Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. (amlodipine, indapamide, Perindopril)
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Film-coated tablets Buy Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. (amlodipine, indapamide, Perindopril) in newyork free shipping. Fast international shipping USA, AU, EU, UK and others.
Film-coated tablets Buy Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. (amlodipine, indapamide, Perindopril) in newyork free shipping. Fast international shipping USA, AU, EU, UK and others.
Release form
Film-coated tablets
Indications
As a therapy in patients with arterial hypertension with a decrease in blood pressure while taking amlodipine, indapamide and perindopril in the same doses.
Contraindications
Hypersensitivity to active and excipients that are part of the drug, sulfonamide derivatives, derivatives of dihydropyridine, other ACE inhibitors, any other substances that are part of the drug
Patients with severe hemodialysis renal failure (creatinine clearance (CC) less than 30 ml / min)
Moderate renal failure (creatinine clearance (CC) less than 60 ml / min) for ozirovki perindopril / indapamide 10 mg / 2.5 mg (i.e. Tripliksam® mg + 5 mg + 10 mg or 10 mg + Tripliksam® 2 5 mg + 10 mg)
Angioedema (Quincke's edema) with the use of ACE inhibitors in history (see section "Special instructions")
Hereditary / idiopathic angioedema
Pregnancy (see section "Use during pregnancy and during breastfeeding ")
Breastfeeding period (see section" Use during pregnancy and during breastfeeding ")
Hepatic encephalopathy: Severe liver failure
Hypokalemia
Severe hypotension (systolic blood pressure less than 90 mm Hg. )
Shock (including cardiogenic)
Left ventricular outflow tract obstruction (e.g. clinically significant stenosis of the aortic orifice)
Hemodynamically unstable heart failure after acute myocardial
concurrent use with aliskiren-containing drugs in patients with diabetes mellitus or impaired renal function (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2 of surface area body) (see sections "Interaction with other drugs" and "Pharmacodynamics")
Bilateral renal artery stenosis, stenosis of a single kidney artery
Concomitant use with prep arats that can cause polymorphic ventricular tachycardia of the pirouette type
Concurrent use with drugs that extend the QT interval
Concurrent use with potassium-sparing diuretics, potassium and lithium preparations, in patients with elevated plasma potassium
Age up to 18 years (efficacy and safety not established).
With caution (see also the sections “Special Instructions” and “Interaction with Other Medicines”)
The presence of only one functioning kidney, disturbances in water-electrolyte balance, systemic diseases of the connective tissue, therapy with immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis), acute myocardial infarction (and within 1 month after myocardial infarction), sinus node weakness syndrome (severe tachy and bradycardia), with simultaneous administration with inhibitors or induction ramie isoenzyme CYP3A4, hepatic failure mild to moderate severity, inhibition of bone marrow hematopoiesis, decreased blood volume (diuretics, diet with restriction of sodium chloride, vomiting, diarrhea, hemodialysis), hyperuricemia (especially accompanied by gout and urinary nephrolithiasis), the simultaneous use of dantrolene, estramustna, blood pressure lability, before the procedure of apheresis of low density lipoproteins (LDL) using the state after dextran sulfate kidney transplantation, patients of the Negroid race, coronary heart disease, cerebrovascular disease, renovascular hypertension, diabetes mellitus, chronic heart failure (III and IV functional class according to NYHA classification), the simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and lithium, surgery / general anesthesia, hemodialysis using high-flow membranes (for example, AN69®), simultaneous desensitizing therapy with allergens (eg, hymenoptera poison), aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy, advanced age.
Special instructions
All precautions associated with the use of individual components of the drug should be considered when using their fixed combination in the composition of the drug TriplexamВ®.
Amlodipine
Chronic heart failure
Patients with chronic heart failure should be treated with caution.
When using amlodipine in patients with chronic heart failure III and functional class according to NYHA classification, pulmonary edema may develop. Blockers of "slow" calcium channels, including amlodipine, should be used with caution in patients with chronic heart failure, due to a possible increase in the risk of adverse events from the cardiovascular system and mortality.
In patients with severe chronic heart failure (NYHA class IV functional class), treatment should begin with lower doses and under close medical supervision.
Patients with arterial hypertension and coronary heart disease should not stop taking beta-blockers: an ACE inhibitor should be used in conjunction with beta-blockers.
Hypertensive crisis
The efficacy and safety of amlodipine in hypertensive crisis has not been established.
Indapamide
Hepatic encephalopathy
In the presence of impaired liver function, taking thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy. In this case, you should immediately stop taking a diuretic.
Photosensitivity
Cases of a photosensitivity reaction have been reported with thiazide and thiazide-like diuretics (see section “Side effects”). If a photosensitivity reaction develops while taking the drug, treatment should be discontinued. If it is necessary to continue therapy with diuretics, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.
Plasma calcium ion
Thiazide and thiazide-like diuretics can reduce the excretion of calcium ions by the kidneys and lead to a slight and temporary increase in plasma calcium levels. Severe hypercalcemia may result from previously undiagnosed hyperparathyroidism. In such cases, you should stop taking diuretics and conduct a study of the function of the parathyroid glands (see section "Side effects").
Uric acid
In patients with an increased concentration of uric acid in the blood plasma during therapy, the incidence of gout attacks may increase.
Perindopril
Potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes and dietary supplements
The simultaneous administration of perindopril and potassium-sparing diuretics, as well as potassium preparations, potassium-containing substitutes for edible salt and nutritional supplements is not recommended (see section “Interaction with other drugs” .
Double blockade of the renin-angiotensin-aldosterone system (RAAS)
There is evidence of an increased risk of arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) with the simultaneous use of ACE inhibitors with ARA II or aliskiren. Therefore, the double blockade of RAAS as a result of the combination of an ACE inhibitor with ARA II or aliskiren is not recommended (see sections "Interaction with other drugs" and "Pharmacodynamics"). If double blockade is necessary, then this should be done under the strict supervision of a specialist with regular monitoring of renal function, plasma electrolytes and blood pressure. ACE inhibitors should not be used simultaneously with ARA II in patients with diabetic nephropathy.
