INDICATIONS
ATACAND is indicated for the treatment of hypertension.
It may be used alone or in combination with other antihypertensive
agents.
DOSAGE AND ADMINISTRATION
Dosage must be individualized. Blood pressure response
is dose related over the range of 2-32 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 four to six weeks
of ATACAND treatment.
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). For patients
with possible depletion of intravascular volume (e.g., 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). In patients
with moderate hepatic impairment, consideration should be
given to initiation of ATACAND at a lower dose (See CLINICAL
PHARMACOLOGY, Special Populations)
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.
HOW SUPPLIED
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 61113 - 004 - 31 unit of use bottles of 30
NDC 61113 - 004 - 54 unit of use bottles of 90
NDC 61113 - 004 - 28 unit dose packages of 100
NDC 61113 - 004 - 82 bottles of 1000.
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 61113 - 008 - 31 unit of use bottles of 30
NDC 61113 - 008 - 54 unit of use bottles of 90
NDC 61113 - 008 - 28 unit dose packages of 100
NDC 61113 - 008 - 82 bottles of 1000.
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 61113 - 016 - 31 unit of use bottles
of 30
NDC 61113 - 016 - 54 unit of use bottles
of 90
NDC 61113 - 016 - 28 unit dose packages
of 100
NDC 61113 - 016 - 82 bottles of 1000.
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 61113 - 032 - 31 unit of use bottles
of 30
NDC 61113 - 032 - 54 unit of use bottles
of 90
NDC 61113 - 032 - 28 unit dose packages
of 100
NDC 61113 - 032 - 82 bottles of 1000.
Storage: Store at 25oC (77oF) excursions
permitted to 15-30oC (59-86oF) [see USP Controlled Room
Temperature]. Keep container tightly closed.
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