CHARTIL-D PILLS 2.5 MG/12.5 MG
CHARTIL-D PILLS 2.5 MG/12.5 MG - 28 TABS
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Symptoms of arterial hypotension
In patients with uncomplicated arterial hypertension, symptoms of arterial hypotension are rarely observed. In patients with arterial hypertension who take ramipril, the likelihood of arterial hypotension increases with a decrease in circulating blood volume (for example, as a result of diuretic treatment, restriction of salt intake, dialysis, diarrhea or vomiting), as well as in severe forms of renin-dependent arterial hypertension. Symptoms of arterial hypotension were observed in patients with heart failure, regardless of whether it is combined with renal failure. This is most often observed in patients with more severe heart failure, who are forced to take high doses of "loop" diuretics, in whom hyponatremia or functional renal failure is observed. Patients with an increased risk of arterial hypotension require close observation in the initial period of treatment and in the selection of the dose. This also applies to patients with coronary heart disease or vascular disease of the brain, in which a significant drop in blood pressure can lead to myocardial infarction or impaired cerebral circulation. In case of arterial hypotension, the patient should be placed on his back, his legs raised and, if necessary, intravenous infusion of sodium chloride solution.Transient hypotensive reaction is not a contraindication for subsequent administration of the drug. In some heart failure patients with normal or low BP, ramipril may cause an additional decrease in systolic BP. This effect can be foreseen, so it is usually not a reason to stop treatment. If hypotension is manifested by symptoms, it may be necessary to reduce the dose or discontinue treatment.
Aortic and mitral stenosis / hypertrophic cardiomyopathy
Like other ACE inhibitors, ramipril requires caution when prescribing to patients with aortic stenosis or difficulty of ejection from the left ventricle (for example, in aortic stenosis or hypertrophic cardiomyopathy). In some cases, the hemodynamic pattern may make it unacceptable to take a fixed combination of ramipril and hydrochlorothiazide.
Primary aldosteronism (Conn's disease)
The use of fixed combinations of ramipril and hydrochlorothiazide is contraindicated, because patients with primary aldosteronism are not sensitive to antihypertensive agents, which are based on the suppression of the renin-angiotensin system.
Patients with heart failure at the beginning of treatment with ACE inhibitors may experience renal impairment. In such situations, described cases of acute renal failure , usually transient.
In some patients with narrowing of both renal arteries or with stenosis of the artery of a single kidney, ACE inhibitors increase the level of urea in the blood and creatinine in the blood serum; usually, these changes disappear after stopping the medication. The likelihood of this is especially high in renal failure. In the presence of renovascular hypertension, there is a high risk of developing severe arterial hypotension and renal failure. In such patients, treatment should begin under close medical supervision with small doses, which should be carefully selected. Since diuretics can contribute to the clinical dynamics described above, they should be discontinued during the first weeks of ramipril treatment, and renal function needs careful monitoring.
In some patients with arterial hypertension without obvious kidney disease, taking ramipril, especially against the background of diuretics, causes an increase in blood urea and creatinine in serum; these changes are usually minor and transient. The probability of their occurrence is higher in patients already suffering from renal dysfunction. In such cases, it may be necessary to reduce the dose and / or stop taking diuretic and / or ramipril.
Condition after kidney transplantation
Due to the lack of experience with the use of ramipril in patients who have recently undergone kidney transplantation, ramipril is not recommended for such patients.
Increased sensitivity / angioedema
Angioedema of the face, extremities, lips, tongue, vocal cords and / or larynx rarely develops in patients receiving ACE inhibitors, including ramipril. During treatment, angioedema can develop at any time. In this case, the reception of ramipril should be immediately discontinued, appropriate treatment should be carried out and patient monitoring should be established; Before letting go of the patient, make sure that all the symptoms of edema are eliminated. Even in cases where the edema is limited only to the tongue and there are no signs of impaired breathing, patients may need long-term follow-up, since treatment with angistamines and corticosteroids may not be sufficient. In rare cases, death of patients due to angioedema of the larynx or tongue has been recorded.
If the edema spreads to the tongue, vocal cords or larynx, it is very likely that the airways overlap, especially in patients who have previously undergone respiratory surgery. In such cases, it is necessary to take emergency treatment measures (see section Overdose). It may include the administration of epinephrine (adrenaline) and / or the maintenance of the airway. The patient must be under close medical supervision until the symptoms disappear completely and permanently.
In patients with a history of angioedema that is not associated with taking an ACE inhibitor, the risk of developing angioedema in response to taking an ACE inhibitor may be increased.
