Retapres - instructions for use, dose, side effects, contraindications

Excipients: guar gum, lactose, sodium lauryl sulfate, talc purified, magnesium stearate, silicon dioxide colloid, hydroxypropylmethylcellulose (hypromellose), titanium dioxide, polyethylene glycol.

Description:

White round biconvex tablets, covered with a film membrane.

Pharmacotherapeutic group:diuretic

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

Indapamide belongs to the sulfonamide derivatives and is pharmacologically similar to thiazide diuretics. Indapamide inhibits the absorption of sodium in the cortical segment of the renal tubules, which increases the urinary excretion of sodium and chlorine ions, and leads to increased diuresis. To a lesser extent, the drug increases the excretion of potassium and magnesium ions. In addition to its diuretic effect indapamide has a vascular effect associated with a decrease in arteriolar and general peripheral resistance. Indapamide has an antihypertensive effect in doses that do not have a pronounced diuretic effect. In high doses does not affect the degree of lowering blood pressure (BP), despite an increase in diuresis.

Indapamide, like other thiazide diuretics, reduces hypertrophy of the left ventricle.

In therapeutic doses practically does not affect the lipid and carbohydrate metabolism.

Pharmacokinetics:

Indapamide is rapidly and almost completely absorbed in the gastrointestinal tract.

Eating somewhat slows down absorption, but does not significantly affect the amount adsorbed preparation. The maximum concentration in the blood plasma is achieved 12 hours after taking a single dose.At repeated receptions of fluctuation of concentration of a preparation in a blood plasma in an interval between two doses are smoothed out.

However, there are individual differences in individual patients.

Indapamide binds to plasma proteins by 79%. The half-life period is from 14 to 24 hours (an average of 18 hours). Repeated reception does not lead to the accumulation of the drug in the body.

Metabolised in the liver. 70% of indapamide is excreted by the kidneys mainly in the form of metabolites (the fraction of unchanged drug is about 5%). About 20% is excreted in the form of inactive metabolites.

In patients with insufficient renal function, the pharmacokinetic parameters of the preparation do not change significantly.

Indications:Arterial hypertension.

Contraindications:

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

- severe renal failure (anuria stage);

- hepatic encephalopathy or severe hepatic impairment;

- hypokalemia;

- simultaneous reception of drugs that extend the interval QT (see the section "Interaction with other drugs");

- age to 18 years (efficacy and safety not established).

Carefully:

Diabetes mellitus, impaired renal and / or liver function, water-electrolyte balance disorders, hyperparathyroidism, patients with an increased interval QT on an electrocardiogram or receiving a combination therapy, hyperuricemia (especially accompanied by gout or urate nephrolithiasis).

Pregnancy and lactation:

Taking indapamide during pregnancy is not recommended. The use of the drug may cause fetoplacental ischemia with the risk of slowing the development of the fetus.

It is not recommended to use the drug during lactation (indapamide penetrates into breast milk).

Dosing and Administration:

Inside, 1 tablet of Retapresa ® once a day, preferably in the morning, with a sufficient amount of liquid.

Side effects:

Co cardiovascular system: orthostatic hypotension, changes in ECG (hypokalemia), arrhythmia, palpitations.

Co side of the central nervous system: headache, dizziness, nervousness, asthenia.

Co the sides of the digestive system: constipation or diarrhea, dyspepsia, nausea, abdominal pain,possibly the development of hepatic encephalopathy, rarely pancreatitis.

Co the side of the genitourinary system: frequent infections, nocturia, polyuria.

Allergic reactions: skin itch, patchy-papular rash, hives, hemorrhagic vasculitis.

From the respiratory system: cough, pharyngitis, sinusitis.

Laboratory indicators: Hypercalcemia, hyperuricemia, hypochloremia, hyponatremia, hyperglycemia

Rarely: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia and hemolytic anemia.

Other: possibly exacerbation of systemic lupus erythematosus.

Overdose:

Symptoms acute poisoning is mainly associated with water-electrolyte disorders (hyponatremia, hypokalemia) and manifest as nausea, vomiting, lowering blood pressure, convulsions, dizziness, drowsiness, inhibition, polyuria or oliguria, which can result in anuria (due to hypovolemia).

Treatment: measures aimed at removing the drug from the stomach by washing it, and / or using activated carbon. Follow-up activities conducted in a medical institution should be aimed at restoring the water electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

With the simultaneous use of: lithium and indapamide preparations, careful monitoring of lithium concentration in blood plasma and correction of dosage are necessary, it is possible to increase the concentration of lithium in blood plasma with symptoms of an overdose in the same way as with a salt-free diet (decrease in the release of lithium in the urine).

