Ramazid H (Ramazid H)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceRamipril + HydrochlorothiazideRamipril + Hydrochlorothiazide
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  • Ramazid H
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  • Hartil®-D
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    EGIS ZAO Pharmaceutical Plant     Hungary
    • Dosage form: & nbsppills
    Composition:

    Active substance: ramipril / hydrochlorothiazide - 2.5 / 12.5 mg; 5/25 mg. Excipients: sodium carbonate, lactose monohydrate, croscarmellose sodium, corn pregelatinized starch, sodium stearyl fumarate.

    Description:

    Flat oval tablets, white or almost white with a notch on one side and a mark "12.5" (for tablets with a dosage of 2.5 / 12.5 mg) and "25" (for tablets with a dosage of 5/25 mg).

    Pharmacotherapeutic group: hypotensive combined agent (ACE inhibitor + diuretic)
    ATX: & nbsp

    C.09.B.A   ACE inhibitors in combination with diuretics

    C.09.B.A.05   Ramipril in combination with diuretics

    Pharmacodynamics:

    Ramiprs. The ACE inhibitor prevents the conversion of angiotensin I into angiotensin II without a compensatory increase in the heart rate. Reduces the production of aldosterone, general vascular peripheral resistance, pressure in the pulmonary capillaries, resistance in pulmonary vessels, does not change the rate of glomerular filtration, enhances coronary blood flow. With prolonged use of the drug, myocardial hypertrophy decreases in patients with arterial hypertension,the frequency of arrhythmias decreases with myocardial reperfusion; improves circulation of the ischemic myocardium. Cardioprotective effect is due to the effect on the synthesis of prostaglandins, induction of the formation of nitric oxide in endotheliocytes. The drug reduces the aggregation of platelets. The onset of hypotensive action is 1.5 hours after ingestion, the maximum effect is 5-9 hours, the duration of action is 24 hours. The drug has no withdrawal syndrome.

    Hydrochlorothiazide. 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 the excretion of calcium ions, uric acid. Has antihypertensive properties; the hypotensive effect develops due to a decrease in the volume of circulating blood, a change in the reactivity of the vascular wall, a decrease in the pressor effect of vasoconstrictive amines (epinephrine, norepinephrine) and enhance the depressor effect on the ganglion. Virtually no effect on normal blood pressure (BP). Diuretic effect occurs in 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours.Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

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

    Pharmacokinetics:

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

    The absorption of ramipril averages 50 - 60%. Eating does not affect the degree of absorption, but it reduces its speed, TCmax- 2-4 hours.

    After oral intake of hydrochlorothiazide is 60-80%. The maximum concentration of hydrochlorothiazide in the blood is reached 1-5 hours after ingestion. The connection of ramipril with plasma proteins is 73%, ramiprilata - 56%. Binding to plasma proteins hydrochlorothiazide - 64%. The half-life (T1 / 2) for ramipril is 5.1 hours; in the phase of distribution and elimination, a decrease in the concentration of ramiprilate in the serum takes place from T1 / 2 to 4-5 days. T1 / 2 increases with renal insufficiency. The volume of distribution of Ramipril - 90 liters, ramiprilata - 500 liters.Metabolism of ramipril occurs mainly in the liver with the formation of an active metabolite of ramiprilata, which inhibits ACE in 6 times more active than ramipril and an inactive metabolite of diketopiperazine, which are then glucuronized. The drug is excreted mainly in the form of metabolites, kidneys - 60%, intestines - 40%. Hydrochlorothiazide It is not metabolized and is quickly excreted through the kidneys. The half-life is 5-15 hours.

    Indications:

    Arterial hypertension (patients who are shown combined therapy).

    Contraindications:

    Ramipril

    Hypersensitivity to ramipril and any other ingredient in the drug or other ACE inhibitors, angioedema in the history, including associated with previous therapy with ACE inhibitors, hemodynamically significant bilateral stenosis of the renal arteries, stenosis of the single kidney artery, condition after kidney transplantation, hemodialysis, renal insufficiency (creatinine clearance less than 20 ml / min.), hemodynamically significant aortic or mitral stenosis (risk of excessive blood pressure lowering with subsequent violation of fu kidney ktsii)hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, pregnancy and lactation, age under 18 years (efficacy and safety not established).

    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 (I trimester), lactation.

    Carefully:ramipril

    With caution: TEAsevere cardiovascular and cerebral arterial lesions (risk of blood flow reduction with excessive blood pressure lowering), unstable angina, severe ventricular arrhythmias, chronic heart failure of stage IV, decompensated pulmonary heart, renal and / or hepatic insufficiency, hyperkalemia, hyponatremia (including against a background of diuretics and a diet with a restriction of salt intake), conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting), systemic connective tissue diseases, sah arnie diabetes, oppression of bone marrow circulation, elderly age.

    Hydrochlorothiazide

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

    Dosing and Administration:

    Inside. The dose is selected individually. Usual dose for adults -1 tablet Ramazid H (2.5 mg / 12.5 mg) per day, if necessary, can be increased to 1 tablet Ramazid H (5.0 mg / 25 mg).

    If the renal function is mild or moderate (creatinine clearance> 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.

    Side effects:

    Ramipril

    From the cardiovascular system: reduction of blood pressure, orthostatic hypotension, orthostatic collapse, tachycardia, rarely - arrhythmia, angina pectoris, myocardial infarction.

    From the genitourinary system, development or strengthening of symptoms of renal failure, proteinuria, decrease in the volume of urine, decreased libido.

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

    From the sense organs: vestibular disorders, taste disorders (eg, metallic taste), smell, hearing and vision, tinnitus.

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

    From the respiratory system: "dry" cough, bronchospasm, dyspnea, rhinorrhea, rhinitis, sinusitis, bronchitis.

