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Ravel cf instructions for use. International nonproprietary name

Klacid SR

Composition and release form Klacid sr

Klacid SR extended-release film-coated tablets yellow, oval; on the cross section two layers are visible: the core is almost white, surrounded by a yellow film.
1 tablet contains clarithromycin 500 mg;
excipients: citric acid anhydrous hydrogen phosphate, sodium alginate, sodium calcium alginate, lactose, povidone K30, talc, stearic acid, magnesium stearate;
shell composition: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide, quinoline yellow dye (E104), sorbic acid;
in a blister there are 5, 7, 10 or 14 pcs., in a box there are 1 or 2 blisters.

Pharmacological action Klacid sr

Klacid is an antibiotic of the macrolide group. Clarithromycin inhibits protein synthesis in microbial cells by interacting with the 50S ribosomal subunit of bacteria. Highly active in relation to wide range aerobic, anaerobic, gram-positive and gram-negative bacteria.
Clarithromycin has demonstrated high activity in vitro against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm high efficiency clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae.
The drug is also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, mycobacteria Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacferium intracellulare.
To clarithromycin insensitive Enterobacteriaceae, Pseudomonas spp., as well as other non-lactose-degrading gram-negative bacteria.
The production of b-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.
Clarithromycin is effective in vitro against most strains of the following microorganisms (however, the safety and effectiveness of clarithromycin in clinical practice not confirmed by clinical studies, and the practical significance remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci ( groups C,F,G), streptococci of the Viridans group; aerobic gram-negative microorganisms: Bordeteila pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.
The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Naemophilus influenzae, for which the effectiveness of the metabolite is 2 times higher. Starting material and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture.
Extended-release tablets are a homogeneous crystalline base, which, when passed through the gastrointestinal tract, provides prolonged release active substance.

Indications Klacid sr

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
– upper tract infections respiratory tract(pharyngitis, tonsillitis and sinusitis);
– infections of the lower respiratory tract (bronchitis, pneumonia);
– otitis media;
– infections of the skin and soft tissues (impetigo, folliculitis, cellulitis, abscesses);
– disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare;
– localized infections caused by Mycobacterium fortuitum, Mycobacterium kansasii, Mycobacterium chelonae.

Contraindications Klacid sr

– severe renal dysfunction (with CC less than 30 ml/min); such patients are prescribed immediate-release clarithromycin;
– simultaneous use of astemizole, cisapride, pimozide, terfenadine;
– porphyria;
– pregnancy;
– lactation (breastfeeding);
– increased sensitivity to macrolide antibiotics.

Directions for use and dosage Klacid sr

KLATSID SR is prescribed adults 500 mg (1 tablet) 1 time/day.
For severe infections the dose is increased to 1 g (2 tablets) 1 time/day.
In patients with renal failure , at CC less than 30 ml/min, the dose of the drug should be reduced by 2 times. The maximum course duration for patients in this group should be no more than 14 days.
The tablets should be taken with meals, swallowed whole, without breaking or chewing.

Side effect
From the outside cardiovascular system: rarely - ventricular arrhythmia, including ventricular tachycardia(with increasing QT interval).
From the digestive system: nausea, abdominal pain, vomiting, diarrhea, gastralgia, pancreatitis, glossitis, stomatitis, oral candidiasis, discoloration of the tongue and teeth; rarely - pseudomembranous enterocolitis. Tooth discoloration is reversible and usually recovers professional cleaning at the dentist. Rarely observed liver dysfunction, incl. increased activity of liver enzymes, liver cell and/or cholestatic hepatitis with or without jaundice. These liver problems can be severe, but are usually reversible. Very rare cases of liver failure and death have been observed, mainly due to severe concomitant diseases and/or concomitant drug therapy.
From the side of the central nervous system: transient headaches, dizziness, anxiety, insomnia, nightmares, ringing in the ears, depersonalization, hallucinations, convulsions, feelings of fear; rarely - psychosis, confusion; V in some cases- hearing loss (when clarithromycin was stopped, hearing was restored), changes in the sense of smell (usually accompanied by distortions in the sense of taste).
Allergic reactions: urticaria, skin hyperemia, itchy skin, anaphylaxis, Stevens-Johnson syndrome.
From the hematopoietic system: leukopenia, thrombocytopenia.
From the outside laboratory parameters: increase in creatinine content in the blood; rarely - hypoglycemia (with simultaneous administration hypoglycemic drugs).
Others: development of microbial resistance.

