Ravel CP

Active material: Indapamid
When ATH: C03BA11
CCF: Diuretic. Antihypertensive drugs
ICD-10 codes (testimony): I10
When CSF: 01.08.02.02
Manufacturer: Krka-RUS OOO (Russia)

DOSAGE FORM, COMPOSITION AND PACKAGING

Sustained-release tablets, coated white or nearly white, round, lenticular.

Excipients: hydroxypropyl (gipromelloza), tsellaktoza, povidone, silicon oxide, colloidal anhydrous, magnesium stearate, Opadry Y-1-7000 (a mixture of hypromellose, macrogol 400 titanium oxide), water.

10 PC. – packings Valium planimetric (2) – packs cardboard.
10 PC. – packings Valium planimetric (3) – packs cardboard.
10 PC. – packings Valium planimetric (6) – packs cardboard.

Pharmacological action

Diuretic. Antihypertensive drugs. Indapamide is a sulfonamide derivatives and pharmacologically similar to thiazide diuretics.

Indapamide inhibits the reabsorption of sodium in the cortical segment of the renal tubules, which increases urinary excretion of sodium and chloride ions, and leads to increased diuresis. To a lesser extent the drug increases the excretion of potassium and magnesium.

In addition to its diuretic effect indapamide affects the vascular tone, expressed in the reduction of arteriolar and total peripheral resistance.

Indapamide has antihypertensive effect in doses, does not have a pronounced diuretic effect. In high doses, it does not affect the degree of decrease in blood pressure, despite an increase in urine output.

Indapamid, Like other thiazides, reduces left ventricular hypertrophy.

At therapeutic doses, has practically no effect on the lipid and carbohydrate metabolism.

Pharmacokinetics

Absorption and distribution

After oral administration indapamide is rapidly and almost completely absorbed from the gastrointestinal tract. Eating slows down the absorption rate, but did not significantly affect the amount of the drug has grown deep. C_max achieved through 12 hours after receiving a single dose of. Repeated receptions fluctuations in the plasma concentration of the drug in the interval between doses 2 reduced doses. Repeated reception does not lead to accumulation of the drug. The binding to plasma proteins – 79%.

Metabolism and excretion

It is metabolized in the liver. T_1/2 – 14-24 no (average 18 no). Write mainly with urine (70% – as metabolites, in unchanged form – about 5%), with feces – about 20% active metabolites.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency pharmacokinetics unchanged.

Testimony

- Arterial hypertension.

Dosage regimen

The drug is taken orally, by 1.5 mg (1 tab.) 1 time / day, preferably in the morning hours, drinking plenty of fluids.

Side effect

Cardio-vascular system: orthostatic hypotension, ECG changes (kaliopenia), arrhythmia, heartbeat.

CNS: headache, dizziness, nervousness, asthenia.

From the digestive system: constipation or diarrhea, dyspepsia, nausea, abdominal pain, hepatic encephalopathy; rarely – pancreatitis.

From the urinary system: frequent infections, nocturia, polyuria.

Allergic reactions: itching, maculopapular rash, hives, gemorragicheskiy vasculitis.

The respiratory system: cough, pharyngitis, sinusitis.

From the laboratory parameters: hypercalcemia, hyperuricemia, giponatriemiya, chloropenia, giperglikemiâ.

From the hematopoietic system: rarely – thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, gemoliticheskaya anemia.

Other: possible exacerbation of systemic lupus erythematosus.

Contraindications

- Severe renal insufficiency (Stage anurii);

- Severe hepatic impairment (incl. encephalopathy);

- Hypokalemia;

- Concomitant use of drugs, prolonging the QT interval;

- Childhood and adolescence up 18 years (efficacy and safety have not been established);

- Hypersensitivity to any component of the drug and other sulfonamide derivatives.

FROM caution prescribe the drug for patients with diabetes, renal dysfunction and / or liver, disruption of water and electrolyte balance, giperparatireoze, QT prolongation on the ECG, hyperuricemia (gout especially manifested or urate nephrolithiasis).

Pregnancy and lactation

Not recommended the appointment of indapamide in pregnancy. Use of the drug can cause placental ischemia with risk of fetal growth retardation.

Not recommended for use during lactation (breast-feeding), tk. indapamide is excreted in breast milk.

Cautions

If abnormal liver function receiving thiazide diuretics may cause hepatic encephalopathy. When it occurs the drug should be discontinued immediately.

