Amprilan - instructions for use, reviews, analogs and forms of release (tablets of 1.25 mg, 2.5 mg, 5 mg and 10 mg, 2.5 mg + 12.5 mg of NL, 5 mg + 25 mg of ND with a diuretic) a drug for the treatment of hypertension in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Amprilan. Comments of visitors of the site - consumers of this medication, as well as opinions of specialists on the use of Amprilan in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Amprilan in the presence of existing structural analogues. Use to treat hypertension and reduce blood pressure in adults, children, as well as during pregnancy and lactation.

 

Amprilan - long-acting ACE inhibitor. ACE catalyzes the conversion of angiotensin 1 into angiotensin 2. ACE is identical to kinase (an enzyme that catalyzes the breakdown of bradykinin). The ACE blockade leads to a decrease in angiotensin 2 concentration, an increase in renin activity in the blood plasma, an increase in the effect of bradykinin and an increase in the secretion of aldosterone, which may be the reason for an increase in serum potassium levels.

 

The antihypertensive and hemodynamic effects of Ramipril (the active substance of the drug Amprilan) in patients with arterial hypertension are the result of vasodilatation and a decrease in OPSS, resulting in a gradual decrease in blood pressure. Heart rhythm usually does not change. With prolonged treatment, hypertrophy of the left ventricle decreases without a negative effect on the function of the heart. The hypotensive effect after taking a single dose is manifested in 1-2 hours, reaches a maximum after 3-6 hours and lasts 24 hours.

 

Ramipril is effective in the treatment of chronic heart failure. In patients with signs of chronic heart failure after myocardial infarction, the drug reduces the risk of sudden death, the progression of heart failure and reduces the number of hospitalizations for heart failure.

 

As in patients with diabetes, and without it, the drug significantly reduces the existing microalbuminuria and the risk of developing nephropathy. These effects are observed in patients with both elevated and normal BP.

 

Amprilan NL and ND - a combined antihypertensive drug containing an ACE inhibitor and a diuretic.

 

Hydrochlorothiazide is a thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron.

 

Delays excretion of calcium ions, uric acid. Has antihypertensive effect, which develops due to the expansion of arterioles. Virtually no effect on normal blood pressure. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts for 6-12 hours.

 

Ramipril and hydrochlorothiazide have an additive effect. Ramipril reduces the loss of potassium ions caused by the intake of hydrochlorothiazide.

 

Composition

 

Ramipril + excipients.

 

Ramipril + Hydrochlorothiazide + excipients (Amprilan ND and NL).

 

Pharmacokinetics

 

After ingestion, ramipril is quickly absorbed from the digestive tract, the absorption is 50-60%. Eating does not slow down absorption. Ramipril is metabolized in the liver with the formation of an active metabolite - ramiprilata, whose activity is 6 times higher than that of ramipril and inactive diketopiperazine, which is then glucuronized. The binding of ramipril with plasma proteins is about 73%, ramiprilata - 56%. Ramipril and ramiprilate are excreted from the body mainly by the kidneys (about - 60%) mainly in the form of metabolites, less than 2% of the accepted dose is excreted as unchanged ramipril. Ramipril is excreted in several stages.

 

The pharmacokinetics of ramipril and hydrochlorothiazide with simultaneous administration does not differ from that in their separate administration.

 

Indications

• arterial hypertension;
• chronic heart failure (CHF) (as part of combination therapy), incl. developed on 2-9 days after myocardial infarction;
• diabetic nephropathy and nondiabetic nephropathy on the background of chronic diffuse kidney diseases (preclinical and clinical stages), incl. chronic glomerulonephritis with severe proteinuria;
• reducing the risk of myocardial infarction, stroke, and cardiovascular death in patients at high cardiovascular risk, including patients with documented coronary heart disease (myocardial infarction, or without it), patients undergoing percutaneous transluminal coronary angioplasty, coronary bypass surgery, stroke in the anamnesis and patients with occlusive lesions of peripheral arteries.

