Vaseretic (Enalapril Maleate / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

VASERETIC is indicated for the treatment of hypertension.

This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION).

In using VASERETIC, consideration should be given to the fact that another 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 enalapril does not have a similar risk (see WARNINGS).

In considering use of VASERETIC, 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

Enalapril and hydrochlorothiazide are effective treatments for hypertension. The usual dosage range of enalapril is 10 to 40 mg per day administered in a single or two divided doses; hydrochlorothiazide is effective in doses of 12.5 to 50 mg daily. The side effects (see WARNINGS) of enalapril 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 enalapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects but the addition of enalapril 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 enalapril or hydrochlorothiazide monotherapy may be given VASERETIC 10-25. Further increases of enalapril, hydrochlorothiazide or both depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed. In general, patients do not require doses in excess of 20 mg of enalapril or 50 mg of hydrochlorothiazide. The daily dosage should not exceed two tablets of VASERETIC 10-25.

Replacement Therapy: The combination may be substituted for the titrated components.

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

HOW SUPPLIED

VASERETIC Tablets 10-25 mg, are rust, oval shaped tablets, with one side "MSD 720" and scored and the other side scored. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows:

NDC 64455-146-01 bottles of 100 (with desiccant).

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.

Vaseretic® is a registered trademark of Biovail Laboratories International SRL.

Manufactured by:
Merck Sharp & Dohme Ltd.
Cramlington, Northumberland UK NE23 3JU

For:
BTA Pharmaceuticals, Inc.
Bridgewater, NJ 08807, USA

Tablets made in the United Kingdom.

BIOVAIL^®

Rev. 03/08

LB0027-05