Description
Release form
Tablets.
Packing
30 pcs. 5 + 25 mg each.
Pharmacological action of
ramipril. An ACE inhibitor prevents the conversion of angiotensin I to angiotensin II without a compensatory increase in heart rate. It reduces the production of aldosterone, OPSS, pressure in the pulmonary capillaries, resistance in the pulmonary vessels, does not change the glomerular filtration rate, and enhances coronary blood flow. With prolonged use of the drug, myocardial hypertrophy in patients with arterial hypertension decreases, the frequency of arrhythmias decreases during myocardial reperfusion, and blood circulation of the ischemic myocardium improves. The cardioprotective effect is due to the effect on the synthesis of GHGs, the induction of the formation of nitric oxide in endotheliocytes. The drug reduces platelet aggregation. The onset of the hypotensive effect is 1.5 hours after ingestion, the maximum effect is 5 9 hours, the duration of action is 24 hours. Ramipril does not cause withdrawal syndrome.
hydrochlorothiazide. A thiazide diuretic, the diuretic effect of which is associated with a violation of the reabsorption of sodium, chlorine, potassium, magnesium, water ions in the distal nephron, delays the excretion of calcium ions, uric acid. It has antihypertensive properties. Virtually no effect on normal blood pressure. The diuretic effect occurs after 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours. The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. Ramipril and hydrochlorothiazide have an additive effect. Ramipril reduces the loss of potassium ions caused by hydrochlorothiazide.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Special instructions
Ramipril.
At the beginning of treatment, it is necessary to evaluate renal function. It is necessary to carefully monitor renal function during treatment with ramipril, especially in patients with impaired renal function, with damage to the renal vessels (for example, clinically insignificant renal artery stenosis or hemodynamically significant stenosis of a single kidney artery) with heart failure.
The risk of hypersensitivity and allergic-like (anaphylactoid) reactions is increased in patients who are taking ACE inhibitors and undergoing hemodialysis using AN69 dialysis membranes. Similar reactions were detected with apheresis of low density lipoproteins using dextran sulfate, so this method should be avoided when using ACE inhibitors.
During treatment with ramipril in patients with impaired renal function, especially with simultaneous treatment with diuretics, serum urea and creatinine levels may increase. In this case, treatment should be continued with lower doses of ramipril or discontinued. In patients with impaired renal function, the risk of hyperkalemia is increased.
In patients with impaired hepatic function, ramipril metabolism and the formation of an active metabolite may be slowed due to a decrease in the activity of ² Ñliver ² Ñ enzymes. In this regard, the treatment of such patients should be started only under strict medical supervision.
Caution must be exercised when administering ramipril to patients on a low-salt or salt-free diet (increased risk of developing arterial hypotension). In patients with reduced BCC (as a result of diuretic therapy), during dialysis, with diarrhea and vomiting, symptomatic hypotension may develop.
Transient arterial hypotension is not a contraindication for continued treatment after stabilization of blood pressure. In case of repeated occurrence of severe arterial hypotension, the dose should be reduced or the drug should be discontinued. In patients undergoing extensive surgery or receiving other hypotension-inducing agents during general anesthesia, ramipril may cause blockade of angiotensin II formation during compensatory release of renin. If the doctor associates the development of arterial hypotension with the mechanism mentioned above, arterial hypotension can be corrected by an increase in blood plasma volume.
In rare cases, agranulocytosis, erythrocytopenia, thrombocytopenia, hemoglobinemia, or bone marrow suppression are observed during treatment with ACE inhibitors. At the beginning and during treatment, it is necessary to control the number of white blood cells to identify possible neutropenia / agranulocytosis. More frequent monitoring is recommended in patients with renal failure, with connective tissue diseases (for example, systemic lupus erythematosus or scleroderma) and in patients simultaneously taking drugs that affect blood formation (see ² ÑInteractions ² Ñ). The counting of blood cells should also be carried out when clinical signs of neutropenia / agranulocytosis and increased bleeding occur.
In patients with arterial hypertension, treatment with ramipril rarely increases serum potassium levels. The risk of hyperkalemia increases with chronic heart failure, simultaneous treatment with potassium-sparing diuretics (spironolactone, amiloride, triamteren) and the appointment of potassium preparations.
When using ACE inhibitors during desensitizing therapy for aspen or bee venom, anaphylactoid reactions (eg arterial hypotension, shortness of breath, vomiting, skin rash) can occur, which can be life-threatening. Hypersensitivity reactions can occur with insect bites (such as bees or wasps). If it is necessary to carry out desensitizing treatment with bee or wasp venom, it is necessary to cancel ACE inhibitors and continue treatment with suitable drugs from other groups.
hydrochlorothiazide.
For the prevention of potassium and magnesium deficiency, a diet with their high content, potassium-sparing diuretics, potassium and magnesium salts are prescribed. Regular monitoring of plasma levels of potassium, glucose, uric acid, lipids and creatinine is required.
