Comparison of the effectiveness of Prestance and Prestarium A
The effectiveness of Prestance is quite similar to Prestarium A - this means that the ability of the medicinal substance to provide the maximum possible effect is similar.
For example, if the therapeutic effect of Prestance is more pronounced, then using Prestarium A even in large doses will not achieve this effect.
Also, the speed of therapy - an indicator of the speed of therapeutic action - Prestance and Prestarium A are approximately the same. And bioavailability, that is, the amount of a drug reaching its site of action in the body, is similar. The higher the bioavailability, the less it will be lost during absorption and use by the body.
Differences
The main difference between Prestance and Prestarium is that it contains not only perindopril, but also amlodipine, which has an additional antihypertensive effect and enhances the effect of the drug. It is worth considering that “Prestarium” can be replaced with “Prestance”, but vice versa – not.
The first medication has more indications for use. It is prescribed not only for hypertension and ischemia, but also for heart failure and after a stroke.
If we compare the contraindications, Prestance has many more of them than the first drug. This is due to the fact that Prestance additionally contains amlodipine.
Comparison of safety of Prestansa and Prestarium A
The safety of a drug includes many factors.
At the same time, in Prestance it is quite similar to Prestarium A. It is important where the drug is metabolized: medicinal substances are excreted from the body either unchanged or in the form of products of their biochemical transformations. Metabolism occurs spontaneously, but most often involves major organs such as the liver, kidneys, lungs, skin, brain and others. When assessing metabolism in Prestance, as well as in Prestarium A, we look at which organ is the metabolizing organ and how critical the effect on it is.
The risk-benefit ratio is when the prescription of a drug is undesirable, but justified under certain conditions and circumstances, with the obligatory observance of caution in use. At the same time, Prestance does not have any risks when used, just like Prestarium A.
Also, when calculating safety, it is taken into account whether only allergic reactions occur or possible dysfunction of the main organs. In other matters, as well as the reversibility of the consequences of using Prestance and Prestarium A.
Prestance
Use during pregnancy and breastfeeding
Pregnancy
The drug is contraindicated for use during pregnancy.
If planning pregnancy, the drug should be discontinued and other antihypertensive drugs approved for use during pregnancy should be prescribed. If pregnancy occurs, you should immediately stop taking Prestance and, if necessary, prescribe other antihypertensive therapy.
It is known that the effect of ACE inhibitors on the fetus in the second and third trimesters of pregnancy can lead to disruption of its development (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia).
If the patient received ACE inhibitors in the second or third trimesters of pregnancy, it is recommended to conduct an ultrasound examination of the fetus to assess the condition of the skull and renal function.
Newborns whose mothers received ACE inhibitors during pregnancy should be under close medical supervision due to the risk of developing arterial hypotension, oliguria and hyperkalemia.
Amlodipine
In experimental studies, the fetotoxic and embryotoxic effects of amlodipine have not been established, but use during pregnancy is possible only when the expected benefit to the mother outweighs the potential risk to the fetus.
Some patients treated with calcium channel blockers have experienced a reversible decrease in sperm motility.
There is insufficient clinical data regarding the potential effect of amlodipine on reproductive function.
Breastfeeding period
Amlodipine
There is no data indicating the excretion of amlodipine in breast milk. However, other slow calcium channel blockers, dihydropyridine derivatives, are known to be excreted in breast milk. In this connection, if it is necessary to prescribe amlodipine during lactation, the issue of stopping breastfeeding should be resolved.
Perindopril
Due to the lack of information regarding the use of perindopril during breastfeeding, the use of perindopril is not recommended; it is preferable to adhere to an alternative treatment with a better studied safety profile during breastfeeding.
Prestance
It is not recommended to take Prestance during lactation due to the lack of relevant clinical experience with the use of perindopril and amlodipine, both as monotherapy and as part of combination therapy. If it is necessary to take the drug during lactation, breastfeeding should be stopped.
Use for liver dysfunction
Caution should be exercised when prescribing Prestans to patients with liver failure due to the lack of recommendations for dosing of the drug in such patients.