 

Forms of release

 

Tablets of 1.25 mg, 2.5 mg, 5 mg and 10 mg.

 

Tablets 2.5 mg + 12.5 mg (Amprilan NL).

 

Tablets 5 mg + 25 mg (Amprilan ND).

 

Instructions for use and dosage

 

Tablets taken orally, as a whole, without chewing, with a sufficient quantity of liquid, regardless of the meal.

 

The dose is selected depending on the therapeutic effect and the tolerance of the drug to the patient.

 

Amprilan treatment is long, its duration in each case is determined by the doctor.

 

Arterial hypertension

 

The recommended initial dose of Amprilan is 2.5 mg once a day. Depending on the patient's reaction, the dose can be doubled with a 1-2 week interval. Usually the maintenance dose is 2.5-5 mg per day, the maximum daily dose is 10 mg.Patients taking diuretics should cancel or reduce their dose at least 3 days before the start of Amprilan.

 

Chronic heart failure

 

The recommended initial dose of Amprilan is 1.25 mg once a day. Depending on the therapeutic effect, the dose can be doubled with an interval of 1-2 weeks. The maximum daily dose is 10 mg. In patients receiving large doses of diuretics, before the start of therapy with Amprilan, the dose of diuretics must be reduced.

 

Heart failure, developed for several days (from 2 to 9 days) after acute myocardial infarction

 

The recommended initial dose is 5 mg per day, divided into 2 single doses of 2.5 mg (1 tablet), one of which is taken in the morning, and the second in the evening. If the patient does not tolerate the initial dose (there is an excessive decrease in blood pressure), it should be reduced to 1.25 mg twice a day. Then, depending on the patient's reaction, the dose can be doubled again (2.5 mg) at intervals of 1-3 days. Later, the daily dose, which was initially divided into two, can be given only once.The maximum daily dose is 10 mg. If the patient does not tolerate a dose increase to 2.5 mg twice a day, then the drug should be discontinued.

 

Diabetic nephropathy and nephropathy in the background of chronic diffuse kidney diseases

 

The recommended initial dose of Amprilan is 1.25 mg once a day. Depending on the patient's tolerability of ramipril, the dose of the drug may increase in the future: it is recommended to double the dose every 2 weeks to a maintenance dose of 5 mg once a day.

 

Reducing the risk of developing myocardial infarction, stroke and cardiovascular mortality

 

The recommended initial dose of Amprilan is 2.5 mg once a day, which then gradually increases depending on the tolerance of the drug: it is recommended to double the dose after 1 week of therapy, and then after another 2-3 weeks - until the target maintenance dose is 10 mg 1 time per day.

 

Use of Amprilan in selected patient groups

 

In patients with QC more than 30 ml / min dose adjustment is not required. For patients with QC less than 30 ml / min - the initial daily dose is 1.25 mg, and the maximum daily dose - 5 mg.

 

In patients with violations of liver function, the initial dose is 1.25 mg once a day, the maximum dose is 2.5 mg once a day.

 

Careful observation of elderly patients (over 65 years of age) taking diuretics is necessary. The dose of Amprilan should be selected depending on the level of blood pressure.

 

Amprilan NL

 

The drug should be taken orally. The dose is selected individually.

 

The usual dose for adults is 1 tablet per day (2.5 mg / 12.5 mg) of Amprilan NL. If necessary, the dose may be increased to 1 tablet per day (5.0 mg / 25 mg) of Amprilan ND.

 

If the kidney function is mild or moderate (QC more than 30 ml / min, serum creatinine about 3 mg / dl or 265 μmol / l), the usual dose of the drug is recommended. With QC less than 30 ml / min, the drug is not recommended.

 

The duration of therapy is not limited.

 

Amprilan ND

 

Inside. The dose is selected individually. Daily intake for adults - 1 tablet Amprilan ND per day.

