Coversyl Plus 10mg/2.5mg Servier medicine for hypertension (30 tablets)

Dosage form Box of 30 tablets
Specifications Perindopril, indapamide
Ingredient High blood pressure

Ingredient

Composition informationContent
Perindopril10mg
Indapamide2.5mg

Uses

Indications

Coversyl Plus 10/2.5 drugs are indicated in the following cases:

  • Treatment of hypertension. Inhibition of enzymes) with indapamide (is a chlorosulphamyl group diuretic). The pharmacological properties of the drug are pharmacological properties of each component, in addition to the synergistic effect of the two components.

    Pharmacological effects

    Related to Perindopril:

    Perindopril inhibits the enzyme, the enzyme metabolizes angiotensin I into angiotensin II (is vasoconstrictor); In addition, this enzyme stimulates the secretion of aldosterone from the adrenal shell and also stimulates the breakdown of Bradykinin (is a vasodilator) into the loss -inactive heptides.

    That leads to:

  • reduce Aldosterone secretion. Appears in patients with low or normal renin concentrations.

    Perindopril shows its active metabolites, Perindoprilat. Other metabolites are no longer active.

    perindopril reduces the heart due to:

  • Varicose veins, possibly due to changing the metabolism of prostaglandin: reducing the burden.
  • There is a decrease in the pressure of the right and left ventricle.

    Related to indapamide:

    Indapamide is a sulfonamide derivative that has an indole, pharmacological related to the group of thiazide diuretics. Indomamide inhibits sodium reabsorption through the dilution of the kidney shell. This drug increases the secretion of sodium and chloride through the urine and also increases the excretion of a part of potassium and magnesi, thereby increasing the amount of urine secretion and has the effect of lowering blood pressure.

    Pharmacological effects

    Related to Coversyl Plus 10/2.5:

    In patients with hypertension at all ages, Coversyl Plus 10/2.5 has an anti -hypertension effect on dosage on systolic and diastolic artery blood pressure both on their backs or when standing.

    This anti -hypertension effect lasts up to 24 hours. Reducing blood pressure achieved in less than a month without getting used to the drug quickly; Stop treatment does not cause response effects.

    In clinical trials, combination of Perindopril and Indopamide will create a synergistic effect on anti -hypertension related to the effectiveness of each drug when used separately.

    Picxel, a multi -centered study, random, double blind, controlled with Enalapril, based on an echocardiogram, is a study to evaluate the effectiveness of Perindopril/Indapamide combination in reducing left ventricular hypertrophy (LVH).

    In the picxel study, patients with hypertension with left ventricular hypertrophy (LVH) (assessed by the left ventricular muscle mass index (LVMI)> 120 g/m2 in male patients and> 100 g/m2 in female patients), randomly selected in 2 treatment groups within 1 year: or use in combination of Perindopril Tert-butylamine 2 mg (equivalent to 2.5 mg perindoprilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilrilamine (equivalent Arginine)/indapamide 0.625 mg or use enalapril 10 mg, with 1 time of day.

    Based on the patient's blood pressure, the dose can be adjusted to the dose of Perindopril Tert-butylamine 8mg (equivalent to 10 mg of Perindopril arginine) and indapamide 2.5 mg or Enalapril 40 mg once used during the day. Only 34% of patients maintain the dose of Perindopril Tert-butylamine 2 mg (equivalent to 2.5 mg of Perindopril arginine)/indapamide 0.625 mg (compared to 20% of patients maintaining enalapril treatment dose 10 mg).

    At the end of the treatment phase, the left ventricular mass index (LVMI) is significantly reduced in the group using perindopril/indapamide (-10.1 g/m2) compared to (-1.1 g/m2) in the enalapril group on the total number of patients with random division. The difference in the left ventricular mass index between the two groups is -8.3 g/m2 (CI 95% (-11.5; -5,0), P

    Assessment of blood pressure, the difference between the two groups is randomly divided, is -5.8 mmHg (CI 95% (-7,9; -3,7), P Related to Perindopril:

    Perindopril works on all levels of hypertension, from light to medium and severe. A decrease in systolic and diastolic arterial blood pressure is in both lying position as well as vertical posture.

    Anti -hypertension effect after using a single dose will reach a maximum within 4 to 6 hours and last for 24 hours.

    The enzyme blocking effect exists after 24 hours is still high, about 80%.

    For patients who respond to drugs, blood pressure will be normal after about 1 month and maintain without the phenomenon of fast familiar medicine.

    The stopping of the drug does not cause response effects on blood pressure.

    Perindopril has the properties of vasodilation and restores the elasticity of the main blood vessels, corrected changes in histological forms in the arteries to create resistance and reduce the hypertrophy of the left ventricle.

    When necessary, using additional diuretics thiazide will give the combination effect.

    Combining an enzyme inhibitor with thiazide diuretics will reduce the risk of hypokalemia caused by diuretics when used separately.

    Related to indapamide:

    Used in monomers, indapamide has a long -term anti -hypertension effect for 24 hours. This effect is achieved immediately with the doses that diuretic is the lowest.

    Anti -hypertension effects of indapamide are proportional to the level of artery function improvement and the level of resistance of the entire peripheral vascular system.

    indapamide reduces left ventricular hypertrophy.

    When overdose of thiazide diuretics and diuretics are related to Thiazide, anti -hypertension effects maintain at the plateau while harmful effects increase. So if treatment is not effective, do not increase the dose.