Use for renal impairment
The elimination of perindoprilate in patients with renal failure is slow. Therefore, in such patients it is necessary to regularly monitor the concentration of creatinine and potassium in the blood plasma. Prestance can be prescribed to patients with CC ≥ 60 ml/min. Prestance is contraindicated in patients with CC < 60 ml/min. In such patients, individual selection of doses of perindopril and amlodipine is recommended. Changes in the concentration of amlodipine in blood plasma do not correlate with the severity of renal failure.
Use in children
Prestance should not be prescribed to children and adolescents under 18 years of age due to the lack of data on the effectiveness and safety of the use of perindopril and amlodipine in these groups of patients, both as monotherapy and in combination therapy.
special instructions
Special instructions regarding perindopril and amlodipine apply to Prestance.
Perindopril
Hypersensitivity/angioedema
When taking ACE inhibitors, incl. and perindopril, in rare cases, the development of angioedema of the face, extremities, lips, mucous membranes, tongue, vocal folds and/or larynx may occur. If symptoms appear, the drug should be stopped immediately and the patient should be observed until signs of edema completely disappear. If the swelling affects only the face and lips, it usually resolves on its own, although antihistamines may be used to treat symptoms.
Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction. If such symptoms occur, epinephrine (adrenaline) should be immediately administered subcutaneously and/or the airway should be secured. The patient should be under medical supervision until symptoms disappear completely and permanently.
Patients with a history of angioedema not associated with taking ACE inhibitors may have an increased risk of developing it when taking drugs of this group.
In rare cases, angioedema of the intestine develops during therapy with ACE inhibitors. In this case, patients experience abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases, without previous angioedema of the face and with normal levels of C1-esterase. The diagnosis is made using computed tomography of the abdominal region, ultrasound, or at the time of surgery. Symptoms disappear after stopping ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, when carrying out differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during LDL apheresis
In rare cases, life-threatening anaphylactoid reactions may occur in patients receiving ACE inhibitors during LDL apheresis using dextran sulfate. To prevent an anaphylactoid reaction, ACE inhibitor therapy should be temporarily discontinued before each apheresis procedure.
Anaphylactoid reactions during desensitization
There are isolated reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy (for example, hymenoptera venom). In these same patients, an anaphylactoid reaction was avoided by temporarily discontinuing ACE inhibitors, and if the drug was accidentally taken, the anaphylactoid reaction occurred again.
Neutropenia, agranulocytosis, thrombocytopenia, anemia
While taking ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia rarely develops. Perindopril should be used with extreme caution in patients with systemic connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, especially in patients with impaired renal function.
Some patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should report any signs of infectious diseases (eg, sore throat, fever) to their doctor.
Arterial hypotension
ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients without concomitant diseases. The risk of an excessive decrease in blood pressure is increased in patients with reduced blood volume, which can be observed during diuretic therapy, following a strict salt-free diet, hemodialysis, diarrhea and vomiting, as well as in patients with severe arterial hypertension with high renin activity. In patients at increased risk of developing symptomatic hypotension, blood pressure, renal function and serum potassium levels should be carefully monitored during therapy with Prestance.
A similar approach is also used in patients with angina pectoris and cerebrovascular diseases, in whom severe arterial hypotension can lead to myocardial infarction or cerebrovascular accident.
If arterial hypotension develops, the patient should be placed in a supine position with legs elevated. If necessary, the bcc should be replenished with the intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle to further taking the drug. After restoration of blood volume and blood pressure, treatment can be continued.
Mitral stenosis, aortic stenosis, hypertrophic obstructive cardiomyopathy
Prestan, like other ACE inhibitors, should be administered with caution to patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as to patients with mitral stenosis.
Renal dysfunction
In patients with renal failure (creatinine clearance less than 60 ml/min), individual selection of doses of perindopril and amlodipine is recommended. Such patients require regular monitoring of potassium and creatinine levels in the blood serum.
