Indapamide, Perindopril | Indapamide / Perindopril-Teva tablets coated. 0.625 mg + 2.5 mg 30 pcs.
Special Price
$18.43
Regular Price
$27.00
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SKU
BID604869
Release form
Tablets, film-coated
Tablets, film-coated
Release form
Tablets, film-coated
Pharmacological action of
armacodynamics. Perindopril / Indapamide-Teva is a combination of an ACE inhibitor perindopril tosylate and an indapamide sulfonamide diuretic. The pharmacological effect of the drug is due to the properties of each component (perindopril and indapamide) and their additive synergism.
The pharmacological mechanism of action of the drug is the additive synergistic effect of two antihypertensive components.
Perindopril / Indapamide-Teva reduces systolic and diastolic pressure in patients with hypertension of any age who are both in the supine position and in the standing position. The antihypertensive effect of the drug depends on the dose and lasts 24 hours. A decrease in blood pressure is achieved in less than 1 month without the occurrence of tachyphylaxis, discontinuation of treatment does not cause withdrawal. Proven that the simultaneous administration of perindopril and indapamide has a hypotensive effect of synergistic origin, which is the result of individual effects of the components of the drug.
Perindopril is an ACE inhibitor that converts angiotensin I to angiotensin II (a vasoconstrictor substance), stimulates the secretion of aldosterone by the adrenal cortex and the breakdown of bradykinin (a vasodilating substance) to inactive heptapeptides.
ACE inhibition leads to: a decrease in the secretion of aldosterone
an increase in plasma renin activity, while aldosterone does not adversely affect
a decrease in OPSS due to the predominant effect on the vessels of the muscles and kidneys. In this case, there is no delay in water and salts and reflex tachycardia with prolonged treatment.
Perindopril also reduces blood pressure in patients with normal and low plasma renin levels.
Perindopril acts through its active metabolite, perindoprilat. Other metabolites are inactive.
Perindopril reduces the load on the heart through: a vasodilator effect on the veins (possibly due to changes in the metabolism of prostaglandins): decreased preload
decreased OPSS: decreased afterload on the heart.
In numerous studies involving patients with heart failure, it has been shown that the use of perindopril leads to: a decrease in the filling pressure of the left and right ventricles
, a decrease in the heart rate of
, an increase in cardiac output and optimization of the cardiac index
increase in blood flow in the myocardium.
Significantly improved performance tests with physical activity.
Characterization of the antihypertensive effect of perindopril
Perindopril effectively reduces blood pressure for all degrees of hypertension: mild, moderate and severe decrease in systolic and diastolic blood pressure is observed both in the supine position and in the standing position.
The maximum antihypertensive effect develops 4-6 hours after a single dose and lasts more than a day.
Perindopril has a high level of final blocking of an ACE inhibitor - approximately 80% 24 hours after administration.
In patients who responded to treatment, normalization of blood pressure occurs within a month and persists without the occurrence of tachyphylaxis.
Perindopril has vasodilating properties, restores the elasticity of large arteries, corrects histomorphometric changes in arterial resistance and reduces left ventricular hypertrophy. Adding, if necessary, a thiazide diuretic leads to additional synergism.
The combination of an ACE inhibitor and a thiazide diuretic reduces the risk of hypokalemia that may occur when a diuretic is prescribed as monotherapy.
Indapamide is a sulfonamide diuretic with an indole ring, which is pharmacologically related to thiazide diuretics. Indapamide inhibits sodium reabsorption in the cortical segment of the kidney. This increases the excretion of sodium and chloride with urine and, to a lesser extent, excretion of potassium and magnesium, thus increasing diuresis. This mechanism provides a hypotensive effect with a slight diuretic effect.
Characterization of the antihypertensive effect of indapamide
The antihypertensive effect of indapamide during monotherapy lasts 24 hours and is associated with an improvement in arterial elasticity and a decrease in arteriole resistance and OPSS. Indapamide reduces left ventricular hypertrophy.
When the recommended dose is exceeded, the therapeutic effect of thiazides and thiazide-like diuretics does not increase, while the number of side effects increases. If the treatment is not effective enough, increasing the dose is not recommended.
Indapamide has not been shown to affect lipid metabolism (TG, LDL cholesterol and HDL cholesterol) and carbohydrates, even in patients with hypertension and diabetes mellitus.
Pharmacokinetics. The pharmacokinetic parameters of perindopril and indapamide as part of the drug Perindopril / Indapamide-Teva do not differ from those of perindopril and indapamide as single drugs.
Perindopril. After taking perindopril, it is rapidly absorbed and Cmax is reached after 1 h. T perindopril from plasma is 1 hour.
Perindopril is a prodrug. 27% of the accepted dose of perindopril enters the bloodstream as an active metabolite of perindopril. In addition to active perindoprilat, perindopril forms another 5 inactive metabolites. Cmax of perindoprilat in blood plasma is reached in 3-4 hours. Since eating reduces the conversion of perindopril to perindoprilat and, consequently, its bioavailability decreases, it is recommended to take perindopril orally in a single dose in the morning before meals. There is a linear relationship between the dose of perindopril and its concentration in blood plasma.
The volume of distribution of unbound perindoprilat is approximately 0.2 l / kg. The binding of perindoprilat to plasma proteins is 20%, mainly from ACE, but is dose-dependent. Perindoprilat is excreted in the urine, and T unbound perindoprilat is approximately 17 hours. The equilibrium state is reached after 4 days.
Perindoprilat excretion is reduced in elderly patients and those with heart or kidney failure. For patients with renal failure, the dose should be adapted depending on the degree of impaired renal function (creatinine clearance). The dialysis clearance of perindoprilat is 70 ml / min.
The kinetics of perindopril changes in patients with cirrhosis: the hepatic clearance of the main molecule is halved. However, the amount of perindoprilat formed does not decrease. Therefore, such patients do not need to select a dose (see APPLICATION and SPECIAL INSTRUCTIONS).
indapamide. Indapamide is rapidly and completely absorbed in the digestive tract. Cmax in plasma is reached 1 hour after oral administration. Plasma protein binding - 79%. T is 14-24 hours (an average of 18 hours). With the regular use of cumulation does not occur.
Indapamide is excreted in urine (70% of the dose) and feces (22%) as inactive metabolites.
In patients with renal failure, pharmacokinetic parameters do not change.
Indications
Sensitive hypertension.
