Captopril Recall

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Questions & Answers

Side Effects & Adverse Reactions

Anaphylaclold and Possibly Related Reactions

Presumably because angiotensln·converting enzyme inhibitors affect the metabolism of elcosanoids and polypeptides, inclUding

endogenous bradykinin, patients receiving ACE}nhibitors (including caplopril) may be subject to avariety 01 adverse reactions, some of

them serious.

Headand Neck Angioedema: AngioedemaInvolving the extremities, face, Ij~, mucous membranes, longue, glottis or larynx has been

seen In patients Irealed with ACE inhibitors, Including captopril. If angioedema Involves the tongue, glottis or larynx, airway obstruction

may occur and be falal. Emergencytherapy, including but not necessarily limited 10, sUbculaneous administration of a1:1000 solution of

epinephrine should be prompUyinsUtuted.

Swelling confined to ~_e face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuatJon of

captopril; some cases required medlcallherapy. (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS.)

Intestinal Angioedema: Intestinal angioedema has been reported in patients trealed wah ACE lnhibil.ors. These patients presenled

with abdominal pain (with or without naUSeaorvomiting); in somecasesIherewas noprior history of facial angioedemaandC·l esterase

levels were normal. Thf! angioedema Vias diagnosed by procedures Including abdominal CT scan or ultrasound, or at surgery, and

symploms resolved after slopping the ACE inhibitor.lnlestinal angioedema shouldbe Included In the dillerential diagnosis of patlents on

ACEInhibitorspresenting with abdominal pain.

Anaphylactoid reactions during desensitization: Two patienls undergoing desensitizing lreatment wilh hymenoplera venom while

receiving ACE Inhibitors suslained liIe-threatenlng anaphylactoid reactions. In the same patients, these reacUonswere avoided When

ACE inhibilors were temporarity wHhheld, butthey reappeared uponinadvertentrechallenge.

Anaphylactoid reactions during membrane exposure: Anaphylactoid reactions have been reported in pauenls dIalyzed with highflux

membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patienls

undergoing low-densitylipoproleln apheresls with dextran sulfate absorption.


Neutropenia «1OOO!mm~ with myeloid hypoplasia has resulted from use of caplopril. About hal( of the neutropenic patients developed

syslemic or oral cavity inlecUons or other features Qf the syndrome of agranUlocytosis.

The risk of neutropeniais dependenton the clinical status of the paUent :

In clinical trials inpatients with hypertension who have normal renat function (serum creatinine less than 1.6 ml}'dL and no collagen

vascular disease), neutropenia hasbeen seenin one patient oul of over 8,600 exposed.

In patienls with some degree of renal failure (serum creatinine at least 1.6 mgldl) but no collagen vascular disease, the risk of

neutropenia in cl!nicallrials was about 1per 500, afrequency over 15 times that for uncomplicated hYpertension. Dally doses of

caplopril were relatively highin these patients, p~rticulartyln view of Ihelrdiminished renal function. In foreign markeling experience

In patients wilh renal fallure, use of allopUrinol concomitantly with caplopril has been assoclaled with neutropenIa but this

association has notappeared in U.S. reports.

In patient& with collagen vascular diseases (e.g' systemic lupus el)"thematosus, scleroderma) and impaired renal function,·

neutropenia occurred in 3.7 percent oipalients In c1inicat trials.

While f1pne of the over 750 patlents In formal clinlcallrials of heart failure .developed neulropenla, it has occurred during the

subsequent clinical experience. About half of the reported cases had &erurn creatinine ~1.6 mgldL and more than 75 percent were In

patlenls also receiving procainamide.ln heart failure, itappears thatlhe same risk factors for neutropenia are present.

The neutropenia has usually been detected within three months alter caplopril was started. Bone marrow examinations in palienls with

neutropenia consistently showed myeloId hypoplasia, frequently accompanied by erythroid hypoplasia and decreased numbers of

megakaryocytes (e,g' hypoplasticbone marrowand pancytopenia); anemia and thrombocytopenia were sometimes seen.