Anaphylactoid reactions in patients receiving hemodialysis treatment
There are reports of anaphylactoid reactions in patients on hemodialysis using membranes with high hydraulic permeability (for example, AN 69) with simultaneous use of ACE inhibitors. In such cases, the use of another type of membrane or antihypertensive drugs of another class should be considered.
Anaphylactoid reactions in the apheresis of low-density lipoprotein (LDL)
In rare cases, patients taking an ACE inhibitor during low-density lipoprotein (LDL) apheresis with dextran sulfate develop life-threatening anaphylactoid reactions. Such reactions can be avoided by temporarily refraining from taking an ACE inhibitor before each apheresis procedure.
Long-term anaphylactoid reactions develop in patients taking ACE inhibitors during desensitization therapy (for example, with hymenoptera). If such patients refrained from taking ACE inhibitors for the period of desensitization, no reactions were observed, however, the accidental administration of ACE provoked an anaphylactoid reaction.
Associated with the use of ACE inhibitors is the development of a rare syndrome,which begins with cholestatic jaundice or hepatitis and turns into transient liver necrosis, sometimes with a fatal outcome. The mechanism for the development of this syndrome is not clear. If patients taking ramipril develop jaundice or significantly increase the activity of liver enzymes, the drug should be discontinued, leaving the patient under medical supervision until the symptoms disappear.
Neutropenia / Agranulocytosis
It has been reported that patients taking ACE inhibitors may develop neutropenia / agranulocytosis, thrombocytopenia and anemia. With normal kidney function and in the absence of complications, neutropenia rarely develops. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor. Extreme caution should be exercised when prescribing ramipril to patients suffering from connective tissue diseases with vascular manifestations, undergoing treatment with antidepressants, taking Allopurinol or procainamide, as well as a combination of these factors, especially against the background of renal dysfunction. Some of these patients develop severe infections that are not always amenable to intensive antibiotic therapy. If ramipril is used in the treatment of such patients, it is recommended to periodically check the number of leukocytes, and patients should be warned to report any signs of infection.
ACE inhibitors more often cause the development of angioedema in patients of the Negroid race as compared with patients of a different race.
Like other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black patients than in other races, possibly due to a higher incidence of people with low renin levels in a population of black patients suffering from hypertension.
It has been reported that taking ACE inhibitors may be accompanied by coughing. Characteristically, the cough is dry and persistent; It passes after drug withdrawal. The fact that a cough is caused by taking an ACE inhibitor should be considered a differential diagnostic sign.
Surgical intervention / general anesthesia
In patients undergoing surgery or general anesthesia with drugs that reduce blood pressure, ramipril can block the increase in the formation of angiotensin II under the influence of compensatory renin release. If it is assumed that arterial hypotension develops by this mechanism, it can be corrected by increasing the volume of circulating blood.
Some patients taking ACE inhibitors, including ramipril, have an increase in serum potassium. At risk of developing hyperkalemia include patients suffering from renal failure or diabetes, taking potassium-sparing diuretics, or potassium-containing salt substitutes, as well as those who take other drugs that increase serum potassium levels (eg, heparin).If taking the drugs listed above while being treated with an ACE inhibitor is deemed necessary, regular monitoring of serum potassium levels is recommended (see Interaction section).
Patients with diabetes
In patients with diabetes mellitus, taking hypoglycemic agents for oral administration or insulin , it is necessary to carefully monitor blood sugar levels during the first month of treatment with an ACE inhibitor (see the Interaction section).
It is usually not recommended to combine lithium and ramipril intake (see the Interaction section).
Potassium-containing dietary supplements, potassium-saving diuretics, or potassium-containing salt substitutes
Although serum potassium levels in clinical trials of ACE inhibitors usually remained within the normal range, some patients still developed hyperkalemia. The risk of developing hyperkalemia is associated with a number of factors, including renal failure, diabetes mellitus and simultaneous intake of potassium-saving diuretics (for example, spironolactone, triamterene or amiloride), as well as potassium-containing food additives or salt substitutes. The use of potassium-containing dietary supplements, potassium-sparing diuretics, or potassium-containing salt substitutes can lead to a significant increase in serum potassium, especially in patients with impaired renal function.
While taking ramipril on the background of potassium-diuretic diuretics, the hypokalemia caused by their intake may be weakened.
In patients with kidney disease, thiazides may cause azotemia. Taking medication on the background of renal dysfunction can lead to cumulative effects. If renal failure is progressing, characterized by an increase in non-protein nitrogen, the need for therapy should be carefully assessed and the possibility of stopping diuretics should be considered.
