Aceon (perindopril) is an ACE inhibitor. Aceon is used to treat high blood pressure (hypertension) and heart failure. Aceon may also be used for purposes not listed in this medication guide. You should not use Aceon if

  • you are allergic to perindopril
  • if you have a history of angioedema
  • you have severe kidney disease
  • if you are pregnant.

If you take insulin or oral diabetes medicine to treat diabetes, ask your doctor if your dose needs to be changed when you start using Aceon. You may need a second form of blood pressure medication such as a diuretic (“water pill”). ACE inhibitors can cause birth defects. Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. If you have diabetes, Aceon may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any new symptoms of high or low blood sugar. You may need a special dose-measuring spoon or cup, not a regular table spoon. Ask your pharmacist where to get it. To make sure Aceon is safe for you, tell your doctor if you have ever had: kidney disease (or if you are on dialysis), liver disease, heart problems, congestive heart failure, high blood potassium levels; or asthma or allergies.

ACE inhibitors can decrease sweating and you may be more prone to heat stroke. Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of fluids as directed by your doctor to prevent dehydration, especially in hot weather and during exercise. You should not use Aceon if you are allergic to perindopril, or if:You should not breast-feed while using this medicine. ACE inhibitors can decrease sweating and you may be more prone to heat stroke. Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of fluids as directed by your doctor to prevent dehydration, especially in hot weather and during exercise.

Aceon

Pharmacokinetics

Aceon is rapidly and completely absorbed following oral administration. The absolute bioavailability of Aceon is about 25%. Peak plasma concentration (Cmax) and area under the plasma concentration curve (AUC) increase linearly with increasing dose over the range of 2-16 mg. Administration with food decreases the Cmax by about 20% but does not affect AUC.

The plasma half-life of Aceon is about 12 hours in healthy subjects and 18 hours in patients with congestive heart failure. The pharmacokinetics of Aceon are not altered by renal impairment.

Indications and Usage

Aceon® (perindopril erbumine) tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Aceon.

Aceon is also indicated for reduction of cardiovascular risk in hypertensive patients with left ventricular dysfunction (ejection fraction < 40%).

ACEON has not been evaluated in pregnant women and it should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing age should be advised to use an effective method of contraception while using ACEON and for one month after cessation. If pregnancy occurs, ACEON should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.

Contraindications

Aceon is contraindicated in patients with known hypersensitivity to any of its ingredients, pregnant women and nursing mothers. Hypersensitivity reactions including anaphylactic/anaphylactoid reactions have been reported. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a cephalosporin allergy. Allergic manifestations may include skin rash, urticaria, pruritus, angioedema of face, lips and tongue, and bronchospasm. Anaphylaxis has rarely been reported.

ACEON is also contraindicated in patients with hereditary or idiopathic angioedema. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of developing angioedema while receiving an ACE inhibitor. In such patients, ACEON should be started under close medical supervision and the patient should be informed of the signs and symptoms of angioedema and advised to discontinue Aceon immediately if these occur. The use of ACE inhibitors has been associated with a higher frequency of severe hypersensitivity reactions in some populations of black patients than among caucasians.

ACEON is also contraindicated in patients with history of ACE inhibitor-induced or idiopathic angioedema and in patient who are receiving concomitant mTOR inhibitors (e.g., temsirolimus, everolimus), or an aliskiren-containing product. Angioedema associated with laryngeal edema may be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, Aceon should be discontinued immediately, the airway protected if indicated and appropriate therapy instituted promptly.

Concomitant aliskiren use in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) is contraindicated.

Side Effects

FDA pregnancy category D. Aceon can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking Aceon, and tell your doctor if you become pregnant. It is not known whether perindopril passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Take this medication exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Use the medicine exactly as directed.

Warnings and Precautions

Angioedema: Angioedema, including laryngeal edema, may occur at any time during treatment with ACE inhibitors. In aceon clinical trials and postmarketing surveillance, angioedema has been reported more frequently in black than non-black patients. The incidence of ACE inhibitor-induced angioedema is higher among women than men and among patients older than 65 years compared to those who are younger than 65 years old of both sexes.