Neutropenia / agranulocytosis / thrombocytopenia / anemia
There are reports of the development of neutropenia / agranulocytosis, thrombocytopenia and anemia while taking ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia develops rarely. With extreme caution, perindopril should be used in patients with systemic diseases of the connective tissue, while taking immunosuppressants, allopurinol or procainamide, or when combined, especially in patients with impaired renal function.
Some of these patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril, it is recommended that such patients periodically monitor white blood cells in the blood, and patients should inform the doctor of any signs of an infectious disease (for example, sore throat, fever) (see section “Side effects”).
Hypersensitivity / angioedema
When taking ACE inhibitors, including perindopril, in rare cases, the development of angioedema of the face, limbs, lips, tongue, glottis and / or larynx can be observed. This can occur at any time during therapy. When symptoms appear, the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely. If edema affects only the face and lips, then its manifestations usually go away on their own, although antihistamines can be used to treat symptoms.
Angioneurotic edema, accompanied by laryngeal edema, can be fatal. Swelling of the tongue, glottis or larynx can lead to airway obstruction, in which case intensive care should be taken immediately. If such symptoms appear, an epinephrine (adrenaline) solution of 1: 1000 (0.3–0.5 ml) should be immediately administered and / or airway should be ensured. The patient should be under medical supervision until the symptoms disappear completely and persistently.
In patients of the Negroid race, a higher incidence of angioedema was observed with ACE inhibitors compared with other races.
In patients with a history of Quincke's edema, not associated with ACE inhibitors. the risk of its development when taking the drug may be increased (see section "Contraindications"). There are reports of rare cases of the development of angioedema of the intestine during therapy with ACE inhibitors. Moreover, patients had abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases, without prior angioedema of the face and at a normal level of C1 esterase. The diagnosis was made using computed tomography of the abdominal region, ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps)) ACE inhibitors should be used with caution in patients with a burdened allergic history or a tendency to allergic reactions undergoing desensitization procedures, and the use of an ACE inhibitor in patients receiving immunotherapy with hymenoptera venom should be avoided. However, an anaphylactoid reaction can be avoided by temporarily disabling the ACE inhibitor at least 24 hours before the start of the desensitization procedure.
Anaphylactoid reactions during LDL apheresis
In rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions when performing LDL apheresis using dextran sulfate. To prevent anaphylactoid reaction, ACE inhibitor therapy should be temporarily discontinued before each apheresis procedure.
Hemodialysis
Anaphylactoid reactions have been observed in patients receiving ACE inhibitors when hemodialysis using high-flow membranes (e.g. AN69В®). Therefore, it is desirable to use a different type of membrane or to use an antihypertensive agent of another pharmacotherapeutic group.
Pregnancy
ACE inhibitors are contraindicated during pregnancy. If continued therapy with ACE inhibitors is necessary, patients should switch to other types of antihypertensive therapy with an established safety profile when taken during pregnancy. When pregnancy occurs, ACE inhibitors should be discontinued immediately and, if necessary, alternative antihypertensive therapy should be started (see sections “Contraindications” and “Use in Pregnancy and During Breastfeeding”).
Cough
Dry cough may occur during therapy with an ACE inhibitor. The cough persists for a long time while taking drugs of this group and disappears after they are canceled. If a patient develops a dry cough, one should remember the possible iatrogenic nature of this symptom. If the doctor believes that the patient needs an ACE inhibitor therapy, you can consider continuing to take the drug.
Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy
ACE inhibitors should be used with caution in patients with left ventricular outflow tract obstruction.
Ethnic differences
Perindopril, like other ACE inhibitors, apparently has a less pronounced antihypertensive effect in patients of the Negroid race compared to other races. Maybe, this difference is due to the fact that patients with arterial hypertension of the Negroid race are more likely to have low renin activity.
Surgery / General Anesthesia
The use of ACE inhibitors in patients undergoing surgery with general anesthesia can lead to a marked decrease in blood pressure, especially when using general anesthesia drugs that have antihypertensive effects.
It is recommended that you stop taking long-acting ACE inhibitors, including perindopril, as much as possible one day before surgery.
Patients with Renovascular Hypertension
Revascularization is a treatment for renovascular hypertension. However, the use of ACE inhibitors has a beneficial effect in patients both awaiting surgery, and when surgery is not possible.
When using the drug TriplexamВ® in patients with existing or suspected renal artery stenosis, treatment should be started in a low-dose hospital setting with constant monitoring of the state of the kidneys and the level of potassium in the blood, since such patients may develop functional renal failure, which disappears upon termination of therapy.
Atherosclerosis
The risk of arterial hypotension exists in all patients, however, special care should be taken when using the drug in patients with coronary heart disease and cerebrovascular insufficiency. In such patients, treatment should begin with low doses of the drug.
Perindopril / Indapamide.
Lithium preparations
The simultaneous use of a combination of perindopril and indapamide with lithium preparations is not recommended (see section "Interaction with other drugs").
Arterial hypotension and impaired water-electrolyte balance
The presence of initial hyponatremia is associated with the risk of sudden development of arterial hypotension (especially in patients with renal artery stenosis). Therefore, when monitoring patients, attention should be paid to possible symptoms of dehydration and a decrease in the electrolyte content in blood plasma, for example, after diarrhea or vomiting. Such patients need regular monitoring of plasma electrolytes. With severe arterial hypotension, intravenous administration of a 0.9% sodium chloride solution may be required.
Transient arterial hypotension is not a contraindication for continued therapy. After the restoration of BCC and blood pressure, you can resume therapy using low doses of the combination, or use the drug in monotherapy.
