Triplixamamamamamamamamamamamamamham medicine/10mg Servier Treatment of hypertension (30 tablets)

indapamid is a sulfonamid derivative with an indol core, related to pharmacological with thiazid diuretics. Indomamid inhibits the reabsorption of sodium in 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 magnesium, thus increasing the secretion of urine and has the effect of lowering blood pressure.

amlodipin

Amlodipin is a calcium channel blocker of the dihydropyridine group (slow channel blockers or calcium ions) and inhibits the diagonal calcium that penetrates the membrane into the heart muscle and blood vessel muscle.

Amlodipine's hypotension mechanism is due to the effect of direct relaxation of blood vessel smooth muscles. The exact mechanism of relief of amlodipine angina has not been completely determined but Amlodipine reduces the whole burden of ischemic by the following two effects:

Amlodipin relaxes peripheral arteries and thereby reduces the total peripheral resistance (post -burden), opposite the activity of the heart. When the heart rate maintains stable, this impact of reducing the heart reduces energy consumption and reduces the oxygen needs of the heart muscle.

The mechanism of action of amlodipine may also be associated with coronary artery dilatation and coronary artery, both normal and ischemic.

This vasodilation increases oxygen supply to the heart muscle in patients with coronary artery spasms (Prinzmetal syndrome or angina forms).

In patients with hypertension, using amlodipine once a day shows a significant decrease in clinical blood pressure in both lying and standing positions during 24 hours. Due to the slow onset, amlodipine is taken orally does not cause acute hypotension.

Amlodipin is not related to any adverse reactions on metabolic or lipid changes in plasma and drugs are used for patients with bronchial asthma, diabetes and gout.

perindopril/indapamid

In patients with age -related hypertension, the combination of perindopril/indapamid creates hypotension effect dependent on the dosage on diastolic blood pressure and centrifugal blood pressure to collect both lying position and standing position. In clinical trials, drink simultaneously Perindopril and Indopamid to create an effective synergistic effect compared to taking each separate medicine.

pharmacokinetics

triplixam

Take PCRIndoprililililililination and Amlodipin without changing the pharmacokinetic properties compared to each part of each component.

perindopril

absorption and bioavailability:

After oral use, Perindopril is quickly absorbed and the peak concentration is within 1 hour (Prindopril is the precursor and Perindoprilat is active metabolites).

Peridopril's plasma sale time is 1 hour. Foods reduces convert into Perindoprilat, so to ensure bioavailability, drink Perindopril arginin once a day in the morning before meals.

Distribution:

Perindoprilat distribution volume is about 0.2 l/kg.

Perindoprilat's linkage ratio with plasma proteins is 20%, mainly with angiotensin transition enzymes, but the ratio of the bond depends on the dose.

Biological metabolism:

Perindopril is a medication. 27% of Perindopril oral dose absorbed into the general circulation in the form of metabolites with Perindoprilat activity. Besides Perindoprilat is active, Perindopril also converts into 5 non -activity metabolites.

Peak peak concentration of Perindoprilat is achieved within 3 to 4 hours.

Era:

Perindoprilat is eliminated through the urine and the semi -discharged time of the free form is about 17 hours, reaching a stable state within 4 days.

Linear/non -linear:

The correlation between Perindopril's dose and the total amount of drugs in plasma has been proven to be linear.

Special patient population:

Elderly: Eliminating Perindoprilat decreases in the elderly, similar to patients with heart failure and kidney failure.

Patients with renal failure: The dose adjustment in patients with renal impairment may consider depending on the degree of renal failure (creatinine clearance).

In case of hemolysis; The clearance of Perindoprilate is 70 ml/min.

Perindopril's mugger: Perindopril's pharmacokinetics are changed, the liver clearance of tamarind drugs is half reduced. However, the amount of Perindoprilat is not reduced, so there is no need to adjust the dose.

indapamid

absorption:

indapamid is absorbed quickly and completely through the gastrointestinal tract.

Peak concentration in plasma is achieved in people about an hour after taking the medicine.

Distribution:

The ratio of binding with plasma proteins is 79%.

Metabolism and elimination:

Sell waste time ranges from 14 and 24 hours (an average of 18 hours). Use repeated dose does not cause accumulation of drugs.

Elimination mainly through urine (70 % of oral dose) and feces (22 %) in the form of non -activity metabolites.

