed myeloid hypoplasia, frequently accompanied by erythroid hypoplasia and decreased numbers of megakaryocytes, and anemia and thrombocytopenia were sometimes seen. Neutrophils generally return to normal about two weeks after discontinuation of captopril, and serious infections are usually limited to clinically complex patients. About 13 percent of the cases of neutropenia have ended fatally, but almost all fatalities were inpatients with serious illness, having collagen vascular disease, renal failure, heart failure or immunosuppressant therapy, or a combination of these complicating factors.

If captopril is used in patients with impaired renal function, white blood cell and differential counts should be evaluated prior to starting treatment and at approximately two-week intervals for about three months, then periodically.

In patients with collagen vascular disease or who are exposed to other drugs known to affect the white cells or immune response, particularly when there is impaired renal function, captopril should be used only after an assessment of benefit and risk, and then with caution.

All patients treated with captopril should be told to report any signs of infection (e.g., sore throat, fever). If infection is suspected, white cell counts should be performed without delay.

Total urinary proteins greater than 1 g per day were seen in about 0.7 percent of patients receiving captopril. About 90 percent of affected patients had evidence of prior renal disease or received relatively high doses of captopril (in excess of 150 mg/day), or both. The nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months whether or not captopril was continued. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria.

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, captopril will block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Some patients may be at risk of excessive hypotension, particularly those having heart failure with systolic blood pressure below 100 mmHg, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. If symptomatic hypotension develops, a dose reduction or discontinuation of captopril or concomitant diuretic may be necessary.

ACE inhibitors have been rarely associated with hepatic failure characterized by cholestatic jaundice with progression to fulminant hepatic necrosis and sometimes death. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and seek medical attention.

As with all vasodilators, captopril should be given with caution to patients with obstruction in the outflow tract of the left ventricle.

Oliguria, progressive azotemia, acute renal failure and/or death have been reported during ACE inhibitor therapy, particularly in patients with severe congestive heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system. Increases in blood urea nitrogen and serum creatinine may occur in hypertensive patients with unilateral or bilateral renal artery stenosis. Such increases are usually reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy.

Hyperkalemia can occur with ACE inhibitors, particularly in patients with renal insufficiency, diabetes mellitus, and those taking potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.

Persistent nonproductive cough has been reported with all ACE inhibitors and almost always resolves after discontinuation of therapy.

Dialysis

Captopril is moderately hemodialyzable (20%-50%). A post dialysis dose or a 25%-35% supplemental dose should be administered.

Captopril is not removed by peritoneal dialysis. A supplemental dose is not necessary.

Other Comments

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 previous antihypertensive drug regimen for 1 week before starting captopril.
A maximum daily dose of 450 mg should not be exceeded.

Compared with Caucasian patients, Black patients have a reduced blood pressure response to monotherapy with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers; however, the reduced response is largely eliminated if combination therapy that includes an adequate dose of a diuretic is instituted.

Following first-time MI, all ACE inhibitors, at comparable appropriate dosages, appear to be equally effective for reducing mortality and recurrent MI rates.

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