In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney during therapy with ACE inhibitors, an increase in serum urea and creatinine levels is possible, which usually resolves when therapy is discontinued. This effect is most often observed in patients with renal failure. The additional presence of renovascular hypertension causes an increased risk of severe hypotension and renal failure in such patients.
In some patients with arterial hypertension without signs of renal vascular damage, an increase in the concentration of urea and creatinine in the blood serum is possible, especially when perindopril is co-administered with a diuretic, usually slight and transient. This effect is more often observed in patients with pre-existing renal impairment.
Liver failure
In rare cases, cholestatic jaundice occurs while taking ACE inhibitors. As this syndrome progresses, fulminant liver necrosis develops, sometimes with death. The mechanism of development of this syndrome is unclear. If jaundice or a significant increase in the activity of liver enzymes occurs while taking ACE inhibitors, you should stop taking the drug.
Ethnic differences
In patients of the Negroid race, angioedema develops more often than in representatives of other races while taking ACE inhibitors.
Perindopril, like other ACE inhibitors, may have a less pronounced antihypertensive effect in patients of the Black race compared to representatives of other races. This difference may be due to the fact that black patients with arterial hypertension are more likely to have low renin activity.
Cough
During therapy with an ACE inhibitor, a dry cough may occur. The cough persists for a long time while taking drugs of this group and disappears after their discontinuation. If a patient develops a dry cough, one should be aware of the possible iatrogenic nature of this symptom.
Surgery/general anesthesia
The use of ACE inhibitors in patients undergoing major surgery and/or general anesthesia can lead to a significant decrease in blood pressure if general anesthesia agents with a hypotensive effect are used. This is due to blocking the formation of angiotensin II against the background of a compensatory increase in renin activity. If the development of arterial hypotension is associated with the described mechanism, the volume of circulating plasma should be increased. It is recommended to warn the surgeon/anesthesiologist that the patient is taking ACE inhibitors and stop taking the drug 24 hours before surgery.
Hyperkalemia
Hyperkalemia may develop during treatment with ACE inhibitors, incl. and perindopril. Risk factors for hyperkalemia are renal failure, age over 70 years, diabetes mellitus, some concomitant conditions (dehydration, acute decompensation of chronic heart failure, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride), and also potassium preparations or potassium-containing substitutes for table salt, as well as the use of other drugs that increase the content of potassium in the blood plasma (for example, heparin). The use of potassium supplements, potassium-sparing diuretics, and potassium-containing table salt substitutes can lead to a significant increase in potassium levels in the blood, especially in patients with reduced renal function.
Hyperkalemia can cause serious, sometimes fatal, abnormal heart rhythms. If simultaneous use of perindopril and the above drugs is necessary, treatment should be carried out with caution against the background of regular monitoring of potassium levels in the blood serum.
Patients with diabetes mellitus
When prescribing the drug to patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose concentrations should be carefully monitored during the first month of therapy.
Amlodipine
The effectiveness and safety of amlodipine in hypertensive crisis has not been established.
Heart failure
Patients with heart failure should be treated with caution. When using amlodipine in patients with chronic heart failure of functional class III and IV according to the NYHA classification, pulmonary edema may develop. Slow calcium channel blockers, including amlodipine, should be used with caution in patients with chronic heart failure due to a possible increased risk of cardiovascular adverse events and mortality.
Liver failure
In patients with impaired liver function, T1/2 and AUC of amlodipine are increased. Taking amlodipine should be started with the lowest doses and precautions should be taken both at the beginning of treatment and when increasing the dose. In patients with severe hepatic impairment, the dose should be increased gradually, ensuring careful monitoring of the clinical condition.
Elderly patients
In elderly patients, T1/2 may increase and amlodipine clearance may decrease. No dose changes are required, but more careful monitoring of patients in this category is necessary.
In patients with impaired renal function, monitoring of the condition is necessary.
Kidney failure
Patients with renal failure can take amlodipine in standard doses. Changes in plasma concentrations of amlodipine do not correlate with the degree of renal failure. Amlodipine is not excreted from the body by dialysis.
Prestance
Excipients
Due to the presence of lactose in the drug, Prestance should not be prescribed to patients with hereditary lactose intolerance, lactase deficiency and glucose/galactose malabsorption syndrome.