Special patient population:

Pharmacokinetics does not change in patients with renal failure.

amlodipin

absorption and bioavailability:

After drinking at the level of treatment, Amlodipin is well absorbed with a peak concentration of 6-12 hours. Absolute bioavailability is about 64% and 80%.

Amlodipine's bioavailability is not affected by food.

Distribution:

The distribution volume is about 21L/kg. In vitro studies show that about 97.5% amlodipine in the blood binds to plasma proteins.

Metabolism:

Amlodipin is strongly metabolized in the liver into non -active metabolites with 10% of the parent and 60% of metabolites excreted in the urine.

Era:

Selling waste time from plasma is about 35-50 hours and therefore can be used one-time dosage a day.

Special patient population:

Use drugs for the elderly: Time to achieve the plasma concentration of amlodipine in the elderly is similar to young people. Amlodipine clearance tends to decrease with the results of increasing scope and the sale time in elderly patients.

Increased AUC and the time of selling excretion in patients with congested heart failure have been expected in research groups.

Using drugs in patients with liver function impairment: There is very little clinical data on the use of oral amlodipin in patients with liver failure.

Patients with hepatic impairment will reduce Amlodipine clearance, resulting in increasing the time of waste and increasing AUC by 40-60%.

Be cautious when using

All warnings related to each component, listed below, should be applied in the fixed dose coordination of TriplixamamamamamamamamamamamamamamamamammamamAM

Warning when using

lithium

Combining lithium with combination of perindopril/indapamid is usually not recommended.

Renin-Anotensin-Aldosteron (RAAS)

There has been evidence of simultaneous use of enzyme inhibitors-angiotensin-shaped, angiotensin II or Aliskiren receptor inhibitors that increase the risk of lowering blood pressure, hyperkalemia and impaired kidney function (including acute renal failure). Therefore, the Renin-Anotensin-Aldosteron double blockbasses by combining Angiotensin-shifting enzyme inhibitors with Angiotensin II receptor inhibitors (ARB) or Aliskiren are not recommended.

If the double closed maple therapy is really necessary, this treatment should only be performed under the supervision of health experts and patients should be closely monitored for kidney, electrolytes and blood pressure. Should not use the enzyme inhibitors in the form of angiotensin shifting and angiotensin II receptor inhibitors in patients with diabetes.

Potassium diuretics, potassium supplements or alternative salts contain potassium

Combining Perindopril with potassium diuretic, potassium supplements or replacement salts containing conventional potassium is not recommended.

Neutral leukemia/grain leukemia/thrombocytopenia/anemia

Neutral leukemia/grain leukemia, thrombocytopenia and anemia have been reported in patients using angiotensin -shaped enzyme inhibitors. In patients with normal renal function and no risk factors, neutrophils are rarely occurring.

Perindopril should be used with special caution in patients with glue -generating hematopathy, being treated with immunosuppressive drugs, being treated with Allopurinol or Procainamid, or the combination of these complex elements, especially if there has been impaired renal function before.

Some patients will develop severe infections, but in some cases, they do not respond to strong antibiotics. If Perindopril is used in these patients, the number of white blood cells should be checked periodically and the patient should be instructed on how to report the signs of infection (for example, sore throat, fever).

Hydromatically 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.

Hypersensitivity/eagles

Facility on the face, limb, lips, tongue, subjects and/or larynx have been reported rare in patients treated with angiotensin -shift enzyme inhibitors, including perindopril. This reaction may appear at any time during treatment.

In such cases, it is advisable to stop using Perindopril in time and start the appropriate monitoring process, continue until the symptoms appear completely retreat. During this period, the symptoms of facial swelling and lips are usually stopped without treatment, even if antihistamine drugs can effectively reduce symptoms.

Thiche related to the subject can be fatal. When symptoms of edema in the tongue, bar or larynx appear, it can lead to obstruction of the airway, appropriate measures including subcutaneous injection of Epinephrine 1: 1000 (0.3ml -0.5ml) and/ or or measures to ensure good airways should be applied promptly.

Black skin patients have been reported to have a higher rate of angioedema than other patients when using angiotensin -shifting enzyme inhibitors.

Patients with a history of angioedema are not related to the treatment of enzyme inhibitors that can increase the risk of angiotic angiotensin when using angiotensin -shifting enzyme inhibitors.

The gastrointestinal angioedema has been recognized as rare in patients treated with enzyme inhibitors in the form of angiotensin. These patients appear symptoms of abdominal pain (with or without nausea or vomiting); In some cases, there is no front appearance and C-1 esterase concentration is normal.