    Moreover, in patients with hypertension for short, medium and long -term drugs, see indapamide:

  • does not affect the metabolism of lipid (triglycerides, ldl-cholesterol and HDL-cholesterol)
  • without affecting the metabolism of carbon hydrate, even in patients with diabetes with diabetes.

    Two random, random studies, verified ontarget (comparison of single-therapy telmisartan and coordinate with Ramipril on cardiovascular outcomes) and VA NEPRON-D (Veteran research on kidney disease in diabetes patients) that verified the use of enzyme inhibitors transferred with Angiotensin II receptor inhibitors.

    ontarget is performed in patients with a history of cardiovascular disease or cerebrovascular disease, or diabetes, type 2, which has evidence of the target organ damage. And Nepon-D is a study performed in patients with type 2 diabetes and patients with diabetes kidney disease.

    These studies have shown that there is no obvious effect on the kidneys and/or cardiovascular disease and the mortality rate, while the risk of hyperboly serum, acute kidney damage and/or hypotension increases compared to a single treatment of a drug.

    Due to the same pharmacokinetic properties, these results are also related to the use of other transfer enzyme inhibitors and angiotensin II receptor inhibitors.

    Therefore, the enzyme inhibitors should not be used simultaneously with Angiotensin II receptor inhibitors in patients with diabetic kidney disease.

    Altitude (Researching the role of Aliskiren on cardiovascular and renal disease in patients with type 2 diabetes) is a study designed to evaluate the effectiveness of Aliskiren in the standard treatment that is inhibiting the enzyme inhibitors or inhibiting Angiotensin II receptor in patients with type 2 diabetes and chronic nephropathy, or both. The study had to stop early due to increased risk of adverse events. Cardiovascular death and stroke are observed with more frequency in the group using Aliskiren compared to the Placebo group, the common and serious adverse events (increased potassium, hypotension, kidney failure) are also reported with more frequency in the group using Aliskiren compared to Placeboo.

    Pediatric patients:

    There is no data on the use of CoverSyl Plus 10/2.5 in children.

    Dynamic pharmacokinetics

    Related to Coversyl Plus:

    Perindopril combination with indapamide does not change the pharmacokinetic properties of both drugs compared to when used separately.

    Related to Perindopril:

    absorption:

    After oral use, the absorption of Perindopril occurs quickly, the maximum concentration reached within 1 hour. Perindopril's waste sale time in plasma is 1 hour.

    Eating food reduces the convert into Perindoprilat. Therefore, to increase bioavailability, Perindopril Arginine should be used by oral once a day in the morning before meals.

    Distribution:

    The distribution volume is about 0.2 l/kg with non -linked perindoprilat. Perindoprilat ratio is linked to plasma proteins of 20%, mainly for angiotensin conversion enzymes, but depends on Perindoprilat concentration.

    Metabolism:

    Perindopril is a precursor medicine. Twenty -seven percent of Perindopril orally transferred into the blood in the form of active metabolites, Perindoprilat. In addition to the active Perindoprilat, Perindopril also produces 5 other metabolites that are not active. Perindoprilat's maximum concentration appears within 3 to 4 hours.

    Era:

    Perindoprilat is excreted in the urine, and the remaining half-life (Terminal Half-Life) of the protein is not at about 17 hours, creating a stable state lasting for 4 days.

    Linear/non -linear: proven to have linear relationship between the dose of perindopril and this concentration of plasma.

    Special subjects:

  • The elderly: The elimination of Perindoprilat decreases in the elderly, and even in patients with heart failure or kidney failure. ml/min. The clearance of the liver of this substance drops to half. However, the amount of perindoprilat formed is not reduced, and therefore there is no need to adjust the dose.

    absorption:

    Indapamide absorbs quickly and completely through the digestive tract. The peak concentration of plasma in humans is about an hour after taking the medicine.

    Distribution:

    Attach 79% to plasma protein.

    Metabolism and elimination:

    Selling time is about 14-24 hours (average 18 hours). Continuous use does not cause accumulation of drugs. Elimination mainly through urine (70% of the dose) and feces (22% of the dose) in the form of active metabolites.

    Special subjects:

  • Kidney failure: Indiamide pharmacokinetics does not change in patients with renal failure.
  • Before taking Coversyl Plus 10mg/2.5mg Servier medicine for hypertension (30 tablets)

    How to use

    Coversyl Plus 10/2.5 Film tablets for oral. Should drink in the morning and before meals.

    Dosage

    Common dose: 1 Coversyl Plus 10/2.5 x 1 time/day.

    Special subjects:

    Old people:

  • In the elderly, plasma creatinine values ​​need to be corrected by age, weight and gender.
  • Contraindicated drugs on patients with severe and medium renal impairment (creatinine clearance below 60 ml/min).
  • Contraindicated to use drugs with patients with severe liver failure. In patients with medium liver failure, no dose adjustment.
  • Pediatric patients:

  • The safety and effectiveness of Coversyl Plus 10/2.5 in children and minors has not been established.
  • There is no available data. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? Salt and water disorders (low salt concentrations, low potassium concentrations) may occur.

    How to handle: The first measure includes quickly eliminating the drug from the body through the gastrointestinal tract by washing the intestine and/or taking activated carbon, then compensating and the electrolyte balance at the Specialized Center until these indicators return to normal.