Impact on the ability to drive vehicles and operate machinery
Although no negative effects on the ability to drive vehicles or other complex mechanisms were observed while taking the drug Prestance, however, due to a possible excessive decrease in blood pressure, the development of dizziness, drowsiness and other adverse reactions, caution should be exercised in these situations, especially at the beginning of treatment and with increasing dose.
Comparison of addiction between Prestance and Prestarium A
Like safety, addiction also involves many factors that must be considered when evaluating a drug.
So, the totality of the values of such parameters as “syndrome o” in Prestance is quite similar to the similar values in Prestarium A. Withdrawal syndrome is a pathological condition that occurs after the cessation of the intake of substances that cause addiction or dependence into the body. And resistance is understood as initial immunity to a drug; in this it differs from addiction, when immunity to a drug develops over a certain period of time. The presence of resistance can only be stated if an attempt has been made to increase the dose of the drug to the maximum possible. At the same time, in Prestance the meaning of “syndrome o” is quite small, however, the same as in Prestarium A.
Similarities
The drugs belong to the same pharmacological group and have the same properties:
- Lower blood pressure.
- Dilate blood vessels.
- Makes large arteries more elastic.
- Normalize the functioning of the heart muscle and prevent its hypertrophy.
The drugs have the same medicinal properties due to the fact that they contain the same active ingredient - perindopril . It is this that ensures a decrease in pressure in the arteries and restoration of their elasticity.
The drugs are available in tablets and have the same indications for use: arterial hypertension, prevention of complications in coronary heart disease. These drugs are also taken for some other cardiovascular pathologies in order to prevent complications.
These medications are absolutely contraindicated for pregnant and lactating women. It has been proven that ACE inhibitors negatively affect the development of the fetus in the womb and can cause congenital pathologies of the kidneys, heart, brain and other organs. Women planning a pregnancy should stop taking the drug and replace it with another that is safe for pregnant women.
Also, the products are contraindicated for persons under 18 years of age and those who have ever had angioedema.
The maximum antihypertensive effect of medications is achieved 4-6 hours after administration and persists throughout the day. Persistent normalization of blood pressure occurs after 1 month of regular tablet use and persists for a long time. At the same time, after stopping any medication, there is no sharp increase in pressure.
Both drugs are produced in France (Prestarium is also produced in Russia and Ireland). Available only with a doctor's prescription.
Comparison of side effects of Prestance and Prestarium A
Side effects or adverse events are any adverse medical event that occurs in a subject after administration of a drug.
Prestance has almost the same level of adverse events as Prestarium A. Both of them have a small number of side effects. This implies that the frequency of their occurrence is low, that is, the indicator of how many cases of an undesirable effect of treatment are possible and registered is low. The undesirable effect on the body, the strength of influence and the toxic effect of Prestance are similar to Prestarium A: how quickly the body recovers after taking it and whether it recovers at all.
Comparison of ease of use of Prestance and Prestarium A
This includes dose selection taking into account various conditions and frequency of doses. At the same time, it is important not to forget about the release form of the drug; it is also important to take it into account when making an assessment.
The ease of use of Prestance is approximately the same as Prestarium A. However, they are not convenient enough to use.
The drug ratings were compiled by experienced pharmacists who studied international research. The report is generated automatically.
Last update date: 2020-12-04 13:45:39
Prestarium
Antihypertensive drug. Helps lower blood pressure, reduces pressure in the pulmonary capillaries. Restores the elasticity of large arteries, reduces hypertrophy of the heart muscle, and moderately reduces the heart rate.
Active substance: perindopril.
Release form: tablets of 2, 4 and 8 mg.
Indications for use:
- Arterial hypertension.
- Chronic heart failure.
- Prevention of the development of cardiovascular complications in patients with coronary artery disease.
- Prevention of recurrent stroke.
Do not use if you have an intolerance to the substances included in the product, angioedema (history), during pregnancy (including in preparation for pregnancy) and lactation.
Produced in France. Dispensed by prescription.
