What is Perindocyl?
Perindocyl 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.
Perindocyl works by blocking a substance in the body that causes the blood vessels to tighten. As a result, Perindocyl relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Perindocyl is also used in patients with coronary artery disease to prevent heart attacks.
Perindocyl is available only with your doctor's prescription.
Perindocyl indications
Stable Coronary Artery Disease: Reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.
Conventional treatment for management of coronary artery disease eg, antiplatelet, antihypertensive or lipid-lowering therapy.
Hypertension: Treatment of patients with essential hypertension. It may be used alone or given with other classes of antihypertensives, especially thiazide diuretics.
When using Perindocyl, consideration should be given to the fact that another ACE inhibitor (captopril) has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to determine whether Perindocyl has a similar potential.
In considering use of Perindocyl, it should be noted that in controlled trials, ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. 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 non-Blacks.
How should I use Perindocyl?
Use Perindocyl as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Perindocyl by mouth with or without food.
- Take Perindocyl on a regular schedule to get the most benefit from it.
- Taking Perindocyl at the same time(s) each day will help you to remember to take it.
- Continue taking Perindocyl even if you feel well. Do not miss any doses.
- If you miss a dose of Perindocyl, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Perindocyl.
Uses of Perindocyl in details
Perindocyl is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is also used to prevent heart attacks in patients with a certain type of heart disease (stable coronary artery disease).
Perindocyl belongs to a class of drugs known as ACE inhibitors. It works by relaxing blood vessels so blood can flow more easily.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat congestive heart failure and to help protect the kidneys from damage due to diabetes.
How to use Perindocyl
Take this medication by mouth as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment.
To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
It may take several weeks before you get the full benefit of this drug.
Tell your doctor if your condition does not get better or if it gets worse (for example, your blood pressure readings remain high or increase).
Perindocyl description
Perindocyl is the tert-butylamine salt of Perindocyl, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindocyl tert-butylamine is chemically described as (2S, 3αS, 7αS)-1-[(S)-N-[(S)-1-Carboxy-butyl] alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1). Its molecular formula is C19H32N2O5C4H11N.
Perindocyl tert-butylamine has molecular weight of 368.47 (free acid) or 441.61 (salt form).
Perindocyl is the free acid form of tert-butylamine, is a pro-drug and metabolized in vivo by hydrolysis of the ester group to form perindoprilat, the biologically active metabolite.
Perindocyl dosage
Perindocyl Dosage
Generic name: Perindocyl erbumine 2mg
Dosage form: tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Hypertension
Use in Uncomplicated Hypertensive Patients: In patients with essential hypertension, the recommended initial dose is 4 mg once a day. The dose may be titrated, as needed to a maximum of 16 mg per day. The usual maintenance dose range is 4 mg to 8 mg administered as a single daily dose or in two divided doses.
Use in Elderly Patients: The recommended initial daily dosage of Perindocyl for the elderly is 4 mg daily, given in one or two divided doses. Experience with Perindocyl is limited in the elderly at doses exceeding 8 mg. Dosages above 8 mg should be administered with careful blood pressure monitoring and dose titration.
Use with Diuretics: In patients who are currently being treated with a diuretic, symptomatic hypotension can occur following the initial dose of Perindocyl. Consider reducing the dose of diuretic prior to starting Perindocyl.
Stable Coronary Artery Disease
In patients with stable coronary artery disease, Perindocyl 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 (greater than 70 years), Perindocyl 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.
Dose Adjustment in Renal Impairment and Dialysis
Perindoprilat elimination is decreased in renally impaired patients. Perindocyl is not recommended in patients with creatinine clearance <30 mL/min. For patients with lesser degrees of impairment, the initial dosage should be 2 mg/day and dosage should not exceed 8 mg/day. During dialysis, Perindocyl is removed with the same clearance as in patients with normal renal function.
More about Perindocyl (Perindocyl)
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Consumer resources
- Perindocyl
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Professional resources
- Perindocyl (AHFS Monograph)
- Perindocyl (FDA)
Related treatment guides
- Coronary Artery Disease
- Diabetic Kidney Disease
- Heart Attack
- Heart Failure
- High Blood Pressure
- More (1) »
Perindocyl interactions
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What other drugs will affect Perindocyl?
Diuretics: Patients on diuretics and especially those started recently, may occasionally experience an excessive reduction of blood pressure after initiation of Perindocyl therapy. The possibility of hypotensive effects can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Perindocyl. If diuretics cannot be interrupted, close medical supervision should be provided with the 1st dose of Perindocyl, for at least 2 hrs and until blood pressure has stabilized for another hour.
