What is Revosyl 8?
Revosyl 8 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.
Revosyl 8 works by blocking a substance in the body that causes the blood vessels to tighten. As a result, Revosyl 8 relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Revosyl 8 is also used in patients with coronary artery disease to prevent heart attacks.
Revosyl 8 is available only with your doctor's prescription.
Revosyl 8 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 Revosyl 8, 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 Revosyl 8 has a similar potential.
In considering use of Revosyl 8, 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 Revosyl 8?
Use Revosyl 8 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Revosyl 8 by mouth with or without food.
- Take Revosyl 8 on a regular schedule to get the most benefit from it.
- Taking Revosyl 8 at the same time(s) each day will help you to remember to take it.
- Continue taking Revosyl 8 even if you feel well. Do not miss any doses.
- If you miss a dose of Revosyl 8, 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 Revosyl 8.
Uses of Revosyl 8 in details
Revosyl 8 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).
Revosyl 8 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 Revosyl 8
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).
Revosyl 8 description
Revosyl 8 is the tert-butylamine salt of Revosyl 8, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Revosyl 8 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.
Revosyl 8 tert-butylamine has molecular weight of 368.47 (free acid) or 441.61 (salt form).
Revosyl 8 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.
Revosyl 8 dosage
Revosyl 8 Dosage
Generic name: Revosyl 8 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 Revosyl 8 for the elderly is 4 mg daily, given in one or two divided doses. Experience with Revosyl 8 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 Revosyl 8. Consider reducing the dose of diuretic prior to starting Revosyl 8.
Stable Coronary Artery Disease
In patients with stable coronary artery disease, Revosyl 8 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), Revosyl 8 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. Revosyl 8 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, Revosyl 8 is removed with the same clearance as in patients with normal renal function.
More about Revosyl 8 (Revosyl 8)
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Consumer resources
- Revosyl 8
- Revosyl 8 (Advanced Reading)
Professional resources
- Revosyl 8 (AHFS Monograph)
- Revosyl 8 (FDA)
Related treatment guides
- Coronary Artery Disease
- Diabetic Kidney Disease
- Heart Attack
- Heart Failure
- High Blood Pressure
- More (1) »
Revosyl 8 interactions
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What other drugs will affect Revosyl 8?
Diuretics: Patients on diuretics and especially those started recently, may occasionally experience an excessive reduction of blood pressure after initiation of Revosyl 8 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 Revosyl 8. If diuretics cannot be interrupted, close medical supervision should be provided with the 1st dose of Revosyl 8, for at least 2 hrs and until blood pressure has stabilized for another hour.
The rate and extent of Revosyl 8 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: Revosyl 8 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 Revosyl 8.
Digoxin: A controlled pharmacokinetic study has shown no effect on plasma digoxin concentrations when co-administered with Revosyl 8, but an effect of digoxin on the plasma concentration of Revosyl 8/perindoprilat has not been excluded.
Gentamicin: Animal data have suggested the possibility of interaction between Revosyl 8 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 Revosyl 8 with food does not significantly lower the rate or extent of Revosyl 8 absorption relative to the fasted state. However, the extent of biotransformation of Revosyl 8 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, Revosyl 8 was generally administered in a nonfastingstate.
Revosyl 8 side effects
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What are the possible side effects of Revosyl 8?
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
Revosyl 8 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 Revosyl 8-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with Revosyl 8® (Revosyl 8) 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 Revosyl 8 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 Revosyl 8 and in those treated with placebo (approximately 75% in each group). The only adverse events whose incidence on Revosyl 8 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 Revosyl 8 group (8.2%) than in the placebo group (8.5%), but its likelihood increased with dose, suggesting a causal relationship with Revosyl 8.
Stable Coronary Artery Disease
Revosyl 8 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 Revosyl 8 than placebo were cough, drug intolerance and hypotension.
Postmarketing Experience
Voluntary reports of adverse events in patients taking Revosyl 8 that have been received since market introduction and are of unknown causal relationship to Revosyl 8 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 Revosyl 8, 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% Revosyl 8 versus 0.9% placebo) and AST (0.5% Revosyl 8 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.
Revosyl 8 contraindications
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What is the most important information I should know about Revosyl 8?
Hypersensitivity to Revosyl 8 or to any of the excipients of Revosyl 8 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 Revosyl 8.
Use in pregnancy: Revosyl 8 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.
Revosyl 8 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 Revosyl 8 have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Active ingredient matches for Revosyl 8:
List of Revosyl 8 substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Prexanil (Croatia (Hrvatska), Czech Republic, Estonia, Serbia, Slovenia) | |
| Prexanil A (Croatia (Hrvatska)) | |
| Prexanil Combi A (Croatia (Hrvatska)) | |
| Prexum (Indonesia, South Africa) | |
| Pricoron (Czech Republic, Romania) | |
| Prilam (Georgia) | |
| Prindace (Ireland) | |
| Prindex (Bulgaria, Estonia, Latvia, Lithuania, Romania) | |
| Syrup; Oral; Carbinoxamine Maleate 25 mg; Pseudoephedrine Hydrochloride 60 mg / 5 ml (Medicamenta) | |
| Tablet, Film-Coated; Oral; Carbinoxamine Maleate 2.5 mg; Pseudoephedrine Hydrochloride 60 mg (Medicamenta) | |
| Prinopril (Bulgaria) | |
| Prinwin (Taiwan) | |
| Prinwin 8 mg | |
| Pritnox (Poland) | |
| Procaptan (Italy) | |
| Provinace (Malaysia) | |
| Provinace 4 mg x 3 Blister x 10 Tablet | |
| Provinace 4 mg x 30's | |
| Ran-Perindopril (South Africa) | |
| Ranbapril (Serbia) | |
| Relika (Croatia (Hrvatska)) | |
| Revosyl 4 | |
| Rindolex (Slovenia) | |
| Serperil (Turkey) | |
| Spec Perindopril (South Africa) | |
| Spopress (Poland) | |
| Stoppress (Romania) | |
| Stopress (Bulgaria, Estonia, Latvia, Lithuania) | |
| Terc-butilaminijev (Slovenia) | |
| Terry White Chemists Perindopril (Australia) | |
| Tablet; Oral; Perindopril Erbumine 2 mg | |
| Tablet; Oral; Perindopril Erbumine 4 mg | |
| Tablet; Oral; Perindopril Erbumine 8 mg | |
| Terry White Chemists Perindopril Arginine (Australia) | |
| Trezen (Romania) | |
| Vectoryl (South Africa) | |
| Versil (Bangladesh) | |
| Versil 6 mg Tablet (Silver Biotech (Sanify Healthcare Pvt. Ltd.)) | $ 0.18 |
| Vidotin (Czech Republic, Estonia, Latvia, Lithuania, Poland, Romania) | |
| Vidotin 4 mg (Hungary) | |
| Vidotin 8 mg (Hungary) | |
| Viritin (Vietnam) | |
| Viritin 4 (Vietnam) | |
| Viritin 4 4 mg x 1 Blister x 30 Tablet | |
| Zimpril | |
| Zimpril 4mg Tablet (Zee Laboratories) | $ 0.10 |
| Zimpril 8mg Tablet (Zee Laboratories) | $ 0.17 |
| Zydus Perindopril (South Africa) | |
See 543 substitutes for Revosyl 8 | |
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).
Reviews
The results of a survey conducted on ndrugs.com for Revosyl 8 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Revosyl 8. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
