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
Univasc Indications, Dosage, Storage, Stability - Moexipril
Univasc Indications, Dosage, Storage, Stability - Moexipril
INDICATIONS
UNIVASC® is indicated for treatment
of patients with hypertension. It may be used alone or in combination
with thiazide diuretics. In using UNIVASC®, consideration
should be given to the fact that another ACE
inhibitor, captopril,
has caused agranulocytosis, particularly in patients with renal
impairment or collagen-vascular
disease. Available data are insufficient to show
that UNIVASC® does not have a similar risk
(see WARNINGS). In considering
use of UNIVASC®, it should be noted that in controlled
trials ACE inhibitors have
an effect on blood
pressure that is less
in black patients than
in non-blacks. In addition,
ACE inhibitors (for which
adequate data are available) cause
a higher rate of angioedema
in black than in non-black
patients (see WARNINGS, Angioedema).
DOSAGE AND ADMINISTRATION
Hypertension
The recommended initial
dose of UNIVASC®
in patients not receiving diuretics is 7.5 mg, one hour prior to
meals, once daily. Dosage should be adjusted according to blood
pressure response.
The antihypertensive effect of UNIVASC® may diminish
towards the end of the dosing
interval. Blood pressure
should, therefore, be measured just prior to dosing to determine
whether satisfactory blood
pressure control
is obtained. If control is not adequate, increased dose
or divided dosing can be tried. The recommended dose
range is 7.5 to 30 mg
daily, administered in one or two divided doses one hour before
meals. Total daily doses above 60 mg a day have not been studied
in hypertensive
patients.
In patients who are currently being treated with a diuretic,
symptomatic hypotension may occasionally occur following the initial
dose of UNIVASC®.
The diuretic should,
if possible, be discontinued for 2 to 3 days before therapy with
UNIVASC® is begun, to reduce
the likelihood of hypotension
(see WARNINGS). If the patient's
blood pressure
is not controlled with UNIVASC® alone, diuretic
therapy may then be
reinstituted. If diuretic
therapy cannot be discontinued,
an initial dose
of 3.75 mg of UNIVASC®
should be used with medical
supervision until blood
pressure has stabilized
(see WARNINGS and PRECAUTIONS,
Drug Interactions).
Dosage Adjustment in Renal Impairment
For patients with a creatinine
clearance £40
mL/min/1.73 m2, an initial
dose of 3.75 mg
once daily should be given cautiously. Doses may be titrated upward
to a maximum daily dose
of 15 mg.
HOW SUPPLIED
UNIVASC® (moexipril hydrochloride) 7.5 mg
tablets are pink colored, biconvex, film-coated and scored with
engraved code 707
on the unscored side and
SP above and 7.5 below the score. They are supplied
as follows:
| Bottles of 90 (Unit-of-Use) |
NDC 0091-3707-09 |
| Bottles of 100 |
NDC 0091-3707-01 |
UNIVASC® (moexipril hydrochloride) 15 mg tablets
are salmon colored, biconvex, film-coated, and scored with engraved
code 715 on the unscored side
and SP above and 15 below the score. They are supplied
as follows:
| Bottles of 90 (Unit-of-Use) |
NDC 0091-3715-09 |
| Bottles of 100 |
NDC 0091-3715-01 |
Store, tightly closed, at controlled room
temperature. Protect from excessive moisture.
If product package is
subdivided, dispense
in tight containers as described in USP-NF.
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