The rate and extent of Perindocyl absorption and elimination are not affected by concomitant diuretics. The bioavailability of perindoprilat was reduced by diuretics, however, and this was associated with a decrease in plasma ACE inhibition.
Potassium Supplements and Potassium-Sparing Diuretics: Perindocyl may increase serum potassium because of its potential to decrease aldosterone production. Use of potassium-sparing diuretics (spironolactone, amiloride, triamterene and others), potassium supplements or other drugs capable of increasing serum potassium (indomethacin, heparin, cyclosporine and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution and the patient's serum potassium should be monitored frequently.
Lithium: Increased serum lithium and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be co-administered with caution and frequent monitoring of serum lithium concentration is recommended. Use of a diuretic may further increase the risk of lithium toxicity.
Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Perindocyl.
Digoxin: A controlled pharmacokinetic study has shown no effect on plasma digoxin concentrations when co-administered with Perindocyl, but an effect of digoxin on the plasma concentration of Perindocyl/perindoprilat has not been excluded.
Gentamicin: Animal data have suggested the possibility of interaction between Perindocyl and gentamicin. However, this has not been investigated in human studies. Co-administration of both drugs should proceed with caution.
Food Interaction:
Oral administration of Perindocyl with food does not significantly lower the rate or extent of Perindocyl absorption relative to the fasted state. However, the extent of biotransformation of Perindocyl to the active metabolite, perindoprilat, is reduced approximately 43%, resulting in a reduction in the plasma ACE inhibition curve of approximately 20%, probably clinically insignificant. In clinical trials, Perindocyl was generally administered in a nonfastingstate.
Perindocyl side effects
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What are the possible side effects of Perindocyl?
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience
The following adverse reactions are discussed elsewhere in labeling:
- Anaphylactoid reactions, including angioedema
- Hypotension
- Neutropenia and agranulocytosis
- Impaired renal function
- Hyperkalemia
- Cough
Hypertension
Perindocyl has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. The data presented here are based on results from the 1,417 Perindocyl-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with Perindocyl® (Perindocyl erbumine) for at least one year.
In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with Perindocyl and 6.7% in patients treated with placebo. The most common causes were cough, headache, asthenia and dizziness.
Among 1,012 patients in placebo-controlled U.S. trials, the overall frequency of reported adverse events was similar in patients treated with Perindocyl and in those treated with placebo (approximately 75% in each group). The only adverse events whose incidence on Perindocyl was at least 2% greater than on placebo were cough (12% vs. 4.5%) and back pain (5.8% vs. 3.1%).
Dizziness was not reported more frequently in the Perindocyl group (8.2%) than in the placebo group (8.5%), but its likelihood increased with dose, suggesting a causal relationship with Perindocyl.
Stable Coronary Artery Disease
Perindocyl has been evaluated for safety in EUROPA, a double-blind, placebo-controlled study in 12,218 patients with stable coronary artery disease. The overall rate of discontinuation was about 22% on drug and placebo. The most common medical reasons for discontinuation that were more frequent on Perindocyl than placebo were cough, drug intolerance and hypotension.
Postmarketing Experience
Voluntary reports of adverse events in patients taking Perindocyl that have been received since market introduction and are of unknown causal relationship to Perindocyl include: cardiac arrest, eosinophilic pneumonitis, neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia, acute renal failure, nephritis, hepatic failure, jaundice (hepatocellular or cholestatic), symptomatic hyponatremia, bullous pemphigoid, pemphigus, acute pancreatitis, falls, psoriasis, exfoliative dermatitis and a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive antinuclear antibody (ANA), leukocytosis, eosinophilia or an elevated erythrocyte sedimentation rate (ESR).
Clinical Laboratory Test Findings
Hematology
Small decreases in hemoglobin and hematocrit occur frequently in hypertensive patients treated with Perindocyl, but are rarely of clinical importance. In controlled clinical trials, no patient was discontinued from therapy due to the development of anemia. Leukopenia (including neutropenia) was observed in 0.1% of patients in U.S. clinical trials.
Liver Function Tests
Elevations in ALT (1.6% Perindocyl versus 0.9% placebo) and AST (0.5% Perindocyl versus 0.4% placebo) have been observed in placebo-controlled clinical trials. The elevations were generally mild and transient and resolved after discontinuation of therapy.
Perindocyl contraindications
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What is the most important information I should know about Perindocyl?