    If hypotension is significantly, the patient should be treated by placing the patient in a lying position with a lower head. If the intravenous salt water is required, or may use measures to increase the volume of circulating. Perindoprilat is a form of Perindopril that can be separated.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

  • Side Effects

    When using CoverSyl Plus 10/2.5, you may experience unwanted effects (ADR).

    The use of Perindopril will inhibit the renin-analiotensin-aldosterone axis and lead to reduced potassium loss due to indapamide. 6% of patients treated with Coversyl Plus 10/2.5 have hypokalemia (potassium concentration

    The most commonly reported reactions are:

    Perindopril: dizziness, headache, paresthesia, taste disorders, vision loss, dizziness, tinnitus, hypotension, cough, shortness of breath, abdominal pain, constipation, indigestion, diarrhea, nausea, vomiting, itching, rats, cramps and weakness.

    indapamide: Hypersensitivity reactions, mainly in the skin, on individuals tend to suffer from allergic and asthma reactions and lumpy rash. Common, ADR> 1/100

    Perindopril
    indapamide Nervous system disorders dizziness, pain, abnormalities, abnormalities Enlightenment - Eye disorders visual impairment - Ear disorders and maze Tinnitus dizziness The pulse hypotension (and the effects related to hypotension) - Abdominal, constipation, diarrhea, indigestion, nausea, nausea, vomiting - Withdraw - 1/100
    perindopril
    indapamide Vascular vasculitis - mouth vomit Skin and subcutaneous disorders
    urticaria, veins - Blood and lymphatic disorders NGO hyposopenam - Blood - Mental disorders Mood changes, sleep disorders - Quick - Certificate falls - 1/1000
    Perindopril
    indapamide Supply - Eye Candles - Blood - Bacteria and parasitic infections rhinitis - Nervous system disorders Secondary stroke due to excessive hypotension in high-risk patients - Circuit - Hypotension (and effects related to hypotension) Form
    epidermal necrotic necrosis, Stevens-Johnson syndrome
    Bridge Metabolic and nutrition disorders - Hypercalcemia Heart angina, arrhythmia (including bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction can be excessive blood pressure in high -risk patients
    arrhythmia (including bradycardia, tachycardia on ventricular, atrial fibrillation) Bridge - Level

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Coversyl Plus 10/2.5 contraindications in the following cases:

    Related to Perindopril:

    Hypersensitivity to Perindopril or any other transferred enzyme inhibitors.

    There is a history of angioedema (edema) when using the previous transferred enzyme inhibitors.

    Genetic/spontaneous veins.

    Pregnant for more than 3 months.

    Simultaneously used with Aliskiren products in patients with diabetes or renal failure (glomerular filtration

    Use simultaneously with Sacubitril/Valsartan.

    Demonstration treatments lead to blood exposure to negative charge surfaces.

    Nest of kidney artery on both sides or significant artery stenosis leads to kidney function on one side.

    Related to indapamide:

    Hypersensitivity to indapamide or any other sulfonamide.

    Severe renal failure (creatinine clearance below 30 ml/minute).

    Hepatitis.

    Severe liver failure.

    Hemolytic reduction.

    According to the general principle, it is not recommended to use simultaneously with anti -arrhythmic drugs that can cause torsion.

    breastfeeding.

    Related to Coversyl Plus 10/2.5:

    Hypersensitivity to any ingredient of the drug.

    Due to the lack of treatment experience, Coversyl Plus 10/2.5 should not be used on the following objects:

    Patient with blood accumulation.

    Patients with untreated heart failure.

    Caution when using

    Special prudence:

    Caution for Perindopril and Indapamide:

    Lithi: There is no recommendation to use a combination of lithium with Perindopril and Indapamide combination.

    Related to Perindopril:

    Double blockade of the renin-ankiotensin-aldosterone system (RAAS):

    There is evidence that the simultaneous use of enzyme inhibitors, Angiotensin II or Aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Dual blockade of RAAS systems using a combination of enzyme inhibitors, Angiotensin II receptor blockers or Aliskiren therefore is not recommended.

    If the dual blockade therapy is certainly considered necessary, this use is only performed under the supervision of the expert and should be closely monitored regularly for kidney, electrolyte and blood pressure.

    Transfer enzyme inhibitors and Angiotensin II receptor blockers should not be used simultaneously in patients with diabetic kidney disease.

    Potassium drugs, potassium supplements or alternative salt containing potassium: usually do not recommend the use of Perindopril and potassium -keeping drugs, potassium supplements or alternative salt containing potassium.

    Neutral leukopenia/granulocytopenia/thrombocytopenia/anemia:

    There have been reports on neutropenia/granulocytosis, thrombocytopenia and anemia when patients treated with enzyme inhibitors. In patients with normal renal function and no other pathological factors, neutrophils decreased rarely occur.

    Be careful when using Perindopril in patients with collagen vascular disease, being treated with immunosuppressive drugs, allopurinol or process, or combining these factors, especially if the patient has previously been impaired renal function. Some of these patients have progressed into severe infections, but in some cases do not respond to strong antibiotic therapy.

    If using Perindopril in these patients, periodic white blood cell formula should be used and patients should be instructed to report any signs of infection (eg sore throat, fever).

    Aortic hypertension:

    There is the ability to increase the risk of hypotension and renal failure when the patient has narrowed kidney stenosis on both sides or the kidney artery stenosis leads to the kidney function on the one side is treated with inhibition of enzyme.