Storage conditions Klacid sr

Store in a place protected from light, out of reach of children, at a temperature not exceeding 30°C.

Shelf life of Klacid sr

tablets - 3 years;

Klacid sr

In an online pharmacy Klacid sr can be purchased with home delivery. The quality of all products in our online pharmacy, including Klacid sr, undergo product quality control by our trusted suppliers. You can buy Klacid sr on our website by clicking on the "Buy" button. We will be happy to deliver Klacid sr to you completely free of charge to any address within our delivery area.

Arterial hypertension refers to diseases of the cardiovascular system. Hypertension means a constant state of the body under conditions high blood pressure.

If not supported normal pressure in the body, the state of high blood pressure leads to a heart attack or stroke. To maintain normal blood pressure, medications are used that can normalize it.

Such medications may also be called diuretics.

These medications can relieve headaches, dizziness, and other symptoms that may occur with hypertension. These tablets include the drug Ravel SR.

Instructions for use

Ravel SR is a Slovenian drug intended for the treatment of diseases of the cardiovascular system. Ravel SR refers to sulfonamides and has properties similar to thiazide diuretics. Promotes sodium absorption into the segment renal tubules. Reduces arteriolar and general peripheral resistance. Helps reduce left ventricular hypertrophy. Has excellent absorption.

Indications for use

The main indication is arterial hypertension.

Directions for use

Used in the morning with a drink a large number water, in the amount of 1 tablet during the day.

Video: "What is hypertension and how to diagnose it?"

Composition and release form

The medicine is presented in the form of round tablets, coated with a white (possibly milky) coating, 1.5 mg each. Long-acting tablets. Packed in cell plates of 2 pieces, 3 or 6 pieces per cardboard box. Instructions included.

Compound: active substance – indapamide. It contains additional substances: cellactose, hydroxymethylcellulose (hypromellose), colloidal anhydrous silicon oxide, povidone, opadry Y-1-7000 (a mixture of hypromellose, macrogol 400), magnesium stearate, titanium oxide water.

Interaction with other drugs

Negative interaction:

Subject to availability arterial hypotension or hyponatremia should: stop taking the drug for at least three days before starting ACE inhibitors and start taking potassium-sparing diuretics; start taking ACE with small doses, monitoring the concentration of creatinine in the blood, with a gradual increase in the daily norm.

Drugs that cause hypokalemia: amophotericin B, tetracosactide, gluco- and mineralocorticosteroids, laxatives. Monitoring the content of potassium ions in the blood is very important.
Reception together with baclofen may enhance the antihypertensive effect of indapamide.
Reception together with cardiac glycosides may lead to glycoside intoxication. It is necessary to monitor the content of potassium ions in the blood, monitor ECG indicators.

Pay attention to combined use with drugs:

Tacrolimus and cyclosporine, which can help increase the concentration of creatinine in the blood without changing the concentration of cyclosporine.
Potassium-sparing diuretics(triamterene, spironolactone, amiloride). Use is possible, but in case of renal failure or diabetes mellitus there is a risk of developing hyperkalemia.
Large doses iodine-containing products because there is a risk acute development renal failure. Before joint use With diuretics, it is recommended to monitor the water and electrolyte balance of the blood.
Metformin. The risk of developing lactic acidosis increases due to possible development renal failure due to taking diuretics. When the concentration of creatinine in the blood is more than 15 mg/l in men and 12 mg/l in women, it is not recommended to take metformin.
Tricyclic antidepressants and antipsychotics, which can enhance the hypotensive effect, which can lead to the development of orthostatic hypotension.
Containing calcium salts, which can lead to the development of hypercalcemia.

Side effects

Certain organs and organ systems may react to the use as follows.

Cardiovascular system: heartbeat, ECG abnormalities, orthostatic hypotension, arrhythmia.

CNS: dizziness, depression, migraine, asthenia, drowsiness, nervousness.

Respiratory system: sinusitis, cough, pharyngitis.

Digestive system: nausea, abdominal pain, diarrhea, possible constipation, possible development of hepatic encephalopathy, in in rare cases pancreatitis.

Genitourinary system: polyuria, infections, nocturia.

Allergic manifestations: urticaria, itching, rash, hemorrhagic vasculitis.

Circulatory system: in rare cases - thrombocytopenia, hemolytic anemia, leukopenia, agranulocytosis.

