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
Benicar Indications, Dosage, Storage, Stability - Olmesartan medoxomil
Benicar Indications, Dosage, Storage, Stability - Olmesartan medoxomil
INDICATIONS AND USAGE
BENICAR™ 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. The usual recommended starting
dose of BENICAR™ 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 of BENICAR™ 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- and Salt-Depleted Patients).
BENICAR™ may be administered with or without
food.
If blood pressure is not controlled by BENICAR™
alone, a diuretic may be added. BENICAR™ may be administered
with other antihypertensive agents.
HOW SUPPLIED
BENICAR™ is supplied as yellow, round, film-coated
tablets containing 5 mg of olmesartan medoxomil, as white, round, film- coated
tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped,
film-coated tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed
with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20,
and 40 mg tablets, respectively.
Tablets are supplied as follows:
| |
5 mg
|
20 mg
|
40 mg
|
|
Bottle of 30
|
NDC 65597-101-30
|
NDC 65597-103-30
|
NDC 65597-104-30
|
|
Bottle of 90
|
Not available
|
NDC 65597-103-90
|
NDC 65597-104-90
|
|
Blister 10 cards X 10
|
|
NDC 65597-103-10
|
NDC 65597-104-10
|
Storage
Store at 20-25°C (68-77°F) [See USP
Controlled Room Temperature]. Manufactured by Sankyo Pharma GmbH, Munich,
Germany
Manufactured for Sankyo Pharma Inc., New York,
NY 10017
Updated Aug 21, 2003.
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