    Treatment with diuretics can be a contribution. Kidney failure may even appear with slight changes in serum creatinine in patients with kidney stenosis on one side.

    sensitivity/angioedema:

    Facial edema, limbs, lips, tongue, subjects and/or larynx have been reported rare in patients treated with enzyme inhibitors, including Perindopril.

    This phenomenon can occur at any time during treatment.

    In that case, it is necessary to stop using Perindopril immediately and set a comprehensive solution to this symptom before they are completely excluded from the patient. If the swelling is limited to the face and lips, this condition is generally resolved without treatment, although antihistamine drugs are very effective in the treatment of symptoms.

    Evaluation phenomenon with laryngeal edema can lead to death. In case of an appropriate tongue, tongue or larynx may cause airway obstruction, then it is necessary to conduct an injection under the skin Epinephrin 1: 1000 (0.3 ml to 0.5 ml) and/or treat to ensure the release of the patient's airway. Black skin patients using enzyme inhibitors have been reported to have a higher rate of angioedema than other patients.

    Patients with a history of angioedema are not related to the transferred enzyme inhibitors that may increase the risk of angioedema when using these groups.

    The gastrointestinal angioedema phenomenon has been reported rare in patients treated with enzyme inhibitors. These patients show signs of abdominal pain (with or without nausea or vomiting); In some cases, there is no priority and C-1 Enterase concentration at a normal level.

    Evaluation is diagnosed with a procedure including a CT scan, or ultrasound or when surgery and improved symptoms after stopping the transferred enzyme inhibitor. Gastrointestinal angioedema should be used as a sign to distinguish the patient using enzyme inhibitors with abdominal pain.

    Simultaneously used with MTor inhibitors (such as syrolimus, Everolimus, Temsirolimus): Patients treated simultaneously with MTOR inhibitors (such as Sirolimus, Everolimus, Temsirolimus) may increase the risk of angioedema (such as swelling of the airway or tongue, attached or not accompanied by respiratory failure).

    Combining Perindopril with Sacubitril/Valsartan is contraindicated due to increased risk of angioedema. Sacubitril/Valsartan is only started to take 36 hours after the end of Perindopril's final dose. If treated with Sacubitril/Valsartan, Perindopril therapy will only start 36 hours after the last dose of sacubitril/valsartan.

    The simultaneous use of NEP inhibitors (such as racecadotril) and enzyme inhibitors may also increase the risk of angioedema. Therefore, it is necessary to evaluate benefits - risks carefully before starting treatment with NEP inhibitors (such as racecadotril) on patients taking Perindopril.

    Anaphylaxis in the sensitive process: Some single reports about patients with anaphylaxis are maintained, life -threatening when taking enzyme inhibitors transferred during the sensitivity of the membrane (bee, insects).

    Transfered enzyme inhibitors should be used carefully in patients with allergies sensitive, and avoid used for patients using venom therapy immunity. However, these reactions can be prevented by temporarily stop using enzyme inhibitors for at least 24 hours before treatment on patients need to combine both enzyme inhibitors and hypersensitivity.

    Anaphylaxis in the process of filtering low density lipoprotein (LDL): Rarely cases of patients taking enzyme inhibitors transferred during low density lipoprotein extraction (LDL) with dextran sulphate are life -threatening shock. This reaction can be prevented by temporarily stop using enzyme inhibitors before each filter.

    Patients with hemorrhage: There is a report on anaphylactic shock in patients with high speed filter (e.g., an69®) and is being treated simultaneously the enzyme inhibitors. In this case, it is advisable to consider the use of other types of separation membranes or other anti -hypertension drugs.

    Increase Aldosterone first: Patients with hyperplation hyperplasia are generally not responding to anti-hypertension drugs operating through inhibiting the renin-angiotensin system. Therefore the use of this drug is not recommended.

    Related to indapamide:

    Hepatic brain disease: When the liver function is impaired, the thiazide diuretics and diuretics related to the thiazide group can cause liver's brain disease. Need to stop the use of diuretics if this situation occurs.

    Light sensitivity: Cases of patients sensitive to light have been reported to the thiazide diuretics and diuretics related to the Thiazide group.

    If light sensitivity occurs during treatment, the patient is recommended to stop taking the drug. If the reuse of diuretics is necessary, it is necessary to recommend that patients protect the skin in contact with sunlight or with artificial UVA rays.

    Note when using:

    General notes for Perindopril and Indapamide:

    kidney failure:

    In case of severe and medium renal failure (Creatinine clearance

    Some patients with hypertension without manifestation of kidney damage earlier but blood test results show that the kidney function is affected, need to stop treatment and can also re -re -rule at low doses or with either of the two components.

    In these patients, regular check -ups include potassium and creatinine tests, after 2 weeks of treatment and then every two months during the stable treatment period. There have been reports on renal failure mainly in patients with severe heart failure or kidney failure with kidney stenosis.

    usually do not recommend medication in the case of kidney artery stenosis on both sides or only one side of the kidneys.

    Low blood pressure and dehydration and electrolytes:

    Patients are at risk of hypotension suddenly if they have had sodium loss (especially for patients with renal artery stenosis). Therefore, it is necessary to check the overall clinical signs of dehydration and electrolytes, which can occur with the recurrence of diarrhea and vomiting symptoms. For these patients, they should regularly check the electrolytes in plasma.

    Case of significant hypotension should conduct intravenous salt water transmission.

    Hypotension is not contraindicated for continuing treatment. After restoring the volume of blood and normal blood pressure, the treatment may be started again with a decrease in doses or with a single component.

