Hartil pills 5 mg №28

Dosage form

Pills

Composition

1 pill contains: Ramipril 5 mg.
Excipients: sodium bicarbonate, lactose monohydrate, pregelatinized starch 1500, croscarmellose sodium, sodium fumarate.

Packaging

In the blister of 7 tablets. In a cardboard bundle 4 blisters.

Mechanism of action

Hartil - an antihypertensive drug, an ACE inhibitor. As a result of the suppression of ACE activity (regardless of plasma renin activity), the hypotensive effect develops (in the position of the patient lying and standing) without a compensatory increase in heart rate. Suppression of the activity of ACE increases the activity of renin in the blood plasma, reduces the levels of angiotensin II and aldosterone. Ramipril acts on the ACE, circulating in the blood and located in the tissues, including in the vascular wall. Reduces OPSS (afterload), pressure in the pulmonary capillaries (preload); increases cardiac output and increases exercise tolerance.
With prolonged use, ramipril contributes to the reverse development of myocardial hypertrophy in patients with arterial hypertension. Ramipril reduces the incidence of arrhythmias during myocardial reperfusion; improves blood supply to ischemic myocardium.Ramipril prevents the breakdown of bradykinin and stimulates the formation of nitric oxide (NO) in the endothelium.
The antihypertensive effect begins 1-2 hours after taking the drug by mouth, the maximum effect develops within 3-6 hours and lasts for 24 hours. With daily use, the antihypertensive effect is enhanced for 3-4 weeks and persists with long-term treatment (1-2 of the year). Antihypertensive efficacy does not depend on the sex, age and body weight of the patient.
In patients with acute myocardial infarction, ramipril limits the area of ​​necrosis, improves the prognosis of life; reduces mortality in the early and late period of myocardial infarction, the incidence of recurrent heart attacks; reduces the severity of manifestations of heart failure, slows its progression.
With prolonged use (at least 6 months), it reduces the degree of pulmonary hypertension in patients with congenital and acquired heart defects. Ramipril reduces pressure in the portal vein with portal hypertension; inhibits microalbuminuria (in the initial stages) and deterioration of renal function in patients with severe diabetic nephropathy. When non-diabetic nephropathy, accompanied by proteinuria (more than 3 g / day) and renal failure, slows down further deterioration of renal function, reduces proteinuria, reduces the risk of increased creatinine or the development of terminal renal failure.

Indications and usage

- Arterial hypertension.
- Chronic heart failure.
- Chronic heart failure after acute myocardial infarction in patients with stable hemodynamics.
- Diabetic nephropathy and chronic diffuse kidney disease (non-diabetic nephropathy).
- To reduce the risk of myocardial infarction, stroke or coronary death in high-risk cardiovascular patients with coronary artery disease, including patients after myocardial infarction, percutaneous transluminal coronary angioplasty, aorto-coronary bypass surgery.

Contraindications

- Angioedema in history, including associated with prior therapy with ACE inhibitors.
- Hemodynamically significant bilateral renal artery stenosis or arterial stenosis of a single kidney.
- Hypotension or unstable hemodynamics.
- Pregnancy.
- Lactation period (breastfeeding).
- Primary hyper aldosteronism.
- Renal failure (CC <20 ml / min).
- Hypersensitivity to ramipril or any other component of the drug.
Use with caution when:
- Hemodynamically significant aortic or mitral stenosis (the risk of an excessive decrease in blood pressure, followed by impaired renal function).
- Severe primary malignant arterial hypertension.
- Severe lesions of the coronary and cerebral arteries (the danger of reducing blood flow with an excessive decrease in blood pressure).
- Unstable angina.
- Severe ventricular arrhythmias.
- Terminal stage of CHF.
- Decompensated pulmonary heart.
- For diseases requiring the use of corticosteroids and immunosuppressants (no clinical experience) - including with systemic connective tissue diseases.
- Severe renal and / or liver failure.
- Hyperkalemia.
- Hyponatremia (including while taking diuretics and sodium-restricted diets).
- Initial or pronounced manifestations of fluid and electrolyte deficiency; conditions accompanied by a decrease in BCC (including diarrhea, vomiting), diabetes mellitus.
- Inhibition of bone marrow hematopoiesis.
- Condition after kidney transplantation.
- In elderly patients.
- In children and adolescents under the age of 18 years (efficacy and safety have not been established).
There is only limited experience with ramipril in patients on dialysis.

Pregnancy and breastfeeding

Use in pregnancy and lactation is contraindicated. The drug causes impaired development of the kidneys of the fetus, lowering blood pressure of the fetus and newborns, impaired renal function, hyperkalemia, cranial hypoplasia, oligohydramnios, contracture of the extremities, skull deformity, pulmonary hypoplasia.

