Captopril and Hydrochlorothiazide (Captopril / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

Captopril and Hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive.

This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.

When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.

Treatment may, therefore, be initiated with Captopril and Hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION).

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

Captopril and Hydrochlorothiazide may be used 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 and Hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations.

ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Captopril: Head and Neck Angioedema and Intestinal Angioedema).

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED ACCORDING TO PATIENT'S RESPONSE.

Captopril and Hydrochlorothiazide tablets may be substituted for the previously titrated individual components.

Alternatively, therapy may be instituted with a single tablet of Captopril and Hydrochlorothiazide 25 mg/15 mg taken once daily. For patients insufficiently responsive to the initial dose, additional captopril or hydrochlorothiazide may be added as individual components or by using Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg or 50 mg/25 mg, or divided doses may be used.

Because the full effect of a given dose may not be attained for 6 to 8 weeks, dosage adjustments should generally be made at 6 week intervals, unless the clinical situation demands more rapid adjustment.

In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg.

Captopril and Hydrochlorothiazide tablets should be taken one hour before meals.

Dosage Adjustment in Renal Impairment

Because captopril and hydrochlorothiazide are 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 of Captopril and Hydrochlorothiazide.

After the desired therapeutic effect has been achieved, the dose intervals should be increased or the total daily dose reduced until the minimal effective dose is achieved. When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic is preferred for use with captopril; therefore, for patients with severe renal dysfunction the captopril-hydrochlorothiazide combination tablet is not usually recommended. (See WARNINGS: Captopril: Anaphylactoid Reactions During Membrane Exposure and PRECAUTIONS: Hemodialysis).

HOW SUPPLIED

Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with M 81 on one side and is quadrisected on the reverse side. They are available as follows:

    NDC 0378-0081-01
    bottles of 100 tablets

Captopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with M 83 on one side and is quadrisected on the reverse side. They are available as follows:

    NDC 0378-0083-01
    bottles of 100 tablets

Captopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with M 84 on one side and is partially bisected on both sides. They are available as follows:

    NDC 0378-0084-01
    bottles of 100 tablets

Captopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with M 86 on one side and is partially bisected on both sides. They are available as follows:

    NDC 0378-0086-01
    bottles of 100 tablets

Dispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.

Keep container tightly closed.

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

REVISED MARCH 2006

CPHZ:R7