    Potassium level:

    The combination of perindopril and indapamide does not prevent the onset of hypokalemia, especially in patients with diabetes or kidney failure. As for any antihypertensive drugs contain diuretic components, it is necessary to control the concentration of plasma potassium.

    excipients:

    Do not use Coversyl Plus 10/2.5 for patients with rare genetic disorders such as galactose intolerance, all lactase deficiency or under glucose - galactose tolerance.

    Related to Perindopril:

    ho:

    The dry cough has been recorded when using enzyme inhibitors. Cough is usually persistent and ends after stopping treatment. If this symptom occurs, it is necessary to consider the cause of the treatment. If the prescription of the transferred enzyme inhibitors is still selected, the continued treatment may be considered.

    Pediatric patients:

    Perindopril's efficiency and tolerance effectiveness in children and adolescents, in a single form or a combination of two components, has not been set up.

    The risk of arterial hypotension and/or impaired renal function (in case of heart failure, dehydration and electrolytes, ...):

    The strong stimulation of the renin-ankiotensin-aldosterone system has been observed, especially in the case of dehydration and significant electrolytes (due to the rigorous diet without salt or due to prolonged diuretic treatment), in patients with low blood pressure at low treatment, kidney artery stenosis, hemorrhagic heart failure or cohesian cirrhosis.

    Inhibiting this system by taking transferred enzyme inhibitors can cause a sudden reduction in blood pressure and/or an increase in plasma creatinine, especially at the time of the beginning and in the first 2 weeks, leading to impaired renal function.

    Sometimes this phenomenon occurs at the time of arising, although rarely occurs, and also at different times. In those cases, the treatment should be started at low doses and gradually increase the dose.

    Old people:

    It is necessary to check the kidney function and blood potassium level before starting. Then adjust the starting dose according to the patient's blood pressure level, especially in the case of dehydration and electrolytes, in order to avoid sudden hypotension.

    Atherosclerosis:

    The risk of hypotension may occur in all patients, but it is necessary to be particularly cautious for patients with myocardial anemia or brain circulation that is not sufficient, need to start treatment with low doses in these patients.

    Hypertension due to kidney stenosis:

    Treatment of hypertension due to kidney stenosis by pulse. However, transferred enzyme inhibitors may be effective for patients with signs of hypertension due to kidney stenosis waiting for surgery or in case of unable to surgery.

    Treatment with Coversyl Plus 10/2.5 is not suitable for patients with a history or suspected kidney stenosis due to the treatment that needs to be conducted in the hospital at a lower dose of Coversyl Plus 10/2.5

    Heart failure/heart failure:

    In patients with severe heart failure (level IV) treatment with Coversyl Plus 10/2.5 is inappropriate, it is necessary to start treatment under tight supervision and dose reduction. Beta inhibitors should not be stopped in patients with hypertension with coronary artery inserts: The transferred enzyme inhibitors should be added to the beta blocker treatment.

    Patients with diabetes:

    In patients with insulin dependent diabetes (tendency to spontaneously increasing blood potassium level), Coversyl Plus 10/2.5 treatment is inappropriate, so the beginning of treatment under the close supervision of health workers and low doses.

    Should closely monitor blood sugar levels in patients with diabetes treated with drugs for oral diabetes or previous insulin, specifically in the first month of treatment with enzyme inhibitors.

    Race:

    Similar to other transferred enzyme inhibitors, Perindopril's hypotension can be less effective in black skin patients, which may be due to low ratio of lenamic lyin activity in higher hypertension patients with hypertension patients.

    surgery/anesthesia:

    Transfer enzyme inhibitors can cause hypotension in case of anesthesia, especially when anesthesia with drugs can cause hypotension. Therefore, it is advisable to stop taking the medication a day before surgery if treated with an enzyme inhibitor has a long -lasting effect like Perindopril.

    Aortic stenosis and hypertrophic myocardial valve:

    Be careful when using enzyme inhibitors transferred to patients with blood clogged from left ventricle.

    Hepatic failure:

    Rarely cases of enzyme inhibitors that are converted to syndrome begins with cholestasis jaundice and progresses into spreading liver necrosis and (sometimes) death. The mechanism of this syndrome is not well known. Patients taking enzyme inhibitors with progressive jaundice or increased liver enzyme should stop taking the drug and medical monitoring.

    Serum hyperpass:

    Serum hyperpass has been recorded in a number of patients taking enzyme inhibitors, including Perindopril.

    Risk factors that increase blood potassium include kidney failure, renal function, age (> 70 years old), diabetes, patients with accompanying events, especially dehydration, acute cardiac loss, metabolic acidosis and simultaneous use with potassium diuretics (such as spironolactone, eplerenone, triamterene, amiloride ...) Or patients taking other drugs that increase serum potassium (e.g. heparin, co-trimoxazole is known as trimethoprim/sulfamethoxazole, other transferred enzyme inhibitors, angiotensin II receptor antagonists, acetylsalicylic acid ≥ 3 g/day, COX-2 inhibitors and non-selective drugs, expressionless drugs such as expressions inhibitors inhibitors ciclosporin or tacrolimus, trimethoprim).

    The use of potassium supplements, potassium diuretics or alternative salts containing special potassium in patients with renal impairment may increase the meaning of serum potassium concentration. Hyperboly hyperkalemia may be serious, sometimes causing arrhythmia leading to death. If the same use of the above drugs is considered necessary, it is necessary to use caution and regularly monitor serum potassium.