    Allergic reactions: skin rash, itching, hives, conjunctivitis,

    photosensitization; angioneurotic edema of the face, extremities, lips, tongue, throat and / or larynx, exfoliative dermatitis, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), pemphigus, serositis, onycholysis, vasculitis, myositis, myalgia, arthralgia, arthritis, eosinophilia.

    Other: seizures, alopecia, hyperthermia, increased sweating.

    Laboratory indicators: hypercreatininaemia, increased urea nitrogen levels, increased activity of "hepatic" transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia, the appearance of antinuclear antibodies.

    Influence on the fetus: impaired fetal function, decreased fetal and newborn infants, impaired renal function, hyperkalemia, skull bones hypoplasia, oligohydramnia, limb contracture, skull bones deformation, lung hypoplasia. Hydrochlorothiazide

    From the side of water-electrolyte and acid-base balance: hypokalemia and hypochloraemic alkalosis may develop (dry mouth, thirst, heart rhythm, mood and psyche, convulsions or muscle pain, nausea, vomiting, weakness, hypochloraemic alkalosis may develop

    hepatic encephalopathy or hepatic coma), hyponatremia (confusion, convulsions, apathy, slowing down the process of thinking, fatigue, irritability), hypomagnesemia (arrhythmias).

    On the part of the hematopoiesis 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, noncardiogenic pulmonary edema), photosensitization; anaphylactic reactions (up to the life threatening anaphylactic shock).

    Overdose:

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

    Treatment: the patient is given a horizontal position with raised legs, in mild cases of overdose - gastric lavage, the introduction of adsorbents and sodium sulfate (it is advisable to carry out the activities within the first 30 minutes after taking the drug). With a decrease in blood pressure - intravenous injection of catecholamines, angiotensin II; with bradycardia - the use of pacemaker. The drug is not excreted during hemodialysis.

    Interaction:

    Ramipril

    Strengthens the inhibitory effect of ethanol on the central nervous system. Taking salt with food can reduce the hypotensive effect of ramipril.

    With the simultaneous use of ramipril and other means that reduce blood pressure (eg diuretics, nitrates, tricyclic antidepressants, anesthetics) 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 (adrenaline, norepinephrine) can reduce the hypotensive effect of ramipril. In this regard, with simultaneous treatment should carefully monitor blood pressure.

    The simultaneous administration of ramipril and allopurinol, immunosuppressants, corticosteroids, procainamide, cytotoxic drugs increases the likelihood of a changeIy peripheral blood picture.

    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 (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 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 the 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 bind intensely to 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, ethanol.

    Hydrochlorothiazide enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic drugs, norepinephrine, epinephrine and antidotal drugs, increases cardiotoxic and neurotoxic effects of drugs Li +, the effect of peripheral muscle relaxants, reduces the excretion of quinidine. With the simultaneous administration of methyldopa, the development of hemolysis is possible. Kolestyramine reduces the absorption of hydrochlorothiazide.

    Hydrochlorothiazide reduces the effect of oral contraceptives.

    Special instructions:

    Ramipril

    At the beginning of treatment, it is necessary to evaluate the kidney function. Care should be taken to monitor renal function during treatment with ramipril, especially in patients with impaired renal function, renal vessel damage (eg, clinically insignificant stenosis of the renal arteries or 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 were revealed in the apheresis of low-density lipoproteins using dextran sulfate, therefore, in the treatment of ACE inhibitors, this method should be avoided.

    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 "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 contraindication for the continuation of treatment after stabilization of 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 can cause blockade of the formation of angiotensin II 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 (eg, systemic lupus erythematosus or scleroderma) and in patients taking medications that affect hemopoiesis simultaneously (see Interactions with Other Drugs). 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, anaphylactoid reactions (eg, arterial hypotension, dyspnoea, vomiting, skin rashes) can occur to aspen or bee venom, 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.

    During the treatment with Ramazid H, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (possibly dizziness, especially after the initial dose of an ACE inhibitor in patients taking diuretic medicines). Patients are advised to refrain from driving and working with the mechanisms until the response to treatment is clear.

    Hydrochlorothiazide

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

    Effect on the ability to drive transp. cf. and fur:

    During the treatment with Ramazid H, care should be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and rapidity of psychomotor reactions (possibly dizziness, especially after the initial dose of an ACE inhibitor in patients taking diuretic medicines). Patients are advised to refrain from driving and working with the mechanisms until the response to treatment is clear.

    Form release / dosage:

    Tablets 2.5 / 12.5 mg; 5/25 mg.

    By 7, 10 or 14 tablets per blister from PVC / aluminum foil or in \

    blister of A1 / A1, laminated PVC; 2 or 4 blisters (no 7 tablets), 1 or 3 blisters (10 tablets each), 1 or 2 blisters (14 tablets each), along with instructions for application in a cardboard box.

    For 10, 30 or 60 blisters (10 each tablets) together with the instructions for application in a cardboard box (for hospitals).

    Packaging:

    By 7, 10 or 14 tablets per blister from PVC / aluminum foil or in \

    blister of A1 / A1, laminated PVC; 2 or 4 blisters(no 7 tablets), 1 or 3 blisters (10 tablets each), 1 or 2 blisters (14 tablets each), along with instructions for application in a cardboard box.

    For 10, 30 or 60 blisters (10 each tablets) together with the instructions for application in a cardboard box (for hospitals).

    Storage conditions:

    At a temperature not inyshe 25 ° C.

    Keep out of the reach of children!

    Shelf life:3 years (PVC blister / aluminum foil); 2 years (blister Al / Al, laminated PVC). The drug is not should be applied after the expiration date the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003066/07
    Date of registration:09.10.2007
    Manufacturer: & nbsp
    Information update date: & nbsp17.02.2015
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