INDICATIONS AND USAGE
ACEON® (perindopril erbumine) Tablets is indicated
for the treatment of patients with essential hypertension.
ACEON® Tablets may be used alone or given with other
classes of antihypertensives, especially thiazide diuretics.
When using ACEON® Tablets, consideration should be
given to the fact that another angiotensin converting
enzyme inhibitor (captopril) has caused agranulocytosis,
particularly in patients with renal impairment or collagen
vascular disease. Available data are insufficient to determine
whether ACEON® Tablets has a similar potential. (See
WARNINGS.)
In considering use of ACEON® Tablets, it should be
noted that in controlled trials ACE inhibitors have an
effect on blood pressure that is less in black patients
than in nonblacks. In addition, it should be noted that
black patients receiving ACE inhibitor monotherapy have
been reported to have a higher incidence of angioedema
compared to nonblacks. (See WARNINGS: Angioedema.)
DOSAGE AND ADMINISTRATION
Use in Uncomplicated Hypertensive Patients:
In patients with essential hypertension, the recommended
initial dose is 4 mg once a day. The dosage may be titrated
upward until blood pressure, when measured just before
the next dose, is controlled or to a maximum of 16 mg
per day. The usual maintenance dose range is 4 to 8 mg
administered as a single daily dose. ACEON® Tablets
may also be administered in two divided doses. When once-daily
dosing was compared to twice-daily dosing in clinical
studies, the B.I.D. regimen was generally slightly superior,
but not by more than about 0.5 to 1.0 mm Hg.
Use in the Elderly Patients: As in younger
patients, the recommended initial daily dosage of ACEON®
Tablets for the elderly (>65 years) is 4 mg daily,
given in one or two divided doses. The daily dosage may
be titrated upward until blood pressure, when measured
just before the next dose, is controlled, but experience
with ACEON® Tablets is limited in the elderly at doses
exceeding 8 mg. Dosages above 8 mg should be administered
with caution and under close medical supervision. (See
PRECAUTIONS: Geriatric Use.)
Use in Concomitant Diuretics: If blood
pressure is not adequately controlled with perindopril
alone, a diuretic may be added. In patients currently
being treated with a diuretic, symptomatic hypotension
occasionally can occur following the initial dose of perindopril.
To reduce likelihood of such reaction, the diuretic should,
if possible, be discontinued 2 to 3 days prior to the
beginning of ACEON® Tablets therapy. (See WARNINGS.)
Then, if blood pressure is not controlled with ACEON®
Tablets alone, the diuretic should be resumed.
If the diuretic cannot be discontinued, an initial dose
of 2 to 4 mg daily in one or in two divided doses should
be used with careful medical supervision for several hours
and until blood pressure has stabilized. The dosage should
then be titrated as described above. (See WARNINGS and
PRECAUTIONS: Drug Interactions.)
Use in Patients with Impaired Renal Function:
Kinetic data indicate that perindoprilat elimination is
decreased in renally impaired patients, with a marked
increase in accumulation when creatinine clearance drops
below 30 mL/min. In such patients (creatinine clearance
<30 mL/min), safety and efficacy of ACEON® Tablets
have not been established. For patients with lesser degrees
of impairment (creatinine clearance above 30 mL/min),
the initial dosage should be 2 mg/day and dosage should
not exceed 8 mg/day due to limited clinical experience.
During dialysis, perindopril is removed with the same
clearance as in patients with normal renal function.
HOW SUPPLIED
Tablets 2 mg: Scored one side, white,
oblong (debossed "ACN 2" on one side and debossed
with "SLV" on both sides of score on the other
side) Bottles of 100.....................................................................................NDC
0032-1101-01
Tablets 4 mg: Scored one side, pink,
oblong (debossed "ACN 4" on one side and debossed
with "SLV" on both sides of score on the other
side) Bottles of 100.....................................................................................NDC
0032-1102-01
Tablets 8 mg: Scored one side, salmon-colored,
oblong (debossed "ACN 8" on one side and debossed
with "SLV" on both sides of score on the other
side) Bottles of 100.....................................................................................NDC
0032-1103-01
Storage Conditions: Store at controlled
room temperature 20° to 25°C (68° to 77°F)
[see USP]. Protect from moisture. Keep out of the reach
of children.
Marketed by: Solvay Pharmaceuticals,
Inc. Marietta, GA 30062, © 2001 Solvay Pharmaceuticals,
Inc., 50064514/50064919 9E Rev 2/2002
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