Hypertension

ATACAND is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Heart Failure

ATACAND is indicated for the treatment of heart failure (NYHA class II-IV) in patients with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. (See Clinical Trials.) ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.

Hypertension

Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with ATACAND.

No initial dosage adjustment is necessary for elderly patients, for patients with mildly impaired renal function, or for patients with mildly impaired hepatic function (see CLINICAL PHARMACOLOGY, Special Populations). In patients with moderate hepatic impairment, consideration should be given to initiation of ATACAND at a lower dose (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (eg, patients treated with diuretics, particularly those with impaired renal function), ATACAND should be initiated under close medical supervision and consideration should be given to administration of a lower dose (see WARNINGS, Hypotension in Volume- and Salt-Depleted Patients).

ATACAND may be administered with or without food.

If blood pressure is not controlled by ATACAND alone, a diuretic may be added. ATACAND may be administered with other antihypertensive agents.

Heart Failure

The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.

No. 3782 — Tablets ATACAND, 4 mg, are white to off-white, circular/biconvex-shaped, non-film- coated tablets, coded ACF on one side and 004 on the other. They are supplied as follows:

NDC 0186-0004-31 unit of use bottles of 30.

No. 3780 — Tablets ATACAND, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated tablets, coded ACG on one side and 008 on the other. They are supplied as follows:

NDC 0186-0008-31 unit of use bottles of 30.

No. 3781 — Tablets ATACAND, 16 mg, are pink, circular/biconvex-shaped, non-film-coated tablets, coded ACH on one side and 016 on the other. They are supplied as follows:

NDC 0186-0016-31 unit of use bottles of 30
NDC 0186-0016-54 unit of use bottles of 90
NDC 0186-0016-28 unit dose packages of 100.

No. 3791 — Tablets ATACAND, 32 mg, are pink, circular/biconvex-shaped, non-film-coated tablets, coded ACL on one side and 032 on the other. They are supplied as follows:

NDC 0186-0032-31 unit of use bottles of 30
NDC 0186-0032-54 unit of use bottles of 90
NDC 0186-0032-28 unit dose packages of 100.

Storage

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

ATACAND is a trademark of the AstraZeneca group of companies. Manufactured under the license from Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, S-151 85 Södertälje, Sweden for: AstraZeneca LP, Wilmington, DE 19850. Made in Sweden. FDA Rev date: 8/17/2006

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