Amprilan nl pills 2.5 mg + 12.5 mg N30
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Active ingredients
Hydrochlorothiazide + Ramipril
Release form
Uncoated Tablets
Composition
Ramipril 2.5 mg; hydrochlorothiazide 12.5 mg; Excipients: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch (starch 1500), sodium fumarate.
Pharmacological effect
Combined antihypertensive drug containing an ACE inhibitor and a diuretic.; Ramipril is an ACE inhibitor that prevents angiotensin I from converting to angiotensin II without a compensatory increase in heart rate. , enhances coronary blood flow. With prolonged use of the drug, myocardial hypertrophy is reduced in patients with arterial hypertension, the frequency of arrhythmias during myocardial reperfusion decreases; the blood circulation of the ischemic myocardium is improved. The cardioprotective effect is due to the effect on the synthesis of prostaglandins, the induction of the formation of nitric oxide in endothelial cells. The drug reduces platelet aggregation. The onset of hypotensive action is 1.5 hours after ingestion, the maximum effect is 5–9 hours, the duration is 24 hours. The drug does not have withdrawal syndrome. Hydrochlorothiazide is a thiazide diuretic, the diuretic effect of which is associated with impaired sodium and chlorine ion potassium, magnesium, water in the distal nephron.; Delays the excretion of calcium ions, uric acid. It has an antihypertensive effect that develops due to the expansion of arterioles. Virtually no effect on normal blood pressure. The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. The diuretic effect occurs after 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 taking hydrochlorothiazide.
Pharmacokinetics
The pharmacokinetics of ramipril and hydrochlorothiazide, when administered simultaneously, does not differ from that when they are used separately.; Absorption; After oral administration, absorption of ramipril averages 50-60%.Eating does not affect the degree of absorption, but reduces its speed. Тmax is 2-4 hours; After oral administration, the absorption of hydrochlorothiazide is 60-80%, Cmax of hydrochlorothiazide in the blood is reached in 1-5 hours; Distribution; Binding of ramipril to plasma proteins is 73%, ramiprilat is 56%. Vd ramipril - 90 l, ramiprilat - 500 l.; Hydrochlorothiazide plasma protein binding is 64%; Metabolism; Ramipril metabolism occurs mainly in the liver with the formation of an active metabolite of ramiprilat, which inhibits ACE 6 times more active than ramipril and an inactive metabolite diketopiperazine, which are then glucuronized.; Hydrochlorothiazide is not metabolized.; Withdrawal; T1 / 2 ramipril - 5.1 h; in the distribution and elimination phase, a decrease in the concentration of ramiprilat in the serum occurs from T1 / 2 - 4-5 days. Ramipril is excreted mainly in the form of metabolites: with urine - 60%, with feces - 40%. Unchanged form of hydrochlorothiazide is rapidly excreted in the urine. T1 / 2 is 5-15 hours; Pharmacokinetics in special clinical situations; T1 / 2 of ramipril and its metabolites increases with renal failure.
Indications
- arterial hypertension (to patients for whom combination therapy is indicated).