In general, neutrophlls returried to normal in about two weeks after captopril was discontinued,·and serious infections Were limned to

clinically complex patients. About 13 percent oIlhe cases of neutropenia have eooed fatally, but afmostall falalitles were In patients with

serious illness, having collagen vascular disease, renalfaHure, heart failure or immunosuppressant therapy, or acombination of these


Evaluation of the hypertensive orheart failure pallent should always Include assessmenl of renal function.

If captoprills used In patients with ImpaIred renal function, white blood cell and differenllal counts shoUld be evalualedpn"orto starting

treatment and at approxlmalely two·weekIntelvels foraboul three monlhs, Ihen periodically.

In patients with collagen vascular disease or Who are exposed to other drugs known to affect the while 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


All patients Ireated wilh capt~'" shouldbe told to report any signs of Infection (e.g., sore Ihroat, fever). 'infection Is susPected, white cell

counts should be performed without delay,

~ince discontinuation of captopril and other drugs has genera/ly led to prompt relurn of the white count to normal, upon confirmation of

neutropenia(neutrophil count<1OOOImm~ Ihe physlcien should wilhdraw captopol and closely follow the patienrs course.


Total urinary proteins greater than 1gperday were seen in about 0.7 percentaf patients receiving captopril. Aboul90 petcentofaffected

patlents had evidence of prior renal disease or received relatively high doses of captopril (in excess 01150 rng/day), or both. The

nephrotic syndrome occurred In aboul one·fifth of protelnuric 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 s~ldom altered In the patients

with proteinuria.


Excessive hypotension was rarely seen in hypertensive paUenls but is apossible consequence of captopril use in salVvolume depleted

persons (such as those treated vigorously with diurelics), patients with heart faflure or those paUenls undergoing renal dialysis (see

PRECAUTIONS: Drug Interactions.)

In heart failure, where the blood pressure was elther nonnal or low, lranslentdecreases In mean blood pressure greater than 20 percent

were recorded in about half of the patients. This transient hypotension is more likely 10 occur after any of the first several doses and Is

usually welliolerated, producing

either no symptoms or brief mUd IIghUleadedness although,

In rare Instances it has been assoclaled with arrhythmia or conduction defects. Hypotension was the reason for discontinuation of drug in 3.6 patients with heart failure.



Astarting dosa of 6.25 or 12.5mg t.i.d. may minimize the hypotensive effect

Pellents should

be followed closely for the first two weeks of treatment and whenever the dose of captopril and/or diurelic Is increased. In patients with

hearffailure, reducing the dose of diuretic, if feasible, mayminimize the fall in blood pressure.

Hypotension is not per se a reason to disconlinue captoprll. Some decrease of systemic blood pressure is acommon and desirable

observation upon initiation of caploprillablets, USP treatment in heart failure. The magnItude of the decrease Is greatesl earty in the

course of treatment; this effect stabHizes within a week or two, and generally relums to prelreatmentlevels, without a decrease in

therapeutic efficacy, wilhlntwomonlhs.

FetallNeonatal MorbiditY and Mortality

ACE inhibitors can cause fetal and neonalal morbidity and death when admlnlslered to pregnant women. Several dozen cases have

been reported In the world literature.WhenpregnancyIs delected,ACE inhibitors should bediscontinuedas soon as possible.

The use of ACE InhIbitors during the second and third trimeslers of pregnancy has been associated with fetal and neonatal injury,

Including hypolension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure. and death. OligohydramnIos has also

been reported, presumably resulling from decreased fetal renal function; oligohydramnios

in this selling has been assoclated with fetal

limb cootraclures, craniofacial defonnalfon, and hypoplastic lung developmenl. Premalunty, Intrauterine growth retardation, and patent

ductus. arteriosus havEl alsobeen reported, althougbJt Is notdear' ~~~e opcurrences were dueto the ACE·inhlbltor exposure.

These adverse effects do notappear to have resulted from Intraulerine ACE·inhibitor exposure that has been limited to the first trimester.

Mothers whose embryos and fetuses are exposed to ACE inhlbilors only during the first trimester should be so Informed Nonetheless,

when patients becomepregnant, physicians shouldmake every effort to discontinue the use 01 captopril as soon a~ possible.

Rarely (probably less often than once In everylhousand pregnancies), no alternative toACE lnhlbll6ts will be found. In these rare cases,

the molhers should be apprised of the potential hazatds to their feluses, and serial ultrasOund examinations should be peJfOlmed to

assess the Intraamnlotlcenvironment.