 

If the kidney function is mild or moderate (creatinine clearance more than 30 ml / min, serum creatinine about 3 mg / dL or 265 μmol / l), the usual dose of the drug is recommended. When creatinine clearance is less than 30 ml / min. the drug is not recommended.

 

The duration of therapy is not limited.

 

Side effect

 

Ramipril

• a decrease in blood pressure;
• orthostatic hypotension;
• orthostatic collapse;
• tachycardia;
• arrhythmia;
• palpitation;
• exacerbation of Raynaud's syndrome;
• myocardial ischemia (stenocardia of myocardial infarction);
• cerebral ischemia (possibly with a dynamic violation of cerebral blood flow or stroke);
• development or strengthening of symptoms of renal failure;
• proteinuria, oliguria;
• interstitial nephritis;
• nephrotic syndrome;
• decrease in the volume of urine;
• gynecomastia;
• decreased potency;
• libido;
• dizziness;
• headache;
• weakness;
• drowsiness;
• peripheral neuropathy (paresthesia);
• nervous excitability;
• anxiety;
• tremor;
• muscular spasm;
• mood disorders;
• apathy;
• insomnia;
• anxiety;
• depression;
• ataxia;
• confusion of consciousness;
• fainting;
• vestibular disorders;
• impairment of taste (eg, metallic taste), smell, hearing and vision;
• blepharitis;
• dryness of the conjunctiva;
• lacrimation;
• noise in ears;
• nausea, vomiting;
• diarrhea or constipation;
• pain in the epigastric region;
• intestinal obstruction;
• flatulence;
• pancreatitis;
• hepatitis;
• cholestatic jaundice;
• cholecystitis (with presence of cholelithiasis);
• violation of liver function with the development of hepatic insufficiency;
• melena;
• ileus;
• dry mouth;
• thirst;
• decreased appetite;
• stomatitis, glossitis;
• inflammation of the salivary glands;
• cough;
• bronchospasm;
• dyspnea;
• rhinorrhea;
• rhinitis;
• sinusitis;
• pharyngitis;
• hoarseness;
• bronchitis;
• interstitial pneumonia;
• pulmonary embolism;
• lung infarction;
• pulmonary edema;
• skin rash;
• itching;
• hives;
• conjunctivitis;
• photosensitization;
• angioedema, swelling of the face, extremities, lips, tongue, pharynx and / or larynx;
• exfoliative dermatitis;
• multiforme exudative erythema (including Stevens-Johnson syndrome);
• toxic epidermal necrolysis (Lyell's syndrome);
• pemphigus;
• serosite;
• onycholysis;
• vasculitis;
• myositis;
• muscle weakness;
• myalgia;
• arthralgia;
• arthritis;
• eosinophilia;
• convulsions;
• alopecia;
• shingles;
• hyperthermia;
• increased sweating;
• hypercreatininaemia;
• increase in the level of urea nitrogen;
• increased activity of hepatic enzymes;
• hyperbilirubinemia;
• hyperkalemia, hyponatremia;
• anemia;
• reduction of hemoglobin and hematocrit;
• neutropenia, thrombocytopenia, agronulocytosis, pancytopenia;
• hemolytic anemia;
• the appearance of antinuclear antibodies.

 

Influence on the fetus: impaired fetal function, decreased blood pressure (BP) of the fetus and newborns, impaired renal function, hyperkalaemia, skull bones hypoplasia, oligohydramnia, limb contracture, skull bones deformation, lung hypoplasia

 