All diuretics can cause hyponatremia. which sometimes leads to serious complications. Hyponatremia at the initial stage may not be accompanied by clinical symptoms, therefore, regular laboratory monitoring is necessary. More frequent monitoring of the content of sodium ions is indicated for elderly patients and patients with cirrhosis (see sections "Side effects" and "Overdose").
Patients with diabetes
In patients with type 1 diabetes mellitus (risk of spontaneous increase in potassium ion content), treatment should begin with lower doses and under close medical supervision.
When prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral administration or insulin, regular monitoring of blood glucose concentration is necessary during the first month of therapy. It is necessary to control the level of glucose in the blood in patients with diabetes mellitus, especially in the presence of hypokalemia.
Amlodipine / perindopril
Hepatic insufficiency
In rare cases, while taking ACE inhibitors, cholestatic jaundice occurs. With the progression of this syndrome, fulminant liver necrosis develops, sometimes with a fatal outcome. The mechanism of development of this syndrome is unclear. If there is jaundice or a significant increase in the activity of “liver” enzymes in patients taking ACE inhibitors, you should stop taking the ACE inhibitor and consult a doctor (see the section "Side effects").
In patients with impaired liver function T and AUC of amlodipine increases. Amlodipine should be taken at the lowest doses and precautions should be taken, both at the beginning of treatment and when increasing the dose. In patients with severe hepatic insufficiency, the dose should be increased gradually, providing careful monitoring of the clinical condition.
TriplixamВ® has not been tested in patients with hepatic impairment. Given the influence of each component that is part of the drug, individually, TriplexixВ® is contraindicated in patients with severe hepatic impairment, and also requires special care when prescribed to patients with moderate to mild hepatic impairment.
Amlodipine / indapamide / perindopril
Renal impairment
The drug is contraindicated in patients with severe renal failure (CC less than 30 ml / min) (see section "Contraindications").
In patients with moderate renal insufficiency (CC 30–60 ml / min), the use of Triplexam® is contraindicated in dosages containing 10 mg of perindopril and 2.5 mg of indapamide (i.e. dosage of Triplexam® 5 mg + 2.5 mg + 10 mg and 10 mg + 2.5 mg + 10 mg).
In some patients with arterial hypertension without a previous obvious impairment of renal function, laboratory signs of functional renal failure may appear during therapy. In this case, treatment with the drug should be discontinued with a further opportunity to resume combination therapy using low doses of the drug, or use the components of the drug in monotherapy. Such patients need regular monitoring of serum potassium and creatinine ions - 2 weeks after the start of therapy and every 2 months thereafter. Renal failure often occurs in patients with severe chronic heart failure or an initial impaired renal function, including renal artery stenosis.
TriplexamВ® is not recommended for patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney.
There is a risk of arterial hypotension and / or renal failure (in the presence of chronic heart failure, dehydration and a decrease in electrolyte levels in blood plasma, etc.): in some pathological conditions, significant activation of RAAS can be noted, especially with severe hypovolemia and a decrease in the content blood plasma electrolytes (on the background of a salt-free diet or prolonged intake of diuretics), in patients with initially low blood pressure, renal artery stenosis (including bilateral), and chronic cardiac th failure or cirrhosis with edema and ascites.
Blockade of RAAS by ACE inhibitors may be accompanied by a sharp decrease in blood pressure and / or an increase in plasma creatinine concentration, indicating the development of functional renal failure. These phenomena are more often observed when taking the first dose of the drug or during the first two weeks of therapy. Sometimes these conditions develop sharply and the time of their onset can vary. In such cases, it is recommended to resume therapy starting from lower doses, gradually increasing them. In patients with coronary heart disease and cerebrovascular diseases, a sharp decrease in blood pressure can lead to myocardial infarction or impaired cerebral circulation.
Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly impaired renal function (plasma creatinine in adult patients is below 25 mg / L or 220 Ојmol / L). In elderly patients, creatinine levels should be evaluated taking into account age, body weight and gender.
At the beginning of treatment with diuretics, patients due to hypovolemia and hyponatremia may experience a temporary decrease in glomerular filtration rate and an increase in the concentration of urea and creatinine in blood plasma. This transient functional renal failure is not dangerous for patients with unchanged renal function, however, in patients with initial renal failure, its severity may increase. Patients with renal failure may take amlodipine in standard doses. Changes in plasma concentrations of amlodipine do not correlate with the degree of renal failure.
Special studies on the use of the drug TriplexamВ® in renal failure have not been conducted. When using the drug TriplixamВ® for renal failure, the effects noted when taking the individual components of the drug should be taken into account.
Potassium ion in plasma
Combined therapy with indapamide, perindopril and amlodipine does not prevent the development of hypokalemia, especially in patients with diabetes mellitus or renal failure. As with other antihypertensive agents in combination with a diuretic, regular monitoring of the content of potassium ions in the blood plasma is necessary.
Hyperkalemia may develop in some patients during treatment with ACE inhibitors. including perindopril. Risk factors for hyperkalemia are renal failure, impaired renal function, advanced age (> 70 years), diabetes mellitus, some concomitant conditions (dehydration, acute decompensation of cardiac activity, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamteren, amiloride), potassium preparations or potassium-containing substitutes for edible salt, as well as the use of other agents that increase the content of potassium ions in blood plasma (for example, heparin). The use of food additives / potassium preparations, potassium-sparing diuretics, potassium-containing salt substitutes can lead to a significant increase in blood potassium, especially in patients with impaired renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If combined use of the above drugs is necessary, treatment should be carried out with caution, against the background of regular monitoring of the content of potassium ions in the blood serum (see section "Interaction with other drugs"). Thiazide and thiazide-like diuretics are associated with a risk of hypokalemia. It is necessary to avoid hypokalemia (less than 3.4 mmol / l) in the following categories of patients at high risk: elderly patients and / or emaciated patients (even if they do not receive combined drug therapy), patients with cirrhosis with edema and ascites, patients with coronary heart disease, chronic heart failure. Hypokalemia in these patients enhances the toxic effect of cardiac glycosides and increases the risk of arrhythmias.