    Related to indapamide:

    Water and electrolyte balance:

    Sodium concentration:

    It is necessary to check these parameters before starting treatment, then conduct periodic tests.

    Reducing the level of sodium may start asymptomatic and thus regular checking this parameter is particularly important.

    Checking should be conducted more often in the elderly and cirrhosis patients. Any treatment with diuretics can cause blood hyponatremia, sometimes very serious consequences.

    Hypoglyc sodium with a decrease in blood volume can lead to dehydration and vertical hypotension. Simultaneously lost chloride ions can lead to secondary metabolic alkaline infections: the incidence and the degree of this effect are light.

    Potassium concentration:

    Hypotension is the main risk when taking thiazide diuretics and diuretics related to the Thiazide group.

    It is necessary to prevent the risk of reducing the concentration of potassium potassium (

    In those cases, reduced blood potassium levels will increase cardiotoxicity of the heart glycoside and the risk of arrhythmia.

    Patients with long QT are also at risk, although the cause is congenital or due to treatment. Hypotension with slow heartbeat will increase the risk of serious arrhythmia, especially the risk of torsion, which can lead to death.

    In all cases, it is necessary to regularly check the concentration of potassium potassium. The first blood potassium should be conducted in the first week of treatment. If the concentration of low blood potassium needs to be adjusted.

    Calcium concentration: Thiazide diuretics and related to the thiazide group can reduce calcium secretion in the urinary tract, causing slight increase and airy blood calcium concentration. A significant increase in calcium concentration may be associated with unprocessed hyperpointed gland hyperplasia. In that case, it is necessary to stop taking the drug before checking the parathyroid function.

    Blood glucose: Control of blood glucose is important in diabetes patients, especially when potassium concentration is low.

    Uric acid: Patients with high blood uric acid levels will tend to get gout.

    Kidney function and diuretics:

    Thiazide diuretics and related to the Thiazide group only promote the entire efficiency when the normal kidney function or only mild renal failure (creatinine concentration is about 25mg/l lower, meaning 220 µmol/l in adults). In the elderly, plasma creatinine values ​​should be adjusted according to the age, weight and gender of the patient, according to Cockroft formula:

    CLCR = (140 - Age) x Weight/0.814 x Plasma creatinine concentration.

    In which: age (year), weight (kg), plasma creatinine levels (micromol/l).

    This formula is suitable for elderly male patients, in female patients who need to be caused by 0.85.

    Dehydration and sodium due to diuretics at the beginning of treatment may cause a decrease in circulatory volume, leading to a reduction in glomerular filtration volume. This causes hyper urea and hypertreatinin. This temporary influence on the renal function does not cause complications in patients with normal renal function, but can be worse in patients who have previously suffered from kidney failure.

    Athletes:

    Athletes should be noted that this product contains components that can cause positive results for doping tests.

    Nearly -sagged myopia and secondary closed angle:

    sulfonamide, or sulfonamide conductor can cause a specific reaction that leads to an open myopia and a closed angle of glaucoma. If not treated with acute angle glaucoma can lead to permanent vision loss. The main treatment is to stop taking the medicine as quickly as possible. It may be necessary to consider medical treatment or fast surgery if the intraocular pressure is still not controlled. Risk factors for progression of acute angle glaucoma may include a history of allergies to sulfonamide or penicillin.

    The ability to drive and operate machinery

    both active ingredients and Coversyl Plus 10/2.5 do not affect alertness, but there are some side effects related to the phenomenon of reducing blood pressure may occur in some patients. In this case, the ability to drive and operate machinery will be affected.

    Pregnancy

    With the proven effects of each component in this combination of pregnant women, it is not recommended to use Coversyl Plus 10/2.5 in the first three months of pregnancy. Contraindications use Coversyl Plus 10/2.5 from the fourth month onwards of pregnancy.

    Related to Perindopril:

    It is not recommended to use enzyme inhibitors in the first three months of pregnancy. The use of enzyme inhibitors is contraindicated from the fourth month of pregnancy.

    Epidemiological evidence about the risk of teratogenicity when taking enzyme inhibitors transferred during the first three months of pregnancy has not been determined; However, it is not possible to rule out the possibility of this risk increasing. Unless the use of enzyme inhibitors is very important, female patients who have a plan to become pregnant should turn to alternative therapy have evidence of safety to treat hypertension in pregnant women. When pregnant, the treatment with an enzyme inhibitor should be stopped immediately, and, if possible, should start an alternative therapy.

    The use of enzyme inhibitors from the third month of pregnancy is thought to be toxic to the fetus (reducing kidney function, less amniotic fluid, slowdown development of skull frame) and toxicity on infants (kidney failure, hypertension, hyperkalemia).

    In case of pregnant women from the fourth month onwards, there is an enzyme inhibitor, recommend that patients with ultrasound test kidney function and skull test.

    Babies whose mothers use the transferred enzyme inhibitors should be closely monitored to avoid hypotension.

    Related to indapamide:

    No or data restriction (results with

    Animal studies do not show direct or indirect effects related to reproductive toxicity.

    As a preventive measure, it is best to avoid using indapamide during pregnancy.

    Lactating period

    Contraindications to use Coversyl Plus 10/2.5 when breastfeeding. On the basis of considering the importance of this treatment on the mother, it is necessary to decide to stop breastfeeding or stop taking Coversyl Plus.

