Amprilan ND pills 25mg+5mg, 30pcs

Composition

Active ingredients:

ramipril – 5 mg,

hydrochlorothiazide-25 mg.

Auxiliary substances:

sodium bicarbonate;

lactose monohydrate;

croscarmellose sodium;

pregelatinized starch (starch 1500);

sodium stearyl fumarate.

Pharmacological action

Ramipril.

ACE inhibitor, prevents the conversion of angiotensin I to angiotensin II without compensatory increase in heart rate. Reduces the production of aldosterone, OPSS, pressure in the pulmonary capillaries, resistance in the pulmonary vessels, does not change the glomerular filtration rate, increases coronary blood flow. With prolonged use of the drug, myocardial hypertrophy decreases in patients with arterial hypertension, the frequency of arrhythmias decreases during myocardial reperfusion; blood circulation of the ischemic myocardium improves. The cardioprotective effect is due to the effect on the synthesis of PG, the induction of nitric oxide formation in endotheliocytes. The drug reduces platelet aggregation. The onset of antihypertensive action is 1.5 hours after oral use, the maximum effect is 5-9 hours, and the duration of action is 24 hours. Ramipril does not cause withdrawal syndrome.

Hydrochlorothiazide.

Thiazide diuretic, the diuretic effect of which is associated with a violation of the reabsorption of sodium, chlorine, potassium, magnesium, and water ions in the distal nephron; delays the excretion of calcium and uric acid ions. It has antihypertensive properties. It has virtually no effect on normal blood pressure. The diuretic effect occurs in 1-2 hours, reaches a maximum in 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 taking hydrochlorothiazide.

Indications

Arterial hypertension (patients who are indicated for combination therapy).

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Contraindications

Ramipril.

• Hypersensitivity to ramipril and any other ingredient of the drug or other ACE inhibitors.
• Angioedema in the anamnesis, including those associated with previous therapy with ACE inhibitors.
• Hemodynamically significant bilateral renal artery stenosis.
• Stenosis of the artery of a single kidney.
• Condition after kidney transplantation; hemodialysis.
• Renal failure (Cl
• Hemodynamically significant aortic or mitral stenosis (risk of excessive lowering of blood pressure with subsequent renal dysfunction).
• Hypertrophic obstructive cardiomyopathy.
• Primary hyperaldosteronism.
• Pregnancy and lactation.
• Age up to 18 years (efficacy and safety have not been established).

With caution: severe lesions of the coronary and cerebral arteries (risk of decreased blood flow due to excessive BP reduction); unstable angina; severe ventricular arrhythmias; stage IV chronic heart failure; decompensated “pulmonary heart”; renal and/or hepatic insufficiency; hyperkalemia, hyponatremia (including against the background of diuretics and a diet with limited salt intake); conditions accompanied by a decrease in BCC (including diarrhea, vomiting); systemic connective tissue diseases, including scleroderma and systemic lupus erythematosus; diseases requiring the use of corticosteroids and immunosuppressants (lack of clinical experience); diabetes mellitus; suppression of bone marrow hematopoiesis; elderly age.

Hydrochlorothiazide.

• Hypersensitivity to the drug or other sulfonamides in the anamnesis.
• Gout.
• Diabetes mellitus (severe forms).
• Chronic renal failure (Cl
• Severe liver failure.
• Refractory hypokalemia, hypercalcemia, hyponatremia.
• Pregnancy.
• Lactation period.
• Age up to 3 years (solid dosage form).

With caution: hypokalemia, hyponatremia, hypercalcemia; CHD; liver failure, cirrhosis; a history of bronchial asthma; elderly age.

Side effects

Ramipril.

From the cardiovascular system: decreased blood pressure, orthostatic hypotension, orthostatic collapse, tachycardia, rarely-arrhythmia, palpitations, exacerbation of Raynaud’s syndrome. With an excessive decrease in blood pressure, mainly in patients with CHD and clinically significant narrowing of the cerebral vessels, myocardial ischemia (angina pectoris, myocardial infarction) and cerebral ischemia (possibly with dynamic cerebral circulatory disorders or stroke) may develop.

From the genitourinary system: development or intensification of symptoms of renal failure, proteinuria, oliguria, interstitial nephritis, nephrotic syndrome, decreased urine volume, gynecomastia, decreased potency, libido.

From the central nervous system: dizziness, headache, weakness, drowsiness, peripheral neuropathy (paresthesia), nervous excitability, restlessness, tremor, muscle spasm, mood disorders, apathy, when used in high doses — insomnia, anxiety, depression, ataxia, confusion, fainting.

From the sensory organs: vestibular disorders, taste disorders (for example, metallic taste), smell, hearing and vision, blepharitis, dry conjunctiva, lacrimation, tinnitus.