Patients with an extended QT interval also belong to the risk group, and it does not matter if this increase is caused by congenital causes or the effect of drugs.
Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, in particular polymorphic ventricular tachycardia of the pirouette type, which can be fatal. In all the cases described above, regular monitoring of the content of potassium ions in the blood plasma is necessary. The first measurement of the content of potassium ions must be carried out during the first week from the start of therapy.
If hypokalemia is detected, appropriate treatment should be prescribed.
Elderly patients
Before taking the drug, it is necessary to evaluate the functional activity of the kidneys and the content of potassium ions in blood plasma. At the beginning of therapy, the dose of the drug is selected, taking into account the degree of decrease in blood pressure, especially in the case of a decrease in the volume of circulating blood (BCC) and loss of electrolytes. Such measures can avoid a sharp decrease in blood pressure.
In elderly patients, an increase in dose should be carried out with caution (see sections "Dosage and Administration" and "Pharmacokinetics").
Effect on the ability to drive vehicles,
mechanisms Due to the possibility of weakness, dizziness during the use of the drug TriplixamВ®, care must be taken when driving vehicles and working with other technical devices that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tablet 5 mg + 1.25 mg + 5 mg: contains active ingredients of amlodipine besylate 6.935 mg, corresponds to 5.0 mg of amlodipine, 1.25 mg of indapamide and perindopril arginine 5 mg.
Dosage and administration
Inside, 1 tablet 1 time per day, preferably in the morning before meals.
The dose of TriplexamВ® is selected after a previous titration of doses of individual components. The maximum daily dose is 1 tablet at a dosage of 10.0 mg + 2.5 mg + 10.0 mg.
Special patient groups
Patients with renal failure (see Pharmacokinetics, Contraindications and Special Instructions)
TriplexamВ® is contraindicated in patients with severe renal failure (CC less than 30 ml / min) (see Contraindications ) For patients with moderate renal failure (CC 30-60 ml / min), TriplexamВ® is contraindicated in a dosage of 5.0 mg + 2.5 mg + 10.0 mg and 10.0 mg + 2.5 mg + 10.0 mg. It is recommended to start therapy with the selection of doses of monocomponents.
Ongoing medical supervision should include regular monitoring of plasma creatinine and potassium concentrations. Concomitant use with aliskiren is contraindicated in patients with impaired renal function (GFR <60 ml / min / 1, 73 m2 of body surface area) (see section "Contraindications").
Patients with hepatic impairment (see Pharmacokinetics Contraindications and Special Instructions)
Patients with severe hepatic insufficiency TriplexamВ® is contraindicated.
For patients with mild or moderate hepatic insufficiency, dose selection should be carried out with caution, since there are no unequivocal recommendations on the dosage of amlodipine for this group of patients.
Elderly patients (see section "Special instructions")
Excretion of perindoprilat in elderly patients is slowed down (See section "Pharmacokinetics"). Therapy should be carried out taking into account the function of the kidneys.
Pediatric Patients
There is currently no data on the safety and efficacy of TriplexamВ® in children and adolescents.
Side effects
The most common adverse reactions reported with perindopril are indapamide and amlodipine as monotherapy were: dizziness, headache, paresthesia, vertigo, drowsiness, visual impairment, tinnitus, palpitations, flushing of blood to the skin of the face, decreased blood pressure (and effects associated with hypotension), cough, shortness of breath gastrointestinal disturbances (abdominal pain, constipation, diarrhea, taste perversion, nausea, dyspepsia, vomiting), skin itching, rash, maculopapular rash, muscle cramps, swelling in the ankles, asthenia, swelling and fatigue.
Overdose of
There is no information on an overdose of Triplexam®.
Amlodipine
Information on overdose of amlodipine is limited.
Symptoms.
There is evidence of the development of excessive peripheral vasodilation with the possible development of reflex tachycardia. The risk of developing severe and persistent arterial hypotension, including with the development of shock and death.
Methods of providing medical care.
With clinically significant hypotension resulting from an overdose of amlodipine, it is necessary to carry out activities aimed at maintaining the function of the cardiovascular system, including placing the limbs in an elevated position, controlling bcc and urine output, and monitoring cardiac and respiratory activity.
To normalize vascular tone and blood pressure, vasoconstrictor drugs can be used, provided that there are no contraindications to their use. To eliminate the effects of calcium channel blockade, intravenous administration of calcium gluconate is possible.
In some cases, gastric lavage may be effective. In healthy volunteers, it has been demonstrated that the use of activated carbon within 2 hours after taking 10 mg of amlodipine reduces the rate of absorption of amlodipine.
Since amlodipine binds to proteins, hemodialysis is ineffective.
Combination of perindopril / indapamide
Symptoms
For the combination of perindopril / indapamide, the most likely symptom of an overdose is arterial hypotension, sometimes in combination with nausea, vomiting, convulsions, dizziness, drowsiness, confusion of consciousness and oligouria, which can go into anuria (as a result of hypovolemia). Electrolyte disturbances (hyponatremia, hypokalemia) may also occur.
Methods of providing medical care
Emergency measures are reduced to removing the drug from the body: washing the stomach and / or taking activated charcoal with the subsequent restoration of water-electrolyte balance.
With a significant decrease in blood pressure, the patient should be placed in the supine position with raised legs, and if necessary, correct hypovolemia (for example, intravenous infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed from the body by dialysis (see Pharmacokinetics)
Storage conditions
At a temperature not exceeding 25 ° C. Keep out of the reach of children.
Expiration
2 years.