Hydrochlorothiazide

• development of hypokalemia and hypochloraemic alkalosis (dry mouth, increased thirst, heart rhythm disturbance, mood and psyche changes, cramps or muscle pain, nausea, vomiting, weakness, hypochloremic alkalosis may develop hepatic encephalopathy or hepatic coma), hyponatremia (confusion , convulsions, apathy, slowing down the process of thinking, fatigue, irritability), hypomagnesemia (arrhythmia);
• agranulocytosis, thrombocytopenia, hemolytic and aplastic anemia, leukocytopenia, eosinophilia, neutropenia, pancytopenia;
• arrhythmia;
• orthostatic hypotension;
• tachycardia;
• cholecystitis;
• pancreatitis;
• jaundice;
• diarrhea;
• sialadenitis;
• constipation;
• anorexia;
• pain in epigastrium;
• hypercholesterolemia, hypertriglyceridemia, hyperglycemia, glucosuria, hyperuricemia, hypercalcemia;
• exacerbation of gout;
• depression;
• sleep disturbance;
• anxiety;
• paresthesia;
• confusion of consciousness;
• dizziness;
• xantopsy;
• visual impairment;
• impaired renal function;
• decreased potency;
• interstitial nephritis;
• skin rash;
• hives;
• purpura;
• necrotizing vasculitis;
• Stevens-Johnson syndrome;
• Respiratory distress syndrome (pneumonitis, noncardiogenic pulmonary edema);
• toxic epidermal necrolysis;
• photosensitization;
• anaphylactic reactions (up to the life threatening anaphylactic shock);
• hyperthermia;
• weakness.

 

Contraindications

 

Ramipril

• angioedema in history, including those associated with previous therapy with ACE inhibitors;
• hemodynamically significant bilateral stenosis of the renal arteries;
• stenosis of the artery of a single kidney;
• condition after kidney transplantation;
• hemodialysis;
• renal failure (creatinine clearance less than 30 ml / min.);
• hemodynamically significant aortic or mitral stenosis (risk of excessive blood pressure lowering with subsequent renal dysfunction);
• hypertrophic obstructive cardiomyopathy;
• primary hyperaldosteronism;
• pregnancy and lactation;
• age under 18 years (effectiveness and safety not established);
• increased sensitivity to ramipril and any other ingredient in the drug or other ACE inhibitors.

 

Carefully:

• severe lesions of the coronary and cerebral arteries (the risk of a decrease in blood flow with excessive decrease in blood pressure);
• unstable angina;
• severe ventricular rhythm disturbances;
• chronic heart failure 4 stages;
• decompensated pulmonary heart;
• renal and / or liver failure;
• Hyperkalemia, hyponatremia (including diuretics and diets with a restriction of salt intake);
• conditions, accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting);
• systemic connective tissue diseases, including scleroderma and systemic lupus erythematosus;
• diseases requiring the appointment of glucocorticosteroids (GCS) and immunosuppressants (lack of clinical experience);
• diabetes;
• oppression of bone marrow hematopoiesis;
• elderly age.

 

Hydrochlorothiazide

• gout;
• diabetes mellitus (severe forms);
• chronic renal failure (creatinine clearance less than 20-30 ml / min, anuria);
• severe hepatic impairment;
• refractory hypokalemia, hypercalcemia, hyponatremia;
• pregnancy, lactation;
• age up to 3 years (solid dosage form);
• hypersensitivity to the drug or other sulfonamides in the anamnesis.

 

Carefully:

• hypokalemia, hyponatremia, hypercalcemia;
• cardiac ischemia;
• liver failure;
• cirrhosis;
• bronchial asthma in history;
• elderly age.

 

Application in pregnancy and lactation

 

Amprilan is contraindicated in pregnancy. At the onset of pregnancy, the drug should be stopped immediately. If it is necessary to prescribe the drug during lactation it is necessary to stop breastfeeding.

 

Use in children

 

Contraindicated in children and adolescents under the age of 18 years.

 

Application in elderly patients

 

With caution in old age.

 

special instructions

 

Ramipril

 

At the beginning of treatment, it is necessary to evaluate the kidney function. Care should be taken to monitor kidney function during Ramipril treatment especially in patients with impaired renal function, renal vessels (for example,clinically insignificant stenosis of the renal arteries, hemodynamically significant stenosis of the artery of a single kidney); heart failure.