With astemizole, biperidinom, erythromycin (with iv introduction), halofantrine, pentamidine, sultopride, terfenadine and vincamine, antiarrhythmics IA class (quinidine, hydroquinidine, disopyramide, amiodarone, brethylum, sotalol) - the probability of occurrence of heart rhythm disturbances such as "pirouette" increases. Risk factors are hypokalemia, bradycardia, and previous lengthening of the interval QT.

With non-steroidal anti-inflammatory drugs (for systemic administration), high doses of salicylates - there is a risk of acute renal failure in dehydrated patients (decreased glomerular filtration rate). It is necessary to compensate for the loss of fluid and, at the beginning of the treatment, monitor the function of the kidneys.

With amphotericin B (IV); gluco- and mineralocorticosteroids (for systemic administration), tetracosactide,laxatives, stimulating intestinal motility, cardiac glycosides - increases the risk of hypokalemia (additive effect). It is necessary to control the level of potassium in the blood plasma of the ECG, if necessary - the appointment of appropriate treatment.

With baklofenom - increased antihypertensive effect.

With cyclosporine - an increase in the concentration of creatinine in the blood plasma, with an unchanged concentration of circulating cyclosporine.

Tricyclic antidepressants, neuroleptics - increases the antihypertensive effect of indapamide and increases the risk of developing orthostatic hypotension (additive effect).

With angiotensin-converting enzyme (ACE) inhibitors - increased risk of developing arterial hypotension.

With iodine-containing contrast agents (in high doses) - dehydration of the body and an increased risk of acute renal failure. Before using iodine-containing contrast agents, patients should compensate for fluid loss. Calcium salts - an increase in the concentration of calcium ions in the blood plasma due to a decrease in excretion in the urine.

Potassium-sparing diuretics (ailoride, spironolactone, triamterene) - the risk of hypokalemia or hyperkalemia, especially in patients with diabetes mellitus and patients with impaired renal function.

Special instructions:

In patients with impaired liver function, thiazide diuretics can cause hepatic encephalopathy. If it occurs, diuretics should be discontinued immediately.

Any diuretic drug can cause hyponatremia, in some cases accompanied by serious consequences. The level of sodium in the blood plasma is measured before the start of treatment, and then during treatment at regular intervals. Initially, the drop in the concentration of sodium in the blood plasma can be asymptomatic, so regular monitoring is important. In elderly patients and patients with liver cirrhosis, control should be even more frequent.

The greatest risk in the treatment of thiazide diuretics is hypokalemia.

The risk of hypokalaemia (less than 3.4 mmol / L) should be prevented in certain high-risk populations, such as weakened patients and / or taking several medicines at the same time, elderly patients, patients with cirrhosis, peripheral edema and ascites, ischemic heart disease and heart failure.In these patients, hypokalemia increases the toxic effect of cardiac glycosides and the risk of arrhythmias.

The high-risk group also includes patients with an elongated interval QT on the ECG, regardless of the cause - congenital or induced by drugs. Hypokalemia (as well as bradycardia) is a predisposing factor in the occurrence of severe arrhythmias, especially the potentially dangerous type of pirouette.

All these patients require more frequent monitoring of the potassium concentration in the blood plasma. The first measurement of the potassium concentration in the plasma should be performed during the first week of treatment.

When a low level of potassium is detected, its correction is required.

Controlling blood glucose is important in patients with diabetes, especially with hypokalemia.

In patients with hyperuricemia, the frequency of gouty attacks may increase. Thiazide and thiazide-like diuretics are effective only in normal or slightly reduced (creatinine clearance in adults below 25 mg / L or 220 μmol / L) of renal function. In elderly patients, the level of plasma creatinine may vary depending on age, body weight and sex.

Secondary hypovolemia due to loss of water and sodium, induced by diuretics at the beginning of treatment, causes a decrease in glomerular filtration. This can lead to increased levels of urea and creatinine in the blood plasma. If the kidney function in the patient is not broken, then this transient functional renal failure, as a rule, passes without consequences, but can worsen already existing renal failure.

Athletes should take into account that the drug contains an active substance, which can cause a positive reaction during doping control.

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

In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment or with the addition of another antihypertensive agent. As a result, the ability to drive and work with mechanisms that require increased attention can be reduced.

Form release / dosage:Tablets with modified release, coated with a coating, 1.5 mg.

Packaging:

For 10, 14 tablets in a blister AL / PVC.

For 1, 2, 3 and 5 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

Store in a dry, protected light place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001704

Date of registration:01.06.2010

The owner of the registration certificate:M. J. Biofarm Pvt. Ltd.M. J. Biofarm Pvt. Ltd. India

Manufacturer: & nbsp

M.J. BIOPHARM, Pvt. Ltd. India

Representation: & nbspM.J. BIOFARM Pvt. Ltd. division of the corporation MJ Group M.J. BIOFARM Pvt. Ltd. division of the corporation MJ Group India

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Retapres® (Retapres®)