Laboratory studies have shown the possibility of developing the following side effects: hypochloremia, hyperglycemia, hypercalcemia, hyponatremia, hyperuricemia. There is a possibility of exacerbation of systemic lupus erythematosus.

Video: "Secondary arterial hypertension"

Contraindications

Severe liver failure, hepatic encephalopathy.
Hypokatemia.
High sensitivity to one or more components of the drug.
Age (up to 18 years).

Use with caution:

For diabetes mellitus.
Elderly people.
In case of water-electrolyte imbalance.
In case of liver (and/or kidney) dysfunction.
With hyperuricemia.
Athletes (may occur positive reaction for doping).
With hyperparathyroidism.
Pregnancy and lactation period.

Storage conditions and periods

Ravel SR can be stored for 4 years at a storage temperature of up to 25°C, out of the reach of children.

Price

Dosage	Quantity	Price in Russia	Price in Ukraine
1.5 mg	30 pcs.	from 185 to 250 rub.	from 140 to 170 UAH.
1.5 mg	60 pcs.	from 230 to 400 rub.	from 300 to 350 UAH.

Analogs

Excipients: hypromellose (hydroxypropyl methylcellulose) - 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.

Shell composition: opadry Y-1-7000 - 5 mg (hypromellose, titanium dioxide, macrogol 400 (polyethylene glycol)).

10 pcs. - contour cell packaging (2) - cardboard packs.
10 pcs. - contour cell packaging (3) - cardboard packs.
10 pcs. - contour cell packaging (6) - cardboard packs.

The description of the drug is based on official instructions for use and approved by the manufacturer.

Pharmacological action

Diuretic. Indapamide is a sulfonamide derivative and pharmacological properties close to thiazide diuretics.

It has moderate saluretic and diuretic effects, which are caused by inhibition of the reabsorption of sodium, chlorine ions and, to a lesser extent, potassium and magnesium ions in the proximal tubules of the kidneys and in the cortical segment of the distal tubule of the nephron.

Indapamide reduces tone smooth muscle arteries and has a vasodilating effect, reduces peripheral vascular resistance. These effects are mediated by decreased reactivity vascular wall to norepinephrine and angiotensin II, an increase in the synthesis of prostaglandin E2, which has vasodilatory activity, as well as inhibition of calcium flow in smooth muscle cells vessels.

Indapamide helps reduce left ventricular hypertrophy. It has an antihypertensive effect in doses that do not have a pronounced diuretic effect. In therapeutic doses does not affect lipid and carbohydrate metabolism(including in patients with concomitant diabetes mellitus).

After taking a single dose maximum effect noted after 24 hours.

Pharmacokinetics

Suction

After oral administration, indapamide is quickly and almost completely absorbed from the gastrointestinal tract. Eating slightly slows down the rate of absorption, but does not significantly affect the amount of drug absorbed. Cmax is achieved 12 hours after taking a single dose. With repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between doses of the drug are smoothed out. However, there is individual variability in drug absorption rates.

Distribution

Binding to blood plasma proteins is 71-79%. C ss is established after 7 days of regular use of the drug. Does not accumulate.

Has a large Vd, penetrates histohematic barriers (including placental). Excreted in breast milk.

Metabolism and excretion

Metabolized primarily in the liver. T 1/2 - 14-24 hours (average 18 hours). 70% of indapamide is excreted in the urine in the form of inactive metabolites (about 5% is excreted unchanged) and 22% is excreted in the feces.

Pharmacokinetics in special clinical situations

In patients with renal failure, the pharmacokinetic parameters of the drug do not change significantly.

Indications

- arterial hypertension.

Dosage regimen

The drug is taken orally, 1.5 mg (1 tablet) 1 time / day, preferably in morning hours, regardless of food intake. Take without chewing, with a drink sufficient quantity liquids.

Increasing the dose of the drug does not increase the antihypertensive effect.

Side effect

Frequency classification side effects(WHO): very common (≥ 10%), common (≥ 1% -< 10%), нечасто (≥ 0.1% - < 1%), редко (≥ 0.01% - < 0.1%), очень редко (≥ 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.

From the hematopoietic organs: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, bone marrow aplasia.

From the central nervous system and peripheral nervous system: rarely - dizziness, headache, paresthesia, increased excitability, asthenia, drowsiness, vertigo, insomnia, depression, increased fatigue, muscle spasms of the limbs, tension, irritability, anxiety.

