Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
CAS Number: 62571-86-2
May cause fetal and neonatal morbidity and mortality if used during pregnancy.401 402 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue captopril as soon as possible.115 402
Sulfhydryl ACE inhibitor.1 3 4 5
Uses for Captopril
Management of hypertension (alone or in combination with other classes of antihypertensive agents).115 317 500
ACE inhibitors are recommended as one of several preferred agents for the initial management of hypertension; other options include angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics.501 502 503 504 While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.500 501 502 504 Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).500 501 502 503 504 515
ACE inhibitors may be preferred in hypertensive patients with heart failure, ischemic heart disease, diabetes mellitus, chronic kidney disease, or cerebrovascular disease or post-MI.500 501 502 504 520 523 524 525 526 527 534 535 536 543
Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to ACE inhibitors.379 380 386 399 400 500 501 504 However, diminished response to an ACE inhibitor is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.500 504
The optimum BP threshold for initiating antihypertensive drug therapy is controversial.501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP thresholds/goals; individualize treatment decisions.501 503 507 515 526 530
JNC 7 recommends initiation of drug therapy in all patients with uncomplicated hypertension and BP ≥140/90 mm Hg;500 JNC 8 panel recommends SBP threshold of 150 mm Hg for patients ≥60 years of age.501 Although many experts agree that SBP goal of <150 mm Hg may be appropriate for patients ≥80 years of age,502 504 505 530 application of this goal to those ≥60 years of age is controversial, especially for those at higher cardiovascular risk.501 502 505 506 508 511 515
In the past, initial antihypertensive drug therapy was recommended for patients with diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg;367 385 388 389 500 503 current hypertension management guidelines generally recommend a BP threshold of 140/90 mm Hg for these individuals (same as for the general population of patients without these conditions), although a goal of <130/80 mm Hg may still be considered.501 502 503 504 520 530 535 536 541
Has been used in the management of hypertensive urgencies†.231 232 233 234 235 236 237 238 313 314 500
Management of diabetic nephropathy manifested by proteinuria (urinary protein excretion >500 mg/24 hours) in patients with type 1 diabetes mellitus and diabetic retinopathy.115 262 263 264 265 268 269
A recommended agent in the management of patients with diabetes mellitus and persistent albuminuria who have modestly elevated (30–300 mg/24 hours) or higher (>300 mg/24 hours) levels of urinary albumin excretion; slows rate of progression of renal disease in such patients.520 535 536
Management of heart failure, usually in conjunction with other agents such as cardiac glycosides, diuretics, and β-adrenergic blocking agents (β-blockers).115 210 246 247 248 249 250 252 253 254 256 257 292 304 320 524 700
Some evidence indicates that therapy with an ACE inhibitor may be less effective than angiotensin receptor-neprilysin inhibitor (ARNI) therapy (e.g., sacubitril/valsartan) in reducing cardiovascular death and heart failure-related hospitalization.700 702
ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend that patients with chronic symptomatic heart failure and reduced left ventricular ejection fraction (LVEF) (NYHA class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality.700 701 703
Left Ventricular Dysfunction After Acute MI
Treatment of clinically stable patients with left ventricular dysfunction (ejection fraction ≤40%) to improve survival following MI and to reduce the incidence of overt heart failure and subsequent hospitalizations for heart failure.115 524
Expert guidelines recommend initiation of an oral ACE inhibitor within the first 24 hours of acute MI in patients with an anterior infarct, heart failure, or ejection fraction ≤40% who do not have any contraindications (e.g., hypotension, shock, renal dysfunction).527 Use with caution (and with gradual upward titration) during initial postinfarction period because of the possibility of hypotension or renal dysfunction.527 1100
Continue therapy indefinitely in patients with left ventricular dysfunction or other compelling indications (e.g., hypertension, diabetes mellitus, chronic kidney disease).525 1100
Captopril Dosage and Administration
BP Monitoring and Treatment Goals
Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.500 501
When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months.501
If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug.501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug.501
Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg.500 501 503 504
Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies.500 501 (See Hypertension under Uses.)
Administer orally 1 hour before meals to maximize absorption.115
Dosage has been reduced in proportion to body weight; titrate carefully.115 Some experts recommend an initial dosage of 0.9–1.5 mg/kg daily (given as 0.3–0.5 mg/kg 3 times daily).398 Increase dosage as necessary to a maximum of 6 mg/kg daily.398
JNC 8 expert panel recommends initial dosage of 50 mg daily (given in 2 divided doses) and target dosage of 150–200 mg daily (given in 2 divided doses) based on dosages used in randomized controlled studies.501
Manufacturer recommends initial dosage of 25 mg 2 or 3 times daily; if response is inadequate after 1–2 weeks, dosage may be increased to 50 mg 2 or 3 times daily.115
Lower initial dosages (e.g., 6.25 mg twice daily to 12.5 mg 3 times daily) may be effective in some patients, particularly those already receiving a diuretic.a (See Hypotension under Cautions.)
