Captopril tablet

Captopril tablet
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Black Box Warning

Fetal Toxicity

See full prescribing information for complete Boxed Warning.

*When pregnancy is detected, discontinue captopril as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See

Overview

Captopril tablet is {{{aOrAn}}} Angiontensin converting enzyme inhibitor that is FDA approved for the {{{indicationType}}} of hypertension, heart failure, left ventricular dysfunction after myocardial infarction, diabetic nephropathy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, rash, hyperkalemia (11% ), disorder of taste, cough (0.5% to 2%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

Captopril tablets, USP are indicated for the treatment of hypertension.

In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis.

Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.

Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.

Heart Failure

Dosing Information

(Dosage)

Captopril tablets, USP are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.

Left Ventricular Dysfunction After Myocardial Infarction

Dosing Information

(Dosage)

Captopril tablets, USP are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.

Diabetic Nephropathy

Dosing Information

(Dosage)

Captopril tablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).

In considering use of captopril, it should be noted that 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information/Recommendation

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Condition 2

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

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Non–Guideline-Supported Use

Condition 1

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Condition 2

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Condition 3

Dosing Information

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Captopril tablet FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information/Recommendation

(Dosage)

Condition 2

Developed by: (Organisation)

Class of Recommendation: (Class) (Link)

Strength of Evidence: (Category A/B/C) (Link)

Dosing Information/Recommendation

(Dosage)

Non–Guideline-Supported Use

Condition 1

Dosing Information

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Condition 2

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Condition 3

Dosing Information

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Contraindications

Hypersensitivity to this product or any other angiotensin-converting enzyme inhibitor
History of angioedema during therapy with any other ACE inhibitor)

Warnings

Fetal Toxicity

See full prescribing information for complete Boxed Warning.

*When pregnancy is detected, discontinue captopril as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See

Fetal Toxicity

Pregnancy Category: D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue captopril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mothers and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue, captopril unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to captopril for hypotension, oliguria, and hyperkalemia.

When captopril was given to rabbits at doses about 0.8 to 70 times (on a mg/kg 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 a mg/kg basis, the doses used were up to 150 times (in hamsters) and 625 times (in rats) the maximum recommended human dose.