Contraindications
Ramipril; - angioedema in history (including associated with previous therapy with ACE inhibitors); - hemodynamically significant bilateral renal artery stenosis; - stenosis of the artery of the only kidney; - condition after kidney transplantation; - hemodialysis; - renal failure (CC <30 ml / min); - hemodynamically significant aortic or mitral stenosis (risk of an excessive decrease in blood pressure, followed by impaired renal function); - hypertrophic obstructive cardiomyopathy; - primary hyper aldosteronism; - pregnancy; - lactation period; - children's and teenage age up to 18 years (efficiency and safety are not established); - hypersensitivity to ACE inhibitors; - hypersensitivity to ramipril and / or components of the drug.; The drug should be prescribed with caution in severe lesions of the coronary and cerebral arteries (risk of blood flow reduction in excessive blood pressure), unstable angina, severe ventricular arrhythmias, chronic heart failure stage IV, decompensated pulmonary heart, renal and / or liver failure, hyperkalemia, hyponatremia (includingon the background of the use of diuretics and diets with restriction of salt intake), conditions accompanied by a decrease in BCC (including diarrhea, vomiting), systemic connective tissue diseases (including scleroderma and SLE), diseases requiring the prescription of GCS and immunosuppressants (no clinical experience), diabetes mellitus, oppression of bone marrow hematopoiesis, elderly patients.; Hydrochlorothiazide; gout; - diabetes mellitus (severe forms); - chronic renal failure (CC <20-30 ml / min, anuria); - severe liver failure; - refractory hypokalemia; - hypercalcemia; - hyponatremia; - pregnancy; - lactation period; - children's age up to 3 years (for pills); - Hypersensitivity to sulfonamides in history; - Hypersensitivity to the components of the drug. With caution should take the drug in hypokalemia, hyponatremia, hypercalcemia, coronary artery disease, liver failure, liver cirrhosis, bronchial asthma in history, in elderly patients.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy. When pregnancy occurs, the drug should be immediately discontinued. If necessary, use of the drug during lactation should decide on the termination of breastfeeding.
Dosage and administration
The drug should be taken orally. The dose is selected individually.; The usual dose for adults is 1 tab./day (2.5 mg / 12.5 mg) of Amprilan NL. If necessary, the dose can be increased to 1 tab./day (5.0 mg / 25 mg) Amprilana ND.; In case of impaired mild or moderate renal function (CC> 30 ml / min, serum creatinine approximately 3 mg / dL or 265 μmol / l) the usual dose is recommended. When QA <30 ml / min, the drug is not recommended.; The duration of therapy is not limited.
Side effects
Ramipril; On the part of the cardiovascular system: lowering 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 coronary artery disease and clinically significant narrowing of cerebral vessels, myocardial ischemia (angina pectoris, myocardial infarction) and cerebral ischemia (possibly with dynamic impairment of cerebral circulation or stroke) can develop; nausea, vomiting, diarrhea or constipation, pain in the epigastric region, intestinal obstruction, flatulence, pancreatitis, hepatitis,cholestatic jaundice, cholecystitis (with cholelithiasis), abnormal liver function with the development of liver failure, melena, ileus, dry mouth, thirst, loss of appetite, stomatitis, glossitis, inflammation of the salivary glands.; CNS and peripheral nervous system: dizziness, headache, weakness, drowsiness, peripheral neuropathy (paresthesias), nervous irritability, anxiety, tremor, muscle spasm, mood disorders, apathy; when used in high doses - insomnia, anxiety, depression, ataxia, confusion, fainting. On the respiratory system: dry cough, bronchospasm, shortness of breath, rhinorrhea, rhinitis, sinusitis, pharyngitis, hoarseness, bronchitis, interstitial pneumonia, pulmonary embolism , pulmonary infarction, pulmonary edema.; From the urinary system: development or intensification of symptoms of renal failure, proteinuria, oliguria, interstitial nephritis, nephrotic syndrome, decrease in urine volume;; Reproductive system: g Inecomastia, decrease in potency, libido. From the sense organs: vestibular disorders, taste disturbances (for example, metallic taste), smell, hearing and vision, blepharitis, conjunctiva dryness, tearing, tinnitus.; From the hemopoietic system: anemia, decrease in hemoglobin and hematocrit, neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, the appearance of antinuclear antibodies, eosinophilia.; From the side of metabolism: hypercreatininemia, increased level of urea nitrogen, increased activity these liver enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia.; Allergic reactions: skin rash, pruritus, urticaria, conjunctivitis, photosensitization, angioedema of the face, extremities, lips, tongue, pharynx and / or larynx, exfoliated dermatitis of the face, extremities, lips, tongue, throat and / or larynx, exfoliative dermatitis . h. