Captopril
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- CAPTOPRIL DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- PHARMACODYNAMICS
- INDICATIONS & USAGE
- CAPTOPRIL CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- CAPTOPRIL ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
CAPTOPRIL DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of ActionPHARMACOKINETICS
DOSAGE AND ADMINISTRATION
PHARMACODYNAMICS
INDICATIONS & USAGE
HypertensionWARNINGS
Heart Failure
Left Ventricular Dysfunction After Myocardial Infarction
Diabetic Nephropathy
WARNINGS: Head and Neck AngioedemaIntestinal Angioedema
CAPTOPRIL CONTRAINDICATIONS
WARNINGS
Anaphylactoid and Possibly Related ReactionsHead and Neck Angioedema
PRECAUTIONS: Information for PatientsADVERSE REACTIONS
Intestinal Angioedema
Anaphylactoid reactions during desensitization
Anaphylactoid reactions during membrane exposure
Neutropenia/Agranulocytosis
Proteinuria
Hypotension
PRECAUTIONS: Drug Interactions
Fetal/Neonatal Morbidity and Mortality
Hepatic Failure
PRECAUTIONS
GeneralImpaired Renal Function
Hypertension
Heart Failure
SeeCLINICAL PHARMACOLOGY,DOSAGE AND ADMINISTRATION,ADVERSE REACTIONS: Altered Laboratory Findings.
Hyperkalemia
PRECAUTIONS: Information for PatientsandDrug InteractionsADVERSE REACTIONS: Altered Laboratory Findings.)
Cough
Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
Valvular Stenosis
There is concern, on theoretical grounds, that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction as others.
Surgery/Anesthesia
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.
Hemodialysis
Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors. In these patients, consideration should be given to using a different type of dialysis membrane of a different class medication. (SeeWARNINGS: Anaphylactoid reactions during membrane exposure.)
INFORMATION FOR PATIENTS
WARNINGS: Head and Heck AngioedemaIntestinal AngioedemaPRECAUTIONS: GeneralDrug InteractionsADVERSE REACTIONS.)
Patients should be warned against interruption or discontinuation of medication unless instructed by the physician.
Heart failure patients on captopril therapy should be cautioned against rapid increases in physical activity.
Patients should be informed that captopril should be taken one hour before meals (seeDOSAGE AND ADMINISTRATION).
Pregnancy
Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to ACE-inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.
DRUG INTERACTIONS
Hypotension-Patients on Diuretic TherapyAgents Having Vasodilator Activity
Agents Causing Renin Release
Agents Affecting Sympathetic Activity
Agents Increasing Serum Potassium
Inhibitors of Endogenous Prostaglandin Synthesis
Lithium
Cardiac Glycosides
Loop Diuretics
Allopurinol
Gold
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
PREGNANCY
Teratogenic Effects: Categories C (first trimester) and D (second and third trimesters)WARNINGS: Fetal/Neonatal Morbidity and Mortality
NURSING MOTHERS
PRECAUTIONS: Pediatric UsePEDIATRIC USE
CAPTOPRIL ADVERSE REACTIONS
WARNINGS
WARNINGS
WARNINGSPRECAUTIONS: Drug Interactions
WARNINGS: Head and Neck AngioedemaIntestinal AngioedemaPRECAUTIONS: Information for Patients
PRECAUTIONS: General: Cough
WARNINGS: Anaphylactoid and Possible Related ReactionsPRECAUTIONS: Hemodialysis
Fetal/Neonatal Morbidity and Mortality
WARNINGS: Fetal/Neonatal Morbidity and Mortality
Altered Laboratory Findings
PRECAUTIONS
OVERDOSAGE
DOSAGE & ADMINISTRATION
Hypertension
WARNINGSPRECAUTIONS: Drug Interactions
PRECAUTIONS: Drug Interactions
Heart Failure
WARNINGS: Hypotension
For most patients the usual initial daily dosage is 25 mg tid. After a dose of 50 mg tid is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg tid. A maximum daily dose of 450 mg of captopril should not be exceeded.
Captopril should generally be used in conjunction with a diuretic and digitalis. Captopril therapy must be initiated under very close medical supervision.
Left Ventricular Dysfunction After Myocardial Infarction
The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.
Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, captopril therapy should be initiated at 12.5 mg t.i.d. Captopril should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated (seeCLINICAL PHARMACOLOGY).
Captopril may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.
Diabetic Nephropathy
The recommended dose of captopril for long term use to treat diabetic nephropathy is 25 mg t.i.d.
Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with captopril if additional therapy is required to further lower blood pressure.
Dosage Adjustment in Renal Impairment
Because captopril is excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. 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 captopril 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.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment. (See alsoWARNINGS: Anaphylactoid reactions during membrane exposureandPRECAUTIONS: Hemodialysis.)
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
CaptoprilCaptopril TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