Usual maintenance dosage: Manufacturers recommend 25–150 mg 2 or 3 times daily (usually not necessary to exceed 150 mg daily).115
Some experts have recommended usual dosage range of 25–100 mg daily given in 2 divided doses; rationale for this lower dosage range is that it may be preferable to add another antihypertensive drug rather than continue to increase dosage of captopril.397 500
If intolerable adverse effects occur, consider dosage reduction; if adverse effects worsen or fail to resolve, may need to discontinue and switch to another antihypertensive drug class.501
Captopril/Hydrochlorothiazide Fixed-combination TherapyOral
If combination therapy is initiated with captopril/hydrochlorothiazide fixed-combination preparation, initial dosage of captopril 25 mg and hydrochlorothiazide 15 mg once daily; adjust dosage (generally at 6-week intervals) by administering each drug separately or by advancing the fixed-combination preparation.102 259
Severe (e.g., accelerated, malignant) hypertension: 25 mg 2 or 3 times daily, initiated promptly under close supervision with frequent monitoring of BP.115 May continue previous diuretic therapy, but discontinue other hypotensive agents.115 May increase dosage at intervals of ≤24 hours under continuous supervision until optimum BP response is attained or 450 mg daily is given.115 Adjunctive therapy with other hypotensive agents may be necessary.a
Hypertensive urgency†: Acute therapy (e.g., 12.5–25 mg, repeated once or twice if necessary at intervals of 30–60 minutes or longer) has been used. 231 232 259
25 mg 3 times daily.115 262
Manufacturers recommend initial dosage of 25 mg 3 times daily;115 in patients with normal or low BP who may be volume- and/or salt-depleted, initial dosage of 6.25 or 12.5 mg 3 times daily.115 Increase dosage gradually to 50 mg 3 times daily; delay further dosage increases for ≥2 weeks to assess response.115
ACCF and AHA recommend initial dosage of 6.25 mg 3 times daily, with gradual titration to 50 mg 3 times daily.524 Generally titrate dosage to prespecified target (i.e., ≥150 mg daily) or highest tolerated dosage rather than according to response.524
Left Ventricular Dysfunction After Acute MI
Manufacturers recommend initiation of therapy ≥3 days post-MI with single dose of 6.25 mg, followed by 12.5 mg 3 times daily.115 Increase dosage over next several days to 25 mg 3 times daily and then over next several weeks (as tolerated) to 50 mg 3 times daily.115
Some clinicians recommend initiation of therapy within the first 24 hours following MI.527
Recommended maintenance dosage: 50 mg 3 times daily.115
Maximum 6 mg/kg daily.398
Maximum 450 mg daily.115
Dosage of captopril/hydrochlorothiazide fixed-combination generally should not exceed captopril 150 mg and hydrochlorothiazide 50 mg daily.102
Maximum dosage recommended by manufacturer is 450 mg daily.115 Experts suggest maximum dosage of 50 mg 3 times daily.524
Manufacturers recommend initial dosage of <75 mg daily; increase dosage in small increments at 1- to 2-week intervals.115 After desired therapeutic effect has been attained, slowly reduce dosage to minimum effective level.115
Patients with Clcr 10–50 mL/minute: 75% of usual captopril dosage or administration of usual dose every 12–18 hours suggested by some clinicians.211
Clcr <10 mL/minute: 50% of usual dosage or administration of usual dose every 24 hours suggested by some clinicians.211
Patients undergoing hemodialysis may require supplemental dose after dialysis.211
Fixed-combination captopril/hydrochlorothiazide tablets usually are not recommended for patients with severe renal impairment.102
Usual adult dosages generally have been used; dosages of 6.25–12.5 mg 1–4 times daily used occasionally.175
Volume-and/or Salt-Depleted Patients
Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.115 116 148 153 (See Dosage: Heart Failure, under Dosage and Administration.)