If oligohydramnios is obselVed, caploprilshould be discon~nued unless it is considered life.saving for lhe mother. Contraction stress

lesting{CST}, a non-stress tosl (NST), or biophysical profiling (BPP) may be approprtate, depending upon the weak 01 pregnency.

Patients and physldans should be aware, however,that oligohydramnios may nol appear unl!! after the fetus has sustained Irreversible


Infants with histories of in utero expOsure to ACE inhibitors should be closely observed for hypolension, oliguria, and hyperkalemia. If

oliguria occurs. atlention.should be directed toward support of blood pressure and renal perfusion. Exchangetransfusion or dialysis may

be required as ameans of reversing hypotension and/or sUbsli!utingIor disordered renal fuoction. While captopril maybe removed from

the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the

clrculalion ofneonates orchildren. Peritoneal dialysis is not effective for removing captopril; there is no Informationconcerning exchange

transfusion for removing captopril from the general circulation. ".

When caplopril was given to rabbits at doses about 0.8 to 70 Urnes (on amglkg basis) the maximum recommended human dose, low

incidences of craniofacial malformations were seen. No teratogenic effects of captopril were seen In studies of pregnant rats and

hamsters. On amg!k:g basts, the doses used were up to 150 times (in hamsters) and 625 times ~n rats} the maximum recommended


Hepatic Failure

Rarely, ACE inhibitors have been associated with asyndrome that starts with cholestaUc Jaundice and progresses to fulminant h!3psllc

necrosis and {sometimes} death. The mechanism of this syndrome Is not understood. Patienls receMng ACE inhibitors who develop

Jaundice or marked elevations of hepaticenzymesshould discontinue theACEinhlbllorand receive appropriate medical follOW-Up.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Hypertension: Captopril tablets US?are indicated for the Teatment of hypertension.

tn using captopril, conslderallon should be gtven to the risk of neutropenia!agranutocytosls (seeWARNINGS).

Captoprll maybe used as Initial therapy for patientswilh normal renal function, In whomthe rlskls relatively low. In patients with impaired

renal function, particularly those wfth collagen vascular olSeas6, captopril should be reseNed for,hypertenslves who have either

develoPed unacceptable side effecls on otherdrugs, orhave failed to responq satislactorily 10drug cOmbinations.

Captopril is effective alone and in combination with other antihypertensive agents, ~peclally thiazide-type diuretics. The blood pressure

lowering effecls of captoprif and thlazldes are approximalaly a<!dlltva.Heart Failure:Captopril tabletsare indicated in the treatmentof congestive heart failure usually in cornblnatlpn with

diuretics and

di9italls_ The beneficial effect 01 captopril in~eart failure does the presence 01 digllaUs, however, most controlled cliniCal trial

experience with captopril has been in paUentsreceMng digitalis, as well as dluretlctrealmen!. .

Left V~ntrlcular Dysfunction After MYQcar~lal tnlarctlon : Gaplopril tablels are indicated to Improve survival following myocardial

fnfarclion In clinically stable patients with left ventriCUlardysfUnction manlfesled as an ejection fraction ::;40% and 10 reduce the Incidence

01 overt heart failure and subsequenthospitalizations forcongesUve heart failure In these patients.

Diabetic Nephropathy: Captopril lablels are indicated fortha trealment ot diabetic nephropathy (proteinuria> 500 mg/day) in paUents

with type Ilnsulin-dependenl diabetes mellitus and retinopathy. Caplopriltablets decreases the rate of progression of renallns·uffJcienCy

and development of serious adverse clinical outcomes {death or need for renallransplantation or dialysisl.

In considering use of caplopril tablets, it should be noted that In controlled trtals ACE inhibllors have an effect on blogd pressure that is

less in black patients than In nonblacks. In addition, ACE Inhibitors (for which adequate data are available) cause a higher rate of

angioedema in black than In non-black palients {seeWARNINGS: Head and NeckAngloedema and Intestinal AngIQedema}.


There is currently no drug history available for this drug.