Deystvuyuschee substances
amlodipine, indapamide, Perindopril
Conditions for the drugstore from
Prescription
Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. (amlodipine, indapamide, Perindopril) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. - S
Film-coated tablets
Indications
As a therapy in patients with arterial hypertension with a decrease in blood pressure while taking amlodipine, indapamide and perindopril in the same doses.
Contraindications
Hypersensitivity to active and excipients that are part of the drug, sulfonamide derivatives, derivatives of dihydropyridine, other ACE inhibitors, any other substances that are part of the drug
Patients with severe hemodialysis renal failure (creatinine clearance (CC) less than 30 ml / min)
Moderate renal failure (creatinine clearance (CC) less than 60 ml / min) for ozirovki perindopril / indapamide 10 mg / 2.5 mg (i.e. Tripliksam® mg + 5 mg + 10 mg or 10 mg + Tripliksam® 2 5 mg + 10 mg)
Angioedema (Quincke's edema) with the use of ACE inhibitors in history (see section "Special instructions")
Hereditary / idiopathic angioedema
Pregnancy (see section "Use during pregnancy and during breastfeeding ")
Breastfeeding period (see section" Use during pregnancy and during breastfeeding ")
Hepatic encephalopathy: Severe liver failure
Hypokalemia
Severe hypotension (systolic blood pressure less than 90 mm Hg. )
Shock (including cardiogenic)
Left ventricular outflow tract obstruction (e.g. clinically significant stenosis of the aortic orifice)
Hemodynamically unstable heart failure after acute myocardial
concurrent use with aliskiren-containing drugs in patients with diabetes mellitus or impaired renal function (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2 of surface area body) (see sections "Interaction with other drugs" and "Pharmacodynamics")
Bilateral renal artery stenosis, stenosis of a single kidney artery
Concomitant use with prep arats that can cause polymorphic ventricular tachycardia of the pirouette type
Concurrent use with drugs that extend the QT interval
Concurrent use with potassium-sparing diuretics, potassium and lithium preparations, in patients with elevated plasma potassium
Age up to 18 years (efficacy and safety not established).
With caution (see also the sections “Special Instructions” and “Interaction with Other Medicines”)
The presence of only one functioning kidney, disturbances in water-electrolyte balance, systemic diseases of the connective tissue, therapy with immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis), acute myocardial infarction (and within 1 month after myocardial infarction), sinus node weakness syndrome (severe tachy and bradycardia), with simultaneous administration with inhibitors or induction ramie isoenzyme CYP3A4, hepatic failure mild to moderate severity, inhibition of bone marrow hematopoiesis, decreased blood volume (diuretics, diet with restriction of sodium chloride, vomiting, diarrhea, hemodialysis), hyperuricemia (especially accompanied by gout and urinary nephrolithiasis), the simultaneous use of dantrolene, estramustna, blood pressure lability, before the procedure of apheresis of low density lipoproteins (LDL) using the state after dextran sulfate kidney transplantation, patients of the Negroid race, coronary heart disease, cerebrovascular disease, renovascular hypertension, diabetes mellitus, chronic heart failure (III and IV functional class according to NYHA classification), the simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and lithium, surgery / general anesthesia, hemodialysis using high-flow membranes (for example, AN69®), simultaneous desensitizing therapy with allergens (eg, hymenoptera poison), aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy, advanced age.
Special instructions
All precautions associated with the use of individual components of the drug should be considered when using their fixed combination in the composition of the drug TriplexamВ®.
Amlodipine
Chronic heart failure
Patients with chronic heart failure should be treated with caution.
When using amlodipine in patients with chronic heart failure III and functional class according to NYHA classification, pulmonary edema may develop. Blockers of "slow" calcium channels, including amlodipine, should be used with caution in patients with chronic heart failure, due to a possible increase in the risk of adverse events from the cardiovascular system and mortality.
In patients with severe chronic heart failure (NYHA class IV functional class), treatment should begin with lower doses and under close medical supervision.
Patients with arterial hypertension and coronary heart disease should not stop taking beta-blockers: an ACE inhibitor should be used in conjunction with beta-blockers.
Hypertensive crisis
The efficacy and safety of amlodipine in hypertensive crisis has not been established.
Indapamide
Hepatic encephalopathy
In the presence of impaired liver function, taking thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy. In this case, you should immediately stop taking a diuretic.
Photosensitivity
Cases of a photosensitivity reaction have been reported with thiazide and thiazide-like diuretics (see section “Side effects”). If a photosensitivity reaction develops while taking the drug, treatment should be discontinued. If it is necessary to continue therapy with diuretics, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.
Plasma calcium ion
Thiazide and thiazide-like diuretics can reduce the excretion of calcium ions by the kidneys and lead to a slight and temporary increase in plasma calcium levels. Severe hypercalcemia may result from previously undiagnosed hyperparathyroidism. In such cases, you should stop taking diuretics and conduct a study of the function of the parathyroid glands (see section "Side effects").
Uric acid
In patients with an increased concentration of uric acid in the blood plasma during therapy, the incidence of gout attacks may increase.
Perindopril
Potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes and dietary supplements
The simultaneous administration of perindopril and potassium-sparing diuretics, as well as potassium preparations, potassium-containing substitutes for edible salt and nutritional supplements is not recommended (see section “Interaction with other drugs” .
Double blockade of the renin-angiotensin-aldosterone system (RAAS)
There is evidence of an increased risk of arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) with the simultaneous use of ACE inhibitors with ARA II or aliskiren. Therefore, the double blockade of RAAS as a result of the combination of an ACE inhibitor with ARA II or aliskiren is not recommended (see sections "Interaction with other drugs" and "Pharmacodynamics"). If double blockade is necessary, then this should be done under the strict supervision of a specialist with regular monitoring of renal function, plasma electrolytes and blood pressure. ACE inhibitors should not be used simultaneously with ARA II in patients with diabetic nephropathy.