Contraindications
for perindopril: hypersensitivity to perindopril or to any other ACE inhibitors, angioedema (Quincke's edema) in the history associated with previous treatment with ACE inhibitors, congenital or idiopathic angioedema, pregnancy or its planning.
For indapamide: hypersensitivity to indapamide or any other sulfonamide preparations, severe renal failure (creatinine clearance For Perindopril / Indapamide-Teva: hypersensitivity to the drug components.
Due to the lack of sufficient clinical experience, Perindopril / Indapamide-Teva should not be used hemodialysis patients and patients with untreated decompensated cardiac insufficiency
Special instructions
special warnings, common for perindopril and indapamide
When using a low-dose combination (Perindopril / Indapamide-Teva, tablets 2.5 mg / 0.625 mg), there was no significant reduction in the frequency of adverse reactions compared with the use of each of the components of the drug in the minimum approved doses, except for hypokalemia. An increased frequency of idiosyncratic reactions cannot be ruled out if the patient simultaneously takes 2 new antihypertensive drugs for him. To minimize the risk, it is necessary to carefully monitor the patient's condition.
lithium. The simultaneous use of lithium and a combination of perindopril / indapamide is usually not recommended.
Special warnings regarding perindopril
Neutropenia / agranulocytosis. Among patients using ACE inhibitors, there have been cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and in the absence of other risk factors, neutropenia occurs rarely. Perindopril should be prescribed very carefully to patients with collagenoses, during therapy with immunosuppressants, allopurinol or procainamide, or with a combination of these aggravating factors, especially in the presence of impaired renal function. Some of these patients have developed serious infectious diseases, in several 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, and patients should be aware that any manifestation of an infectious disease (sore throat, fever) must be reported to the doctor.
Hypersensitivity / angioedema. Rare cases of angioedema of the face, limbs, lips, tongue, glottis and / or larynx in patients with ACE inhibitors, including perindopril, have been reported. This can happen at any time during the treatment period. In such cases, it is urgent to stop taking the drug and establish the necessary control over the patient's condition until the symptoms disappear completely. In cases where edema spreads only in the area of ​​the face and lips, the patient's condition usually improves without treatment, although antihistamines reduce the severity of symptoms.
Angioneurotic edema associated with laryngeal edema can be fatal. In cases where the swelling extends to the tongue, glottis or larynx, which can lead to airway obstruction, urgent emergency treatment is necessary, which may include sc administration of epinephrine solution 1: 1000 (0.3-0.5 ml) and / or airway patency.
It has been reported that in patients of the Negroid race ACE inhibitors are more likely to cause angioedema compared with other races.
Patients with a history of angioedema that were not associated with ACE inhibitors may have an increased risk of angioedema while taking ACE inhibitors.
Rare cases of intestinal angioedema have been reported in patients treated with ACE inhibitors. In such patients, abdominal pain was noted (with or without nausea and vomiting), some cases of intestinal angioedema were not accompanied by a manifestation of previous angioedema of the face, and the level of C1 esterase was normal. The diagnosis of intestinal angioedema was established using computed tomography, ultrasound, or during surgery. After the withdrawal of the ACE inhibitor, the symptoms of angioedema disappeared. In case of abdominal pain in patients using ACE inhibitors, differential diagnosis should be made and intestinal angioedema should be excluded.
Anaphylactoid reactions during desensitizing therapy. Isolated cases of prolonged life-threatening anaphylactoid reactions have been reported in patients used ACE inhibitors during desensitizing therapy with preparations containing bee venom. ACE inhibitors should be used with caution in patients with allergies after desensitization and to avoid their appointment during immunotherapy with preparations containing bee venom. However, in patients requiring both ACE inhibitors and desensitization, such reactions can be avoided by temporarily discontinuing the use of an ACE inhibitor at least 24 hours before desensitization.
Anaphylactoid reactions during plasmapheresis of LDL. Rarely, in patients taking ACE inhibitors, during life-threatening anaphylactoid reactions, the development of which can be avoided, has been reported during plasmapheresis of LDL using dextransulfate. if before each plasmapheresis treatment is temporarily discontinued treatment with ACE inhibitors.
Patients on hemodialysis. Cases of anaphylactoid reactions have been reported in patients taking ACE inhibitors while on hemodialysis using high-flow polyacrylic membranes (e.g. AN 69В®). Such patients should use a different type of dialysis membrane or prescribe a different class of antihypertensive drugs.
Patients after kidney transplantation. There is no experience with prescribing perindopril tosylate to patients after a recent kidney transplant operation.
Potassium-sparing diuretics, potassium salts. The combination of perindopril with potassium-sparing diuretics, potassium salts is usually not recommended.
Arterial hypotension in patients with symptomatic heart failure and concomitant renal failure or without it. The occurrence of symptomatic arterial hypotension is most likely in patients with a more severe degree of heart failure, taking high doses of loop diuretics, with hyponatremia or renal failure of a functional nature. To reduce the risk of symptomatic arterial hypotension at the beginning of therapy and at the stage of dose selection, patients should be closely monitored by a doctor. The same warnings exist for patients with coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can cause myocardial infarction or stroke.
ischemic heart disease. When, if during the first month of treatment with perindopril an episode of unstable angina pectoris (of any severity) occurred, the benefit / risk ratio should be carefully weighed before deciding whether to continue therapy.
Special warnings regarding indapamide
In patients with impaired liver function, the use of thiazide and thiazide-like diuretics can cause hepatic encephalopathy. In this case, the use of diuretics should be stopped immediately.
Photosensitivity. Cases of photosensitization reactions have been reported in patients using thiazide and thiazide-like diuretics. If such reactions occur, it is recommended to discontinue treatment with diuretics. If there is a need to prescribe diuretics again, it is recommended to protect vulnerable areas from the sun or from sources of artificial ultraviolet radiation.
Precautions common to perindopril and indapamide
Impaired renal function. In severe renal failure (creatinine clearance) If during the use of the drug in patients with hypertension without visible signs of impaired renal function there are laboratory signs of renal failure, the drug should be discontinued with the possibility of resuming treatment with a lower dose or one of the components of the drug.
Such patients must monitor potassium and creatinine in blood plasma after 2 weeks from the start of treatment and every 2 months during therapeutic stabilization. teas of renal failure was observed mainly in patients with severe heart failure with an existing or impaired renal function, including patients with renal artery stenosis.