Hypersensitivity to Perindocyl or to any of the excipients of Perindocyl or to any other ACE inhibitor; history of angioedema associated with previous ACE inhibitor therapy; hereditary or idiopathic angioedema.
Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency should not take Perindocyl.
Use in pregnancy: Perindocyl should not be used during the 1st trimester of pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. Controlled studies with ACE inhibitors have not been done in humans, but in a limited number of cases with 1st trimester exposure, there do not appear to have been any malformations consistent with human foetotoxicity as described as follows.
Perindocyl is contraindicated during the 2nd and 3rd trimesters of pregnancy.
Prolonged ACE inhibitor exposure during the 2nd and 3rd trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Should exposure to Perindocyl have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Active ingredient matches for Perindocyl:
Perindopril in Belgium.
List of Perindocyl substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Perindobax (Estonia, Lithuania) | |
| perindopil-ratiopharm 4 (Poland) | |
| Perindopril (Aruba, Australia, Bahamas, Bahrain, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Costa Rica, Dominican Republic, El Salvador, France, Georgia, Greece, Grenada, Guatemala, Guyana, Honduras, Iceland, India, Italy, Jamaica, Japan, Malaysia, Malta, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Oman, Panama, Philippines, Portugal, Saint Lucia, Saint Vincent & The Grenadines, Singapore, South Africa, Spain, Thailand, Trinidad & Tobago, Tunisia, Turkey, Venezuela, Vietnam) | |
| Tablet; Oral; Perindopril Erbumine 4 mg (Actavis) | |
| Tablet; Oral; Perindopril Erbumine 8 mg (Actavis) | |
| Tablet; Oral; Perindopril Erbumine 2 mg (Actavis) | |
| Aceon 8 mg tablet (Actavis) | $ 3.14 |
| Perindopril erbumine 8 mg tablet (Actavis) | $ 2.80 |
| Aceon 4 mg tablet (Actavis) | $ 2.58 |
| Perindopril erbumine 4 mg tablet (Actavis) | $ 2.30 |
| Aceon 2 mg tablet (Actavis) | $ 2.22 |
| Perindopril erbumine 2 mg tablet (Actavis) | $ 1.98 |
| Coversyl 8 mg Tablet (Actavis) | $ 1.23 |
| Coversyl 4 mg Tablet (Actavis) | $ 0.88 |
| Coversyl 2 mg Tablet (Actavis) | $ 0.70 |
| Périndopril | |
| Tablet; Oral; Perindopril Erbumine 4 mg | |
| Tablet; Oral; Perindopril Erbumine 8 mg | |
| Tablet; Oral; Perindopril Erbumine 2 mg | |
| Aceon 8 mg tablet | $ 3.14 |
| Perindopril erbumine 8 mg tablet | $ 2.80 |
| Aceon 4 mg tablet | $ 2.58 |
| Perindopril erbumine 4 mg tablet | $ 2.30 |
| Aceon 2 mg tablet | $ 2.22 |
| Perindopril erbumine 2 mg tablet | $ 1.98 |
| Coversyl 8 mg Tablet | $ 1.23 |
| Coversyl 4 mg Tablet | $ 0.88 |
| Coversyl 2 mg Tablet | $ 0.70 |
| Tablet; Oral; Perindopril Erbumine 4 mg | |
| Tablet; Oral; Perindopril Erbumine 8 mg | |
| Tablet; Oral; Perindopril Erbumine 2 mg | |
| Aceon 8 mg tablet | $ 3.14 |
| Perindopril erbumine 8 mg tablet | $ 2.80 |
| Aceon 4 mg tablet | $ 2.58 |
| Perindopril erbumine 4 mg tablet | $ 2.30 |
| Aceon 2 mg tablet | $ 2.22 |
| Perindopril erbumine 2 mg tablet | $ 1.98 |
| Coversyl 8 mg Tablet | $ 1.23 |
| Coversyl 4 mg Tablet | $ 0.88 |
| Coversyl 2 mg Tablet | $ 0.70 |
| Perindopril 1A Pharma (Lithuania) | |
| Perindopril 1A Pharma 4 mg (Hungary) | |
| Perindopril A (Netherlands) | |
| Perindopril Accord (United Kingdom) | |
| Perindopril Actavis (Estonia, Finland, Latvia, Lithuania, Romania, Spain, Switzerland, United Kingdom) | |
| Périndopril Actavis (France) | |
See 519 substitutes for Perindocyl | |
References
- PubChem. "PERINDOPRIL". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "PERINDOPRIL". http://www.drugbank.ca/drugs/DB00790 (accessed September 17, 2018).
- MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