From the digestive system: infrequently - vomiting; rarely - nausea, constipation, dryness of the oral mucosa; very rarely - pancreatitis, anorexia, abdominal pain, diarrhea. In patients with liver failure the development of hepatic encephalopathy is possible.

From the genitourinary system: very rarely - renal failure, nocturia, infections, polyuria.

From the respiratory system: cough, pharyngitis, sinusitis, rhinitis.

Allergic reactions: often - maculopapular rash; uncommon - purpura, very rare - angioedema and/or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, itching.

Others: isolated reports - exacerbation of SLE, photosensitivity reactions.

Laboratory data: in clinical studies, hypokalemia (plasma potassium content 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 potassium content in the blood plasma decreased by an average of 0.23 mmol/l. Very rarely - hypercalcemia, unspecified frequency: decreased potassium levels and the development of hypokalemia, especially significant for patients at risk; hyponatremia, accompanied by hypovolemia and orthostatic hypotension. The simultaneous loss of chloride ions can lead to compensatory metabolic alkalosis, but the incidence of development metabolic alkalosis and its severity is insignificant; hyperuricemia and hyperglycemia (unspecified frequency), increased blood urea nitrogen concentration, hypercreatininemia.

Contraindications

- severe renal failure (CK< 30 мл/мин);

- severe liver failure (including hepatic encephalopathy);

- hypokalemia;

- lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome (since the drug Ravel ® SR contains lactose);

- pregnancy;

- lactation period;

- children's and adolescence up to 18 years of age (efficacy and safety have not been established);

- hypersensitivity to indapamide, other sulfonamide derivatives or any component of the drug.

WITH caution the drug is prescribed for impaired renal and/or liver function, diabetes mellitus in the stage of decompensation, water-electrolyte imbalance, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyperparathyroidism, as well as patients with a prolonged QT interval on the ECG or receiving therapy as a result which may prolong the QT interval (astemizole, erythromycin (iv), pentamidine, sultopride, terfenadine, vincamine (iv), antiarrhythmic medicines Class IA (quinidine, disopyramide) and class III (amiodarone, bretylium tosylate).

Use during pregnancy and breastfeeding

It is not recommended to use the drug during lactation ( breastfeeding), because indapamide is excreted in breast milk. If treatment with Ravel ® SR is necessary during lactation, breastfeeding should be discontinued.

Special instructions

In patients with liver failure, when thiazide-like diuretics are prescribed, hepatic encephalopathy may develop, especially if the water-electrolyte balance is disturbed. If it develops, diuretics should be discontinued.

When using thiazide-like diuretics, cases of photosensitivity reactions have been reported. If they develop, the drug should be discontinued. During therapy with Ravel ® SR, it is necessary to protect exposed areas of the body from exposure sun rays and artificial ultraviolet radiation.

All diuretics can cause hyponatremia. The content of sodium ions in the blood plasma should be measured before starting treatment with Ravel ® CP, and then regularly during the treatment period. Determination of the content of sodium ions in the blood plasma must be carried out before starting therapy with Ravel ® SR, 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 monitoring of sodium ion levels is indicated for elderly patients and patients with liver cirrhosis.

The greatest risk during treatment with thiazide-like diuretics is hypokalemia. Special attention in order to prevent hypokalemia (less than 3.4 mmol/l), it is necessary to pay attention to weakened patients and/or those receiving other therapy (antiarrhythmic drugs and drugs that can prolong the QT interval on the ECG), elderly patients, patients with cirrhosis of the liver, peripheral edema and ascites, with ischemic heart disease and chronic heart failure. Hypokalemia in such patients increases toxic effect cardiac glycosides and increases the risk of arrhythmia.

To the group increased risk also includes patients with a prolonged QT interval on the ECG. Hypokalemia is a predisposing factor in the occurrence of severe arrhythmias, and especially torsade de pointes, which can be fatal.

In all the described cases, it is necessary to regularly monitor the potassium content in the blood plasma. The first determination of potassium content in the blood plasma should be carried out during the first week of therapy with Ravel ® SR. If hypokalemia is detected, appropriate therapy should be administered.

Thiazide-like and thiazide diuretics may reduce the excretion of calcium ions by the kidneys, leading to mild and/or temporary hypercalcemia. Severe hypercalcemia while taking Ravel ® SR may be a consequence of previously undiagnosed hyperparathyroidism. Diuretics should be discontinued before testing parathyroid function.