Cautions for Captopril
Known hypersensitivity (e.g. history of angioedema) to captopril or another ACE inhibitor.115 147 325 326
Possible neutropenia or agranulocytosis; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma).115
Use with caution and only after careful risk/benefit assessment in patients with collagen vascular disease or those taking drugs known to affect leukocytes or immune response.115
If used in patients with renal impairment, determine complete and differential leukocyte counts prior to initiation of therapy, at about 2-week intervals for the first 3 months of therapy, and periodically thereafter.115 Discontinue therapy if confirmed neutrophil count is <1000/mm3.115
Proteinuria possible, particularly in patients with prior renal disease and/or those receiving relatively high dosages (>150 mg daily).115 Usually occurs by the 8th month of treatment1 3 46 and subsides or clears within 6 months whether or not therapy is continued;115 however, may persist in some patients.a
Possible excessive hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis, patients with severe heart failure).1 5 17 23 25 31 66 85 115 116 148 154 156
Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.115
Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).115
To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.a (See Special Populations under Dosage and Administration.) Discontinue other antihypertensive therapy, if possible, 1 week before initiating captopril, except in patients with severe hypertension.115 a Withholding diuretic therapy and/or increasing sodium intake approximately 3–7 days prior to initiation of captopril may minimize potential for severe hypotension.115 116 148 153
Initiate therapy in patients with heart failure under close medical supervision; monitor closely for first 2 weeks following initiation of captopril or any increase in captopril or diuretic dosage.115
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when used during pregnancy.102 115 239 240 241 402 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.402
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.401 402
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.402 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.239
Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.102 115 370
If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.115
Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal.115 Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.115 Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.115
Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption115 275 276 277 or following initiation of hemodialysis that utilized high-flux membrane.102 115 242 243 244
Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.102 155 278
Not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitors.a
Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment, sodium depletion, or hypovolemia; patients with renovascular hypertension, particularly those with bilateral renal-artery stenosis or those with renal-artery stenosis in a solitary kidney;5 86 115 117 122 123 124 207 208 209 372 or patients with chronic or severe hypertension in whom the glomerular filtration rate may decrease transiently.1 115
Possible increases in BUN and Scr in patients with heart failure;115 206 rapidity of onset and magnitude may depend in part on degree of sodium depletion.148 156 206 372
Closely monitor renal function following initiation of therapy in such patients.86 87 115 117 122 123 124 333 372 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.115 156 206 207 209
Possible hyperkalemia,5 7 38 69 70 85 115 122 125 126 162 163 164 177 especially in patients with impaired renal function, heart failure, or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).38 85 115 125 126 148 162 163 164 372 (See Interactions.)
Monitor serum potassium concentration carefully in these patients.126 162 163
Persistent and nonproductive cough; resolves after drug discontinuance.102 115
Possible risk of decreased coronary perfusion in patients with aortic stenosis when treated with captopril.a 115
Use of Fixed Combinations
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.102
Category C (1st trimester); Category D (2nd and 3rd trimesters).115 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)
Distributed into milk.115 Discontinue nursing or the drug.115
Safety and efficacy not established; however, captopril has been used in children.115 Manufacturer states that captopril should be used only when other measures for controlling BP have not been effective.115
Possible excessive, prolonged, and unpredictable decreases in BP and associated complications (e.g., oliguria, seizures) in infants.115
Systemic exposure to captopril may be increased.115 (See Special Populations under Pharmacokinetics.) Initial dosage adjustment recommended in patients with severe renal impairment.115 (See Renal Impairment under Dosage and Administration.)
Deterioration of renal function may occur.115 211 Possible increased risk of neutropenia/agranulocytosis,115 proteinuria,115 and hyperkalemia.115 (See Warnings and General Precautions under Cautions.)
Use of captopril/hydrochlorothiazide fixed combination usually is not recommended in patients with severe renal impairment.102
BP reduction may be smaller in black patients compared with nonblack patients.115 139 177 178 179 180 181 351 (See Hypertension under Uses.)
