A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Teveten Indications, Dosage, Storage, Stability - Eprosartan Mesylate
Teveten Indications, Dosage, Storage, Stability - Eprosartan Mesylate
INDICATIONS
TEVETEN® Tablets are indicated for the treatment of hypertension. It
may be used alone or in combination with other antihypertensives such
as diuretics and calcium channel blockers.
DOSAGE AND ADMINISTRATION
The usual recommended starting dose of TEVETEN® Tablets is 600 mg once
daily when used as monotherapy in patients who are not volume-depleted
(see WARNINGS: Hypotension in Volume-
and/or Salt-Depleted Patients). TEVETEN® Tablets can be administered
once or twice daily with total daily doses ranging from 400 mg to 800
mg. There is limited experience with doses beyond 800 mg/day.
If the antihypertensive effect measured at trough using once-daily dosing
is inadequate, a twice-a-day regimen at the same total daily dose or an
increase in dose may give a more satisfactory response. Achievement of
maximum blood pressure reduction in most patients may take 2 to 3 weeks.
TEVETEN® Tablets may be used in combination with other antihypertensive
agents such as thiazide diuretics or calcium channel blockers if additional
blood-pressure-lowering effect is required. Discontinuation of treatment
with eprosartan does not lead to a rapid rebound increase in blood pressure.
Elderly, Hepatically Impaired or Penally Impaired Patients
No initial dosing adjustment is generally necessary for elderly or hepatically
impaired patients or those with renal impairment.
TEVETEN® Tablets may be taken with or without food.
HOW SUPPLIED
TEVETEN® (eprosartan mesylate) Tablets are available as aqueous filmcoated
tablets as follows:
400 mg pink, scored Tiltab®, oval tablets debossed with 5044 on
both sides of the tablet.
NDC 0051-5044-01 (bottles of 100)
NDC 0051-5044-11 (unit dose box of 100)
600 mg white capsule-shaped tablets, debossed with "SOLVAY" on
one side and 5046 on the other.
NDC 0051-5046-01 (bottles of 100)
NDC 0051-5046-11 (unit dose box of 100)
Storage: Store at controlled room temperature 20° to 25° C (68°
to 77° F) [see USP].
Rx only
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