This drug is not recommended for patients with bilateral renal artery stenosis or single kidney artery stenosis.
Hypotension and deficiency of water and electrolytes. There is a risk of a sharp decrease in blood pressure in patients with sodium deficiency (especially in patients with renal artery stenosis). Therefore, it is necessary to systematically check for symptoms of water and electrolyte deficiency that can occur with vomiting or diarrhea. In such patients, it is necessary to regularly monitor the level of electrolytes in blood plasma.
With significant hypotension, the patient may need to introduce 0.9% sodium chloride solution. Temporary hypotension is not a contraindication for further administration of the drug. After the restoration of BCC and normalization of blood pressure, treatment can be started with the drug in a low dose or with one of the components of the drug.
Plasma potassium level. The combination of perindopril and indapamide does not exclude the possibility of hypokalemia, especially in patients with diabetes mellitus or with renal failure. As with any other drug containing a diuretic, regular monitoring of potassium levels should be carried out.
Precautions While Using Perindopril
Cough. As with other ACE inhibitors, a dry cough may occur, which disappears after discontinuation of the drug. If necessary, treatment can be continued. If the patient needs therapy with an ACE inhibitor, then the question of its continuation may be considered.
Risk of arterial hypotension and / or renal failure (in the presence of heart failure, water deficiency, and electrolytes). Significant stimulation of the renin-angiotensin-aldosterone system was observed during a significant deficiency of water and electrolytes (strict salt-free diet or long-term treatment with diuretics) in patients with low blood pressure, in cases of renal artery stenosis, congestive heart failure, or in patients with cirrhosis with edema and ascites . The blocking of this system by an ACE inhibitor can cause, especially during the first dose and during the first 2 weeks of treatment, a sharp decrease in blood pressure and / or an increase in plasma creatinine, which confirms functional renal failure. Sometimes, although rarely, it can have an acute onset and occur at any time. In such cases, treatment should begin with a lower dose with a gradual increase.
Elderly patients. Before starting treatment, kidney function and potassium levels should be checked. To reduce the risk of sudden hypotension, especially in the presence of water or electrolyte deficiency, the initial dose is adjusted depending on changes in blood pressure during treatment.
Patients with atherosclerosis. The risk of hypotension exists in all patients, but with special care should be prescribed to patients with coronary heart disease or with cerebrovascular insufficiency. In such patients, treatment should be started with the drug in a low dose.
Renovascular hypertension. The treatment for renovascular hypertension is revascularization. However, ACE inhibitors may be useful for patients with renovascular hypertension. pending surgery, or if such an operation is not possible.
If the drug was prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting with the drug at low doses and under the control of potassium levels, as some patients developed functional renal failure, which was reversible after treatment was withdrawn.
Other risk groups. Treatment of patients with severe heart failure (grade IV) or with insulin-dependent diabetes mellitus (due to a tendency to a spontaneous increase in potassium levels) should begin under control with a lower initial dose. The treatment with beta-adrenergic blockers of patients with hypertension with coronary insufficiency should not be discontinued: an ACE inhibitor is added to therapy with beta-adrenergic receptor blockers.
Patients with diabetes. In patients with diabetes, taking oral hypoglycemic agents or receiving insulin, plasma glucose levels should be carefully monitored, especially during the first month of treatment with an ACE inhibitor.
Racial features. Like other ACE inhibitors, perindopril is less effective in lowering blood pressure in patients of the Negroid race with hypertension than in patients of other races, which may be explained by the low level of renin in the blood plasma of these patients.
Surgery / Anesthesia. ACE inhibitors can cause a hypotensive effect during anesthesia, especially when using an anesthetic, which leads to a decrease in blood pressure. Therefore, in the treatment of long-acting ACE inhibitors, such as perindopril, if possible, the drug should be discontinued a day before surgery.
Aortic or mitral valve stenosis / hypertrophic cardiomyopathy. It is necessary to prescribe ACE inhibitors with caution in patients with obstruction of exit from the left ventricle.
Hepatic failure. Rarely, the use of ACE inhibitors has been associated with the onset of a syndrome that begins with cholestatic jaundice and progresses to rapid liver necrosis, sometimes with a fatal outcome. The mechanism of this syndrome is unclear. Patients who develop jaundice with an increase in the level of liver enzymes while taking ACE inhibitors should stop using the ACE inhibitor and ensure proper medical supervision.
Hyperkalemia. In some patients, while taking ACE inhibitors, including perindopril, there was an increase in the concentration of potassium in the blood plasma. Risk factors for hyperkalemia include renal failure or decreased renal function, age (over 70 years), diabetes mellitus, intercurrent conditions such as dehydration, acute cardiac decompensation, metabolic acidosis and the simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride ), with food additives containing potassium, or salt substitutes with potassium or taking other drugs that cause an increase in the concentration of potassium in the blood plasma (heparin). The use of dietary food supplements containing potassium, potassium-sparing diuretics or salt substitutes with potassium, especially in patients with impaired renal function, can lead to a significant increase in plasma potassium levels. Hyperkalemia can cause serious, sometimes fatal arrhythmia. If the simultaneous use of perindopril and any of the above substances is considered appropriate, they should be used with caution and often monitor the level of potassium in the blood plasma.
Precautions While Using Indapamide
Water and electrolyte balance
Blood plasma sodium. Plasma sodium levels must be checked before treatment and regularly during treatment. Any diuretic can cause hyponatremia, which sometimes has serious consequences. Decreased plasma sodium levels may initially be asymptomatic, and regular monitoring is therefore necessary. It should be carried out more often in elderly patients and patients with cirrhosis.
Potassium in blood plasma. A decrease in the level of potassium in the blood plasma with the development of hypokalemia is the main risk with the use of thiazide and thiazide-like diuretics. The risk of developing hypokalemia (In such cases, hypokalemia increases cardiotoxicity of cardiac glycosides and the risk of arrhythmia.
Patients who have an extended Q – T interval of congenital or iatrogenic origin are also at risk. In such patients, hypokalemia, like bradycardia, may contribute to the development of severe heart rhythm disturbances, including paroxysmal ventricular tachycardia of the pirouette type, which can be fatal.rdlkp In all these cases, frequent monitoring of potassium levels is necessary. EFINITIONS potassium plasma levels should be performed during the first week of treatment. When potassium is low, you need to correct it.