 

The risk of hypersensitivity and allergic-like (anaphylactoid) reactions is increased in patients who simultaneously take ACE inhibitors and undergo hemodialysis procedures using dialysis membranes AN69. Similar reactions have been detected in the apheresis of low density lipoproteins with dextran sulfate, so the use of this method should be avoided when treating ACE inhibitors.

 

During treatment with ramipril in patients with impaired renal function, especially with simultaneous treatment with diuretics, the level of urea and creatinine in the serum can increase. In this case, treatment should be continued with lower doses of ramipril or discontinue the drug. In patients with impaired renal function, the risk of hyperkalemia increases.

 

In patients with impaired hepatic function, the metabolism of ramipril and the formation of an active metabolite may be slowed by a decrease in the activity of the liver enzymes.In this regard, the treatment of such patients should be started only under strict medical supervision.

 

Caution should be exercised when prescribing ramipril to patients on a low-salt or salt-free diet (increased risk of developing hypotension). In patients with reduced circulating blood volume (as a result of diuretic therapy), during dialysis, with diarrhea and vomiting, symptomatic hypotension may develop.

 

Transient arterial hypotension is not a contraindication for continuing treatment after stabilizing blood pressure. In the case of repeated occurrence of severe arterial hypotension, the dose should be reduced or the drug should be withdrawn. In patients undergoing extensive surgery or receiving other arterial hypotension agents during general anesthesia, ramipril may cause blockade of the formation of angiotensin 2 due to compensatory release of renin. If the doctor connects the development of arterial hypotension with the mechanism mentioned above, arterial hypotension can be corrected by an increase in the volume of blood plasma.

 

In rare cases, during treatment with ACE inhibitors, agranulocytosis, erythrocytopenia, thrombocytopenia, hemoglobinemia or bone marrow suppression are observed. At the beginning and during treatment it is necessary to control the number of white blood cells to detect possible neutropenia / agranulocytosis. More frequent monitoring is recommended in patients with renal insufficiency, with connective tissue diseases (for example, systemic lupus erythematosus or scleroderma) and in patients taking concomitant medications that affect hemopoiesis. Counting blood cells should also be performed if there are clinical signs of neutropenia / agranulocytosis and increased bleeding.

 

In patients with hypertension in the treatment of ramipril, there is rarely an increase in the serum potassium level. The risk of hyperkalemia increases with chronic heart failure, simultaneous treatment with potassium-sparing diuretics (spironolactone, amiloride, triamterene) and the administration of potassium preparations. With the use of ACE inhibitors during desensitizing therapy, aspen or bee venom may occuranaphylactoid reactions (eg, arterial hypotension, dyspnea, vomiting, skin rash), which can be life-threatening. Hypersensitivity reactions can occur with insect bites (eg, bees or wasps). If it is necessary to conduct desensitizing treatment with bee or aspenic poison, ACE inhibitors should be discontinued and continued treatment with suitable drugs from other groups.

 

Hydrochlorothiazide

 

To prevent deficiency, K and Mg2 are prescribed a diet with a high content of these salts, potassium-sparing diuretics, salts of K and Mg2. Regular monitoring of the potassium, glucose, uric acid, lipid and creatinine levels is necessary.

 

Impact on the ability to drive and machinery

 

During the treatment period, care must be taken when driving vehicles, as well as during occupations, with potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

 

Drug Interactions

 

Ramipril

 

Strengthens the oppressive effect of ethanol (alcohol) on the central nervous system. Taking salt with food can reduce the hypotensive effect of ramipril.

 

With the simultaneous use of ramipril and other agents that lower blood pressure (for example, diuretics, nitrates, tricyclic antidepressants, agents for general anesthesia) leads to an increase in the hypotensive effect of ramipril.

