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Uniretic

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Uniretic

INDICATIONS

Uniretic® is indicated for treatment of patients with hypertension. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

In using uniretic®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that uniretic® does not have a similar risk (see WARNINGS, Neutropenia/ Agranulocytosis). In addition, ACE inhibitors, for which adequate data are available, cause a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Angioedema).

DOSAGE AND ADMINISTRATION

Moexipril and hydrochlorothiazide are effective treatments for hypertension. The recommended dosage range of moexipril is 7.5 to 30 mg daily, administered in a single or two divided doses one hour before meals, while hydrochlorothiazide is effective in a dosage of 12.5 to 50 mg daily.

The side effects (see WARNINGS) of moexipril 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 moexipril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens in which moexipril is combined with low doses of hydrochlorothiazide produce minimal effects on serum potassium. In uniretic® controlled clinical trials, the average change in serum potassium was near zero in subjects who received 3.75 mg / 6.25 mg or 7.5 mg / 12.5 mg, but subjects who received 15 mg / 12.5 mg or 15 mg / 25 mg experienced a mild decrease in serum potassium, similar to that experienced by subjects who received the same dose of hydrochlorothiazide monotherapy. 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 moexipril or hydrochlorothiazide monotherapy may be given uniretic® 7.5 mg / 12.5 mg, uniretic® 15 mg / 12.5 mg or uniretic® 15 mg / 25 mg one hour before a meal. Further increases of moexipril, hydrochlorothiazide or both depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed.

Total daily doses above 30 mg / 50 mg a day have not been studied in hypertensive patients. Patients whose blood pressures are adequately controlled with 25 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve blood pressure control without electrolyte disturbance if they are switched to moexipril 3.75 mg/hydrochlorothiazide 6.25 mg (onehalf of the uniretic® 7.5 mg / 12.5 mg tablet). For patients who experience an excessive reduction in blood pressure with uniretic® 7.5 mg / 12.5 mg, the physician may consider prescribing moexipril 3.75 mg/hydrochlorothiazide 6.25 mg.

Replacement Therapy

The combination may be substituted for the titrated individual active ingredients.

Use in Renal Impairment

The usual dosage regimen of uniretic® does not need to be adjusted as long as the patient's creatinine clearance is > 40 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 uniretic® is not recommended (see PRECAUTIONS, General).

HOW SUPPLIED

Uniretic® (moexipril hydrochloride/hydrochlorothiazide) 7.5 mg / 12.5 mg tablets are yellow, oval, film-coated and scored with engraved code 712 on the unscored side and S and P on either side of the score. They are supplied as follows:

Bottles of 100 NDC 0091-3712-01

Uniretic® (moexipril hydrochloride/hydrochlorothiazide) 15 mg / 12.5 mg tablets are white, oval, film-coated and scored with engraved code 720 on the unscored side and S and P on either side of the score. They are supplied as follows:

Bottles of 100 NDC 0091-3720-01

Uniretic® (moexipril hydrochloride/hydrochlorothiazide) 15 mg / 25 mg tablets are yellow, oval, film-coated and scored with engraved code 725 on the unscored side and S and P on either side of the score. They are supplied as follows:

Bottles of 100 NDC 0091-3725-01

Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.

If product package is subdivided, dispense in tight containers as described in USP-NF.

Manufactured for: UCB, Inc. Smyrna, GA 30080. Rev. 2012

Last reviewed on RxList: 9/24/2012
This monograph has been modified to include the generic and brand name in many instances.

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