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), pemphigus, serositis, onycholysis, vasculitis, myositis, muscle weakness, myalgia, arthralgia, arthritis; Other: convulsions, alopecia, shingles, hyperthermia, increased perspiration, hyperthermia, increased perspiration on the fetus: dysfunction of the fetus, reduction of fetal / newborn blood pressure, renal dysfunction, hyperkalemia,hypoplasia of the bones of the skull, oligohydramnios, contracture of the extremities, deformation of the bones of the skull, hypoplasia of the lungs.; Hydrochlorothiazide; Cardiovascular system: arrhythmia, orthostatic hypotension, tachycardia; , anorexia, epigastric pain. On the side of the central nervous system and peripheral nervous system: depression, sleep disturbance, anxiety, paresthesia, confusion, dizziness.; On the part of the urinary system: impaired function eyeglasses, interstitial nephritis. From the sense organs: xantopsia, visual impairment. From the hematopoietic system: agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, leukocytopenia, eosinophilia, neutropenia, pancitopenia. hypochloremic alkalosis (dry mouth, increased thirst, heart rhythm disturbances, changes in mood and psyche, cramps or muscle pain, nausea, vomiting, weakness; in case of hypochloremic alkalosis, hepatic encephalopathy or hepatic coma may develop, there is an excursion of confusion, confusion, convulsions, apathy, delayed thinking, fatigue, irritability, hypomagnemia (arrhythmia), hypercholesterolemia, hypertriglyceridemia, hyperglycemia, hyperglycemia, hyperglycemia, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, and ; Allergic reactions: skin rash, urticaria, purpura, necrotic vasculitis, Stevens-Johnson syndrome, respiratory distress syndrome (pneumonitis, non-cardiogenic pulmonary edema) , toxic epidermal necrolysis, photosensitivity, anaphylactic reactions (up to life-threatening anaphylactic shock); Other: hyperthermia, weakness, reduced potency.
Overdose
Ramipril; Symptoms: marked reduction 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 elevated legs, in mild cases of overdose - washing the stomach , the introduction of adsorbents and sodium sulfate (it is desirable to hold activities during 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 pacemaker. The drug is not displayed during hemodialysis.; Hydrochlorothiazide; Symptoms: hypokalemia (adynamia, paralysis, constipation, arrhythmias), drowsiness, decreased blood pressure.; Treatment: infusion of electrolyte solutions, compensation for potassium deficiency (prescription of potassium and potassium-sparing diuretics).
Interaction with other drugs
Ramipril; When used simultaneously, ramipril enhances the inhibitory effect of ethanol on the central nervous system. Salt intake with food may reduce the hypotensive effect of ramipril. When used simultaneously with ramipril and other blood pressure reducing agents (including diuretics, nitrates, tricyclic antidepressants, for general anesthesia) the hypotensive effect of ramipril is enhanced. With the simultaneous administration of ramipril and potassium / potassium-sparing diuretic drugs, hyperkalemia can develop. Due to the possible decrease in the hypotensive effect of p Mipril should be carefully monitored for blood pressure with simultaneous use of Amprilan NL with vasopressor sympathomimetics (epinephrine, norepinephrine); Simultaneous use of ramipril with allopurinol, immunosuppressants, GCS, procainamide, cytostatics increases the likelihood of changes in the peripheral blood pattern (risk of leukopenia); with a decrease in the excretion of lithium and the risk of toxic effects, the concentration of lithium in the blood serum should be monitored with the simultaneous use of ramie adjuvant with lithium preparations. When used simultaneously, ACE inhibitors may enhance the effect of hypoglycemic agents (including insulin or sulfonylurea derivatives), which in some cases can cause hypoglycemia. Blood glucose levels should be carefully monitored, especially at the beginning of combination therapy. With simultaneous use of ramipril with NSAIDs (including acetylsalicylic acid, indomethacin), the hypotensive effect of ramipril can be weakened, as well as the development of hyperkalemia and an increased risk of renal impairment .; With the simultaneous use of ramipril with estrogens, a weakening of the hypotensive effect is possible. With the simultaneous use of heparin and ramipril, the development of hyperkalemia is possible.treatment of ACE inhibitors anaphylactic and anaphylactoid reactions to the poison of stinging insects (and possibly to other allergens) are more pronounced. for the likely development of hypokalemia and hypomagnesemia. With simultaneous use, they enhance the hypotensive effect of hydrochlorothiazide: vasodilators, beta-blockers, barbiturates, f enotiaziny, tricyclic antidepressants, ethanol, as well as medicines, intensively binding proteins blood (indirect anticoagulants, clofibrate, NSAIDs) .; With simultaneous application hydrochlorothiazide enhances the neurotoxicity salicylates, cardiotoxic and neurotoxic effects of drugs lithium effect of peripheral muscle relaxants;. In an application hydrochlorothiazide weakens the action of oral contraceptives, oral hypoglycemic agents, norepinephrine, epinephrine and protivopodag dosing of quinidine. With simultaneous use of hydrochlorothiazide with methyldopa, hemolysis may develop. With simultaneous use of hydrochlorothiazide with Kolestiramine, the absorption of hydrochlorothiazide decreases.