    Related to Perindopril

    Due to the lack of information about the use of Perindopril during breastfeeding, Perindopril is not recommended for use and should use alternative therapy with evidence of safety in breastfeeding women, especially for newborn or premature babies.

    Related to indapamide

    There is a lack of data on the excretion of indapamide/metabolites through breast milk. Hypersensitivity to drugs is the substance of sulfonamide and hypokalemia may occur. The risk for newborn/newborns has not been excluded.

    Indapamide is closely related to the thiazide diuretic, this group has the ability to reduce or even stop milking if used during breastfeeding. Contraindications to use indapamide during breastfeeding.

    Drug interactions

    together with perindopril and indapamide:

    Simultaneous use is not recommended:

    Lithi: Increased serum and toxic lithium recovery has been reported when used simultaneously lithium with enzyme inhibitors. Using Perindopril in combination with indapamide and lithium is not recommended, but if this combination is necessary, careful monitoring of serum lithium concentrations.

    Use simultaneously requires special caution:

    baclofen: Increased anti -hypertension effect. Need to control blood pressure and adjust the dose of anti -hypertension if necessary.

    Non-steroid anti-inflammatory drugs (including aspirin ≥ 3 g/day): When using the enzyme inhibitors con the matter, the enzyme inhibitors are transferred to nonsteroidal anti-inflammatory drugs (for example, acetylsalicylic acid in anti-inflammatory doses, COX-2 inhibitors and non-selective steroid anti-inflammatory drugs), a decrease in anti-hypertension. Concentrated use of nonsteroidal enzyme and nonsteroidal anti -inflammatory drugs may increase the risk of renal function, including acute renal impairment, and increase serum potassium levels, especially in patients who had previously had poor kidney function. This combination needs to be used carefully, especially in the elderly.

    Patients need to be fully rehydrated and should monitor the kidney function after initiating and periodically.

    Use Caution Causes:

    Antidepressants like imipramine (three -round antidepressants), neurony drugs: Increasing anti -hypertension effect and increasing the risk of lower posture (additional effect).

    Related to Perindopril:

    Clinical research data has shown the double-analotensin-aldosterone (RAAS) lenses by using a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors that are more frequently involved in adverse disadvantages such as hypotension, hyperpassia and kidney function (including renal impairment) when comparison with the use of impact drugs on the system. Raas.

    Medications that increase blood potassium: Some drugs or therapy may increase the ability to increase blood potassium: Aliskiren, potassium salts, potassium diuretics, transferred enzyme inhibitors, Angiotensin II, Heparin, immunosuppressant drugs such as Ciclosporin or Tacrolimus, Trimethoprim. The combination of these drugs increases the risk of hyperkalemia.

    Contraindicated when using simultaneously:

    Aliskiren: In patients with diabetes or kidney failure, increased the risk of hyperkalemia, worsen kidney disease and cardiovascular disease and increase in death.

    Extracent body treatment: The body's treatment leads to blood exposure to negative charged surfaces such as a juris or dialysis with certain high -speed filters (such as polyacrylonitril film) and removal of low density lipoprotein with dextran sulphate due to increased risk of sensitivity. If this treatment is required, it is necessary to consider using another type of filter or another anti -hypertension drug.

    Sacubitril/Valsartan: Concomitant use of Perindopril with Sacubitril/Valsartan is contraindicated due to the coordination of Neprilysin inhibitors (NEP) and transferred enzyme inhibitors that can increase the risk of angioed. Sacubitril/Valsartan is only started to use 36 hours after Perindopril's last dose. Perindopril therapy only starts 36 hours after the last dose of Sacubitril/Valsartan.

    Simultaneous use is not recommended:

    Aliskiren: In patients without diabetes or kidney failure, the risk of hyperkalemia, impaired renal and cardiovascular disease and increased death.

    Simultaneous treatment with an angiotensin transferred and receptor blocker inhibitors: There is a report in the medical doctrine of patients with atherosclerosis, heart failure, or diabetes with target organs, treating an enzyme inhibitor and an angiotensin receptor blocker is associated with higher frequency of blood pressure, impairment, impairment, impairment. granting) when compared to the use of solo impact on the Renin-Anotensin-Losterone system.

    Dual blockade (for example, by combining an enzyme inhibitor transferred with an Angiotensin II receptor antagonist), it is limited to specific cases in combination with strict monitoring of kidney function, potassium, and blood pressure level.

    estramustine: The risk of increasing unwanted effects such as angioedema.

    co-trimoxazole (trimethoprim/sulfamethoxazole): patients use co-trimoxazole simultaneously (trimethoprim/sulfamethoxazole) may increase the risk of hyperpass potassium.

    Potassium diuretic (eg triamterene, amiloride ...), potassium (salt form): increased blood potassium concentration (likely to lead to death), especially for patients with renal impairment (the effect of hyperkalemia). Simultaneous use of Perindopril with the above drugs is not recommended. If indicated to use simultaneously, be cautious and regularly check the serum potassium level. For using spironolactone to treat heart failure, see the "use simultaneously requires special caution".

    Special use of the Causes Special Causes:

    Drugs for diabetes (insulin, oral hypoglycemic drugs): Epidemiological studies have shown simultaneous use of enzyme inhibitors and diabetic medications (insulin, oral hypoglycemic drugs) that can increase the hypoglycemic effect of the drug, leading to the risk of hypoglycemia. This hypoglycemic phenomenon is more likely to occur in the first weeks of combined treatment and in patients with renal failure.