Admission indapamide may cause hyponatremia, in some cases with serious consequences. The level of sodium in the blood plasma is measured before treatment, and then during treatment at regular intervals. Initially the drop in the concentration of sodium in the blood plasma can be asymptomatic, therefore, regular monitoring is an important. In elderly patients and patients with cirrhosis of the liver monitoring should be more frequent. While taking the drug may develop hypokalemia. Careful and regular monitoring of potassium for the prevention of hypokalemia (potassium content of less than 3.4 mmol / l) should be performed in patients at risk, such as debilitated patients and / or taking multiple medicines, Elderly patients, Patients with cirrhosis, peripheral edema and ascites, Coronary artery disease and heart failure. In these patients, hypokalemia increases the toxic effects of cardiac glycosides and the risk of arrhythmias.

The group also includes high-risk patients with prolonged QT interval on an electrocardiogram, Regardless of the cause – congenital or induced by drugs. Kaliopenia (as well as bradycardia) It is a predisposing factor of severe arrhythmias, especially potentially dangerous type “pirouette”.

All of these patients require more frequent monitoring of potassium concentration in the blood plasma. The first measurement of plasma potassium concentration should be held during the first week of treatment. In identifying low levels of potassium needed its correction.

Controlling blood glucose levels is important in patients with diabetes, especially in the presence of hypokalemia.

In patients with hyperuricemia may increase the frequency of gout attacks.

Thiazide and thiazide diuretics fully effective only under normal or slightly reduced (the content of serum creatinine in adults < 2.5 mg / dL or 220 mmol / l) renal function. Older patients serum creatinine content may vary depending on the age, body weight and sex.

Secondary hypovolemia due to loss of water and sodium, induced diuretic at the start of treatment, causes a reduction in glomerular filtration rate. This may lead to increased levels of urea and creatinine in plasma. If renal function in a patient is not broken, then this transient functional renal failure, usually, passes without consequences, but may worsen already existing renal insufficiency.

Admission indapamide may cause a positive reaction in doping control.

Use in Pediatrics

The efficacy and safety of the drug in children have not been established.

Effects on ability to drive vehicles and management mechanisms

In some cases the individual reactions, associated with changes in blood pressure, especially at the beginning of treatment, or adding other antihypertensives. As a result, it may reduce the ability to drive a car and perform work with the mechanisms, requiring greater attention.

Overdose

Symptoms: water and electrolyte disturbances (giponatriemiya, kaliopenia), manifested in the form of nausea, vomiting, BP reduction, seizures, dizziness, drowsiness, retardation, polyuria or oliguria, up to anuria (due to hypovolemia).

Treatment: gastric lavage, appointment of activated carbon, Correction fluid and electrolyte balance, simptomaticheskaya therapy. No specific antidote.

Drug Interactions

In a joint application indapamide increases the concentration of lithium in the plasma (by reducing urinary excretion) and increases the likelihood of nephrotoxic reactions (requires careful monitoring of lithium concentration in blood plasma and dose adjustment).

The combined use of indapamide with astemizole, bepridil, Erythromycin (for / in the), galofantrinom, pentamidine, sultoprydom, terfenadine, vynkamynom, antiaritmicheskimi preparatami IA Klassa (quinidine, disopyramide) and class III (Amiodarone, bretiliya tosylate, sotalol) It can cause arrhythmia type “pirouette” (predisposing factors are hypokalemia, bradycardia and prolonged QT interval prior).

In a joint application with indapamide NSAIDs (when the system of appointment) the risk of acute renal failure in patients with hypovolemia (due to lower glomerular filtration rate). It is necessary to compensate for the loss of fluid and the beginning of treatment to monitor renal function.

With simultaneous use of indapamide with amphotericin B (for / in the); glitches- and mineralocorticoid (for systemic use), tetrakozaktidom, laxatives, intestinal motility, cardiac glycosides – increased risk of hypokalemia (additive effect). Necessary to control the level of potassium in the blood plasma, ECG, if necessary – the appointment of appropriate treatment.

The combined use of indapamide with baclofen may lead to increased antihypertensive effect.

Tricyclic antidepressants and neuroleptics increase the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).

In a joint application with indapamide ACE inhibitors increase the risk of hypotension.

The combined use of indapamide with cyclosporin increases the concentration of creatinine in the blood plasma concentration of unaltered circulating cyclosporin.

Indapamide increases the risk of renal dysfunction when using iodine radiopaque agents in high doses (dehydration). Before use of iodine-containing contrast medicines to patients need to restore lost fluids.

The combined use of indapamide with drugs, containing calcium, It leads to an increase in calcium ion concentration in the plasma due to a decrease of urinary excretion.

Indapamide combination with kaliysberegayushtimi diuretikami (amilorid, spironolactone, triamterene) It can lead to hypo- or hyperkalemia, especially in patients with diabetes and renal dysfunction.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life - 2 year.