Plasma calcium. Thiazide and thiazide-like diuretics can decrease urinary calcium excretion and lead to a slight and temporary increase in plasma calcium levels. A significant increase in calcium levels may be associated with diagnosed hyperparathyroidism. In such cases, treatment should be discontinued before examination of the function of the parathyroid glands.
Glucose in plasma. Plasma glucose control is very important for patients with diabetes, especially with low potassium levels.
uric acid. In patients with elevated uric acid levels, there may be a tendency to increase the number of gout attacks.
Kidney function and diuretics. Thiazide and thiazide-like diuretics are most effective, if renal function is not impaired or if impaired function is insignificant (plasma creatinine below the level of 25 mg / l, i.e. 220 mmol / l in adults).
In elderly patients, plasma creatinine levels should be determined taking into account age, body weight and gender, using the Cockcroft formula: Creatinine clearance (Clcr) = (140 - age) В· body weight / 0.814 В· plasma creatinine level,
where age is expressed in years body weight - in kg the level of creatinine in blood plasma - in mmol / l.
This formula is used for older men and should be adapted for women by multiplying the result by 0.85.
Hypovolemia caused by loss of water and sodium due to diuretics, at the beginning of treatment leads to a decrease in glomerular filtration. This can lead to an increase in blood urea and creatinine in blood plasma. This transient functional renal failure has no consequences in individuals with normal renal function, but may worsen existing renal failure.
Athletes. This drug contains an active substance that can cause a positive reaction during doping control in athletes.
Excipients. The drug should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Composition
Tablets, film-coated white, oval, biconvex on one side - dividing risk.
1 tab.
perindopril tosylate 2.5 mg
indapamide 0.625 mg
Excipients: lactose monohydrate - 74.056 mg, corn starch - 2.7 mg, sodium bicarbonate - 0.793 mg, pregelatinized corn starch - 7.2 mg, povidone K30 - 0.930 - mg
Shell composition: Opadry II white 85F18422 (polyvinyl alcohol partially hydrolyzed 1.8 mg, titanium dioxide (E171) - 1.125 mg, macrogol-3350 - 0.909 mg, talc - 0.666 mg).
Dosage and administration
is intended for oral use. Tablets can be divided into two identical doses. The tablet fracture line is designed to break the tablet to facilitate swallowing.
Perindopril / Indapamide-Teva, tablets 2.5 mg / 0.625 mg
Adults use 1 tablet 1 time per day, preferably in the morning before meals. If blood pressure has not returned to normal within a month, the dose can be doubled.
Elderly patients. Treatment should be started with the usual dose - 1 tablet of Perindopril / Indapamide-Teva, 2.5 mg / 0.625 mg / day tablets.
Patients with impaired renal function.
Treatment is contraindicated in patients with severe impaired renal function (creatinine clearance. Patients with impaired liver function. Treatment is contraindicated in severe impaired liver function. Patients with moderate hepatic impairment do not require dose adjustment.
Children. This drug is not recommended for the treatment of children and adolescents due to lack of data regarding safety and efficacy for this group of patients.
Side effects of
The use of perindopril inhibits the renin-angiotensin-aldosterone system and helps to reduce the potassium loss caused by indapamide.
From the blood and lymphatic systems: thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia. Anemia was observed with the use of ACE inhibitors in a certain category of patients (after transplantation, kidneys on hemodialysis).
From the nervous system: paresthesia, headache, asthenia, dizziness, confusion, fainting.
From the psyche: mood changes or sleep disturbance.
From the side of the organ of vision: visual impairment.
On the part of the hearing organ: tinnitus.
From the cardiovascular system: arterial hypotension (including orthostatic), stroke can occur due to an excessive decrease in blood pressure in patients at high risk for vasculitis, arrhythmia, including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction, which can occur due to excessive hypotension in patients at high risk, tachycardia of the pirouette type (with a possible fatal outcome).
On the part of the respiratory system, chest and mediastinal organs: dyspnea, bronchospasm, eosinophilic pneumonia, rhinitis, dry cough in patients taking ACE inhibitors. Such a cough was prolonged and disappeared after discontinuation of treatment.
From the digestive system: constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhea, pancreatitis.
From the hepatobiliary system: cytolytic or cholestatic hepatitis, with liver failure may develop hepatic encephalopathy.
From the skin and subcutaneous tissues: rash, itching, maculopapular rash, angioedema of the face, limbs, lips, mucous membranes, tongue, glottis and / or larynx, urticaria, hypersensitivity reactions, mainly of a dermatological nature, can occur in individuals with a tendency to allergic or asthmatic reactions, purpura, exacerbation of existing systemic lupus erythematosus, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity.
From the musculoskeletal system: cramps.
From the kidneys and urinary system: CRF, ARF.
From the reproductive system: impotence.
General disorders: asthenia, excessive sweating.
Laboratory indicators: an increase in the Q ֠T interval on the ECG, an increase in the level of glucose and uric acid in the blood plasma during treatment, a slight increase in the level of creatinine in blood plasma and urine, which disappears after cessation of the drug. Such an increase often occurs in cases of renal artery stenosis, hypertension, which is treated with diuretics, and renal failure, increased activity of liver enzymes.
On the part of the metabolism: hypercalcemia, hypokalemia, increased potassium levels, which are usually temporary, hyponatremia with hypovolemia, which causes dehydration and orthostatic hypotension, hypoglycemia.
Overdose of
The most likely adverse reaction that results from an overdose is arterial hypotension, sometimes associated with nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which can go into anuria (due to hypovolemia) shock. Violations of the water-electrolyte balance (a decrease in the level of potassium and sodium in blood plasma), renal failure, hyperventilation, tachycardia, heart palpitations (palpitation), bradycardia, anxiety, cough, etc. may occur.
First aid measures include rapid elimination of the drug by gastric lavage (only within 1 hour after use and in case of potential severe intoxication) and / or intake of activated charcoal, after which it is necessary to restore the water-electrolyte balance in a hospital.
In case of significant hypotension, the patient must be given a horizontal position with a low headboard. If necessary, carry out iv administration of an isotonic solution or use any other method of restoring blood volume.
Perindoprilat (the active form of perindopril) can be removed from the body by hemodialysis
Storage conditions
wound in a tightly closed container to protect from moisture. The drug does not require special temperature storage conditions.
