Ravel CP coated pills prolonged 1.5 mg N60
Condition: New product
Rating:
Be the first to write a review!
More info
Active ingredients
Indapamide
Release form
Pills
Composition
Indapamide 1.5 mg Supplementary substances: hypromellose (hydroxypropylmethyl cellulose) - 67 mg, cellactose (lactose monohydrate 75%, cellulose 25%) - 121.5 mg, povidone - 8.6 mg, colloidal silicon dioxide - 0.4 mg, magnesium stearate - 1 mg. Composition of the shell: opadry Y-1-7000 - 5 mg (hypromellose, titanium dioxide, macrogol 400 (polyethylene glycol)).
Pharmacological effect
Diuretic. Indapamide is a derivative of sulfonamide and is pharmacologically similar to thiazide diuretics. It has moderate saluretic and diuretic effects, which are caused by inhibition of the reabsorption of sodium ions, chlorine and, to a lesser extent, potassium and magnesium ions in the proximal tubule of the kidneys and in the cortical distal channel band .Indapamid reduces the tone of the smooth muscles of the arteries and has a vasodilating effect, reduces round fissure. These effects are mediated by a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II, an increase in the synthesis of prostaglandin E2, which has vasodilating activity, as well as inhibition of calcium current in vascular smooth muscle cells. Indapamide helps to reduce left ventricular hypertrophy of the heart. It has an antihypertensive effect in doses that do not have a pronounced diuretic effect. In therapeutic doses, it does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus). After taking a single dose, the maximum effect is noted after 24 hours.
Pharmacokinetics
Absorption After ingestion, indapamide is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake somewhat slows down the rate of absorption, but does not significantly affect the amount of absorbed drug. Cmax is achieved 12 hours after a single dose. With repeated administrations, fluctuations in the concentration of the drug in the blood plasma in the interval between intakes of the drug are smoothed out. However, there is individual variability in drug absorption. Distribution Binding to plasma proteins is 71-79%. Css is set after 7 days of regular use of the drug. Does not accumulate. Has a large Vd, penetrates through histohematogenous barriers (including placental).It is excreted in breast milk. Metabolism and excretion Metabolized mainly in the liver. T1 / 2 - 14-24 hours (average 18 hours). 70% of indapamide is excreted in the urine as inactive metabolites (about 5% is excreted unchanged) and 22% is excreted with feces. Pharmacokinetics in special clinical situations in patients with renal insufficiency the pharmacokinetic parameters of the drug do not change significantly.
Indications
- arterial hypertension.
Contraindications
- severe renal failure (CK <30 ml / min); - severe hepatic failure (including hepatic encephalopathy); - hypokalemia; - lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome (because Ravel SR contains lactose); - pregnancy; - lactation period; - childhood and adolescence under 18 years of age (efficacy and safety have not been established); - hypersensitivity to indapamide, other sulfonamide derivatives or any component of the drug. in kidney and / or liver function, diabetes mellitus in the decompensation stage, impaired water-electrolyte balance, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyperparathyroidism, as well as patients with prolonged QT interval on the ECG or receiving therapy, which may result in elongation QT interval (astemizol, erythromycin (w / w), pentamidine, sultoprid, terfenadine, vincamine (w / w), antiarrhythmic drugs of class IA (quinidine, disopyramide) and class III (amiodarone, bretily tosylate).
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
It is not recommended the appointment of the drug Ravel CP during pregnancy.The use of the drug may cause placental ischemia with the risk of slowing the development of the fetus. It is not recommended to use the drug during lactation (breastfeeding), because indapamide is excreted in breast milk. If treatment with Ravel CP is necessary during lactation, then breastfeeding should be stopped.
Dosage and administration
The drug is taken orally, 1.5 mg (1 tab.) 1 time / day, preferably in the morning, regardless of the meal. To accept without chewing, washing down with enough liquid. Increasing the dose of the drug does not lead to increased antihypertensive effect.