In patients with diabetes mellitus, especially in the presence of hypokalemia, monitoring of plasma glucose concentration is necessary.

In patients with hyperuricemia, taking Ravel ® SR may increase the frequency of attacks or exacerbation of gout.

Thiazide and thiazide-like diuretics are effective in to the fullest only in patients with normal or slightly reduced (serum creatinine in adults less than 25 mg/l or 220 µmol/l) renal function.

Severe hypovolemia can lead to the development of acute renal failure (decreased glomerular filtration rate), which may be accompanied by an increase in the concentration of urea and creatinine in the blood plasma. With normal renal function, transient functional renal failure usually resolves without consequences. With existing renal failure, the patient's condition may worsen.

Regular monitoring of creatinine concentration and potassium content in blood plasma is recommended, taking into account the patient's age, body weight and gender. Ravel ® SR can be prescribed to elderly patients with preserved or slightly impaired renal function (creatinine clearance above 30 ml/min).

Indapamide may give a positive result during a doping test.

Use in pediatrics

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

Impact on the ability to drive vehicles and operate machinery

The use of indapamide does not lead to impairment of psychomotor reactions. However, some patients may develop different individual reactions 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 ® SR, it is not recommended to drive vehicles or other complex mechanisms, requiring increased attention.

Overdose

Symptoms: marked decrease 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 liver cirrhosis may develop hepatic coma.

Treatment: symptomatic (gastric lavage and/or administration activated carbon, restoration of water and electrolyte balance). There is no specific antidote.

Drug interactions

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 when observing salt-free diet(decreased excretion of lithium ions by the kidneys).

Combinations requiring special attention

Simultaneous use with any of the drugs that can cause heart rhythm disturbances of the “pirouette” type, incl. antiarrhythmic drugs class IA (quinidine, hydroquinidine, disopyramide), class III antiarrhythmics (amiodarone, dofetilide, ibutilide, bretylium tosylate), sotalol, some antipsychotics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride , tiapride), butyrophenones (droperidol, haloperidol), as well as bepridil, cisapride, difemanil, erythromycin (iv), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine (iv), astemizole, especially against the background of hypokalemia, increases the risk of ventricular arrhythmias. Before starting combination therapy with Ravel ® SR and the above drugs, the potassium content in the blood plasma should be monitored and, if necessary, adjusted. Supervision recommended clinical condition patient, as well as the content of electrolytes in blood plasma and ECG. In patients with hypokalemia, it is necessary to use drugs that do not provoke the development of pirouette-type arrhythmias.

With simultaneous administration of NSAIDs (for systemic use), including selective COX-2 inhibitors, high doses salicylic acid(3 g/day or more) it is possible to reduce the antihypertensive effect of indapamide and develop 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-electrolyte balance and monitor kidney function.

ACE inhibitors in patients with hyponatremia (especially in patients with stenosis renal artery) increase the risk of developing arterial hypotension and/or acute renal failure. Patients with arterial hypertension and possibly hyponatremia due to diuretics should:

- stop taking the drug 3 days before starting therapy ACE inhibitors and switch to therapy with potassium-sparing diuretics;

- or start ACE inhibitor therapy with low doses, followed by a gradual increase in dose if necessary. During the first week of therapy with ACE inhibitors, it is recommended to monitor plasma creatinine concentrations.

When taking drugs that can cause hypokalemia with indapamide, incl. amphotericin B (iv), gluco- and mineralocorticoids (when administered systemically), tetracosactide, laxatives that stimulate intestinal motility, the risk of developing hypokalemia increases (additive effect). If necessary, the content of potassium ions in the blood plasma should be monitored and adjusted.

Concomitant therapy with baclofen enhances the antihypertensive effect of indapamide.

Hypokalemia caused by indapamide increases the toxic effect of cardiac glycosides (glycoside intoxication). With the simultaneous use of indapamide and cardiac glycosides, the content of potassium ions in the blood plasma, ECG parameters should be monitored, and, if necessary, therapy should be adjusted.

Combinations of drugs requiring attention

Concomitant use with potassium-sparing diuretics (amiloride, spironolactone, triamterene) appropriate in some patients, but the possibility of hypokalemia cannot be excluded. Hyperkalemia may develop against the background of diabetes mellitus or renal failure. It is necessary to monitor 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 It is possible to develop renal failure while taking diuretics, especially loop diuretics. Metformin should not be taken if the plasma creatinine concentration is more than 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women.