Higher incidence of angioedema reported with ACE inhibitors in black patients compared with other races.102 115 325 326 327 351 379 380 500
Common Adverse Effects
Rash, pruritus, cough, dysgeusia, proteinuria, tachycardia, chest pain, palpitations.115
Interactions for Captopril
Specific Drugs and Laboratory Tests
Drug or Test
Adrenergic neuron blocking agents (guanethidine)
Possible increased hypotensive effect115
Use with caution115
Decreased rate and extent of captopril absorption197 201
Clinical importance is uncertain197 201
Antidiabetic agents, oral
Possible hypoglycemia in diabetic patients101
Consider risk of hypoglycemia if used concomitantly101
Pharmacokinetic interaction unlikely115
β-Adrenergic blocking agents
Increased (but less than additive) hypotensive effect115
Further documentation of interaction necessarya
Possible increased serum digoxin concentrations in patients with heart failure198 199 200
Monitor serum digoxin concentration;198 200 reduction of digoxin dosage not required upon initiation of captopril198
Possible additive hypotensive effectsa
Pharmacokinetic interaction with furosemide unlikely115
Adjust dosage carefullya (see Dosage under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)
Possible hyperkalemia, especially in patients with renal impairment162 329 331 335
Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;85 115 125 126 148 162 163 164 discontinue or reduce dosage of potassium-sparing diuretic as necessary85 126 148 162 163
Possible hypoglycemia in diabetic patients101
Consider risk of hypoglycemia101
Possible increased serum lithium concentrations, particularly in patients receiving concomitant diuretic therapy115
Use with caution; monitor serum lithium concentrations frequently115
Possible decreased antihypertensive response to captopril;283 284 285 286 287 288 289 290 364 706 potential for acute reduction of renal function;285 291 possible attenuation of hemodynamic actions of ACE inhibitors in patients with heart failure333 364
Monitor BP carefully and be alert for evidence of impaired renal function;285 if interaction is suspected, discontinue NSAIA or modify captopril dosage or use another hypotensive agent285 286
Potassium supplements or potassium-containing salt substitutes
Possible hyperkalemia, especially in patients with renal impairment162
Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;85 115 125 126 148 162 163 164 discontinue or reduce dosage of potassium supplement as necessary85 126 148 162 163
Possible increased blood concentrations of captopril and its metabolites203 204 205 213
Test for urine acetone
Possible false-positive results with sodium nitroprusside reagent54 115
Vasodilating agents (e.g., hydralazine, nitrates, prazosin)
Possible increased hypotensive effect115
If possible, discontinue vasodilating agent before starting captopril; if vasodilating agent is resumed during captopril therapy, administer with caution and possibly at a lower dosage115
Rapidly absorbed following oral administration in fasting individuals,19 20 84 115 with peak blood concentration attained in 1 hour.19 Approximately 60–75% of an oral dose is absorbed.19 20 84 115
Hypotensive effect may be apparent within 15 minutes5 6 16 23 and usually is maximal in 1–2 hours after a single oral dose.1 3 10 15 16 17 21 24 29 Several weeks of therapy may be required before full effect on BP is achieved.1 3 5 16 21 28
Duration of action generally is 2–6 hours but appears to increase with increasing doses.a
Food may decrease absorption of captopril by up to 25–40%;1 3 115 191 195 196 197 202 effect may not be clinically important.191 192 195
Appears to be rapidly distributed into most body tissues, except CNS.1 5
Crosses the placenta and is distributed into milk.115
Plasma Protein Binding
25–30%1 3 22 (mainly albumin).3
About half the absorbed dose is rapidly metabolized.3 5 19 Captopril and its metabolites may undergo reversible interconversions.3
Excreted in urine (95%) as unchanged drug (40–50%) and metabolites.3 19 20 22 115
Elimination half-life is about 20–40 hours in patients with Clcr <20 mL/minute 3 and up to 6.5 days in anuric patients.5 22
Tight containers at ≤30°C.115
Tablets (Captopril and Hydrochlorothiazide)
Tight containers at ≤30°C.102
Suppresses the renin-angiotensin-aldosterone system.1
Advice to Patients
Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.115 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.115
Importance of reporting signs of infection (e.g., sore throat, fever).115
Risk of hypotension.115 Importance of informing clinicians promptly if lightheadedness or fainting occurs.115
Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.115
Importance of not discontinuing or interrupting therapy unless instructed by a clinician.115
Risks of use during pregnancy.115 401 402 (See Boxed Warning.)
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium) as well as any concomitant illnesses.115
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.115
Importance of taking 1 hour before meals.115
Importance of advising patients of other important precautionary information.115 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
25 mg Captopril and Hydrochlorothiazide 15 mg*
Captopril and Hydrochlorothiazide Tablets
25 mg Captopril and Hydrochlorothiazide 25 mg*
Captopril and Hydrochlorothiazide Tablets
50 mg Captopril and Hydrochlorothiazide 15 mg*
Captopril and Hydrochlorothiazide Tablets
50 mg Captopril and Hydrochlorothiazide 25 mg*
Captopril and Hydrochlorothiazide Tablets
AHFS DI Essentials. © Copyright 2018, Selected Revisions November 6, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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a. AHFS drug information 2018. McEvoy GK, ed. Captopril. Bethesda, MD: American Society of Hospital Pharmacists; 2018:.
b. Par. Capoten prescribing information. Spring Valley, NY; 2002 May.
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