Tedematic diagnosis includes abdominal CT scan, or ultrasound, or surgery and loss of symptoms after stopping taking an angiotensin -shaped enzyme inhibitor. Differentiate diagnosis of the gastrointestinal angioedema in patients with an angiotensin enzyme inhibitors with abdominal pain.

Simultaneously used with MTor inhibitors (such as syrolimus, Everolimus, Temsirolimus)

Patients with simultaneous use with MTor inhibitors (such as syrolimus, Everolimus, temsirolimus) may increase the risk of angioedema (such as respiratory or tongue, with or without respiratory decline).

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.

Anaphylactic reactions in the sensitive process

Individual reports in patients who have experienced life -threatening anaphylaxis when using angiotensin -shifting enzyme inhibitors in the sensitivity process with the venom of some insects (bees, bees), inhibit the enzyme in the form of angiotensin should be used with caution in patients with allergens that have been treated with sensitivity, and avoid being used in patients with exclusive treatment patients.

However, these reactions can be prevented by temporarily stopping the enzyme inhibitors in the form of angiotensin within 24 hours before treating patients who need both angiotensin -shaped enzyme inhibitors and hypersensitivity.

Anaphylactic reactions in the process of filtering low density lipoprotein (LDL)

Anaphylactic reactions that are life -threatening are rarely seen in patients using angiotensin -shifting enzyme inhibitors in the process of filtering low density lipoprotein as dextran sulphate. These anaphylactic reactions can be avoided by temporarily stop taking enzyme inhibitors in the form of angiotensin before each filter

Patients with hemorrhage

Anaphylactic reaction has been reported in patients with high -speed filters (for example, An 69) is treated simultaneously with angiotensin -shaped enzyme inhibitors. In these patients, it is advisable to consider the use of other blood membranes or use other anti -hypertension drugs.

Increase Aldosterone Tien Phat

Patients with hypertrophy of primary aldosterone are generally not responding to anti-hypertension drugs that operate through inhibition of the renin-angiotensin system. Therefore the use of this drug is not recommended.

Pregnant women

Do not start using enzyme inhibitors in the form of angiotensin during pregnancy.

Unless it is necessary to continue treatment with enzyme inhibitors in the form of angiotensin, the patient intends to be pregnant, so it should be changed to treatment with other anti -hypertension drugs and the safety when used for pregnant women has been established.

When being diagnosed with pregnancy, it is advisable to stop taking the angiotensin -shifting enzyme inhibitors immediately and should start replacing treatment with another medication if appropriate.

Liver brain

When liver failure, thiazid diuretics and thiazid medications can cause liver's brain disease. Should stop diuretics immediately if this happens.

Sensitive to light

Cases of light sensitivity when using thiazid diuretics or thiazid varieties have been reported. If light -sensitive reactions occur during treatment, stop the drug. If the use of diuretics is really necessary, patients should avoid the skin in contact with sunlight or artificial UVA rays.

Precautions when using

Need to be very cautious when taking drugs for patients in the following cases:

kidney failure

In the case of severe renal failure (creatinine clearance

In medium renal impairment patients (Creatinine clearance In patients with hypertension without the previous kidney damage and blood examination to the kidneys shows that the renal function decreases, the treatment should be stopped and may start again at low doses or monomers.

In these patients medical monitoring include potassium and creatinine control, after 2 weeks of treatment and every 2 months during stable treatment. Renal failure is reported mainly in patients with severe heart failure or have a renal failure platform including kidney stenosis.

This drug is not recommended in the case of kidney artery narrowing on both sides or only one kidney function.

The risk of arterial hypotension and/or kidney failure (in case of heart failure, dehydration and electrolyte ...). The significant disorder of the renin-analiotensin-aldosteron system has been observed with Perindopril when dehydrated and clearly electrolyte (salt diet or prolonged diuretic treatment), in patients with low initial blood pressure, in case of kidney stenosis, congestor or cirrhosis with edema and ascites.

This system inhibitors with an enzyme inhibitor in the form of angiotensin can cause sudden hypotension and/or increase plasma creatinine levels, indicating impaired renal function, during the first time of treatment and in the first 2 weeks of treatment. In some cases, this becomes acute at the beginning, although rare, and onset at different times.