The simultaneous use of large doses of iodine-containing contrast agents against the background of hypovolemia and diuretics increases the risk of developing acute renal failure. It is recommended to restore the water and electrolyte balance of the blood before using the drugs.

Tricyclic antidepressants (imipramine-like) and antipsychotics increase the hypotensive effect and the risk of developing orthostatic hypotension (additive effect).

Preparations containing calcium salts increase the risk of developing hypercalcemia due to decreased excretion of calcium ions by the kidneys.

Cyclosporine and tacrolimus increase the risk of increasing plasma creatinine concentrations without changing the concentration of circulating cyclosporine.

GCS, tetracosactide (when used systemically) reduce the hypotensive effect of indapamide (retention of sodium ions and fluid).

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 4 years.

Ravel is indispensable for people with cardiovascular diseases, in particular in cases where it is necessary to lower blood pressure levels. This drug is a diuretic and helps eliminate many of the symptoms that accompany arterial hypertension, including edema, attacks of dizziness, and headaches.

Ravel is a sulfonamide and also an effective diuretic. International generic name(INN) – Indapamide.

Cost, composition and form

Ravel is produced in tablet form of 1.5 mg active component. The tablets are convex, coated with a whitish film. The cost of the drug depends on the number of tablets in the package. Approximate prices are presented in the table (Table 1).

Table 1 – Average prices in Russia for Ravel

Ingredients of the drug:

indapamide – active ingredient;
magnesium stearate;
hypromellose;
povidone;
Macragol 400;
cellactose;
titanium dioxide;
silicon dioxide.

Pharmacodynamics and pharmacokinetics

Ravel, being a sulfonamide derivative, has a moderate saluretic and diuretic effect. This occurs due to a slowdown in the reabsorption of sodium, chlorine, magnesium and potassium ions (the latter to a lesser extent) in the proximal tubules of the kidneys and in the cortical segment of the distal tubule of the nephron.

Indapamide has an inhibitory effect on left ventricular hypertrophy. Reduces the tone of smooth arterial muscles, helps reduce peripheral general vascular resistance, and dilates blood vessels.

When used in moderate dosages, it has no effect on carbohydrate-lipid metabolic processes Therefore, the drug can be used for diabetes mellitus.

If you combine the use of food and the drug Ravel, then the process of its absorption through the gastrointestinal tract will slow down, but the absorption of the drug will not change. Ravel reaches its highest concentration 12 hours after taking 1 tablet, and the maximum effect of the drug is observed 24 hours after taking the same dose of the drug.

Subsequent use of this medicine smooths out concentration fluctuations active ingredient in blood plasma. Individual variability in the period of absorption of indapamide is often noted.

The active component of the drug is not subject to accumulation. The half-life is from 12 to 24 hours. After 7 days of constant use of the product, an equilibrium concentration is achieved. Indapamide is metabolized in the liver. Exit from the body occurs 70% through the kidneys, 22% through the gastrointestinal tract.

The active component has a great ability to distribute and penetrate through histohematic barriers, including the placental one. It is also possible that indapamide passes into breast milk.

At what pressure to use, and when is use limited?

The main indication for the use of the drug is hypertension of various origins:

essential (hypertension);
symptomatic;
endocrine;
hemodynamic;
neuralgic;
stressful;
an increase in blood pressure as a result of taking medications.

Contraindications:

hypersensitivity to the components of the drug, in particular to sulfonamide derivatives;
severe renal and liver failure;
glucose-galactose malabsorption syndrome, lactose intolerance, lactase deficiency;
hypokalemia;
period of pregnancy and lactation;
up to 18 years old.

Instructions for use

For safe therapy, you need to study the instructions for use of the drug, its compatibility with other drugs and possible side effects.

Method of administration and dosage

Ravel is designed for internal use. As a rule, one dose (1.5 mg) per 24 hours is indicated. It is preferable to consume it in the morning, without biting and drinking plenty of water.

Taking more than 1 tablet within 24 hours will not increase the hypotensive effect, but the saluretic and diuretic effect will increase.

Dosage calculation for elderly patients is carried out as follows:

If there are no renal dysfunctions, or they are minor, then one tablet per day is acceptable. During administration, the concentration of creatinine in the blood plasma is monitored.
For severe age-related changes renal function, the drug is not prescribed.