From the digestive system: nausea, vomiting, diarrhea or constipation, epigastric pain, intestinal obstruction, flatulence, pancreatitis, hepatitis, cholestatic jaundice, cholecystitis (in the presence of cholelithiasis), impaired liver function with the development of liver failure, melena, ileus, dry mouth, thirst, decreased appetite, stomatitis, glossitis, inflammation of the salivary glands.

From the respiratory system: “dry” cough, bronchospasm, shortness of breath, rhinorrhea, rhinitis, sinusitis, pharyngitis, hoarseness, bronchitis, interstitial pneumonia, pulmonary embolism, pulmonary infarction, pulmonary edema.

Allergic reactions: skin rash, pruritus, urticaria, conjunctivitis, photosensitization, angioedema of the face, extremities, lips, tongue, pharynx and/or larynx, exfoliative dermatitis, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), pemphigus, serositis, onycholysis, vasculitis, myositis, muscle weakness, myalgia, arthralgia, arthritis, eosinophilia.

Others: seizures, alopecia, shingles, hyperthermia, increased sweating. Laboratory parameters: hypercreatininemia, increased urea nitrogen levels, increased activity of “liver” enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia, anemia, decreased hemoglobin and hematocrit concentrations, neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, the appearance of antinuclear antibodies.

Effects on the fetus: impaired fetal function, decreased blood pressure in the fetus and newborn, impaired renal function, hyperkalemia, hypoplasia of the skull bones, oligohydramnion, limb contracture, deformity of the skull bones, hypoplasia of the lungs.

Hydrochlorothiazide.

From the side of the water-electrolyte and acid-base balance: hypokalemia and hypochloremic alkalosis may develop (dry mouth, increased thirst, heart rhythm disturbances, mood and mental changes, muscle cramps or pain, nausea, vomiting, weakness; with hypochloremic alkalosis, hepatic encephalopathy or hepatic coma may develop), hyponatremia (confusion, convulsions, apathy, slowing down the thinking process, fatigue, irritability), hypomagnesemia (arrhythmias).

From the hematopoietic system: agranulocytosis, thrombocytopenia, hemolytic and aplastic anemia, leukocytopenia, eosinophilia, neutropenia, pancytopenia.

From the cardiovascular system: arrhythmia, orthostatic hypotension, tachycardia.

From the digestive system: cholecystitis, pancreatitis, jaundice, diarrhea, sialadenitis, constipation, anorexia, epigastric pain.

From the side of metabolism: hypercholesterolemia, hypertriglyceridemia, hyperglycemia, glucosuria, hyperuricemia, hypercalcemia, exacerbation of gout.

From the central nervous system: depression, sleep disorders, anxiety, paresthesia, confusion, dizziness.

Sensory disorders: xanthopsy, visual disturbances.

From the genitourinary system: impaired renal function, decreased potency, interstitial nephritis.

Allergic reactions: skin rash, urticaria, purpura, necrotic vasculitis, Stevens-Johnson syndrome, respiratory distress syndrome (pneumonitis, non-cardiogenic pulmonary edema), toxic epidermal necrolysis, photosensitization; anaphylactic reactions (up to life-threatening anaphylactic shock).

Other: hyperthermia, weakness.

Interaction

Ramipril.

Enhances the depressing effect of ethanol on the central nervous system.

Salt intake with food may reduce the hypotensive effect of ramipril.

Concomitant use of ramipril and other blood pressure-lowering agents (e. g. diuretics, nitrates, tricyclic antidepressants, general anaesthetics) increases the hypotensive effect of ramipril. Concomitant use of ramipril and potassium supplements or potassium-sparing diuretics may 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.

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

Simultaneous use of ramipril and lithium preparations leads to a decrease in lithium excretion, so it is necessary to monitor the concentration of lithium in the blood serum — the risk of toxic effects.

ACE inhibitors can increase the effect of hypoglycemic agents (for example, insulin or sulfonylureas), which in some cases can cause hypoglycemia. In this regard, blood sugar levels should be carefully monitored, especially at the beginning of co-use.

Concomitant use of ramipril and NSAIDs (for example, acetylsalicylic acid and Indometacin) may weaken the hypotensive effect of ramipril.

In addition, concomitant use may cause hyperkalemia and increase the risk of impaired renal function.

Concomitant use of ramipril with estrogens may weaken the hypotensive effect.

Concomitant use of heparin and ramipril may cause hyperkalemia.

Anaphylactic and anaphylactoid reactions to the venom of stinging insects (possibly to other allergens) are more pronounced during treatment with ACE inhibitors.

Hydrochlorothiazide.

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

Drugs that intensively bind to blood proteins (indirect anticoagulants, clofibrate, NSAIDs) enhance the diuretic effect of hydrochlorothiazide.

The hypotensive effect of hydrochlorothiazide is enhanced by vasodilators, beta-blockers, barbiturates, phenothiazines, tricyclic antidepressants, and ethanol.

