Item info.
These highlights do not include all the info. needed to use ACEON? safely and effectively. See full prescribing info. for ACEON.
ACEON (perindopril erbumine) 2, and mg Tablets
Initial U.S. Approval: 1993
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, ACEON should be discontinued as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury to or death of the developing fetus.
INDICATIONS AND USAGE
ACEON is indicated for the treatment of patients with essential hypertension
ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction
DOSAGE AND ADMINISTRATION
Hypertension
The recommended initial dose is mg once day. The dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled or to maximum of 16 mg per day
Stable Coronary Artery Disease
ACEON should be given at an initial dose of mg once daily for weeks, and then increased, as tolerated, to maintenance dose of mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 2, and mg
CONTRAINDICATIONS
Angioedema related to previous treatment with an ACE inhibitor, or history of hereditary or idiopathic angioedema (4.0, 5.1)
WARNINGS AND PRECAUTIONS
Watch for anaphylactoid reactions, including angioedema
Monitor renal function during therapy
Assess for hypotension and hyperkalemia (5.2, 5.6)
ADVERSE REACTIONS
Hypertension: Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain
Stable Coronary Artery Disease: Most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension
To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-354-0026 (ext. 7530) or FDA at 1-800-FDA-1088 or www.FDA.gov/Medwatch.
DRUG INTERACTIONS
Diuretics: Excessive drop in blood pressure
Potassium-sparing diuretics/potassium supplements: Hyperkalemia
Lithium: Increase serum lithium levels, symptoms of lithium toxicity
Injectable gold: Nitritoid reactions (facial flushing, nausea, vomiting, and hypotension)
NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect
INDICATIONS AND USAGE
1.1 Hypertension
ACEON is indicated for the treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics.
1.2 Stable Coronary Artery Disease
ACEON is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Hypertension
Use in Uncomplicated Hypertensive Patients: In patients with essential hypertension, the recommended initial dose is mg once day. The dose may be titrated, as needed to maximum of 16 mg per day. The usual maintenance dose range is mg to mg administered as single daily dose or in two divided doses.
Use in Elderly Patients: The recommended initial daily dosage of ACEON for the elderly is mg daily, given in one or two divided doses. Experience with ACEON is limited in the elderly at doses exceeding mg. Dosages above mg should be administered with careful blood pressure monitoring and dose titration [see Use in Specific Populations ].
Use with Diuretics: In patients who are currently being treated with diuretic, symptomatic hypotension can occur following the initial dose of ACEON. Consider reducing the dose of diuretic prior to starting ACEON [see Drug Interactions ].
2.2 Stable Coronary Artery Disease
In patients with stable coronary artery disease, ACEON should be given at an initial dose of mg once daily for weeks, and then increased as tolerated, to maintenance dose of mg once daily. In elderly patients (greater than 70 years), ACEON should be given as 2 mg dose once daily in the first week, followed by mg once daily in the second week and mg once daily for maintenance dose if tolerated.
2.3 Dose Adjustment in Renal Impairment and Dialysis
Perindoprilat elimination is decreased in renally impaired patients. ACEON is not recommended in patients with creatinine clearance <30 mL/min. For patients with lesser degrees of impairment, the initial dosage should be mg/day and dosage should not exceed mg/day. During dialysis, perindopril is removed with the same clearance as in patients with normal renal function.
3 DOSAGE FORMS AND STRENGTHS
Tablets are oblong with score on one side.
2 mg tablet is white and debossed on the unscored side with ?ACN 2?.
4 mg tablet is pink and debossed on the unscored side with ?ACN 4?.
8 mg tablet is salmon and debossed on the unscored side with ?ACN 8?.
4 CONTRAINDICATIONS
ACEON is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. ACEON is also contraindicated in patients with hereditary or idiopathic angioedema.