Dosage and administration

Tablets should be taken orally, swallowing them whole, without chewing, washing down with a large amount of liquid (approximately 1 glass). pills can be taken regardless of meal times.Dose set individually with regard to therapeutic effect and tolerability.
For hypertension, recommended the initial dose is 2.5 mg 1 time / day. (1 pill 2.5 mg daily). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. The standard maintenance dose is 2.5-5 mg / day. (1 pill 2.5 mg or 1 pill 5 mg). The maximum daily dose should not exceed 10 mg.
In chronic heart failure The recommended initial dose is 1.25 mg 1 time / day. (daily 1 pill Hartila 1.25 mg). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need to take more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 doses. The maximum daily dose should not exceed 10 mg.
For treatment after myocardial infarction taking the drug is recommended to start at 2-9 days after acute myocardial infarction. The recommended initial dose, depending on the condition of the patient and the time elapsed after an acute myocardial infarction, is 2.5 mg 2 times / day. (2 pills of 1.25 mg or 1 pill 2.5 mg 2 times / day.). Depending on the therapeutic effect, the initial dose can be doubled to 5 mg (2 pills of 2.5 mg or 1 pill of 5 mg) 2 times / day. The maximum daily dose should not exceed 10 mg. In case of intolerance of the drug should reduce the dose.
With non-diabetic or diabetic nephropathy The recommended initial dose is 1.25 mg (1 pill 1.25 mg) 1 time / day. daily.Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If necessary, receiving more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 doses. The recommended maximum daily dose is 5 mg.
In order to prevent myocardial infarction, stroke or death from cardiovascular disorders The recommended initial dose is 2.5 mg 1 time / day. Depending on the tolerability of the drug, after 1 week of intake, the dose should be doubled compared with the initial dose. This dose should be doubled again after 3 weeks of administration. The recommended maintenance dose is 10 mg 1 time / day.
Use in elderly patients taking diuretics and / or heart failure, as well as in violation of the function of the liver or kidneys: the dose should be determined by individual selection depending on the patient's response to treatment.
Patients with renal failure correction of dosing regimen required. With moderate renal dysfunction (CC from 20 to 50 ml / min per 1.73 m2 of body surface), the initial dose is usually 1.25 mg 1 time / day. (1 pill 1.25 mg / day.). The maximum daily dose should not exceed 5 mg. If CC is not measured, it can be calculated from the serum creatinine level using the Cockroft formula. For men: QC (ml / min) = (140 - age) x body weight (kg) / 72 x serum creatinine (mg / dL). For women: the result of the calculation should be multiplied by 0.85.
With abnormal liver function the reduced or increased effect of the drug Hartil may equally often be observed, so careful medical supervision is required in the early stages of treatment of this category of patients. The maximum daily dose in such cases should not exceed 2.5 mg.
Use for patients receiving diuretic therapy: Because of the risk of a significant reduction in blood pressure, the possibility of temporary cancellation or at least a reduction in the dose of diuretics no less than 2-3 days (or longer, depending on the duration of the action of diuretics) should be considered before starting the administration of Hartil. For patients who have previously received diuretics, the initial dose is usually 1.25 mg.

Since the cardiovascular system: lowering blood pressure, orthostatic hypotension, tachycardia; rarely - arrhythmia, increased circulatory disorders of the organs caused by narrowing of blood vessels. With an excessive decrease in blood pressure, mainly in patients with coronary artery disease and clinically significant narrowing of cerebral vessels, myocardial ischemia (angina or myocardial infarction) and cerebral ischemia (possibly with dynamic impairment of cerebral circulation or stroke) can develop.
From the urinary system: development or strengthening of renal failure, strengthening of existing proteinuria, reducing urine volume (at the beginning of the drug).
From the side of the central nervous system and peripheral nervous system: dizziness, headache, weakness, drowsiness, paresthesias,nervous irritability, anxiety, tremó, muscle spasm, mood disorders; when used in high doses - insomnia, anxiety, depression, confusion, fainting.
From the senses: vestibular disorders, taste disorders (for example, metallic taste), smell, hearing and vision, tinnitus.
From the digestive system: nausea, vomiting, diarrhea or constipation, pain in the epigastric region, dry mouth, thirst, loss of appetite, stomatitis, hypersensitivity or inflammation of the buccal mucosa, pancreatitis; rarely - hepatitis, cholestatic jaundice, abnormal liver function with the development of acute liver failure.
On the part of the respiratory system: dry cough, bronchospasm (in patients with increased excitability of the cough reflex), shortness of breath, rhinorrhea, rhinitis, sinusitis, bronchitis.
From the side of blood-forming organs: anemia, decrease in hemoglobin and hematocrit, thrombocytopenia, leukocytopenia, neutropenia, agranulocytosis, pancytopenia, hemolytic anemia, decrease in the number of red blood cells, inhibition of bone marrow hematopoiesis.
From the laboratory indicators: hypercreatininemia, increased urea nitrogen level, increased liver transaminase activity, hyperbilirubinemia, hyperkalemia, hyponatremia; extremely rarely - an increase in the titer of antinuclear factor.
Allergic reactions: skin rash, pruritus, urticaria, conjunctivitis, photosensitization; rarely - angioedema of the face, extremities, lips, tongue, pharynx or larynx, exfoliative dermatitis, erythema multiforme (includingStevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), pemphigus (pemphigus), serositis, onycholysis, vasculitis, myositis, myalgia, arthralgia, arthritis, eosinophilia.
Other: Alpetia, hyperthermia, sweating.