Neutropenia / agranulocytosis / thrombocytopenia / anemia
There are reports of the development of neutropenia / agranulocytosis, thrombocytopenia and anemia while taking ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia develops rarely. With extreme caution, perindopril should be used in patients with systemic diseases of the connective tissue, while taking immunosuppressants, allopurinol or procainamide, or when combined, especially in patients with impaired renal function.
Some of these patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril, it is recommended that such patients periodically monitor white blood cells in the blood, and patients should inform the doctor of any signs of an infectious disease (for example, sore throat, fever) (see section “Side effects”).
Hypersensitivity / angioedema
When taking ACE inhibitors, including perindopril, in rare cases, the development of angioedema of the face, limbs, lips, tongue, glottis and / or larynx can be observed. This can occur at any time during therapy. When symptoms appear, the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely. If edema affects only the face and lips, then its manifestations usually go away on their own, although antihistamines can be used to treat symptoms.
Angioneurotic edema, accompanied by laryngeal edema, can be fatal. Swelling of the tongue, glottis or larynx can lead to airway obstruction, in which case intensive care should be taken immediately. If such symptoms appear, an epinephrine (adrenaline) solution of 1: 1000 (0.3–0.5 ml) should be immediately administered and / or airway should be ensured. The patient should be under medical supervision until the symptoms disappear completely and persistently.
In patients of the Negroid race, a higher incidence of angioedema was observed with ACE inhibitors compared with other races.
In patients with a history of Quincke's edema, not associated with ACE inhibitors. the risk of its development when taking the drug may be increased (see section "Contraindications"). There are reports of rare cases of the development of angioedema of the intestine during therapy with ACE inhibitors. Moreover, patients had abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases, without prior angioedema of the face and at a normal level of C1 esterase. The diagnosis was made using computed tomography of the abdominal region, ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) ultrasound or at the time of surgery. Symptoms disappeared after taking ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps) when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization
There are some reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps)) ACE inhibitors should be used with caution in patients with a burdened allergic history or a tendency to allergic reactions undergoing desensitization procedures, and the use of an ACE inhibitor in patients receiving immunotherapy with hymenoptera venom should be avoided. However, an anaphylactoid reaction can be avoided by temporarily disabling the ACE inhibitor at least 24 hours before the start of the desensitization procedure.
Anaphylactoid reactions during LDL apheresis
In rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions when performing LDL apheresis using dextran sulfate. To prevent anaphylactoid reaction, ACE inhibitor therapy should be temporarily discontinued before each apheresis procedure.
Hemodialysis
Anaphylactoid reactions have been observed in patients receiving ACE inhibitors when hemodialysis using high-flow membranes (e.g. AN69В®). Therefore, it is desirable to use a different type of membrane or to use an antihypertensive agent of another pharmacotherapeutic group.
Pregnancy
ACE inhibitors are contraindicated during pregnancy. If continued therapy with ACE inhibitors is necessary, patients should switch to other types of antihypertensive therapy with an established safety profile when taken during pregnancy. When pregnancy occurs, ACE inhibitors should be discontinued immediately and, if necessary, alternative antihypertensive therapy should be started (see sections “Contraindications” and “Use in Pregnancy and During Breastfeeding”).
Cough
Dry cough may occur during therapy with an ACE inhibitor. The cough persists for a long time while taking drugs of this group and disappears after they are canceled. If a patient develops a dry cough, one should remember the possible iatrogenic nature of this symptom. If the doctor believes that the patient needs an ACE inhibitor therapy, you can consider continuing to take the drug.
Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy
ACE inhibitors should be used with caution in patients with left ventricular outflow tract obstruction.
Ethnic differences
Perindopril, like other ACE inhibitors, apparently has a less pronounced antihypertensive effect in patients of the Negroid race compared to other races. Maybe, this difference is due to the fact that patients with arterial hypertension of the Negroid race are more likely to have low renin activity.
Surgery / General Anesthesia
The use of ACE inhibitors in patients undergoing surgery with general anesthesia can lead to a marked decrease in blood pressure, especially when using general anesthesia drugs that have antihypertensive effects.
It is recommended that you stop taking long-acting ACE inhibitors, including perindopril, as much as possible one day before surgery.
Patients with Renovascular Hypertension
Revascularization is a treatment for renovascular hypertension. However, the use of ACE inhibitors has a beneficial effect in patients both awaiting surgery, and when surgery is not possible.
When using the drug TriplexamВ® in patients with existing or suspected renal artery stenosis, treatment should be started in a low-dose hospital setting with constant monitoring of the state of the kidneys and the level of potassium in the blood, since such patients may develop functional renal failure, which disappears upon termination of therapy.
Atherosclerosis
The risk of arterial hypotension exists in all patients, however, special care should be taken when using the drug in patients with coronary heart disease and cerebrovascular insufficiency. In such patients, treatment should begin with low doses of the drug.
Perindopril / Indapamide.
Lithium preparations
The simultaneous use of a combination of perindopril and indapamide with lithium preparations is not recommended (see section "Interaction with other drugs").
Arterial hypotension and impaired water-electrolyte balance
The presence of initial hyponatremia is associated with the risk of sudden development of arterial hypotension (especially in patients with renal artery stenosis). Therefore, when monitoring patients, attention should be paid to possible symptoms of dehydration and a decrease in the electrolyte content in blood plasma, for example, after diarrhea or vomiting. Such patients need regular monitoring of plasma electrolytes. With severe arterial hypotension, intravenous administration of a 0.9% sodium chloride solution may be required.
Transient arterial hypotension is not a contraindication for continued therapy. After the restoration of BCC and blood pressure, you can resume therapy using low doses of the combination, or use the drug in monotherapy.
All diuretics can cause hyponatremia. which sometimes leads to serious complications. Hyponatremia at the initial stage may not be accompanied by clinical symptoms, therefore, regular laboratory monitoring is necessary. More frequent monitoring of the content of sodium ions is indicated for elderly patients and patients with cirrhosis (see sections "Side effects" and "Overdose").