Influence on the ability to drive a car and machinery.
During treatment, care must be taken when driving vehicles, as well as during training in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Composition
Active substances: ramipril – 5 mg, hydrochlorothiazide – 25 mg.
Excipients: sodium lactose bicarbonate croscarmellose monohydrate sodium starch pregelatinized (starch 1500) sodium stearyl fumarate.
Dosage and Administration
Inside. The dose is selected individually. The daily dose for adults is 1 tablet. per day.
In case of mild or moderate renal impairment (Cl creatinine> 30 ml / min, serum creatinine approximately 3 mg / dl or 265 μmol / l), the usual dose of the drug is recommended. With Cl creatinine <30 ml / min, the drug is not recommended. The duration of therapy is not limited. Drug interactions No studies on interactions. Heparin causes a temporary increase in lipo activity Drug Interactions Ramipril. Enhances the inhibitory effect of ethanol on the central nervous system. Taking salt with food can reduce the antihypertensive effect of ramipril. The simultaneous use of ramipril and other blood pressure lowering drugs (e.g. diuretics, nitrates, tricyclic antidepressants, general anesthetics) leads to an increase in the antihypertensive effect of ramipril. The simultaneous administration of ramipril and potassium preparations or potassium-sparing diuretics can cause hyperkalemia. Vasopressor sympathomimetics (epinephrine, norepinephrine) may reduce the hypotensive effect of ramipril. In this regard, with simultaneous treatment, the level of blood pressure should be carefully monitored. Concurrent administration of ramipril and allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics increases the likelihood of changes in the peripheral blood picture (risk of developing leukopenia). The simultaneous administration of ramipril and lithium preparations leads to a decrease in lithium excretion, therefore it is necessary to control the concentration of lithium in the blood serum – the risk of toxic effects. ACE inhibitors can enhance the effect of hypoglycemic agents (for example, insulin or sulfonylurea derivatives), which in some cases can cause hypoglycemia. In this regard, blood sugar levels should be carefully monitored, especially at the beginning of joint use. The concurrent use of ramipril and NSAIDs (eg, acetylsalicylic acid and indomethacin) may attenuate the hypotensive effect of ramipril. In addition, concurrent use can cause hyperkalemia and increase the risk of impaired renal function. The concurrent use of ramipril with estrogens may attenuate the hypotensive effect. Concurrent use of heparin and ramipril can cause hyperkalemia. Anaphylactic and anaphylactoid reactions to stinging venom insects (possibly other allergens) are more pronounced during treatment with ACE inhibitors. hydrochlorothiazide. With the simultaneous use of digitalis glycosides with thiazide diuretics, the likelihood of toxic effects of glycosides (including increased ventricular irritability) increases due to the possible development of hypokalemia and hypomagnesemia. drugs that intensely bind to blood proteins (indirect anticoagulants, clofibrate, NSAIDs), enhance the diuretic effect of hydrochlorothiazide. The antihypertensive effect of hydrochlorothiazide is enhanced by vasodilators, beta-blockers, barbiturates, phenothiazines, tricyclic antidepressants, ethanol. Hydrochlorothiazide enhances the neurotoxicity of salicylates, weakens the effects of oral hypoglycemic agents, norepinephrine, epinephrine and anti-gout drugs, enhances the cardiotoxic and neurotoxic effects of lithium preparations, the effect of peripheral muscle relaxants, and reduces the excretion of quinidine. With the simultaneous administration of methyldopa, hemolysis may develop. Colestyramine reduces the absorption of hydrochlorothiazide. Hydrochlorothiazide reduces the effect of oral contraceptives. Overdose Ramipril. Symptoms: marked decrease in blood pressure, bradycardia, shock, disturbance of water-electrolyte balance, acute renal failure, stupor, dry mouth, weakness, drowsiness. Treatment: to give the patient a horizontal position with legs raised, in mild cases of overdose – gastric lavage, the introduction of adsorbents and sodium sulfate (it is advisable to carry out activities within the first 30 minutes after taking the drug). With a decrease in blood pressure – in / in the introduction of catecholamines, angiotensin II in bradycardia – the use of a pacemaker. The drug is not excreted during hemodialysis. Hydrochlorothiazide. Symptoms: hypokalemia (adynamia, paralysis, constipation, arrhythmias), drowsiness, decreased blood pressure. Treatment: infusion of electrolyte solutions compensation for K + deficiency (prescription of potassium and potassium-sparing diuretics). Storage conditions At a temperature not exceeding 25 ° C. Keep out of the reach and sight of children. active substance hydrochlorothiazide, Ramipril Terms leave through pharmacies In retseptu lekarstvennaja form tablets Prescription For adults prescribed by a doctor Indications Indications prevention of heart attacks and strokes, hypertension, heart failure, Renal KRKA d.d. Novo mesto AO, Slovenia
