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Fosinopril and Hydrochlorothiazide (Fosinopril Sodium / Hydrochlorothiazide) - Indications and Dosage



Fosinopril sodium and hydrochlorothiazide tablets, USP is indicated for the treatment of hypertension.

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

In using fosinopril sodium and hydrochlorothiazide tablets, USP, 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 ).

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


Fosinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg per day. In clinical trials of fosinopril/hydrochlorothiazide combination therapy using fosinopril doses of 2.5 to 40 mg and hydrochlorothiazide doses at 5 to 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 fosinopril sodium and hydrochlorothiazide tablets, USP. Dosage must be guided by clinical response; controlled clinical trials showed that the addition of 12.5 mg of hydrochlorothiazide to 10 to 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 fosinopril sodium and hydrochlorothiazide tablets, USP is not recommended. In patients with lesser degrees of renal impairment, fosinopril sodium and hydrochlorothiazide tablets, USP may be used with no change in dosage.


Fosinopril sodium and hydrochlorothiazide tablets, USP is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below.

Fosinopril sodium and hydrochlorothiazide tablets,USP 10/12.5 Fosinopril sodium and hydrochlorothiazide tablets, USP 20/12.5
fosinopril 10 mg 20 mg
hydrochlorothiazide 12.5 mg 12.5 mg
shape Flat beveled edge, circular tablets Flat beveled edge, circular tablets
color White to off-white White to off-white
debossed RC 3 on one side and plain on the other RC 4 and scoreline on one side and plain on the other
bottles of 30 NDC 63304-403-30 NDC 63304-404-30
bottles of 100 NDC 63304-403-01 NDC 63304-404-01
bottles of 1000 NDC 63304-403-10 NDC 63304-404-10


Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

by: Ranbaxy Laboratories Ltd.

New Delhi – 110 019, India

November 2013

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