Perindopril

Perindopril
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

WARNING: FETAL TOXICITY See full prescribing information for complete Boxed Warning. * When pregnancy is detected, discontinue ACEON as soon as possible. (5.4) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.4)

Overview

Perindopril is an angiotensin converting enzyme inhibitor that is FDA approved for the {{{indicationType}}} of hypertension, stable coronary artery disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hyperkalemia, backache, asthenia, dizziness, headache, cough.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

• Dosing Information

• Use in Uncomplicated Hypertensive Patients:

• Initial dosage: 4 mg PO qd
• Maximun dosage: 16 mg/day PO
• Usually maintaining dosage: 4 mg-8 mg or 2 mg-4 mg PO bid

• Use in Elderly Patients

• Recommended initial dosage: 4 mg PO qd or 2 mg PO bid
• limited dosage: 8 mg/day(Dosages above 8 mg should be administered with careful blood pressure monitoring and dose titration)

Stable Coronary Artery Disease

• Dosing information

• Initial dosage: 4 mg PO qd for 2 weeks
• Maintainance dosage: 8 mg PO qd
• For seniors (age ≥ 70):

• Initial dosage for the 1st week: 2 mg PO qd
• Dosage for the 2nd week: 4 mg PO qd
• Maintaining dosage if tolerated: 8 mg PO qd

Dose Adjustment in Renal Impairment and Dialysis

• Dosing information

• Initial dosage: 2 mg/day
• Maximum dosage: 8 mg/day

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about the guideline-supported off-label use

Non–Guideline-Supported Use

Diabetes mellitus

• Dosing Information

• 2 mg/day or 4 mg/day

Prophylaxis treatment of Cerebrovascular accident

• Dosing information

• 4 mg/day

Duchenne muscular dystrophy

• Dosing information

• 2-4 mg/day

Myocardial infarction

• Dosing information

• 4 mg/day

Prophylaxis treatment of Paroxysmal atrial fibrillation

• Dosing information

• 2 mg

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• There is limited information about Off-Label Non–Guideline-Supported Use of Perindopril in pediatric patients.

Contraindications

ACEON® (perindopril erbumine) 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. Do not co-administer aliskiren with ACEON in patients with diabetes [see Drug Interactions (7.8)].

Warnings

WARNING: FETAL TOXICITY See full prescribing information for complete Boxed Warning. * When pregnancy is detected, discontinue ACEON as soon as possible. (5.4) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.4)

• 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 (7.8)].
• 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.

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Drug Interactions

• (Drug 1)

• (Description)

• (Drug 2)

• (Description)

• (Drug 3)

• (Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Perindopril in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Perindopril in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Perindopril during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Perindopril in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Perindopril in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Perindopril in geriatric settings.

Gender

There is no FDA guidance on the use of Perindopril with respect to specific gender populations.

Race

There is no FDA guidance on the use of Perindopril with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Perindopril in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Perindopril in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Perindopril in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Perindopril in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Perindopril Administration in the drug label.

Monitoring

There is limited information regarding Perindopril Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Perindopril and IV administrations.

Overdosage

There is limited information regarding Perindopril overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Perindopril Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Perindopril Mechanism of Action in the drug label.

Structure

There is limited information regarding Perindopril Structure in the drug label.

Pharmacodynamics

There is limited information regarding Perindopril Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Perindopril Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Perindopril Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Perindopril Clinical Studies in the drug label.

How Supplied

There is limited information regarding Perindopril How Supplied in the drug label.

Storage

There is limited information regarding Perindopril Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Perindopril Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Perindopril interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Perindopril Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Perindopril Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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