Side effects
Classification of the incidence of side effects (WHO): very often (≥ 10%), often (≥ 1% - <10%), infrequently (≥ 0.1% - <1%), rarely (≥ 0.01% - <0.1%), very rarely (≥ 0.001% - <0.01%, including individual messages). From the cardiovascular system: very rarely - decreased blood pressure, arrhythmia, orthostatic hypotension, palpitations, ECG changes characteristic of hypokalemia, hemorrhagic vasculitis. blood formation: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, aplasia of the bone marrow. NA and peripheral nervous system: rare - dizziness, headache, paresthesia, anxiety, asthenia, somnolence, vertigo, insomnia, depression, fatigue, limb muscle spasms, tension, irritability, digestive system side trevozhnost.So: rarely - vomiting; rarely - nausea, constipation, dryness of the oral mucosa; very rarely - pancreatitis, anorexia, abdominal pain, diarrhea. In patients with hepatic impairment, hepatic encephalopathy may develop. From the urogenital system: very rarely - renal insufficiency, nocturia, infections, polyuria. From the respiratory system: cough, pharyngitis, sinusitis, rhinitis. Allergic reactions: often - maculo-papular rash; infrequently - purpura, very rarely - angioedema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, pruritus. Others: individual messages - exacerbation of SLE, photosensitivity reactions. Laboratory data: in clinical studies of hypokalemia (potassium content in blood plasma less than 3.4 mmol / l) was observed in 10% of patients and 3.2 mmol / l in 4% of patients after 4-6 weeks of treatment. After 12 weeks of therapy, the content of potassium in the blood plasma decreased by an average of 0.23 mmol / l.Very rarely - hypercalcemia, unspecified frequency: a decrease in the content of potassium and the development of hypokalemia, which is especially significant for patients at risk; hyponatremia accompanied by hypovolemia and orthostatic hypotension. The simultaneous loss of chlorine ions can lead to a compensatory metabolic alkalosis, however, the frequency of the development of metabolic alkalosis and its severity is insignificant; hyperuricemia and hyperglycemia (unspecified frequency), increased concentration of blood urea nitrogen, hypercreatininemia.
Overdose
Symptoms: marked reduction in blood pressure, water and electrolyte disturbances (hyponatremia, hypokalemia), nausea, vomiting, convulsions, dizziness, drowsiness, lethargy, confusion, respiratory depression, polyuria or oliguria up to anuria (due to hypovolemia). Patients with cirrhosis of the liver may develop hepatic coma. Treatment: symptomatic (gastric lavage and / or administration of activated carbon, restoration of water and electrolyte balance). There is no specific antidote.
Interaction with other drugs
Non-recommended combinations When used simultaneously with lithium preparations, it is possible to increase the concentration of lithium ions in the blood plasma due to a decrease in its excretion from the body, accompanied by the appearance of signs of overdose (nephrotoxic effect), as well as observing the salt-free diet (reducing the excretion of lithium ions by the kidneys). Combinations that require special attention Simultaneous use with any of the drugs that can cause a disturbance of the heart rhythm by the type of pirouette, including antiarrhythmics (class IA) (quinidine) , sultoprid, tiaprid), butyrophenones (droperidol, haloperidol), as well as bepridil, cisapride, diphemanil, erythromycin (i.v.), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, mikolastine, pentamidine, vincamene, moxifloxacin, mikolastine, vincamene, moxifloxacin, mikolastine, pentamidine, sphifloxacin, moxifloxacin hypo aliemii, increases the risk of ventricular arrhythmias.Before starting combination therapy with Ravel CP and the above preparations, it is necessary to control the content of potassium in the blood plasma and, if necessary, correct it. It is recommended to monitor the patient's clinical condition, as well as the content of electrolytes of blood plasma and ECG. In patients with hypokalemia, it is necessary to use drugs that do not provoke the development of pirouette-type arrhythmias. When NSAIDs are administered concurrently (for systemic use), including selective COX-2 inhibitors, high doses of salicylic acid (3 g / day or more), the antihypertensive effect of indapamide may decrease, development of acute renal failure in dehydrated patients (due to a decrease in glomerular filtration rate). At the beginning of therapy with indapamide, it is necessary to restore water and electrolyte balance and monitor renal function. ACE inhibitors in patients with hyponatremia (especially in patients with renal artery stenosis) increase the risk of hypotension and / or acute renal failure. Patients with arterial hypertension and possibly with hyponatremia due to diuretic administration should: - stop taking the drug 3 days before initiating therapy with ACE inhibitors and switch to potassium-sparing diuretics therapy; - or start therapy with ACE inhibitors from low doses, followed by a gradual increase in dose if necessary. In the first week of therapy with ACE inhibitors, it is recommended that plasma creatinine concentrations be monitored. When used simultaneously with indapamide, drugs that can cause hypokalemia, including amphotericin B (w / w), gluco- and mineralocorticoid (for systemic use), tetracosactide, laxatives that stimulate intestinal motility, increases the risk of hypokalemia (additive effect). If necessary, the content of potassium ions in the blood plasma should be monitored and correlated. Simultaneous therapy with baclofen enhances the antihypertensive effect of indapamide. Hypokalemia caused by indapamide increases the toxic effect of cardiac glycosides (glycoside intoxication). With simultaneous use of indapamide and cardiac glycosides should be monitored the content of potassium ions in the blood plasma, ECG readings, and, if necessary,adjust therapy. Combinations of drugs requiring attention Simultaneous use with potassium-sparing diuretics (amiloride, spironolactone, triamteren) is advisable in some patients, but the possibility of hypokalemia is not excluded. On the background of diabetes mellitus or kidney failure, hyperkalemia may develop. It is necessary to control the content of potassium ions in the blood plasma, ECG indicators, and, if necessary, adjust therapy. Metformin increases the risk of developing lactic acidosis, because possible development of renal failure in the presence of diuretics, especially loopback. Metformin should not be taken when plasma creatinine levels exceed 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women. Simultaneous use of large doses of iodine-containing contrast media on the background of hypovolemia and diuretic use increases risk of acute renal failure. It is recommended to restore the water-electrolyte balance of the blood before using the drugs. Tricyclic antidepressants (imipramine-like) and neuroleptics increase the hypotensive effect and the risk of orthostatic hypotension (additive effect). Tacrolimus increases the risk of increasing the concentration of creatinine in the blood plasma without changing the concentration of the circulating cyclosporin. tracosactid (with systemic use) reduces the hypotensive effect of indapamide (sodium ion and fluid retention).