Active ingredient in
indapamide, perindopril
Terms and conditions
prescription
lekarstvennaja form
tablets
Pharma Pharma Dreve Pharma Dreve Pharma Dreve Pharma Pharmaceutical Co., Ltd. Co., Ltd.
Tablets, film-coated
Pharmacological action of
armacodynamics. Perindopril / Indapamide-Teva is a combination of an ACE inhibitor perindopril tosylate and an indapamide sulfonamide diuretic. The pharmacological effect of the drug is due to the properties of each component (perindopril and indapamide) and their additive synergism.
The pharmacological mechanism of action of the drug is the additive synergistic effect of two antihypertensive components.
Perindopril / Indapamide-Teva reduces systolic and diastolic pressure in patients with hypertension of any age who are both in the supine position and in the standing position. The antihypertensive effect of the drug depends on the dose and lasts 24 hours. A decrease in blood pressure is achieved in less than 1 month without the occurrence of tachyphylaxis, discontinuation of treatment does not cause withdrawal. Proven that the simultaneous administration of perindopril and indapamide has a hypotensive effect of synergistic origin, which is the result of individual effects of the components of the drug.
Perindopril is an ACE inhibitor that converts angiotensin I to angiotensin II (a vasoconstrictor substance), stimulates the secretion of aldosterone by the adrenal cortex and the breakdown of bradykinin (a vasodilating substance) to inactive heptapeptides.
ACE inhibition leads to: a decrease in the secretion of aldosterone
an increase in plasma renin activity, while aldosterone does not adversely affect
a decrease in OPSS due to the predominant effect on the vessels of the muscles and kidneys. In this case, there is no delay in water and salts and reflex tachycardia with prolonged treatment.
Perindopril also reduces blood pressure in patients with normal and low plasma renin levels.
Perindopril acts through its active metabolite, perindoprilat. Other metabolites are inactive.
Perindopril reduces the load on the heart through: a vasodilator effect on the veins (possibly due to changes in the metabolism of prostaglandins): decreased preload
decreased OPSS: decreased afterload on the heart.
In numerous studies involving patients with heart failure, it has been shown that the use of perindopril leads to: a decrease in the filling pressure of the left and right ventricles
, a decrease in the heart rate of
, an increase in cardiac output and optimization of the cardiac index
increase in blood flow in the myocardium.
Significantly improved performance tests with physical activity.
Characterization of the antihypertensive effect of perindopril
Perindopril effectively reduces blood pressure for all degrees of hypertension: mild, moderate and severe decrease in systolic and diastolic blood pressure is observed both in the supine position and in the standing position.
The maximum antihypertensive effect develops 4-6 hours after a single dose and lasts more than a day.
Perindopril has a high level of final blocking of an ACE inhibitor - approximately 80% 24 hours after administration.
In patients who responded to treatment, normalization of blood pressure occurs within a month and persists without the occurrence of tachyphylaxis.
Perindopril has vasodilating properties, restores the elasticity of large arteries, corrects histomorphometric changes in arterial resistance and reduces left ventricular hypertrophy. Adding, if necessary, a thiazide diuretic leads to additional synergism.
The combination of an ACE inhibitor and a thiazide diuretic reduces the risk of hypokalemia that may occur when a diuretic is prescribed as monotherapy.
Indapamide is a sulfonamide diuretic with an indole ring, which is pharmacologically related to thiazide diuretics. Indapamide inhibits sodium reabsorption in the cortical segment of the kidney. This increases the excretion of sodium and chloride with urine and, to a lesser extent, excretion of potassium and magnesium, thus increasing diuresis. This mechanism provides a hypotensive effect with a slight diuretic effect.
Characterization of the antihypertensive effect of indapamide
The antihypertensive effect of indapamide during monotherapy lasts 24 hours and is associated with an improvement in arterial elasticity and a decrease in arteriole resistance and OPSS. Indapamide reduces left ventricular hypertrophy.
When the recommended dose is exceeded, the therapeutic effect of thiazides and thiazide-like diuretics does not increase, while the number of side effects increases. If the treatment is not effective enough, increasing the dose is not recommended.
Indapamide has not been shown to affect lipid metabolism (TG, LDL cholesterol and HDL cholesterol) and carbohydrates, even in patients with hypertension and diabetes mellitus.
Pharmacokinetics. The pharmacokinetic parameters of perindopril and indapamide as part of the drug Perindopril / Indapamide-Teva do not differ from those of perindopril and indapamide as single drugs.
Perindopril. After taking perindopril, it is rapidly absorbed and Cmax is reached after 1 h. T perindopril from plasma is 1 hour.
Perindopril is a prodrug. 27% of the accepted dose of perindopril enters the bloodstream as an active metabolite of perindopril. In addition to active perindoprilat, perindopril forms another 5 inactive metabolites. Cmax of perindoprilat in blood plasma is reached in 3-4 hours. Since eating reduces the conversion of perindopril to perindoprilat and, consequently, its bioavailability decreases, it is recommended to take perindopril orally in a single dose in the morning before meals. There is a linear relationship between the dose of perindopril and its concentration in blood plasma.
The volume of distribution of unbound perindoprilat is approximately 0.2 l / kg. The binding of perindoprilat to plasma proteins is 20%, mainly from ACE, but is dose-dependent. Perindoprilat is excreted in the urine, and T unbound perindoprilat is approximately 17 hours. The equilibrium state is reached after 4 days.
Perindoprilat excretion is reduced in elderly patients and those with heart or kidney failure. For patients with renal failure, the dose should be adapted depending on the degree of impaired renal function (creatinine clearance). The dialysis clearance of perindoprilat is 70 ml / min.
The kinetics of perindopril changes in patients with cirrhosis: the hepatic clearance of the main molecule is halved. However, the amount of perindoprilat formed does not decrease. Therefore, such patients do not need to select a dose (see APPLICATION and SPECIAL INSTRUCTIONS).
indapamide. Indapamide is rapidly and completely absorbed in the digestive tract. Cmax in plasma is reached 1 hour after oral administration. Plasma protein binding - 79%. T is 14-24 hours (an average of 18 hours). With the regular use of cumulation does not occur.
Indapamide is excreted in urine (70% of the dose) and feces (22%) as inactive metabolites.
In patients with renal failure, pharmacokinetic parameters do not change.
Indications
Sensitive hypertension.
Contraindications
for perindopril: hypersensitivity to perindopril or to any other ACE inhibitors, angioedema (Quincke's edema) in the history associated with previous treatment with ACE inhibitors, congenital or idiopathic angioedema, pregnancy or its planning.
