Enalapril and Hydrochlorothiazide (Enalapril Maleate / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

Enalapril maleate and hydrochlorothiazide tablets are indicated for the treatment of hypertension.

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

In using enalapril maleate and hydrochlorothiazide tablets, 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 enalapril maleate and hydrochlorothiazide tablets, 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: 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 enalapril maleate and hydrochlorothiazide tablets 5/12.5 or enalapril maleate and hydrochlorothiazide tablets 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 four tablets of enalapril maleate and hydrochlorothiazide tablets 5/12.5 or two tablets of enalapril maleate and hydrochlorothiazide tablets 10/25.

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

Use in Renal Impairment: The usual regimens of therapy with enalapril maleate and hydrochlorothiazide 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 mcmol/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

Enalapril Maleate and Hydrochlorothiazide Tablets USP 5/12.5 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted "APO" on one side and "5" over "12.5" on the other side.  They are supplied as follows:

Bottles of 100 (NDC 60505-0208-1)

Bottles of 1000 (NDC 60505-0208-2)

Enalapril Maleate and Hydrochlorothiazide Tablets USP 10/25 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted "APO" on one side and "10" over "25" on the other side.  They are supplied as follows:

Bottles of 100 (NDC 60505-0209-1)

Bottles of 1000 (NDC 60505-0209-2)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. 

Protect from moisture.

Dispense in a tight, light-resistant container [see USP].

APOTEX INC.

ENALAPRIL MALEATE AND

HYDROCHLOROTHIAZIDE TABLETS USP

5/12.5 mg and 10/25 mg

Manufactured for:

Apotex Corp.

Weston, Florida

USA 33326

Revised: November 2006

Rev. 3