Patients with diabetes
In patients with type 1 diabetes mellitus (risk of spontaneous increase in potassium ion content), treatment should begin with lower doses and under close medical supervision.
When prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral administration or insulin, regular monitoring of blood glucose concentration is necessary during the first month of therapy. It is necessary to control the level of glucose in the blood in patients with diabetes mellitus, especially in the presence of hypokalemia.
Amlodipine / perindopril
Hepatic insufficiency
In rare cases, while taking ACE inhibitors, cholestatic jaundice occurs. With the progression of this syndrome, fulminant liver necrosis develops, sometimes with a fatal outcome. The mechanism of development of this syndrome is unclear. If there is jaundice or a significant increase in the activity of “liver” enzymes in patients taking ACE inhibitors, you should stop taking the ACE inhibitor and consult a doctor (see the section "Side effects").
In patients with impaired liver function T and AUC of amlodipine increases. Amlodipine should be taken at the lowest doses and precautions should be taken, both at the beginning of treatment and when increasing the dose. In patients with severe hepatic insufficiency, the dose should be increased gradually, providing careful monitoring of the clinical condition.
TriplixamВ® has not been tested in patients with hepatic impairment. Given the influence of each component that is part of the drug, individually, TriplexixВ® is contraindicated in patients with severe hepatic impairment, and also requires special care when prescribed to patients with moderate to mild hepatic impairment.
Amlodipine / indapamide / perindopril
Renal impairment
The drug is contraindicated in patients with severe renal failure (CC less than 30 ml / min) (see section "Contraindications").
In patients with moderate renal insufficiency (CC 30–60 ml / min), the use of Triplexam® is contraindicated in dosages containing 10 mg of perindopril and 2.5 mg of indapamide (i.e. dosage of Triplexam® 5 mg + 2.5 mg + 10 mg and 10 mg + 2.5 mg + 10 mg).
In some patients with arterial hypertension without a previous obvious impairment of renal function, laboratory signs of functional renal failure may appear during therapy. In this case, treatment with the drug should be discontinued with a further opportunity to resume combination therapy using low doses of the drug, or use the components of the drug in monotherapy. Such patients need regular monitoring of serum potassium and creatinine ions - 2 weeks after the start of therapy and every 2 months thereafter. Renal failure often occurs in patients with severe chronic heart failure or an initial impaired renal function, including renal artery stenosis.
TriplexamВ® is not recommended for patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney.
There is a risk of arterial hypotension and / or renal failure (in the presence of chronic heart failure, dehydration and a decrease in electrolyte levels in blood plasma, etc.): in some pathological conditions, significant activation of RAAS can be noted, especially with severe hypovolemia and a decrease in the content blood plasma electrolytes (on the background of a salt-free diet or prolonged intake of diuretics), in patients with initially low blood pressure, renal artery stenosis (including bilateral), and chronic cardiac th failure or cirrhosis with edema and ascites.
Blockade of RAAS by ACE inhibitors may be accompanied by a sharp decrease in blood pressure and / or an increase in plasma creatinine concentration, indicating the development of functional renal failure. These phenomena are more often observed when taking the first dose of the drug or during the first two weeks of therapy. Sometimes these conditions develop sharply and the time of their onset can vary. In such cases, it is recommended to resume therapy starting from lower doses, gradually increasing them. In patients with coronary heart disease and cerebrovascular diseases, a sharp decrease in blood pressure can lead to myocardial infarction or impaired cerebral circulation.
Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly impaired renal function (plasma creatinine in adult patients is below 25 mg / L or 220 Ојmol / L). In elderly patients, creatinine levels should be evaluated taking into account age, body weight and gender.
At the beginning of treatment with diuretics, patients due to hypovolemia and hyponatremia may experience a temporary decrease in glomerular filtration rate and an increase in the concentration of urea and creatinine in blood plasma. This transient functional renal failure is not dangerous for patients with unchanged renal function, however, in patients with initial renal failure, its severity may increase. Patients with renal failure may take amlodipine in standard doses. Changes in plasma concentrations of amlodipine do not correlate with the degree of renal failure.
Special studies on the use of the drug TriplexamВ® in renal failure have not been conducted. When using the drug TriplixamВ® for renal failure, the effects noted when taking the individual components of the drug should be taken into account.
Potassium ion in plasma
Combined therapy with indapamide, perindopril and amlodipine does not prevent the development of hypokalemia, especially in patients with diabetes mellitus or renal failure. As with other antihypertensive agents in combination with a diuretic, regular monitoring of the content of potassium ions in the blood plasma is necessary.
Hyperkalemia may develop in some patients during treatment with ACE inhibitors. including perindopril. Risk factors for hyperkalemia are renal failure, impaired renal function, advanced age (> 70 years), diabetes mellitus, some concomitant conditions (dehydration, acute decompensation of cardiac activity, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamteren, amiloride), potassium preparations or potassium-containing substitutes for edible salt, as well as the use of other agents that increase the content of potassium ions in blood plasma (for example, heparin). The use of food additives / potassium preparations, potassium-sparing diuretics, potassium-containing salt substitutes can lead to a significant increase in blood potassium, especially in patients with impaired renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If combined use of the above drugs is necessary, treatment should be carried out with caution, against the background of regular monitoring of the content of potassium ions in the blood serum (see section "Interaction with other drugs"). Thiazide and thiazide-like diuretics are associated with a risk of hypokalemia. It is necessary to avoid hypokalemia (less than 3.4 mmol / l) in the following categories of patients at high risk: elderly patients and / or emaciated patients (even if they do not receive combined drug therapy), patients with cirrhosis with edema and ascites, patients with coronary heart disease, chronic heart failure. Hypokalemia in these patients enhances the toxic effect of cardiac glycosides and increases the risk of arrhythmias.