special instructions
Ramipril; At the beginning of treatment, renal function should be evaluated. Renal function must be carefully monitored during ramipril treatment, especially in patients with impaired renal function, with renal vascular damage (for example, clinically insignificant renal artery stenosis or hemodynamically significant stenosis of a single kidney artery); heart failure.; The risk of hypersensitivity and allergy-like (anaphylactoid) reactions is increased in patients simultaneously taking ACE inhibitors and undergoing hemodialysis using the dialysis membranes of AN 69. avoid using this method. During treatment with ramipril in patients with impaired renal function, especially with simultaneous treatment with diuretics, it may increase The level of urea and creatinine in the serum. 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, due to a decrease in liver enzyme activity, ramipril metabolism and the formation of an active metabolite can be slowed down. In this regard, the treatment of such patients should be started only under strict medical supervision.; Care should be taken when prescribing ramipril to patients on a low-salt or salt-free diet (increased risk of 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 to continue treatment after stabilization of blood pressure. In case of recurrence of severe arterial hypotension, the dose should be reduced or discontinued. In patients undergoing extensive surgical interventions or receiving other means causing arterial hypotension during general anesthesia, ramipril can cause blockade of angiotensin II formation due to compensatory renin release. If the doctor connects the development of arterial hypotension with the mechanism mentioned above, arterial hypotension can be corrected by an increase in plasma volume. In rare cases, during treatment with ACE inhibitors, agranulocytosis, erythrocytopenia, thrombocytopenia, hemoglobinemia or bone marrow 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, diseases of the connective tissue (including SLE or scleroderma), and in patients who simultaneously take drugs that affect blood formation. The counting of blood cells should also be carried out in the event of clinical signs of neutropenia, agranulocytosis, and increased bleeding. In patients with arterial hypertension, ramipril treatment rarely increases the level of potassium in the blood serum.The risk of hyperkalemia increases with chronic heart failure, simultaneous treatment with potassium-sparing diuretics (including spironolactone, amiloride, triamterene) and administration of potassium drugs. Anaphylactoid reactions may occur during the use of ACE inhibitors during desensitizing therapy to wasp or bee venom. arterial hypotension, shortness of breath, vomiting, skin rash), which can be life-threatening. Hypersensitivity reactions may occur when insect bites (including bees, wasps). If you need a desensitizing treatment with bee or wasp venom, you need to cancel ACE inhibitors and continue treatment with suitable drugs from other groups. Hydrochlorothiazide; To prevent potassium and magnesium deficiency, prescribe a diet high in these salts, potassium-saving diuretics, potassium and magnesium salts. Requires regular monitoring of plasma levels of potassium, glucose, uric acid, lipids and creatinine.; Use in Pediatrics; Use of the drug is contraindicated in patients of children and adolescents under 18 years of age (efficacy and safety have not been established); Effect on the ability to drive motor vehicles and management of mechanisms; During the period of treatment, care must be taken when driving vehicles, as well as during classes of potentially hazardous activities that require high concentration of attention and the speed of psychomotor reactions.