INDICATIONS AND USAGE
Stable Coronary Artery Disease
ACEON® (perindopril erbumine) Tablets is indicated in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON® Tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy.
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: Head and Neck Angioedema.)
DOSAGE AND ADMINISTRATION
Stable Coronary Artery Disease
In patients with stable coronary artery disease, ACEON® Tablets should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased as tolerated, to a maintenance dose of 8 mg once daily. In elderly patients (>70 yrs), ACEON® Tablets should be given as a 2 mg dose once daily in the first week, followed by 4 mg once daily in the second week and 8 mg once daily for maintenance dose if tolerated.
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 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.)
After the first dose of ACEON® Tablets, the patient should be followed closely for the first two weeks of treatment and whenever the dose of ACEON® Tablets and/or diuretics is increased (See WARNINGS and PRECAUTIONS: Drug Interactions.) In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ACEON® Tablets. To reduce the likelihood of hypotension, the dose of diuretic, if possible, can be adjusted which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ACEON® Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Dose Adjustment in Renal Impairment
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.
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.
Patheon Pharmaceuticals, Inc.
Cincinnati, OH 45237 USA
Solvay Pharmaceuticals, Inc.
Marietta, GA 30062
© 2008 Solvay Pharmaceuticals, Inc.
500063/500064 Rev Mar 2008