RVP

Drug Catalog - Product Detail

CAPTOPRIL TB 50MG 100

NDC Mfr Size Str Form
00781-8075-01 SANDOZ 100 50MG NA
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Generic Name
CAPTOPRIL
Substance Name
CAPTOPRIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074477
Description
DESCRIPTION Captopril tablets, USP, are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline (MW 217.29) and has the following structure: C 9 H 15 NO 3 S Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril and the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose and stearic acid. Structure
How Supplied
HOW SUPPLIED Captopril Tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of captopril, USP. The 12.5 mg tablets are white to off-white, oval, flat, beveled-edge tablets, debossed with "S1" on one side and partial bisected on both sides. They are available as follows: NDC 0781-8052-01 bottles of 100 tablets NDC 0781-8052-10 bottles of 1000 tablets The 25 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S2" on one side and quadrisected on the other side. They are available as follows: NDC 0781-8061-01 bottles of 100 tablets NDC 0781-8061-10 bottles of 1000 tablets The 50 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S3" on one side and bisected on the other side. They are available as follows: NDC 0781-8075-01 bottles of 100 tablets NDC 0781-8075-10 bottles of 1000 tablets The 100 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S4" on one side and bisected on the other side. They are available as follows: NDC 0781-8080-01 bottles of 100 tablets Captopril tablets, USP may exhibit a slight sulfurous odor. Bottles contain silica gel desiccants. Store at 20o to 25oC (68o to 77oF), excursions permitted to 15o to 30oC (59o to 86oF). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
INDICATIONS AND USAGE Hypertension Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets 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 tablets are 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 Captopril tablets 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 Captopril tablets 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 Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decrease 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 tablets, 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
DOSAGE AND ADMINISTRATION Captopril tablets 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 captopril tablets. The initial dose of captopril tablets is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after 1 or 2 weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when captopril tablets are used alone. The dose of captopril tablets in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after 1 to 2 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 1- to 2-week intervals until its highest usual antihypertensive dose is reached. If captopril tablets are being started in a patient already receiving a diuretic, captopril therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension ), with dosage and titration of captopril as noted above. If further blood pressure reduction is required, the dose of captopril tablets 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 mg to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg captopril tablets 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 captopril 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 captopril tablets 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 captopril tablets 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 captopril 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 mg 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 2 weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 mg or 100 mg t.i.d. A maximum daily dose of 450 mg of captopril tablets should not be exceeded. Captopril tablets 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 3 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 tablets 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 ). Captopril tablets 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 tablets 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 tablets 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 tablets should be reduced, and smaller increments utilized for titration, which should be quite slow (1- to 2-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 ).