In these cases, treatment should be started in low doses and gradually increase the dose, in patients with heart anemia and cerebrovascular disease, excessive hypotension can cause myocardial infarction or stroke.

thiazid diuretics and thiazid diuretics are only completely effective when normal kidney function or slight decline (plasma creatinine levels below 25mg/l, meaning 220µmol/l in adults).

In the elderly, plasma creatinine levels should be adjusted according to age, weight and gender.

Decreased secondary blood volume caused by dehydration and salt caused by diuretic at the beginning of the treatment may cause reduced filtration of glomerular filtration. This can lead to increased blood urea and plasma creatinine. This transient kidney function decline does not cause consequences in individuals with normal renal function but it can worsen the impaired renal function.

Amlodipin can be used in patients with kidney failure in normal doses. Change plasma amlodipine concentration is not related to renal failure.

The effect of combining in Triplixamamamamamamamamamamamamamamamamhu -2.5mg/10mg has not been tested in patients with kidney abnormalities, in patients with renal failure, the dosage of triplixams should respect the doses of ingredients when oral oral.

Hypotension and dehydration and sodium

There is a surprising risk of hypotension when there is a previous sodium loss (especially in patients with kidney artery stenosis). Therefore, the whole body test should be conducted when there are clinical signs of dehydration and electrolytes, which may appear when diarrhea or vomiting. Regular monitoring of plasma electrolytes should be conducted in these patients.

Significant hypotension may need an isotonic intravenous line.

Hypotension is not contraindicated to continue the treatment. After re -establishing the volume of circulatory and blood pressure, treatment may start again or by reducing the dose or with only one ingredient.

Sodium concentration decline may have no initial symptoms, so regular testing should be conducted. Testing should be conducted more often in elderly patients and cirrhosis. Any treatment of diuretics can cause sodium loss, sometimes very serious consequences.

Hypoglycocytic hypoglycemia, accompanied by a decrease in blood volume may be the cause of dehydration and hypotension. The loss of chlorid ions can lead to metabolic alkali infection with secondary compensation: the frequency and level of this influence are light.

Potassium

The combination of indapamid with perindopril and amlodipine does not prevent hypokalemia triggers especially in diabetics or patients with renal impairment. Like all other antihypertensive drugs when coordinating with diuretics, plasma testing should be conducted.

Increasing plasma potassium has been observed in some patients who have been treated with angiotensin -shifting enzyme inhibitors, including Perindopril.

Risk factors that increase blood potassium include renal failure, reduced kidney function, age (> 70 years), diabetes, events that occur simultaneously, especially dehydration, acute cardiac loss, metabolic acidosis and simultaneous use with potassium -keeping drugs (such as spironolacton, eplerenon, triamteren or amilorid), supplements containing kolio and supplements containing salt; Or patients who use other drugs that increase serum potassium (e.g. heparin, co-trimoxazole is known as trimethoprim/sulfamethoxazole).

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. Hemoto hyperpasses can cause serious arrhythmia, sometimes 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.

Potassium loss and hematuria are the main risks of thiazid diuretics and thiazid diuretics. The risk of hypokalemia (

In this case, hypokalemia increases the heart toxicity of heart glycosides and the risk of arrhythmia.

Individuals with long QT distance are also at risk, whether due to congenital or drug use.

Hypotension, as well as a slow heart rate, is a factor leading to serious arrhythmia, especially twisted, which can be life -threatening.

Potassium control more frequently required in all the above cases. Plasma potassium measurement should be conducted in the first week after the beginning of treatment.

If the potassium level is detected, the adjustment is necessary.

calcium

thiazid diuretics and thiazid diuretics can reduce the amount of calcium excreted through urine and increase the amount of plasma calcium. Significant hypercalcemia may be because the thyroid gland has not been detected earlier. In this case, the treatment should be stopped before exploring the thyroid function.

Aortic hypertension

Treatment of kidney hypertension is rejuvenation. However, the angiotensin -shaped enzyme inhibitors may work in patients with hypertension of the kidneys that are waiting for surgery or cannot be surgery.

If Triplixamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamamist is prescribed for patients who have known or suspected kidney stenosis, treatment should be started in the hospital with monitoring of kidney and potassium function, because some patients will have renal failure recovered when stopped treatment.

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Dynamic atherosclerosis

The risk of hypotension may occur in all patients but pay special attention to patients with myocardial oral hypotension or cerebral circulatory diseases, with low -dose treatment.

acute hypertension

The efficiency and safety of amlodipine in acute hypertension patients have not been established.