For indapamide: hypersensitivity to indapamide or any other sulfonamide preparations, severe renal failure (creatinine clearance For Perindopril / Indapamide-Teva: hypersensitivity to the drug components.
Due to the lack of sufficient clinical experience, Perindopril / Indapamide-Teva should not be used hemodialysis patients and patients with untreated decompensated cardiac insufficiency
Special instructions
special warnings, common for perindopril and indapamide
When using a low-dose combination (Perindopril / Indapamide-Teva, tablets 2.5 mg / 0.625 mg), there was no significant reduction in the frequency of adverse reactions compared with the use of each of the components of the drug in the minimum approved doses, except for hypokalemia. An increased frequency of idiosyncratic reactions cannot be ruled out if the patient simultaneously takes 2 new antihypertensive drugs for him. To minimize the risk, it is necessary to carefully monitor the patient's condition.
lithium. The simultaneous use of lithium and a combination of perindopril / indapamide is usually not recommended.
Special warnings regarding perindopril
Neutropenia / agranulocytosis. Among patients using ACE inhibitors, there have been cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and in the absence of other risk factors, neutropenia occurs rarely. Perindopril should be prescribed very carefully to patients with collagenoses, during therapy with immunosuppressants, allopurinol or procainamide, or with a combination of these aggravating factors, especially in the presence of impaired renal function. Some of these patients have developed serious infectious diseases, in several 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, and patients should be aware that any manifestation of an infectious disease (sore throat, fever) must be reported to the doctor.
Hypersensitivity / angioedema. Rare cases of angioedema of the face, limbs, lips, tongue, glottis and / or larynx in patients with ACE inhibitors, including perindopril, have been reported. This can happen at any time during the treatment period. In such cases, it is urgent to stop taking the drug and establish the necessary control over the patient's condition until the symptoms disappear completely. In cases where edema spreads only in the area of ​​the face and lips, the patient's condition usually improves without treatment, although antihistamines reduce the severity of symptoms.
Angioneurotic edema associated with laryngeal edema can be fatal. In cases where the swelling extends to the tongue, glottis or larynx, which can lead to airway obstruction, urgent emergency treatment is necessary, which may include sc administration of epinephrine solution 1: 1000 (0.3-0.5 ml) and / or airway patency.
It has been reported that in patients of the Negroid race ACE inhibitors are more likely to cause angioedema compared with other races.
Patients with a history of angioedema that were not associated with ACE inhibitors may have an increased risk of angioedema while taking ACE inhibitors.
Rare cases of intestinal angioedema have been reported in patients treated with ACE inhibitors. In such patients, abdominal pain was noted (with or without nausea and vomiting), some cases of intestinal angioedema were not accompanied by a manifestation of previous angioedema of the face, and the level of C1 esterase was normal. The diagnosis of intestinal angioedema was established using computed tomography, ultrasound, or during surgery. After the withdrawal of the ACE inhibitor, the symptoms of angioedema disappeared. In case of abdominal pain in patients using ACE inhibitors, differential diagnosis should be made and intestinal angioedema should be excluded.
Anaphylactoid reactions during desensitizing therapy. Isolated cases of prolonged life-threatening anaphylactoid reactions have been reported in patients used ACE inhibitors during desensitizing therapy with preparations containing bee venom. ACE inhibitors should be used with caution in patients with allergies after desensitization and to avoid their appointment during immunotherapy with preparations containing bee venom. However, in patients requiring both ACE inhibitors and desensitization, such reactions can be avoided by temporarily discontinuing the use of an ACE inhibitor at least 24 hours before desensitization.
Anaphylactoid reactions during plasmapheresis of LDL. Rarely, in patients taking ACE inhibitors, during life-threatening anaphylactoid reactions, the development of which can be avoided, has been reported during plasmapheresis of LDL using dextransulfate. if before each plasmapheresis treatment is temporarily discontinued treatment with ACE inhibitors.
Patients on hemodialysis. Cases of anaphylactoid reactions have been reported in patients taking ACE inhibitors while on hemodialysis using high-flow polyacrylic membranes (e.g. AN 69В®). Such patients should use a different type of dialysis membrane or prescribe a different class of antihypertensive drugs.
Patients after kidney transplantation. There is no experience with prescribing perindopril tosylate to patients after a recent kidney transplant operation.
Potassium-sparing diuretics, potassium salts. The combination of perindopril with potassium-sparing diuretics, potassium salts is usually not recommended.
Arterial hypotension in patients with symptomatic heart failure and concomitant renal failure or without it. The occurrence of symptomatic arterial hypotension is most likely in patients with a more severe degree of heart failure, taking high doses of loop diuretics, with hyponatremia or renal failure of a functional nature. To reduce the risk of symptomatic arterial hypotension at the beginning of therapy and at the stage of dose selection, patients should be closely monitored by a doctor. The same warnings exist for patients with coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can cause myocardial infarction or stroke.
ischemic heart disease. When, if during the first month of treatment with perindopril an episode of unstable angina pectoris (of any severity) occurred, the benefit / risk ratio should be carefully weighed before deciding whether to continue therapy.
Special warnings regarding indapamide
In patients with impaired liver function, the use of thiazide and thiazide-like diuretics can cause hepatic encephalopathy. In this case, the use of diuretics should be stopped immediately.
Photosensitivity. Cases of photosensitization reactions have been reported in patients using thiazide and thiazide-like diuretics. If such reactions occur, it is recommended to discontinue treatment with diuretics. If there is a need to prescribe diuretics again, it is recommended to protect vulnerable areas from the sun or from sources of artificial ultraviolet radiation.
Precautions common to perindopril and indapamide
Impaired renal function. In severe renal failure (creatinine clearance) If during the use of the drug in patients with hypertension without visible signs of impaired renal function there are laboratory signs of renal failure, the drug should be discontinued with the possibility of resuming treatment with a lower dose or one of the components of the drug.
Such patients must monitor potassium and creatinine in blood plasma after 2 weeks from the start of treatment and every 2 months during therapeutic stabilization. teas of renal failure was observed mainly in patients with severe heart failure with an existing or impaired renal function, including patients with renal artery stenosis.
This drug is not recommended for patients with bilateral renal artery stenosis or single kidney artery stenosis.