Other Information

Captoprills a specific competitive inhibitor of angio!erlSln I-converting enzyme (ACE), the enzyme responsible for the conversion of

anglolensln Iloanglolensin II.

eaploprills deslgnaled chemically as j-[(2S)-3-mercaplo-2-malhylpropionylj-L-prolina. Moler:ular fonnul. e,H'NO,S [MW 217.29) and

has the follo"NIngstruclural.formula:

Captopril structural formula

Captoprills a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in waler (approx. 160 m9fml),

malhanol, and alhanol and sparingly soluQleln chIorolonn and alhyl acelala.

Each scored tablet, for oral administration, contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril.ln add~ion, each lablet contains the

following inactive ingredients: microcf)"stalline cellulose,comstarch, anhydrous ladose, coHoidalsilicon dioxide, talc andpalmilic acid.

Captopril Manufacturers

  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Captopril Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • State Of Florida Doh Central Pharmacy
    Captopril Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Captopril Tablet [State Of Florida Doh Central Pharmacy]
  • Rebel Distributors Corp
    Captopril Tablet [Rebel Distributors Corp]
  • Legacy Pharmaceutical Packaging
    Captopril Tablet [Legacy Pharmaceutical Packaging]
  • Remedyrepack Inc.
    Captopril Tablet [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Captopril Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Redpharm Drug Inc.
    Captopril Tablet [Redpharm Drug Inc.]
  • Redpharm Drug Inc.
    Captopril Tablet [Redpharm Drug Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Captopril Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Wockhardt Usa Llc.
    Captopril Tablet Captopril (Captorpil) Tablet [Wockhardt Usa Llc.]
  • Wockhardt Limited
    Captopril Tablet Captopril (Captorpil) Tablet [Wockhardt Limited]
  • Bryant Ranch Prepack
    Captopril Tablet [Bryant Ranch Prepack]
  • Mylan Pharmaceuticals Inc.
    Captopril Tablet [Mylan Pharmaceuticals Inc.]
  • Major Pharmaceuticals
    Captopril Tablet [Major Pharmaceuticals]
  • Physicians Total Care, Inc.
    Captopril Tablet [Physicians Total Care, Inc.]
  • Unit Dose Services
    Captopril Tablet [Unit Dose Services]
  • Unit Dose Services
    Captopril Tablet [Unit Dose Services]
  • Unit Dose Services
    Captopril Tablet [Unit Dose Services]
  • Bryant Ranch Prepack
    Captopril Tablet [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Captopril Tablet [Bryant Ranch Prepack]
  • Rebel Distributors Corp
    Captopril (Captorpil) Tablet [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Captopril Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Captopril Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc.
    Captopril (Captorpil) Tablet [Preferred Pharmaceuticals, Inc.]
  • Apotex Corp.
    Captopril (Captopril ) Tablet Captopril Tablet [Apotex Corp.]
  • Golden State Medical Supply, Inc.
    Captopril Tablet [Golden State Medical Supply, Inc.]
  • Aidarex Pharmaceuticals Llc
    Captopril (Captorpil) Tablet [Aidarex Pharmaceuticals Llc]
  • St Marys Medical Park Pharmacy
    Captopril (Captopril) Tablet [St Marys Medical Park Pharmacy]
  • Remedyrepack Inc.
    Captopril Tablet [Remedyrepack Inc. ]
  • Aidarex Pharmaceuticals Llc
    Captopril Tablet [Aidarex Pharmaceuticals Llc]
  • Mylan Institutional Inc.
    Captopril Tablet [Mylan Institutional Inc.]
  • St Marys Medical Park Pharmacy
    Captopril Tablet Captopril Tablet [St Marys Medical Park Pharmacy]
  • Cardinal Health
    Captopril Tablet [Cardinal Health]
  • Bryant Ranch Prepack
    Captopril Tablet [Bryant Ranch Prepack]
  • Preferred Pharmaceuticals, Inc.
    Captopril Tablet [Preferred Pharmaceuticals, Inc.]
  • West-ward Pharmaceutical Corp
    Captopril Tablet [West-ward Pharmaceutical Corp]
  • Glenview Pharma Inc.
    Captopril Tablet [Glenview Pharma Inc.]
  • Remedyrepack Inc.
    Captopril Tablet [Remedyrepack Inc. ]
  • West-ward Pharmaceuticals Corp
    Captopril Tablet [West-ward Pharmaceuticals Corp]

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