Heart failure/heart failure

Patients with heart failure should be treated with care.

In a long-term study, compared to placebo in patients with severe heart failure (LLL-IV), pulmonary side effects are reported higher in the amlodipine group when compared to the placebo group. Calcium channel blockers, including amlodipine, should be used with carefulness in patients with congestive heart failure, as they can increase cardiovascular and death.

thiazid diuretics and thiazid diuretics can reduce the amount of calcium excreted through urine and increase the amount of plasma calcium. Significant hypercalcemia may be because the thyroid gland has not been detected earlier. In this case, the treatment should be stopped before exploring the thyroid function.

In patients with severe heart failure (degree IV), treatment should be started under medical monitoring and reduced the dose of arising. Beta blockers should not be stopped in patients with hypertension with coronary artery disease: A combination of enzyme inhibitors should inhibit the angiotensin -shaped enzyme with beta blockers.

Master stenosis and mitral valve/ hypertrophic heart muscle

Angiotensin -shifting enzyme inhibitors should be used cautiously when used for patients with blood clogged out of the left ventricle.

Diabeten patient

In diabetes patients with insulin dependent (spontaneous trend of increased potassium), treatment should be started under medical supervision and with low doses. Hemorrhage levels should be closely monitored in previous diabetics who have been treated with oral or insulin diabetes, especially in the first month when treated with angiotensin -shaped enzyme inhibitors.

Sugar control is important for diabetics, especially when the potassium level is low.

Race

Similar to other angiotensin -shaped enzyme inhibitors, Perindopril's hypotension can be less efficient in black skin patients, which may be due to low ratio of lenin activity in hypertension patients with higher blood pressure.

surgery/anesthesia

Very rarely, angiotensin -shaped enzyme inhibitors can cause hypotension in case of anesthesia, especially when anesthetic is likely to lower blood pressure.

Therefore, the treatment of angiotensin -shifting enzyme inhibitors has a long -lasting effect like Perindopril is recommended to stop before surgery about a day.

Hepatic failure

Very rarely, the angiotensin -shifting enzyme inhibitors related to the syndrome begins to evidence of cholestasis jaundice and progresses into violent and (sometimes) deaths. The mechanism of this syndrome is not well understood. Patients using angiotensin -shifting enzyme inhibitors are increased and significantly increased liver enzyme, so they stop using angiotensin -shaped enzyme inhibitors and need appropriate medical monitoring.

Amlodipine's waste time is prolonged and higher AUC value in patients with impaired liver function; The dose recommendations have not been set. Therefore amlodipine should be started at low doses with carefulness, both when the arising as well as when increasing the dose. The slow and strict dose adjustment may be required in patients with severe liver failure. The effect of combining in Triplixam 10mg/2.5mg/10mg has not been tested in patients with liver failure. Regarding the effectiveness of each component in this combination, Triplixamamamamamamamamamamamamamamamamamamamamamamamamamamity/10mg is contraindicated in patients with severe liver failure, and cautious for patients with mild to medium liver failure.

Uric acid

The trend of gout can increase in patients with increased blood uric acid.

Elderly

Should check the kidney function and potassium level before starting treatment.

The first dose needs to be adjusted according to the response of the blood pressure level, especially in cases of dehydration and electrolytes to avoid the outset of sudden hypotension.

In older patients should be cautious in increasing the dose of amlodipine.

Drug interaction

Clinical data indicates that the double-renotensin-aldosteron closing system by combining Angiotensin-shifting enzyme inhibitors, Angiotensin II or Aliskiren receptor blockers associated with higher frequency of adverse events such as blood pressure, hyperkemotic hyperkemia and impairment of kidney function (including acute impairment) A Renin-Anotensin-Aldosteron inhibitor.

Hematopathy

A few medications or therapy therapy may increase blood potassium: Aliskiren, potassium salt, potassium diuretic, angiotensin -shaped enzyme inhibitors, angiotensin II (ARB), non -steroidal anti -inflammatory drugs, heparin, immunosuppressants such as Ciclosporin or Tacrolimus, Trimethoprim. The combination of these drugs increases the risk of hyperkalemia.

Combining combinations

Aliskiren: In diabetics or kidney failure, increased risk of hyperkalemia, worsen nephrotic disease and increase the risk of cardiovascular disease and death.

Unreasonable coordination