During treatment with the drug Hartil requires regular medical supervision. After taking the first dose, as well as increasing the dose of diuretic and / or Hartil, patients should be under the supervision of a physician for 8 hours in order to avoid the development of an uncontrolled hypotensive reaction; multiple blood pressure measurement is recommended. If possible, you should adjust the dehydration, hypovolemia, reducing the number of red blood cells before taking the drug. If these disorders are severe, taking ramipril should not be started or continued until measures are taken to prevent an excessive fall in blood pressure and impaired renal function.
Careful observation is required for patients with lesions of the renal vessels (for example, clinically insignificant stenosis of the renal artery or hemodynamically significant stenosis of the artery of a single kidney), impaired renal function, with a marked decrease in blood pressure, mainly in patients with heart failure, and after kidney transplantation.
Impaired renal function can be detected by elevated levels of urea and serum creatinine, especially if the patient is taking diuretics. Due to a decrease in the synthesis of angiotensin II and the secretion of aldosterone in serum, sodium levels may decrease and potassium levels increase.Hyperkalemia is more common in patients with impaired renal function (for example, in diabetic nephropathy) or when taken simultaneously with potassium-sparing diuretics. In the case of an excessive decrease in blood pressure of the patient should be laid, lift the legs; fluids and other measures may also be required. Changes in the blood are more likely in patients with impaired renal function and concomitant connective tissue disease (for example, SLE and scleroderma), as well as in the case of using other drugs that affect the hematopoietic and immune systems. Serum sodium levels should also be regularly monitored in patients taking diuretics at the same time as Hartil. You should also regularly check the number of leukocytes in order to avoid the development of leukopenia. Monitoring should be more frequent at the start of therapy and in patients belonging to any risk group.
Experience with ramipril in patients with severe renal insufficiency (CC <20 ml / min / 1.73 sq. M. Of body surface) and in patients during dialysis is limited.
There are reports of life-threatening anaphylactoid reactions, sometimes turning into shock, in patients on hemodialysis using membranes with high hydraulic permeability (for example, from polyacrylonitrile) with simultaneous administration of ACE inhibitors. Anaphylactoid reactions were also observed in patients undergoing apheresis of low-density lipoproteins with absorption of dextran sulfate.
When desensitizing therapy is carried out to reduce an allergic reaction to insect bites (for example, bees and wasps), a severe, life-threatening anaphylactoid reaction (drop in blood pressure, respiratory failure, vomiting, skin reactions) can occur while taking ACE inhibitors. Therefore, ACE inhibitors should not be given to patients receiving desensitization therapy.
In case of lactase deficiency, galactosemia, or glucose / lactose absorption disorder syndrome, it should be taken into account that each pill of Hartil 10 mg contains 193.2 mg of lactose.
Use in pediatrics: experience with ramipril in children with severe renal insufficiency (CC <20 ml / min / 1.73 m2 of body surface) and during dialysis is limited.
Influence on ability to drive motor transport and control mechanisms: At the beginning of treatment, a decrease in blood pressure may affect the ability to concentrate. In this case, patients are advised to refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed. In the future, the degree of limitation is determined for each patient individually.

With the simultaneous use of Hartil with Allopurinol, corticosteroids, procainamide, cytostatics and other substances that cause changes in the blood, the risk of disturbances from the hematopoietic system increases.With the simultaneous use of the Hartil with hypoglycemic drugs (insulin or sulfonylurea derivatives), an excessive decrease in the blood sugar level is possible. This phenomenon may be due to the fact that ACE inhibitors can increase the sensitivity of tissues to insulin . With simultaneous use with other antihypertensive agents (including diuretics) or other agents with hypotensive effect (for example, nitrates, tricyclic antidepressants and anesthetics): it is possible to enhance the antihypertensive action. Simultaneous reception with ramipril of potassium salts and potassium-sparing diuretics, Heparin is not recommended due to the risk of hyperkalemia. With simultaneous use with lithium preparations, an increase in the concentration of lithium in the blood serum is observed, which leads to an increase in the risk of cardio and nephrotoxicity. NSAIDs and sodium salts reduce the effectiveness of ACE inhibitors.

Symptoms: pronounced decrease in blood pressure, bradycardia, shock, impaired water and electrolyte balance, acute renal failure .
Treatment: in the case of a light overdose - gastric lavage, the introduction of adsorbents and sodium sulfate (preferably within 30 minutes after ingestion). In acute overdose: control and support of vital functions in the ICU; with a decrease in blood pressure - the introduction of catecholamines and angiotensin II. The patient should be laid on his back with an elevated position of the legs, to introduce additional amounts of fluid and sodium. It is not known whether ramipril excretion accelerated diuresis, hemofiltration and correction of urine pH.This should be considered when considering the possibility of hemodialysis and hemofiltration.

The drug should be stored at temperatures below 25 ° C.

2 years.