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Capoten

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Capoten

Indications
Dosage
How Supplied

INDICATIONS

Hypertension

CAPOTEN (captopril) Tablets, USP is indicated for the treatment of hypertension.

In using CAPOTEN, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).

CAPOTEN 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.

CAPOTEN 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

CAPOTEN is 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

CAPOTEN is 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

CAPOTEN is indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. CAPOTEN 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 CAPOTEN, 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 (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

DOSAGE AND ADMINISTRATION

CAPOTEN should be taken one hour before meals. Dosage must be individualized.

Hypertension

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 patient's previous antihypertensive drug regimen for one week before starting CAPOTEN.

The initial dose of CAPOTEN (captopril tablets, USP) is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when CAPOTEN is used alone.

The dose of CAPOTEN in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two 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 one- to two-week intervals until its highest usual antihypertensive dose is reached.

If CAPOTEN is being started in a patient already receiving a diuretic, CAPOTEN therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS regarding hypotension), with dosage and titration of CAPOTEN as noted above.

If further blood pressure reduction is required, the dose of CAPOTEN may be increased to 100 mg b.i.d. or t.i.d. and then, if necessary, to 150 mg b.i.d. or t.i.d. (while continuing the diuretic). The usual dose range is 25 to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg CAPOTEN should not be exceeded.

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 CAPOTEN dosage promptly initiated at 25 mg b.i.d. or t.i.d., under close medical supervision.

When necessitated by the patient's clinical condition, the daily dose of CAPOTEN may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of CAPOTEN is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.

Beta-blockers may also be used in conjunction with CAPOTEN therapy (see PRECAUTIONS: DRUG INTERACTIONS), but the effects of the two drugs are less than additive.

Heart Failure

Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 or 12.5 mg t.i.d. may minimize the magnitude or duration of the hypotensive effect (see WARNINGS: Hypotension); for these patients, titration to the usual daily dosage can then occur within the next several days.

For most patients the usual initial daily dosage is 25 mg t.i.d. After a dose of 50 mg t.i.d. 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 t.i.d. A maximum daily dose of 450 mg of CAPOTEN should not be exceeded.

CAPOTEN should generally be used in conjunction with a diuretic and digitalis. CAPOTEN 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, CAPOTEN therapy should be initiated at 12.5 mg t.i.d. CAPOTEN 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 (see CLINICAL PHARMACOLOGY).

CAPOTEN may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.

Diabetic Nephropathy

The recommended dose of CAPOTEN 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 CAPOTEN if additional therapy is required to further lower blood pressure.

Dosage Adjustment in Renal Impairment

Because CAPOTEN 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 CAPOTEN 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 WARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis.)

HOW SUPPLIED

CAPOTEN® (Captopril Tablets, USP)

12.5 mg tablets in bottles of 100 (NDC 49884-793-01), 25 mg tablets in bottles of 100 (NDC 49884-794-01) and 1000 (NDC 49884-794-10), 50 mg tablets in bottles of 100 (NDC 49884795-01) and 1000 (NDC 49884-795-10), and 100 mg tablets in bottles of 100 (NDC 49884-79601). Bottles contain a desiccant-charcoal canister.

The 12.5 mg tablet is a biconvex oval with a partial bisect bar; the 25 mg tablet is a biconvex rounded square with a quadrisect bar; the 50 and 100 mg tablets are biconvex ovals with a bisect bar.

All captopril tablets are white and may exhibit a slight sulfurous odor.

Storage

Do not store above 30° C (86° F). Keep bottles tightly closed (protect from moisture).

Manufactured and Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977. Revised: 06/2012

Last reviewed on RxList: 10/9/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Hypertension

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