Patients with an extended QT interval also belong to the risk group, and it does not matter if this increase is caused by congenital causes or the effect of drugs.
Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, in particular polymorphic ventricular tachycardia of the pirouette type, which can be fatal. In all the cases described above, regular monitoring of the content of potassium ions in the blood plasma is necessary. The first measurement of the content of potassium ions must be carried out during the first week from the start of therapy.
If hypokalemia is detected, appropriate treatment should be prescribed.
Elderly patients
Before taking the drug, it is necessary to evaluate the functional activity of the kidneys and the content of potassium ions in blood plasma. At the beginning of therapy, the dose of the drug is selected, taking into account the degree of decrease in blood pressure, especially in the case of a decrease in the volume of circulating blood (BCC) and loss of electrolytes. Such measures can avoid a sharp decrease in blood pressure.
In elderly patients, an increase in dose should be carried out with caution (see sections "Dosage and Administration" and "Pharmacokinetics").
Effect on the ability to drive vehicles,
mechanisms Due to the possibility of weakness, dizziness during the use of the drug TriplixamВ®, care must be taken when driving vehicles and working with other technical devices that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tablet 5 mg + 1.25 mg + 5 mg: contains active ingredients of amlodipine besylate 6.935 mg, corresponds to 5.0 mg of amlodipine, 1.25 mg of indapamide and perindopril arginine 5 mg.
Dosage and administration
Inside, 1 tablet 1 time per day, preferably in the morning before meals.
The dose of TriplexamВ® is selected after a previous titration of doses of individual components. The maximum daily dose is 1 tablet at a dosage of 10.0 mg + 2.5 mg + 10.0 mg.
Special patient groups
Patients with renal failure (see Pharmacokinetics, Contraindications and Special Instructions)
TriplexamВ® is contraindicated in patients with severe renal failure (CC less than 30 ml / min) (see Contraindications ) For patients with moderate renal failure (CC 30-60 ml / min), TriplexamВ® is contraindicated in a dosage of 5.0 mg + 2.5 mg + 10.0 mg and 10.0 mg + 2.5 mg + 10.0 mg. It is recommended to start therapy with the selection of doses of monocomponents.
Ongoing medical supervision should include regular monitoring of plasma creatinine and potassium concentrations. Concomitant use with aliskiren is contraindicated in patients with impaired renal function (GFR <60 ml / min / 1, 73 m2 of body surface area) (see section "Contraindications").
Patients with hepatic impairment (see Pharmacokinetics Contraindications and Special Instructions)
Patients with severe hepatic insufficiency TriplexamВ® is contraindicated.
For patients with mild or moderate hepatic insufficiency, dose selection should be carried out with caution, since there are no unequivocal recommendations on the dosage of amlodipine for this group of patients.
Elderly patients (see section "Special instructions")
Excretion of perindoprilat in elderly patients is slowed down (See section "Pharmacokinetics"). Therapy should be carried out taking into account the function of the kidneys.
Pediatric Patients
There is currently no data on the safety and efficacy of TriplexamВ® in children and adolescents.
Side effects
The most common adverse reactions reported with perindopril are indapamide and amlodipine as monotherapy were: dizziness, headache, paresthesia, vertigo, drowsiness, visual impairment, tinnitus, palpitations, flushing of blood to the skin of the face, decreased blood pressure (and effects associated with hypotension), cough, shortness of breath gastrointestinal disturbances (abdominal pain, constipation, diarrhea, taste perversion, nausea, dyspepsia, vomiting), skin itching, rash, maculopapular rash, muscle cramps, swelling in the ankles, asthenia, swelling and fatigue.
Overdose of
There is no information on an overdose of Triplexam®.
Amlodipine
Information on overdose of amlodipine is limited.
Symptoms.
There is evidence of the development of excessive peripheral vasodilation with the possible development of reflex tachycardia. The risk of developing severe and persistent arterial hypotension, including with the development of shock and death.
Methods of providing medical care.
With clinically significant hypotension resulting from an overdose of amlodipine, it is necessary to carry out activities aimed at maintaining the function of the cardiovascular system, including placing the limbs in an elevated position, controlling bcc and urine output, and monitoring cardiac and respiratory activity.
To normalize vascular tone and blood pressure, vasoconstrictor drugs can be used, provided that there are no contraindications to their use. To eliminate the effects of calcium channel blockade, intravenous administration of calcium gluconate is possible.
In some cases, gastric lavage may be effective. In healthy volunteers, it has been demonstrated that the use of activated carbon within 2 hours after taking 10 mg of amlodipine reduces the rate of absorption of amlodipine.
Since amlodipine binds to proteins, hemodialysis is ineffective.
Combination of perindopril / indapamide
Symptoms
For the combination of perindopril / indapamide, the most likely symptom of an overdose is arterial hypotension, sometimes in combination with nausea, vomiting, convulsions, dizziness, drowsiness, confusion of consciousness and oligouria, which can go into anuria (as a result of hypovolemia). Electrolyte disturbances (hyponatremia, hypokalemia) may also occur.
Methods of providing medical care
Emergency measures are reduced to removing the drug from the body: washing the stomach and / or taking activated charcoal with the subsequent restoration of water-electrolyte balance.
With a significant decrease in blood pressure, the patient should be placed in the supine position with raised legs, and if necessary, correct hypovolemia (for example, intravenous infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed from the body by dialysis (see Pharmacokinetics)
Storage conditions
At a temperature not exceeding 25 ° C. Keep out of the reach of children.
Expiration
2 years.
Deystvuyuschee substances
amlodipine, indapamide, Perindopril
Conditions for the drugstore from
Prescription
Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. (amlodipine, indapamide, Perindopril) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Triplexam tablets coated film about 5 mg + 2.5 mg + 10 mg 30 pcs. - S
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