Patients with impaired or progressive liver dysfunction should be prescribed thiazides with caution, since even minor fluctuations in water and electrolyte balance can cause hepatic coma.
Metabolic and endocrine effects
Thiazide therapy may decrease glucose tolerance. In case of diabetes mellitus, it may be necessary to adjust the dose of insulin or oral hypoglycemic agents.
Thiazide therapy may cause latent diabetes.
Thiazide diuretic is associated with increased cholesterol and triglyceride levels. Some patients receiving thiazide diuretics may experience an increase in uric acid levels or manifestations of gout.
In some patients, thiazide therapy may increase uric acid levels and / or cause gout. However, ramipril can increase the excretion of uric acid, thus weakening the degree of increase in uric acid levels under the influence of hydrochlorothiazide.
Disorders of water and electrolyte balance
Any patient receiving diuretic treatment should periodically determine the content of electrolytes in the blood serum.
Thiazides, including hydrochlorothiazide, can cause a disturbance of water and electrolyte balance (hypokalemia, hyponatremia, and hypochloraemic alkalosis). Precursors to water or electrolyte imbalance are dry mouth, thirst, weakness, lethargy, drowsiness, anxiety, myalgia or muscle spasms, muscle fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disorders such as nausea and vomiting.
Although the use of thiazide diuretics may lead to the development of hypokalemia, while taking ramipril, it is possible to reduce the severity of hypokalemia caused by diuretics. The probability of the development of hypokalemia is highest with liver cirrhosis, in patients with elevated diuresis, with inadequate oral electrolyte intake, and also during treatment with corticosteroids and ACTH (see the Interaction section). In hot weather, hyponatremia may develop in patients with peripheral edema. Chloride deficiency is usually insignificant and does not require treatment. Thiazides can reduce the excretion of calcium ions in the urine, leading to a slight periodic increase in the level of calcium in the blood, even in the absence of obvious violations of calcium metabolism. Explicit hypercalcemia may indicate latent hyperparathyroidism.Reception of thiazides should be discontinued until the results of the study of the function of the parathyroid glands are obtained. It has been shown that thiazides increase the renal excretion of magnesium, which can lead to a decrease in the level of magnesium in the blood.
Neutropenia / Agranulocytosis
You should stop taking a combination of fixed doses of ramipril and hydrochlorothiazide in case of or suspected neutropenia (the number of neutrophils less than 1000 / mm3).
Anti doping tests
Hydrochlorothiazide, which is part of this drug, can give a positive reaction with anti-doping control.
Regardless of the history of allergies or asthma, hypersensitivity reactions may develop in patients. It was reported about the possibility of exacerbation of systemic lupus erythematosus.
This drug contains lactose monohydrate.
It should not be prescribed to patients with rare hereditary disorders of tolerance to galactose, hereditary lactose deficiency or glucose-galactose absorption disorder syndrome.
each tablet containsactive substances:2.5 mg ramipril and 12.5 mg hydrochlorothiazide.
Excipients:lactose monohydrate, hypromellose, crospovidone, microcrystalline cellulose, sodium stearyl fumarate.
Hartil-D should be taken once daily in the morning with plenty of fluids.The drug can be taken regardless of the meal. pills are not intended to be divided into parts.
It is recommended to prescribe the combined drug Hartil-D only after an individual selection of doses of each of the components. The dose can be increased with an interval of at least 3 weeks. The usual starting dose is 2.5 mg ramipril and 12.5 mg hydrochlorothiazide. The usual maintenance dose is 2.5 mg ramipril and 12.5 mg hydrochlorothiazide or 5 mg ramipril and 25 mg hydrochlorothiazide. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.
Elderly patients and patients with impaired renal function
For elderly patients and patients with QA from 30 to 60 ml / min. Individual doses of each of the components (ramipril and hydrochlorothiazide) must be carefully selected before switching to the combined drug Hartil-D.
The dose of the drug Hartil-D should be as low as possible. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.
Hartil-D is contraindicated in patients with severely impaired renal function, i.e., when CC is less than 30 ml / min / 1.73 m2.
Before switching to Hartil-D, patients with mild or moderate hepatic impairment should be given a dose of ramipril.
Hartil-D is not allowed to be taken by patients with severely impaired liver function and / or cholestasis (see section Contraindications).
Children and teenagers (under the age of 18)
Charter-D is not recommended for children and adolescents (under the age of 18 years) due to the lack of safety and efficacy data for this age group.
