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BENICAR HCT® is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
The usual recommended starting dose of BENICAR® (olmesartan medoxomil) is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance < 40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients).
Hydrochlorothiazide is effective in doses between 12.5 mg and 50 mg once daily.
The side effects (see WARNINGS) of BENICAR® are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose-dependent (primarily hypokalemia). Some dose-independent phenomena (e.g., pancreatitis) do occur with hydrochlorothiazide. Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.
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.
BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) may be substituted for its titrated components.
Dose Titration by Clinical Effect
BENICAR HCT® is available in strengths of 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by BENICAR® or hydrochlorothiazide alone may be switched to once daily BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide).
Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by BENICAR® alone, hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, BENICAR® may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding BENICAR® or switching to BENICAR HCT® as marked decreases in blood pressure may occur (see WARNINGS, Hypotension in Volume- or Salt-Depleted Patients). Consideration should be given to reducing the dose of hydrochlorothiazide to 12.5 mg before adding BENICAR®. The antihypertensive effect of BENICAR HCT® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg (see CLINICAL PHARMACOLOGY, Clinical Trials). The dose of BENICAR HCT® is one tablet once daily. More than one tablet daily is not recommended.
BENICAR HCT® may be administered with other antihypertensive agents.
Patients with Renal Impairment
The usual regimens of therapy with BENICAR HCT® may be followed provided the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so BENICAR HCT® is not recommended.
Patients with Hepatic Impairment
No dosage adjustment is necessary with hepatic impairment (see CLINICAL PHARMACOLOGY, Special Populations).
BENICAR HCT® is supplied as 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with “Sankyo” debossed on one side and “C22” on the other side. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C23” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C25” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Tablets are supplied as follows:
|20 mg/12.5 mg||40 mg/12.5 mg||40 mg/25 mg|
|Bottle of 30 tablets||NDC 65597-105-30||NDC 65597-106-30||NDC 65597-107-30|
|Bottle of 90 tablets||NDC 65597-105-90||NDC 65597-106-90||NDC 65597-107-90|
|Bottle of 1000 tablets||NDC 65597-105-11||NDC 65597-106-11||NDC 65597-107-11|
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].
Manufactured for Daiichi Sankyo, Inc., Parsippany, NJ 07054. Revised 11/2012
Last reviewed on RxList: 1/16/2013
This monograph has been modified to include the generic and brand name in many instances.
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