Possible side effects

The drug may have negative impact to almost all body systems:

Overdose

As a rule, the drug does not have a toxic effect on the body even with a very high concentration of the active component in the body (up to 0.04 g). Symptoms of poisoning can only appear in connection with disturbances in the salt balance in the patient’s body, for example, with hypokalemia or hyponatremia. In particular, you may experience:

Decreased blood pressure levels.
Dyspeptic manifestations.
Impaired consciousness, vertigo.
Anuria.

To avoid negative reactions, it is important to consider the compatibility of the drug with other drugs:

It is not recommended to combine with lithium preparations.

Use with caution with:

antiarrhythmic drugs of classes 1A and 3;
Sotalol;
some neuroleptics;
NSAIDs;
angiotensin-converting enzyme inhibitors;
cardiac glycosides;
potassium-sparing diuretics;
tricyclic antidepressants;
iodine-containing contrast agents;
glucocorticosteroids.

Structural analogues

Among the generic drugs it is worth highlighting:

- is a diuretic, intended for the treatment of hypertension. The product is available in blue-white capsules containing 2.5 mg of indapamide. Indap is consumed once 24 hours after the morning meal. The capsule must be swallowed without biting and washed down with plenty of water. You can buy 30 capsules of Indapa at a price ranging from 99 to 113 rubles.
- is an antihypertensive drug, diuretic. Recommended for use in cases of essential hypertension. Production is carried out in tablet and capsule form(long-acting). Includes 2.5 mg of indapamide (active ingredient), starch, talc, magnesium stearate, povidone, lactose.

It is necessary to start a therapeutic course with a dosage of 1.25 to 2.5 mg per day. Recommended use in the morning. In the absence positive results After 30 days of treatment, it is recommended to supplement therapy with medications with a different mode of action. Average price Arifona costs 380 rubles for 30 tablets.

- has a diuretic and hypotensive effect. Prescribed when hypertension medium degree, chronic heart failure. Production is carried out in tablet form of 1.5 and 2.5 mg of the active component and in the form of capsules of 2.5 mg of indapamide.

Additional components: pregelatinized starch, colloidal silicon dioxide, magnesium stearate and MCC. Consumption is recommended no more than 1 time per 24 hours after a morning meal. The duration of the therapeutic course and combination with other drugs is determined by the doctor. You can buy Indapamide at a price ranging from 98 to 110 rubles.

- classified as non-thiazide diuretics, prescribed for use in arterial hypertension. Produced in tablet form of 1.5 mg. Has a prolonged effect. As an active ingredient, Vasopamide contains indapamide, additional components: colloidal silicon dioxide, povidone, magnesium stearate, lactose monohydrate, povidone, hypromellose.

It is not recommended to use more than 1 time in 24 hours. Preferably taken in the morning with plenty of water, do not bite. The duration of the therapeutic course is determined by the doctor. You can order Vasopamide through online pharmacies in Ukraine for 213.54 UAH. (505 rubles) without delivery.

- classified as thiazide-like diuretics, antihypertensive drugs. Recommended for use in the presence of hypertension, chronic heart failure, accompanied by water and sodium retention in the body. Produced in tablets of 2.5 mg. The recommended dosage is no more than 1 time per 24 hours in the morning.

If after 14 days of treatment there is no sufficient therapeutic effect, then it is permissible to increase the dosage to no more than 7.5 mg per 24 hours. The highest dosage during the day should not exceed 10 mg for 2 applications (morning and afternoon). The cost of the product is about 120 rubles for 30 tablets.

Hemopamide is a non-thiazide diuretic and is prescribed in the presence of essential hypertension. It contains indapamide as an active ingredient, additional components are: macrogol 6000, lactose monohydrate, colloidal titanium dioxide, silicon dioxide, hypromellose, magnesium stearate, glycerin.

Production is carried out in tablets of 1.5 mg. The product has a prolonged effect. It is recommended to take no more than 1.5 mg 1 time per 24 hours in the morning. For internal use, it should be taken without biting and washed down with plenty of liquid. The duration of the course of therapy is prescribed by the doctor. Average cost of this product is 350 rubles.

Drugs with similar effects

Effective non-structural analogues are:

LS 000406-100717

Trade name:

International nonproprietary name:

indapamide

Dosage form:

extended-release tablets, coated film-coated

Compound

For one tablet

Core

Active substance: Indapamide 1.50 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) 67.00 mg, cellactose [lactose monohydrate 75%, cellulose 25%] 121.50 mg, povidone 8.60 mg. colloidal silicon dioxide 0.40 mg, magnesium stearate 1.00 mg

Shell

Opadry Y-1-7000 *5.00 mg

Composition of Opadry -Y-1-7000: hypromellose, titanium dioxide and macrogol 400 (polyethylene glycol).