 

The simultaneous administration of ramipril and potassium or potassium-sparing diuretics may cause hyperkalemia.

 

Vasopressornye sympathomimetics (epinephrine, norepinephrine) can reduce the hypotensive effect of ramipril. In this regard, with simultaneous treatment should carefully monitor blood pressure.

 

Simultaneous administration of ramipril and allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics increases the likelihood of changes in the peripheral blood picture (the risk of developing leukopenia).

 

Simultaneous administration of ramipril and lithium preparations leads to a decrease in lithium excretion, 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 (eg, insulin or sulfonylurea derivatives), which in some cases can cause hypoglycemia.In this regard, the level of sugar in the blood should be carefully monitored, especially at the beginning of the joint application.

 

The simultaneous use of ramipril and non-steroidal anti-inflammatory drugs (NSAIDs) (eg, Acetylsalicylic acid and indomethacin) can reduce the hypotensive effect of ramipril. In addition, simultaneous use can cause hyperkalemia and increase the risk of impaired renal function. The simultaneous use of ramipril with estrogen can weaken the hypotensive effect.

 

The simultaneous use of Heparin and ramipril can cause hyperkalemia. Anaphylactic and anaphylactoid reactions to the venom of stinging insects (and possibly other allergens) are more pronounced during treatment with ACE inhibitors.

 

Hydrochlorothiazide

 

With simultaneous use of digitalis glycosides with thiazide diuretics, the likelihood of toxic effects of glycosides (including increased excitability of the ventricles) increases due to the likely development of hypokalemia and hypomagnesemia.

 

Medicines that intensely bind to blood proteins (indirect anticoagulants, clofibrate, NSAIDs) increase the diuretic effect of hydrochlorothiazide.The hypotensive effect of hydrochlorothiazide is enhanced by vasodilators, beta-adrenoblockers, barbiturates, phenothiazines, tricyclic antidepressants, ethanol. Hydrochlorothiazide enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic agents, norepinephrine, epinephrine and antidotal drugs, increases cardiotoxic and neurotoxic effects of lithium preparations, the action of peripheral muscle relaxants, reduces the excretion of quinidine. With the simultaneous administration of methyldopa, the development of hemolysis is possible. Colestyramine decreases the absorption of hydrochlorothiazide. Hydrochlorothiazide reduces the effect of oral contraceptives.

 

Analogues of Amprilan

 

Structural analogs for the active substance:

• Amprilan NL;
• Amprilan ND;
• Vazolong;
• Dilaprel;
• Korpril;
• Pyrimil;
• Ramigamma;
• Ramicardium;
• Ramipril;
• Tritace;
• Hartil;
• Hartil D.

 

Analogues for the pharmacological group (ACE inhibitors):

• Akkupro;
• Berlipril;
• Vazolong;
• Gopten;
• Dalnev;
• Dapril;
• Dilaprel;
• Diroton;
• The Zocardis;
• Zokardis plus;
• Zonix;
• Involor;
• Isuzid;
• Irumed;
• Kapoten;
• Captopril;
• Ko-Dalnev;
• Co-Diroton;
• Ko-Perineva;
• Korenitec;
• The Korandil;
• Lysinopril;
• Liziprex;
• Monopril;
• Noliprel;
• Noliprel forte;
• Parnavell;
• Perindopril;
• Perineva;
• Perineva Ku-tab;
• Prestan;
• Prestarium;
• Prilazid;
• Assigned;
• Ramazid H;
• Renipril;
• Renitek;
• Sinopril;
• Tark;
• Tenliza;
• Fosicard;
• Fosinopril;
• Fosinotek;
• Hinapril;
• Cilazapril;
• Egipres;
• Ednit;
• Ecquard;
• Equator;
• Enalapril;
• Enam;
• Enap;
• Enarenal;
• Envas;
• Enipril;
• Enziks;
• Epsetron.

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