Hydrochlorothiazide enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic agents, norepinephrine, epinephrine and anti-gouty drugs, enhances the cardiotoxic and neurotoxic effects of lithium preparations, the effect of peripheral muscle relaxants, reduces the excretion of quinidine.

With simultaneous use of methyldopa, hemolysis may develop.

Colestyramine reduces the absorption of hydrochlorothiazide.

Hydrochlorothiazide reduces the effect of oral contraceptives.

How to take, course of use and dosage

Inside. The dose is selected individually. The daily dose for adults is 1 tablet. per day.

In patients with mild or moderate renal impairment (creatinine clearance > 30 ml / min, serum creatinine is approximately 3 mg / dl or 265 mmol / L), the usual dose of the drug is recommended. With Cl Creatinine

The duration of therapy is not limited.

Overdose

Ramipril.

Symptoms: marked decrease in blood pressure, bradycardia, shock, impaired water-electrolyte balance, acute renal failure, stupor, dry mouth, weakness, drowsiness.

Treatment: give the patient a horizontal position with raised legs, in mild cases of overdose — gastric lavage, use of adsorbents and sodium sulfate (it is advisable to take measures within the first 30 minutes after taking the drug). With a decrease in blood pressure-intravenous use of catecholamines, angiotensin II; with 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 of K+ deficiency (use of potassium preparations and potassium-sparing diuretics).

Special instructions

Ramipril.

Renal function should be evaluated at the beginning of treatment. Renal function should be carefully monitored during treatment with ramipril, especially in patients with impaired renal function, with renal vascular damage (for example, clinically insignificant renal artery stenosis or hemodynamically significant artery stenosis of a single kidney); heart failure.

The risk of hypersensitivity and allergy-like (anaphylactoid) reactions is increased in patients who are simultaneously taking ACE inhibitors and undergoing hemodialysis procedures using AN69 dialysis membranes. Similar reactions were found in low-density lipoprotein apheresis with dextran sulfate, so the use of this method should be avoided during treatment with ACE inhibitors.

During treatment with ramipril, patients with impaired renal function, especially with simultaneous treatment with diuretics, may increase the level of urea and creatinine in the blood serum. In this case, treatment should be continued with smaller doses of ramipril or the drug should be discontinued. Patients with impaired renal function have an increased risk of hyperkalemia.

In patients with impaired hepatic function, the metabolism of ramipril and the formation of the active metabolite may be slowed down due to a decrease in the activity of “liver” enzymes. In this regard, treatment of such patients should be initiated 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 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 continuing treatment after BP stabilization. In case of repeated occurrence of severe hypotension, the dose should be reduced or the drug should be discontinued. In patients undergoing extensive surgery or receiving other hypotensive agents during general anesthesia, ramipril may cause blockage of angiotensin II production with compensatory renin release. If the doctor associates the development of arterial hypotension with the mechanism mentioned above, arterial hypotension can be corrected by increasing the volume of blood plasma.

In rare cases, agranulocytosis, erythrocytopenia, thrombocytopenia, hemoglobinemia, or bone marrow depression are observed during treatment with ACE inhibitors. At the beginning and during treatment, it is necessary to monitor the number of white blood cells to detect possible neutropenia/agranulocytosis. More frequent monitoring is recommended in patients with renal insufficiency, connective tissue diseases (for example, systemic lupus erythematosus or scleroderma) and in patients who are simultaneously taking drugs that affect hematopoiesis (see “Interactions”). The calculation of formed blood elements should also be performed if there are clinical signs of neutropenia/agranulocytosis and increased bleeding.

In patients with arterial hypertension treated with ramipril, an increase in serum potassium levels is rarely observed. The risk of hyperkalemia increases with chronic heart failure, simultaneous treatment with potassium-sparing diuretics (spironolactone, amiloride, triamterene) and the appointment of potassium preparations.

When using ACE inhibitors during desensitizing therapy with aspen or bee venom, anaphylactoid reactions may occur (for example, hypotension, shortness of breath, vomiting, skin rash), which can be life-threatening. Hypersensitivity reactions may occur when bitten by insects (such as bees or wasps). If desensitizing treatment with bee or wasp venom is necessary, ACE inhibitors should be discontinued and treatment with suitable drugs from other groups should be continued.

Hydrochlorothiazide.

To prevent a deficiency of potassium and magnesium, a diet with their increased content, potassium-sparing diuretics, potassium and magnesium salts are prescribed. Regular monitoring of the plasma levels of potassium, glucose, uric acid, lipids and creatinine is necessary.

Influence on the ability to drive a car and mechanisms.

During the treatment period, care should be taken when driving vehicles, as well as when engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Hydrochlorothiazide, Ramipril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Prevention of heart attacks and strokes, Heart failure, Kidney damage