special instructions
In patients with hepatic insufficiency, when thiazide-like diuretics are prescribed, the development of hepatic encephalopathy is possible, especially if the electrolyte balance is disturbed. With its development, diuretic administration should be discontinued. When using thiazide-like diuretics, cases of development of photosensitivity reactions have been noted. If they develop, the drug should be discontinued. During therapy with Ravel CP, it is necessary to protect exposed areas of the body from exposure to sunlight and artificial ultraviolet radiation. All diuretic drugs can cause hyponatremia.The content of sodium ions in the blood plasma should be measured before the start of treatment with Ravel CP, and then regularly during the treatment period. Determination of the content of sodium ions in the blood plasma should be carried out before the start of therapy with Ravel CP, as well as during the period of therapy. It is important to regularly monitor the content of sodium ions in the blood plasma, because initially hyponatremia may be asymptomatic. The most careful control of the content of sodium ions is indicated for elderly patients and patients with cirrhosis of the liver. Hypokalemia is the greatest risk in the treatment of thiazide-like diuretics. In order to prevent hypokalemia (less than 3.4 mmol / l), special attention should be paid to weakened patients and / or receiving other therapy (antiarrhythmic drugs and agents that can prolong the QT interval on an ECG), elderly patients, patients with cirrhosis of the liver, peripheral edema and ascites, with IHD and chronic heart failure. Hypokalemia in these patients increases the toxic effect of cardiac glycosides and increases the risk of developing arrhythmias. Patients with an extended QT interval on an ECG are also among the high-risk group. Hypokalemia is a predisposing factor for the occurrence of severe arrhythmias, and especially pirouette-type arrhythmias, which can be fatal. In all the cases described, it is necessary to regularly monitor the content of potassium in the blood plasma. The first determination of the potassium content in the blood plasma should be carried out during the first week of therapy with Ravel CP. When hypokalemia is detected, appropriate therapy should be given. Thiazide-like and thiazide diuretics can reduce the excretion of calcium ions by the kidneys, leading to minor and / or transient hypercalcemia. Severe hypercalcemia in patients receiving Ravel C may be a consequence of previously undiagnosed hyperparathyroidism. Diuretic therapy should be discontinued before examining the function of the parathyroid glands. Patients with diabetes mellitus, especially in the presence of hypokalemia, need to control plasma glucose concentrations. Patients with hyperuricemia receive Ravel CP may increase the frequency of seizures or exacerbations of gout.diuretics are fully effective only in patients with normal or slightly reduced (serum creatinine in adults less than 25 mg / l or 220 μmol / l) kidney function. Severe hypovolemia can lead to the development of acute renal failure (reduced glomerular filtration rate) accompanied by an increase in the concentration of urea and creatinine in the blood plasma. In normal renal function, transient functional renal failure, as a rule, passes without consequences. With existing renal failure, the patient’s condition may deteriorate. Regular monitoring of creatinine levels and plasma potassium levels is recommended, taking into account the patient’s age, body weight and sex. Ravel CP can be prescribed to elderly patients with preserved or slightly impaired renal function (QC above 30 ml / min). Indapamide may give a positive result during doping control. Use in pediatrics The effectiveness and safety of the drug in children have not been established. driving a car and driving mechanisms; Indapamide use does not lead to a disturbance of psychomotor reactions. However, in some patients, various individual reactions may develop in response to a decrease in blood pressure, especially at the beginning of therapy or when other antihypertensive drugs are added to the therapy. In this regard, at the beginning of treatment with Ravel CP, it is not recommended to drive vehicles or other complex mechanisms that require increased attention.