Hypotension and deficiency of water and electrolytes. There is a risk of a sharp decrease in blood pressure in patients with sodium deficiency (especially in patients with renal artery stenosis). Therefore, it is necessary to systematically check for symptoms of water and electrolyte deficiency that can occur with vomiting or diarrhea. In such patients, it is necessary to regularly monitor the level of electrolytes in blood plasma.
With significant hypotension, the patient may need to introduce 0.9% sodium chloride solution. Temporary hypotension is not a contraindication for further administration of the drug. After the restoration of BCC and normalization of blood pressure, treatment can be started with the drug in a low dose or with one of the components of the drug.
Plasma potassium level. The combination of perindopril and indapamide does not exclude the possibility of hypokalemia, especially in patients with diabetes mellitus or with renal failure. As with any other drug containing a diuretic, regular monitoring of potassium levels should be carried out.
Precautions While Using Perindopril
Cough. As with other ACE inhibitors, a dry cough may occur, which disappears after discontinuation of the drug. If necessary, treatment can be continued. If the patient needs therapy with an ACE inhibitor, then the question of its continuation may be considered.
Risk of arterial hypotension and / or renal failure (in the presence of heart failure, water deficiency, and electrolytes). Significant stimulation of the renin-angiotensin-aldosterone system was observed during a significant deficiency of water and electrolytes (strict salt-free diet or long-term treatment with diuretics) in patients with low blood pressure, in cases of renal artery stenosis, congestive heart failure, or in patients with cirrhosis with edema and ascites . The blocking of this system by an ACE inhibitor can cause, especially during the first dose and during the first 2 weeks of treatment, a sharp decrease in blood pressure and / or an increase in plasma creatinine, which confirms functional renal failure. Sometimes, although rarely, it can have an acute onset and occur at any time. In such cases, treatment should begin with a lower dose with a gradual increase.
Elderly patients. Before starting treatment, kidney function and potassium levels should be checked. To reduce the risk of sudden hypotension, especially in the presence of water or electrolyte deficiency, the initial dose is adjusted depending on changes in blood pressure during treatment.
Patients with atherosclerosis. The risk of hypotension exists in all patients, but with special care should be prescribed to patients with coronary heart disease or with cerebrovascular insufficiency. In such patients, treatment should be started with the drug in a low dose.
Renovascular hypertension. The treatment for renovascular hypertension is revascularization. However, ACE inhibitors may be useful for patients with renovascular hypertension. pending surgery, or if such an operation is not possible.
If the drug was prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting with the drug at low doses and under the control of potassium levels, as some patients developed functional renal failure, which was reversible after treatment was withdrawn.
Other risk groups. Treatment of patients with severe heart failure (grade IV) or with insulin-dependent diabetes mellitus (due to a tendency to a spontaneous increase in potassium levels) should begin under control with a lower initial dose. The treatment with beta-adrenergic blockers of patients with hypertension with coronary insufficiency should not be discontinued: an ACE inhibitor is added to therapy with beta-adrenergic receptor blockers.
Patients with diabetes. In patients with diabetes, taking oral hypoglycemic agents or receiving insulin, plasma glucose levels should be carefully monitored, especially during the first month of treatment with an ACE inhibitor.
Racial features. Like other ACE inhibitors, perindopril is less effective in lowering blood pressure in patients of the Negroid race with hypertension than in patients of other races, which may be explained by the low level of renin in the blood plasma of these patients.
Surgery / Anesthesia. ACE inhibitors can cause a hypotensive effect during anesthesia, especially when using an anesthetic, which leads to a decrease in blood pressure. Therefore, in the treatment of long-acting ACE inhibitors, such as perindopril, if possible, the drug should be discontinued a day before surgery.
Aortic or mitral valve stenosis / hypertrophic cardiomyopathy. It is necessary to prescribe ACE inhibitors with caution in patients with obstruction of exit from the left ventricle.
Hepatic failure. Rarely, the use of ACE inhibitors has been associated with the onset of a syndrome that begins with cholestatic jaundice and progresses to rapid liver necrosis, sometimes with a fatal outcome. The mechanism of this syndrome is unclear. Patients who develop jaundice with an increase in the level of liver enzymes while taking ACE inhibitors should stop using the ACE inhibitor and ensure proper medical supervision.
Hyperkalemia. In some patients, while taking ACE inhibitors, including perindopril, there was an increase in the concentration of potassium in the blood plasma. Risk factors for hyperkalemia include renal failure or decreased renal function, age (over 70 years), diabetes mellitus, intercurrent conditions such as dehydration, acute cardiac decompensation, metabolic acidosis and the simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride ), with food additives containing potassium, or salt substitutes with potassium or taking other drugs that cause an increase in the concentration of potassium in the blood plasma (heparin). The use of dietary food supplements containing potassium, potassium-sparing diuretics or salt substitutes with potassium, especially in patients with impaired renal function, can lead to a significant increase in plasma potassium levels. Hyperkalemia can cause serious, sometimes fatal arrhythmia. If the simultaneous use of perindopril and any of the above substances is considered appropriate, they should be used with caution and often monitor the level of potassium in the blood plasma.
Precautions While Using Indapamide
Water and electrolyte balance
Blood plasma sodium. Plasma sodium levels must be checked before treatment and regularly during treatment. Any diuretic can cause hyponatremia, which sometimes has serious consequences. Decreased plasma sodium levels may initially be asymptomatic, and regular monitoring is therefore necessary. It should be carried out more often in elderly patients and patients with cirrhosis.
Potassium in blood plasma. A decrease in the level of potassium in the blood plasma with the development of hypokalemia is the main risk with the use of thiazide and thiazide-like diuretics. The risk of developing hypokalemia (In such cases, hypokalemia increases cardiotoxicity of cardiac glycosides and the risk of arrhythmia.
Patients who have an extended Q – T interval of congenital or iatrogenic origin are also at risk. In such patients, hypokalemia, like bradycardia, may contribute to the development of severe heart rhythm disturbances, including paroxysmal ventricular tachycardia of the pirouette type, which can be fatal.rdlkp In all these cases, frequent monitoring of potassium levels is necessary. EFINITIONS potassium plasma levels should be performed during the first week of treatment. When potassium is low, you need to correct it.
Plasma calcium. Thiazide and thiazide-like diuretics can decrease urinary calcium excretion and lead to a slight and temporary increase in plasma calcium levels. A significant increase in calcium levels may be associated with diagnosed hyperparathyroidism. In such cases, treatment should be discontinued before examination of the function of the parathyroid glands.