If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. In such cases, ACEON should promptly be discontinued, the patient treated with appropriate emergency therapy, and ventilation maintained until definitive airway management is achieved.

If signs or symptoms of angioedema occur in patients receiving Aceon, discontinue the drug immediately and institute appropriate treatment. Patients requiring angiotensin II receptor antagonists should be so treated while ACEON is administered. Avoidance of cross-reactivity: Patients who have experienced angioedema related to previous ACE inhibitor therapy may have a higher risk for recurrent angioedema while receiving an ACE inhibitor. For patients who have had angioedema associated with ACE inhibitor therapy, avoid use of mTOR inhibitors (e.g., temsirolimus, everolimus), and aliskiren-containing products. Use ACEON with caution in patients who are allergic to other substances such as drugs, foods, or other environmental allergens.

If any manifestations suggestive of angioedema or allergic reactions occur ACEON should be promptly discontinued and appropriate therapy instituted. Patients requiring angiotensin II receptor antagonists should be so treated while ACEON is administered.

Carpal Tunnel Syndrome: Carpal tunnel syndrome has been reported in patients treated with ACE inhibitors. These events have occurred in the absence of laboratory evidence of autoimmune disease. If carpal tunnel syndrome develops during treatment with Aceon, discontinuation of the drug should be considered.

Fetal Toxicity: ACEON may cause fetal renal dysfunction and oligohydramnios when administered to a pregnant woman. Fetal injury, premature delivery, and stillbirth may occur in humans following intra-amniotic infusion of ACE inhibitors in pregnancy; available data cannot exclude the possibility that these effects represent adverse effects of ACE inhibitors on the fetus. When treating pregnant women with ACE inhibitors, observe for signs and symptoms of fetal renal dysfunction and oligohydramnios. If oliguria or progressive azotemia occurs during use of an ACE inhibitor in a pregnant woman, discontinue Aceon as soon as possible. Prevent further exposure to ACE inhibitors during pregnancy.

Heparin-induced Thrombocytopenia (HIT): HIT has been reported in patients receiving ACEON who were also being treated with heparin. There have been isolated reports suggesting that concomitant treatment with ACE inhibitors and heparin may result in increased risk of thrombocytopenia (low platelet count). If HIT is suspected in a patient being treated with ACE inhibitor and heparin concomitantly, discontinue the ACE inhibitor as soon as possible. Do not restart the ACE inhibitor until heparin-induced thrombocytopenia has been excluded.

Hypotension:Symptomatic hypotension may occur after the initial dose of Aceon. This is more likely to occur in patients who are salt-and/or volume depleted as a result of prior diuretic therapy and/or other causes (e.g., vomiting, diarrhea, or sweating). In these patients consider giving an initial dose of 2 mg before increasing to the target maintenance dose. Patients should be cautioned that lightheadedness can occur, especially during the first few days of Aceon therapy, and that it should be reported to a physician. If actual syncope occurs, patients should be advised to discontinue the drug until they have consulted with their physician.

Dosage

The usual starting dose is 4 mg once daily. The target maintenance dose is 8 to 16 mg once daily. If the systolic blood pressure is < 100 mmHg, increase the dose at weekly intervals by 2 to 4 mg until blood pressure is controlled or a maximum of 32 mg/day is reached.

If Aceon has to be discontinued for any reason, it should usually be withdrawn gradually over a period of 2 weeks in order to avoid an exacerbation of hypertension.

Patients with mild to moderate hepatic impairment should start with a 2 mg dose and have their dose titrated up slowly to the target maintenance dose.

Elderly patients may be more susceptible to hypotension and renal insufficiency. Therefore, asymptomatic decreases in blood pressure and/or serum creatinine should be carefully monitored in these patients.

Overdose

There is no specific antidote for overdose with Aceon. If significant hypotension occurs, treatment should be supportive and may include intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used since they may worsen hypotension by a vasodilatory action). Dialysis does not appreciably remove perindopril from the circulation.

Storage

Aceon should be stored at room temperature, below 30°C.