Aceon

Name: Aceon

Perindopril Side Effects

Common Side Effects of Perindopril

Tell your doctor if any of the following side effects become severe or don't go away:

  • Headache
  • Mild dizziness
  • Mild diarrhea
  • Arm or leg pain
  • Back pain
  • A dry cough
  • Mild upset stomach
  • Runny nose

Serious Side Effects of Perindopril

Tell your doctor right away if you experience any of the symptoms listed in the Perindopril Warnings section above, or any of the following serious side effects:

  • Lightheadedness, fainting, or severe dizziness
  • Vision changes
  • Swelling of the hands, ankles, feet, or lower legs
  • Signs of infection, which may include fever, sore throat, or chills
  • Stomach pain
  • Yellowing of the skin or eyes (jaundice)
  • Dark-colored urine
  • Pale stools
  • Loss of appetite
  • Muscle pain, weakness, or cramping
  • Weakness on one side of the body
  • Red, swollen, blistered, or peeling skin
  • Shortness of breath
  • Slurred speech
  • Chest, jaw, or arm pain
  • Decreased or difficult urination
  • Confusion
  • Depression
  • Fast, slow, or irregular heartbeat
  • Sudden, severe headache
  • Signs of anaphylaxis, a severe allergic reaction (may include itching, hives, difficulty swallowing or breathing, hoarseness, chest tightness, or swelling of the mouth, face, lips, tongue, or throat)

Perindopril side effects

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • little or no urination;

  • swelling, rapid weight gain;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;

  • pale skin, easy bruising or bleeding; or

  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • dizziness;

  • back pain; or

  • cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aceon Dosage and Administration

General

BP Monitoring and Treatment Goals

  • Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.500 501

  • When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months.501

  • If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug.501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug.501

  • Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg.500 501 503 504

  • Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies.500 501 (See Hypertension under Uses.)

Administration

Oral Administration

Administer orally once or twice daily1 without regard to meals.2 In clinical studies, administration in 2 divided doses was only slightly more effective than once-daily dosing.1

Dosage

Available as perindopril erbumine; dosage expressed in terms of perindopril erbumine.1

Also available as perindopril arginine (in fixed-combination preparation); dosage expressed in terms of perindopril arginine.46

Adults

Hypertension Perindopril Erbumine Therapy Oral

Initially, 4 mg once daily in patients not receiving a diuretic.1

In patients currently receiving diuretic therapy, discontinue diuretic, reduce diuretic dosage, or increase salt intake, if possible, before initiating perindopril.600 If diuretic therapy cannot be altered, initiate therapy under close medical supervision for at least 2 hours and until BP has stabilized for an additional hour.600

Usual dosage: 4–8 mg once daily.1 2 500

If intolerable adverse effects occur, consider dosage reduction; if adverse effects worsen or fail to resolve, may need to discontinue and switch to another antihypertensive drug class.501

Perindopril Arginine/Amlodipine Fixed-combination Therapy Oral

Fixed-combination perindopril/amlodipine tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.46 Consider potential benefits and risks of initiating therapy with the fixed combination, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs.46

If patient's baseline BP is 170/105 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 26, 40, or 50% and of achieving DBP control (DBP <90 mm Hg) is 31, 46, or 65% with perindopril erbumine (16 mg daily) alone, amlodipine (10 mg daily) alone, or amlodipine (10 mg daily) combined with perindopril arginine (14 mg daily), respectively.46

If BP is not adequately controlled by monotherapy, can switch to perindopril/amlodipine fixed combination.46

In black patients and patients with diabetes mellitus, addition of perindopril arginine (14 mg daily) to amlodipine (10 mg daily) did not provide additional antihypertensive effects beyond those achieved with amlodipine monotherapy.46

If BP is adequately controlled by monotherapy with amlodipine but edema has developed, can switch to perindopril/amlodipine fixed combination to achieve BP control without edema.46

When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is perindopril arginine 3.5 mg and amlodipine 2.5 mg once daily.46

May adjust dosage at intervals of 7–14 days, up to maximum of perindopril arginine 14 mg and amlodipine 10 mg once daily.46

Prescribing Limits

Adults

Hypertension Oral

Perindopril erbumine: Maximum 16 mg daily.1

Perindopril arginine: Maximum 14 mg daily (in fixed combination with amlodipine).46

Special Populations

Renal Impairment

Hypertension

Perindopril erbumine: Initially, 2 mg daily in patients with renal impairment (Clcr >30 mL/minute); titrate until BP is controlled or to maximum of 8 mg daily. (See Renal Impairment under Cautions.)1

Perindopril/amlodipine fixed combination: Not recommended in patients with Clcr<60 mL/minute; insufficient data to support dosage recommendations.46

Hepatic Impairment

Hypertension

Perindopril/amlodipine fixed combination: Not recommended in patients with hepatic impairment; insufficient data to support dosage recommendations.46

Geriatric Patients

Hypertension

Perindopril erbumine: Initially, 4 mg daily, given in 1 dose or 2 divided doses.1 Adjust dosage to achieve BP control.1 Administer dosages >8 mg daily with caution and under close medical supervision.1

Perindopril/amlodipine fixed combination: Not recommended in geriatric patients; insufficient data to support dosage recommendations.46

Heart Failure

Perindopril/amlodipine fixed combination: Not recommended in patients with heart failure; insufficient data to support dosage recommendations.46

Actions

  • Prodrug; not pharmacologically active until hydrolyzed in the liver to perindoprilat.1 2

  • Suppresses the renin-angiotensin-aldosterone system.1

Uses For Aceon

Perindopril is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Perindopril works by blocking a substance in the body that causes the blood vessels to tighten. As a result, perindopril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Perindopril is also used in patients with coronary artery disease to prevent heart attacks.