    Diuretics do not keep potassium: In patients who are taking diuretics, and especially in patients with volume reduced and/or salt, they may be excessive blood pressure after starting treatment with enzyme inhibitors. Hypotension effects that are likely to be reduced when stopping treatment with diuretics, increasing volume or amount of salt, need to start treatment at low dose Perindopril and increase the dose slowly.

    With artery hypertension, previous diuretic treatment can cause salt/volume reduction, or have to stop diuretics before starting treatment with transferred enzyme inhibitors, in this case, a diuretic that does not keep potassium can be used later, or an enzyme inhibitor must be started in low doses and increase the dose slowly.

    With congestive heart failure treated with diuretics, enzyme inhibitors should be started in very low doses, then can reduce the dose of non -potassium diuretics.

    For all cases, renal function (creatinine concentration) must be monitored for the first few weeks of treatment with enzyme inhibitors.

    Potassium -keeping diuretics (Eplerenone, Spironolactone): Eplerenone or Spironolactone at a dose of 12.5 mg to 50 mg daily and enzyme inhibitors in low doses:

    In the treatment of heart failure II-IV (NYHA) with blood emulses

    Before starting combined treatment, checking the appearance of hyperkalemia and kidney failure.

    Advise to closely monitor blood potassium and blood creatinine once a week in the first month of treatment and then each month.

    racecadotril: Enzyme inhibitors (such as perindopril) are known to cause angioedema. This risk can be increased when used simultaneously with racecadotril (a drug used to treat acute diarrhea).

    MTor inhibitors (such as syrolimus, Everolimus, temsirolimus): Patients treated simultaneously with MTOR inhibitors may increase the risk of angioed.

    Use Caution Causes:

    Hemotrogate medications and vasodilators: Concomitance with these drugs may increase the hypotension effect of Perindopril. Simultaneous use with nitroglycerin and other nitrates, or other vasodilators, can lower blood pressure.

    allopurinol, cell medication or immunosuppressant drug, corticosteroids for systemic effects or processes: simultaneously used with transferred enzyme inhibitors can increase the risk of leukopenia.

    Anesthesia: Enzyme inhibitors can increase the hypotension effect of anesthesia.

    Gliptin (linagliptin, saxagliptin, sitagliptin, vildagliptin): increased the risk of angioedema, due to dipeptidyl peptidase IV (DPP-IV) reduced activity due to gliptin in patients treated simultaneously with an enzyme inhibitor.

    Sympathetic stimulants: Sympathetic stimulants can reduce the hypotension effects of enzyme inhibitors.

    Gold: Nitrioid reaction (symptoms including blushing, nausea, vomiting and hypotension) are rare reported in patients being treated simultaneously injected (sodium aurothiomalate) and enzyme inhibitors including Perindopril.

    Related to indapamide:

    Special use of the Causes Special Causes:

    Twisted drugs: Due to the risk of hematuria, indapamide should be used carefully when combined with torsion -causing drugs such as IA anti -arrhythmic drugs (quinidine, hydroquinidine, disopyramide); anti -arrhyths type III (amiodarone, dofetilide, ibutilide, bretylium, sotalol); A few neuroleptic drugs (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, raypride), butyrophenones (droperidol, haloperidol), other nervous drugs (pimozide); Other substances such as Bepridil, Cisapride, Diphemanil, Erythromycin intravenously, Halofantrine, Mizolastine, Moxifloxacin, Pentamidine, Sparfloxacin, Vincamine intravenously, Methadone, Astemizole, Terfenadine. Preventive to lower potassium and adjust if necessary: ​​Monitor the QT interval.

    Potassium -lowering drugs: amphotericin B (intravenous line), glucocorticoid and mineralocorticoid (systemic sugar), tetracosactide, laxatives have a stimulating effect: increase the risk of hypoglycemia (combined effect). Monitor potassium concentration, and adjust if necessary, especially need to consider in cases of treatment with digitalis. Laxatives have a stimulating effect not to be used.

    Digitalis preparations: Low potassium concentration increases the toxicity of digitalis. Potassium and electrocardiogram concentration should be monitored and reviewed if necessary.

    Allopurinol: Concentrated use with indapamid may increase sensitive reactions to allopurinol.

    Use Caution Causes:

    Potassium diuretics (amiloride, spironolactone, triamterene): while this combination is useful for some patients, hypokalemia or hyperkalemia can still occur (especially in patients with kidney or diabetes). Need to control plasma potassium and electrocardiograms, if necessary, review the treatment.

    metformin: Lactic acid contamination caused by metformin caused by renal failure is associated with diuretics and especially diuretics. Do not use metformin when serum creatinine levels exceed 15 mg/l (135 micromol/l) in men and 12 mg/l (110 micromol/l) in women.

    Iodine -containing contrast drugs: In case of dehydration due to diuretic, increased risk of acute renal failure, especially when taking high doses of contrast drugs containing iodine. Water compensation should be done before using contrast drugs containing iodine.

    Calcium (salt form): The risk of increasing calcium concentration due to decline in calcium elimination through urine.

    ciclosporin, tacrolimus: The risk of increased creatinin levels does not change the level of circulation ciclosporin levels, even without salt and water decline.

    Corticosteroids, tetracosactide (body -acting orally): Reducing the effect of lowering blood pressure (salt stasis and water caused by corticosteroids).

    Storage

    Close the vial to avoid moisture. Store at temperatures below 30 ° C.

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