Prinzide (Lisinopril / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

PRINZIDE is indicated for the treatment of hypertension.

These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

In using PRINZIDE, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.)

In considering use of PRINZIDE, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.)

DOSAGE AND ADMINISTRATION

Lisinopril is an effective treatment of hypertension in once-daily doses of 10-80 mg, while hydrochlorothiazide is effective in doses of 12.5-50 mg. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10-80 mg and hydrochlorothiazide doses of 6.25-50 mg, the antihypertensive response rates generally increased with increasing dose of either component.

The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Dose Titration Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to PRINZIDE 10/12.5 or PRINZIDE 20/12.5. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to PRINZIDE 10/12.5. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.

Replacement Therapy

The combination may be substituted for the titrated individual components.

Use in Renal Impairment

The usual regimens of therapy with PRINZIDE need not be adjusted as long as the patient's creatinine clearance is >30 mL/min/1.73 m² (serum creatinine approximately ≤ 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so PRINZIDE is not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).

HOW SUPPLIED

No. 8439 — Tablets PRINZIDE 10-12.5 are blue hexagon-shaped tablets with code 145 on one side and plain on the other. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0145-58 unit of use bottles of 100.

No. 8247 — Tablets PRINZIDE 20-12.5, are yellow, hexagon-shaped tablets with code MSD/140 on one side and scored on the other. Each tablet contains 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0140-58 unit of use bottles of 100.

No. 3595 — Tablets PRINZIDE 20-25, are peach, round, fluted-edge tablets, coded MSD 142 on one side and PRINZIDE on the other. Each tablet contains 20 mg of lisinopril and 25 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0142-58 unit of use bottles of 100.

Storage

Store at controlled room temperature, 15-30°C (59-86°F). Protect from excessive light and humidity.

Dispense in a well-closed container, if product package is subdivided.

Tablets PRINZIDE (lisinopril-hydrochlorothiazide) 10-12.5 mg and 20-12.5 mg are manufactured for:

Merck & Co., Inc.
Whitehouse Station, NJ 08889, USA

by:

MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU

Tablets PRINZIDE (lisinopril-hydrochlorothiazide) 20-25 mg are manufactured for:

Merck & Co., Inc.
Whitehouse Station, NJ 08889, USA

by:

MERCK FROSST CANADA LTD.
Kirkland, Quebec, Canada H9H 3L1

Issued October 2008

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