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MONOPRIL-HCT (fosinopril sodium-hydrochlorothiazide tablets) is indicated for the treatment of hypertension.
These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)
In using MONOPRIL-HCT, 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. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).
DOSAGE AND ADMINISTRATION
Fosinopril 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 per day. In clinical trials of fosinopril/hydrochlorothiazide combination therapy using fosinopril doses of 2.5–40 mg and hydrochlorothiazide doses at 5–37.5 mg, the antihypertensive effects increased with increasing dose of either component.
The hazards (see WARNINGS) of fosinopril 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 fosinopril and hydrochlorothiazide will be associated with both sets of dose-independent hazards. To minimize dose-independent hazards, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration by Clinical Effect
A patient whose blood pressure is not adequately controlled with fosinopril or hydrochlorothiazide monotherapy may be switched to combination therapy with MONOPRIL-HCT. Dosage must be guided by clinical response; controlled clinical trials showed that the addition of 12.5 mg of hydrochlorothiazide to 10–20 mg of fosinopril will typically be associated with additional reduction in seated diastolic blood pressure at 24 hours after dosing. On average, the effect of the combination of 10 mg of fosinopril with 12.5 mg of hydrochlorothiazide was similar to the effect seen with monotherapy using either 40 mg of fosinopril or 37.5 mg of hydrochlorothiazide.
Use in Renal Impairment
In patients with severe renal impairment (creatinine clearance is < 30 mL/min/1.73 m², serum creatine roughly ≥ 3 mg/dL or 265 μmol/L), loop diuretics are preferred to thiazides, so MONOPRIL-HCT is not recommended. In patients with lesser degrees of renal impairment, MONOPRIL-HCT may be used with no change in dosage.
MONOPRIL®-HCT (fosinopril sodium-hydrochlorothiazide tablets) is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below.
|MONOPRIL-HCT 10/12.5||MONOPRIL-HCT 20/12.5|
|Fosinopril||10 mg||20 mg|
|Hydrochlorothiazide||12.5 mg||12.5 mg|
|Debossed||“1492”||“1493” on one side; bisect bar on the other side|
|Bottle of 100||NDC 0087-1492-01||NDC 0087-1493-01|
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.
PRODUCT OF ITALY. Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev June 2008.
Last reviewed on RxList: 7/1/2009
This monograph has been modified to include the generic and brand name in many instances.
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