This medicine is available only with your doctor's prescription.

Proper Use of Aceon

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—At first, 4 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 16 mg per day.
      • Older adults—At first, 4 milligrams (mg) per day, taken in one or two divided doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For coronary artery disease:
      • Adults—At first, 4 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 8 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Warnings and Precautions

Anaphylactoid and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Aceon) may be subject to a variety of adverse events, some of them serious. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.

Head and Neck Angioedema:  Angioedema of the face, extremities, lips, tongue, glottis, or larynx has been reported in patients treated with ACE inhibitors, including Aceon (0.1% of patients treated with Aceon in U.S. clinical trials). Angioedema associated with involvement of the tongue, glottis or larynx may be fatal. In such cases, discontinue Aceon treatment immediately and observe until the swelling disappears. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, administer appropriate therapy, such as subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 mL), promptly.

Intestinal Angioedema:  Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Hypotension

Aceon can cause symptomatic hypotension. Aceon has been associated with hypotension in 0.3% of uncomplicated hypertensive patients in U.S. placebo-controlled trials. Symptoms related to orthostatic hypotension were reported in another 0.8% of patients.

Symptomatic hypotension is most likely to occur in patients who have been volume or salt-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting [see Dosage and Administration (2.1)].

ACE inhibitors may cause excessive hypotension, and may be associated with oliguria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease, an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident.

In patients at risk of excessive hypotension, Aceon therapy should be started under very close medical supervision. Patients should be followed closely for the first two weeks of treatment and whenever the dose of Aceon and/or diuretic is increased.

If excessive hypotension occurs, the patient should be placed immediately in a supine position and, if necessary, treated with an intravenous infusion of physiological saline. Aceon treatment can usually be continued following restoration of volume and blood pressure.

Neutropenia/Agranulocytosis

ACE inhibitors have been associated with agranulocytosis and bone marrow depression, most frequently in patients with renal impairment, especially patients with a collagen vascular disease such as systemic lupus erythematosus or scleroderma.

Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected discontinue Aceon as soon as possible [see Use in Specific Populations (8.1)].

Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. Renal function should be monitored periodically in patients receiving Aceon [see Dosage and Administration (2.3)], [see Drug Interactions (7)].

In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including Aceon, may be associated with oliguria, progressive azotemia, and, rarely, acute renal failure and death.

In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur; usually reversible upon discontinuation of the ACE inhibitor. In such patients, renal function should be monitored during the first few weeks of therapy.

Some Aceon-treated patients have developed minor and transient increases in blood urea nitrogen and serum creatinine especially in those concomitantly treated with a diuretic.

Hyperkalemia

Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including Aceon. Most cases were isolated single values that did not appear clinically relevant and were rarely a cause for withdrawal. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of agents such as potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes [see Drug Interactions (7.2)].

Serum potassium should be monitored periodically in patients receiving Aceon.

Cough

Presumably because of the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, generally resolving after discontinuation of therapy. Consider ACE inhibitor-induced cough in the differential diagnosis of cough.

Hepatic Failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Surgery/Anesthesia

In patients undergoing surgery or during anesthesia with agents that produce hypotension, Aceon may block angiotensin II formation that would otherwise occur secondary to compensatory renin release. Hypotension attributable to this mechanism can be corrected by volume expansion.

Overdosage

In animals, doses of perindopril up to 2,500 mg/kg in mice, 3,000 mg/kg in rats and 1,600 mg/kg in dogs were non-lethal. Past experiences were scant but suggested that overdosage with other ACE inhibitors was also fairly well tolerated by humans. The most likely manifestation is hypotension, and treatment should be symptomatic and supportive. Therapy with the ACE inhibitor should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance and hypotension should be treated by established procedures.

Among the reported cases of perindopril overdosage, patients who were known to have ingested a dose of 80 mg to 120 mg required assisted ventilation and circulatory support. One additional patient developed hypothermia, circulatory arrest and died following ingestion of up to 180 mg of perindopril. The intervention for perindopril overdose may require vigorous support.

Laboratory determinations of serum levels of perindopril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of perindopril overdose.

No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of perindopril and its metabolites. Perindopril can be removed by hemodialysis, with clearance of 52 mL/min for perindopril and 67 mL/min for perindoprilat.

Angiotensin II could presumably serve as a specific antagonist-antidote in the settling of perindopril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of perindopril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat perindopril overdose by infusion of normal saline solution.

Aceon Overdose

If you take too much Aceon call your healthcare provider or poison control center, or seek emergency medical attention right away.

 

 

Patient Handout

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Important information

Do not use Aceon if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use this medicine if you have hereditary angioedema.

If you have diabetes, do not use Aceon together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

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