Glucose in plasma. Plasma glucose control is very important for patients with diabetes, especially with low potassium levels.
uric acid. In patients with elevated uric acid levels, there may be a tendency to increase the number of gout attacks.
Kidney function and diuretics. Thiazide and thiazide-like diuretics are most effective, if renal function is not impaired or if impaired function is insignificant (plasma creatinine below the level of 25 mg / l, i.e. 220 mmol / l in adults).
In elderly patients, plasma creatinine levels should be determined taking into account age, body weight and gender, using the Cockcroft formula: Creatinine clearance (Clcr) = (140 - age) В· body weight / 0.814 В· plasma creatinine level,
where age is expressed in years body weight - in kg the level of creatinine in blood plasma - in mmol / l.
This formula is used for older men and should be adapted for women by multiplying the result by 0.85.
Hypovolemia caused by loss of water and sodium due to diuretics, at the beginning of treatment leads to a decrease in glomerular filtration. This can lead to an increase in blood urea and creatinine in blood plasma. This transient functional renal failure has no consequences in individuals with normal renal function, but may worsen existing renal failure.
Athletes. This drug contains an active substance that can cause a positive reaction during doping control in athletes.
Excipients. The drug should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Composition
Tablets, film-coated white, oval, biconvex on one side - dividing risk.
1 tab.
perindopril tosylate 2.5 mg
indapamide 0.625 mg
Excipients: lactose monohydrate - 74.056 mg, corn starch - 2.7 mg, sodium bicarbonate - 0.793 mg, pregelatinized corn starch - 7.2 mg, povidone K30 - 0.930 - mg
Shell composition: Opadry II white 85F18422 (polyvinyl alcohol partially hydrolyzed 1.8 mg, titanium dioxide (E171) - 1.125 mg, macrogol-3350 - 0.909 mg, talc - 0.666 mg).
Dosage and administration
is intended for oral use. Tablets can be divided into two identical doses. The tablet fracture line is designed to break the tablet to facilitate swallowing.
Perindopril / Indapamide-Teva, tablets 2.5 mg / 0.625 mg
Adults use 1 tablet 1 time per day, preferably in the morning before meals. If blood pressure has not returned to normal within a month, the dose can be doubled.
Elderly patients. Treatment should be started with the usual dose - 1 tablet of Perindopril / Indapamide-Teva, 2.5 mg / 0.625 mg / day tablets.
Patients with impaired renal function.
Treatment is contraindicated in patients with severe impaired renal function (creatinine clearance. Patients with impaired liver function. Treatment is contraindicated in severe impaired liver function. Patients with moderate hepatic impairment do not require dose adjustment.
Children. This drug is not recommended for the treatment of children and adolescents due to lack of data regarding safety and efficacy for this group of patients.
Side effects of
The use of perindopril inhibits the renin-angiotensin-aldosterone system and helps to reduce the potassium loss caused by indapamide.
From the blood and lymphatic systems: thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia. Anemia was observed with the use of ACE inhibitors in a certain category of patients (after transplantation, kidneys on hemodialysis).
From the nervous system: paresthesia, headache, asthenia, dizziness, confusion, fainting.
From the psyche: mood changes or sleep disturbance.
From the side of the organ of vision: visual impairment.
On the part of the hearing organ: tinnitus.
From the cardiovascular system: arterial hypotension (including orthostatic), stroke can occur due to an excessive decrease in blood pressure in patients at high risk for vasculitis, arrhythmia, including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction, which can occur due to excessive hypotension in patients at high risk, tachycardia of the pirouette type (with a possible fatal outcome).
On the part of the respiratory system, chest and mediastinal organs: dyspnea, bronchospasm, eosinophilic pneumonia, rhinitis, dry cough in patients taking ACE inhibitors. Such a cough was prolonged and disappeared after discontinuation of treatment.
From the digestive system: constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhea, pancreatitis.
From the hepatobiliary system: cytolytic or cholestatic hepatitis, with liver failure may develop hepatic encephalopathy.
From the skin and subcutaneous tissues: rash, itching, maculopapular rash, angioedema of the face, limbs, lips, mucous membranes, tongue, glottis and / or larynx, urticaria, hypersensitivity reactions, mainly of a dermatological nature, can occur in individuals with a tendency to allergic or asthmatic reactions, purpura, exacerbation of existing systemic lupus erythematosus, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity.
From the musculoskeletal system: cramps.
From the kidneys and urinary system: CRF, ARF.
From the reproductive system: impotence.
General disorders: asthenia, excessive sweating.
Laboratory indicators: an increase in the Q ֠T interval on the ECG, an increase in the level of glucose and uric acid in the blood plasma during treatment, a slight increase in the level of creatinine in blood plasma and urine, which disappears after cessation of the drug. Such an increase often occurs in cases of renal artery stenosis, hypertension, which is treated with diuretics, and renal failure, increased activity of liver enzymes.
On the part of the metabolism: hypercalcemia, hypokalemia, increased potassium levels, which are usually temporary, hyponatremia with hypovolemia, which causes dehydration and orthostatic hypotension, hypoglycemia.
Overdose of
The most likely adverse reaction that results from an overdose is arterial hypotension, sometimes associated with nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which can go into anuria (due to hypovolemia) shock. Violations of the water-electrolyte balance (a decrease in the level of potassium and sodium in blood plasma), renal failure, hyperventilation, tachycardia, heart palpitations (palpitation), bradycardia, anxiety, cough, etc. may occur.
First aid measures include rapid elimination of the drug by gastric lavage (only within 1 hour after use and in case of potential severe intoxication) and / or intake of activated charcoal, after which it is necessary to restore the water-electrolyte balance in a hospital.
In case of significant hypotension, the patient must be given a horizontal position with a low headboard. If necessary, carry out iv administration of an isotonic solution or use any other method of restoring blood volume.
Perindoprilat (the active form of perindopril) can be removed from the body by hemodialysis
Storage conditions
wound in a tightly closed container to protect from moisture. The drug does not require special temperature storage conditions.
Active ingredient in
indapamide, perindopril
Terms and conditions
prescription
lekarstvennaja form
tablets
Pharma Pharma Dreve Pharma Dreve Pharma Dreve Pharma Pharmaceutical Co., Ltd. Co., Ltd.
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