Ramazid N pills 2.5mg+12.5mg, 30pcs

Composition

of 1 tab. – ramipril 2.5 mg, hydrochlorothiazide 12.5 mg. Auxiliary substances: sodium carbonate, lactose monohydrate, croscarmellose sodium, pregelatinized corn starch, sodium stearyl fumarate.

Pharmacological action

Ramipril is an ACE inhibitor that prevents the conversion of angiotensin I to angiotensin II without a 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. Cardioprotective effect is due to the effect on prostaglandin synthesis, 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. The drug does not have a withdrawal syndrome. Hydrochlorothiazide diuretic, the diuretic effect of which is associated with impaired 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; the hypotensive effect develops due to a decrease in BCC, changes in the reactivity of the vascular wall, a decrease in the pressor effect and an increase in the depressive effect on the ganglia. 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 in 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

The drug is contraindicated during pregnancy and lactation.

Contraindications

Ramipril

— hypersensitivity to ramipril or to any other ingredient of the drug or to other ACE inhibitors;

— a history of angioedema, including that associated with previous therapy with ACE inhibitors;

— hemodynamically significant bilateral renal artery stenosis;

— stenosis of the artery to a solitary kidney;

— condition after kidney transplantation;

— hemodialysis;

— renal failure (CC less than 20 ml/min);

— hemodynamically significant aortic or mitral stenosis (risk of excessive blood pressure reduction with subsequent impairment of renal function);

— hypertrophic obstructive cardiomyopathy;

primary aldosteronism;

— pregnancy and lactation period;

— age under 18 years (effectiveness and safety not established).

With caution:  severe lesions of the coronary and cerebral arteries (risk of reduced blood flow due to excessive blood pressure reduction), unstable angina, severe ventricular arrhythmias, stage IV chronic heart failure, decompensated “pulmonary heart”, renal and/or liver failure, hyperkalemia, hyponatremia (including against the background of diuretics and a diet with limited salt intake), conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting), systemic diseases connective tissue disorders, diabetes mellitus, inhibition of bone marrow circulation, old age.

Hydrochlorothiazide

— hypersensitivity to the drug

— – gout;

– diabetes mellitus (severe forms);

– chronic renal failure (creatinine clearance less than 20-30 ml / min, anuria);

– refractory hypokalemia—

– hypercalcemia—

– hyponatremia—

– pregnancy (1 trimester)—

– lactation.

With caution:  hypokalemia, hyponatremia, hypercalcemia, coronary heart disease, liver cirrhosis, elderly age.

Side effects

Ramipril

From the cardiovascular system:  low blood pressure, orthostatic hypotension, orthostatic collapse, tachycardia, rarely-arrhythmia, angina, myocardial infarction. From the genitourinary system: development or worsening of symptoms of renal failure, proteinuria, decreased urine volume, decreased libido.

From the central nervous system:  brain ischemia, stroke, dizziness, headache, weakness, drowsiness, paresthesia, nervous excitability, restlessness, tremor, muscle spasm, mood disorders, when used in high doses – insomnia, anxiety, depression, confusion, fainting.

From the side of the senses:  vestibular disorders, disorders of taste (for example, metallic taste), smell, hearing and vision, tinnitus.

From the digestive system:  nausea, vomiting, diarrhea or constipation, epigastric pain, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, impaired liver function with the development of liver failure, dry mouth, thirst, decreased appetite, stomatitis, glossitis.

Respiratory system disorders:  “dry” cough, bronchospasm, shortness of breath, rhinorrhea, rhinitis, sinusitis, bronchitis.

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, myalgia, arthralgia, arthritis, and eosinophilia.

Other services:  convulsions, alopecia, hyperthermia, increased sweating.

Laboratory parameters:  hypercreatininemia, increased urea nitrogen levels, increased activity of “hepatic” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia, the appearance of antinuclear antibodies.

Effect on the fetus:  impaired fetal function, decreased fetal and neonatal blood pressure, impaired renal function, hyperkalemia, cranial hypoplasia, oligohydramnion, limb contracture, cranial bone deformity, lung hypoplasia.

Hydrochlorothiazide

From the side of 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.

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:  hyperglycemia, glucosuria, hyperuricemia, exacerbation of gout.

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

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, anesthetics) increases the hypotensive effect of ramipril.

Simultaneous use of ramipril and potassium preparations or potassium-sparing diuretics, it is necessary to monitor the concentration of lithium in the blood serum – the risk of toxic effects. ici 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.

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

Simultaneous use of ramipril and lithium preparations leads to a decrease in l excretion

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 nonsteroidal anti-inflammatory drugs (such as acetylsalicylic acid and indomethacin) may weaken the hypotensive effect of ramipril. Additionally, concomitant use may cause hyperkalemia and increase the risk of impaired renal function. 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 proteins (indirect anticoagulants, clofibrate, NSAIDs) increase 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 drugs, 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 usual adult dose is 1 tab. Ramazid H 2.5 mg / 12.5 mg per day. If necessary, it can be increased to 1 tab. Ramazid H 5 mg / 25 mg.

In patients with mild or moderate renal impairment (creatinine clearance greater than 30 ml / min, serum creatinine approximately 3 mg / dl or 265 mmol / L), the usual dose of the drug is recommended. If the creatinine clearance is less than 30 ml / min, the drug should not be used.

Overdose

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.

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). Patients with reduced circulating blood volume (as a result of diuretic therapy), dialysis, diarrhea and vomiting may develop symptomatic hypotension.

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 due to 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 (e. g., systemic lupus erythematosus or scleroderma) and in patients who are taking concomitant medications that affect hematopoiesis. 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 to wasp or bee venom, anaphylactoid reactions (e. g. hypotension, shortness of breath, vomiting, skin rash) may occur, 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.

During treatment with Ramazid H, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness may occur, especially after the initial dose of an ACE inhibitor in patients taking diuretic medications). Patients are advised to refrain from driving or operating machinery until the response to treatment is clear.

Hydrochlorothiazide

To prevent K+ and Mg2+ deficiency, potassium-sparing diuretics, K+and Mg2+salts are prescribed. Regular monitoring of the plasma levels of potassium, glucose, uric acid, lipids and creatinine is necessary.

Form of production

Tablets are white or almost white in color, flat, oval, with a notch on one side and marked “12.5”.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children!

Shelf

life is 3 years. The drug should not be used after the expiration date indicated on the package.

Active ingredient

Ramipril, Hydrochlorothiazide

Conditions of release from pharmacies

By prescription

Purpose

For adults as directed by your doctor

Indications

Hypertension