A number of adverse reactions have been noted while taking ACE inhibitors, ramipril or hydrochlorothiazide.
Severe arterial hypotension was observed at the beginning of the course of treatment and after increasing the dose. This effect is especially characteristic of some risk groups. Symptoms such as dizziness, general weakness, blurred vision may occur, sometimes in combination with loss of consciousness (fainting). Individual cases of tachycardia, palpitations, arrhythmias, angina pectoris, myocardial infarction, severe arterial hypertension and shock, dynamic cerebral circulation disturbance, cerebral hemorrhage and ischemic stroke were observed while taking ACE inhibitors against arterial hypotension.
The frequency of side effects is determined as follows: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1/10 000), including in isolated cases.
On the part of the blood system: rarely - a decrease in the concentration of hemoglobin and hematocrit, leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia, eosinophilia, hemolytic anemia in patients with deficiency of glucose-6-phosphate dehydrogenase.
From the laboratory parameters: often - hypokalemia, increased levels of uric acid, urea and creatinine in the blood, hyperglycemia,gout; infrequently - hyperkalemia, hyponatremia, hypomagnesemia, hyperchloraemia, hypercalcemia; rarely, water and electrolyte balance disorders (especially in patients with kidney disease), hypochloremia, metabolic alkalosis; very rarely - an increase in the level of trigitseridov in the serum, hypercholesterolemia, increased serum amylase, decompensation of diabetes.
From the side of the central nervous system: often - dizziness, fatigue, headache, weakness; infrequently - apathy, nervousness, drowsiness; rarely - a sense of fear, confusion, sleep disturbances, anxiety, disturbances of smell, imbalance, paresthesia.
On the part of the organ of vision: infrequently - conjunctivitis, blepharitis; rarely - transient myopia, blurred vision.
From the organ of hearing: rarely - ringing in the ears.
From the cardiovascular system: a pronounced decrease in blood pressure; infrequently - ankles swelling; rarely - fainting, thromboembolic complications; very rarely - angina pectoris, myocardial infarction, arrhythmias, palpitations, tachycardia, dynamic cerebrovascular accident, cerebral hemorrhage, exacerbation of the course of Raynaud’s disease, vasculitis, venous disease, thrombosis, embolism.
On the part of the respiratory system: dry cough, bronchitis; rarely - shortness of breath, sinusitis, rhinitis, pharyngitis, glossitis, bronchospasm, allergic interstitial pneumonia; very rarely, angioedema with a fatal airway obstruction *, pulmonary edema due to increased sensitivity to hydrochlorothiazide.
On the part of the digestive system: nausea, abdominal pain, vomiting, dyspepsia ; infrequently - spasms in the epigastric region, thirst, constipation, diarrhea, loss of appetite; rarely - dry mouth, vomiting, taste disorders, inflammation of the mucous membranes of the mouth and tongue, sialadenitis, glossitis; very rarely - intestinal obstruction , hemorrhagic pancreatitis.
On the part of the liver: rarely - increased activity of liver enzymes and / or bilirubin **; very rarely - cholestatic jaundice **, hepatitis, cholecystitis (against the background of cholelithiasis), liver necrosis.
Dermatological reactions: infrequently - photosensitivity, pruritus, urticaria; rarely - flushing of the skin of the face, increased sweating, peripheral edema; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin reactions such as psoriatic or pemphigoid, systemic lupus erythematosus, alopecia, exacerbation of psoriasis, onycholysis.
If skin reactions are pronounced, an urgent consultation with a doctor is necessary. It has been reported that taking this drug can lead to a symptom complex represented by at least one of the following components: fever, vasculitis, myalgia, arthralgia / arthritis, a positive reaction to anti-nuclear antibodies, increased ESR, eosinophilia and leukocytosis, rash, photosensitization (other skin manifestations are also possible).
On the part of the musculoskeletal system: rarely - muscle spasm, myalgia, arthralgia, muscle weakness, arthritis; very rarely - paralysis.
From the urinary system: infrequently - proteinuria; rarely - deterioration of kidney function, increased residual nitrogen and serum creatinine, dehydration; very rarely - acute renal failure, nephrotic syndrome, interstitial nephritis, oliguria.
On the part of the reproductive system: infrequently - decreased libido; rarely - impotence.
Allergic reactions: very rarely - Anaphylactic reactions , angioedema *.
* - angioedema often develops in people of the Negroid race. In a small group of patients, the occurrence of angioedema of the face and oropharyngeal region is associated with the use of ACE inhibitors.
** - in the case of jaundice or increased activity of the liver enzymes of the patient must be observed.