Description

Round, biconvex tablets, film-coated, white or almost white.

Pharmacotherapeutic group:

diuretic

ATX code: S03BA11

Pharmacological properties

Pharmacodynamics

Indapamide is a sulfonamide derivative and is similar in pharmacological properties to thiazide diuretics. It has moderate saluretic and diuretic effects, which are caused by inhibition of the reabsorption of sodium, chlorine ions and, to a lesser extent, potassium and magnesium ions in the proximal tubules of the kidneys and in the cortical segment of the distal tubule of the nephron.

Indapamide reduces the tone of the smooth muscles of the arteries and has a vasodilating effect, reducing the total peripheral vascular resistance. 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 vasodilatory activity, and inhibition of calcium flow in vascular smooth muscle cells.

Indapamide helps reduce left ventricular hypertrophy. 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 observed after 24 hours.

Pharmacokinetics

The drug Ravel SR is available in the form of tablets with prolonged action active substance. Indapamide is rapidly and almost completely absorbed into gastrointestinal tract. Eating slightly slows down absorption, but does not significantly affect the amount of drug absorbed. The maximum concentration in blood plasma is achieved 12 hours after oral administration of a single dose.

With repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between doses of the drug are smoothed out. However, there is individual variability in drug absorption rates.

The connection with blood plasma proteins is 71-79%. The half-life (T1/2) ranges from 14 to 24 hours (average 18 hours). Equilibrium concentration is established after 7 days of regular use of the drug. Does not accumulate.

It has a high volume of distribution and penetrates histohematic barriers (including placental). Passes into breast milk.

Metabolized primarily in the liver. 70% of indapamide is excreted by the kidneys in the form of inactive metabolites (about 5% is excreted unchanged) and 22% is excreted through the intestines.

In patients with renal failure, the pharmacokinetic parameters of the drug do not change significantly.

Indications for use

Arterial hypertension in adults.

Contraindications

Hypersensitivity to indapamide, other sulfonamide derivatives or any component of the drug;
severe renal failure (creatinine clearance (CC) less than 30 ml/min);
severe liver failure, including hepatic encephalopathy;
hypokalemia;
lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome, since the drug Ravel SR contains lactose;
pregnancy and breastfeeding;
age under 18 years (efficacy and safety have not been established).

With caution

Impaired kidney and/or liver function, diabetes mellitus in the stage of decompensation, water-electrolyte imbalance, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyperparathyroidism, in patients with a prolonged QT interval on the ECG or receiving therapy that may result in a prolongation of the QT interval (astemizole, erythromycin (intravenously [i.v.] c]), pentamidine, sultopride, terfenadine, vincamine (iv), antiarrhythmic drugs class IA (quinidine, disopyramide) and class III [amiodarone, bretylium tosylate]).

Use during pregnancy and breastfeeding

There is currently insufficient data on the use of indapamide during pregnancy (less than 300 cases have been described).

Long-term use Thiazide diuretics in the third trimester of pregnancy can cause hypovolemia in the mother and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal growth retardation.

Animal studies have shown no direct or indirect effects on pregnancy. The use of indapamide should be avoided during pregnancy.

It is not known whether indapamide or its metabolites are excreted in breast milk. The newborn may develop hypersensitivity to sulfonamide derivatives and hypokalemia. Therefore, a risk to the newborn/infant cannot be excluded. Indapamide is close to thiazide diuretics, the use of which causes a decrease in the amount breast milk or even suppression of lactation. Indapamide should not be used during breastfeeding.

Preclinical studies have shown no effect on reproductive function in rats of both sexes. Presumably there is no effect on human fertility.

Directions for use and doses

Orally, 1 tablet (1.5 mg) 1 time per day, preferably in the morning, regardless of meal time. Swallow whole, without chewing, with plenty of water. Increasing the dose of Ravel SR does not increase the antihypertensive effect, but enhances the diuretic effect.

Special patient groups

Patients with renal failure (see sections "Contraindications" and "Specialinstructions")

Indapamide is contraindicated in patients with severe renal failure (creatinine clearance less than 30 ml/min). Thiazide and thiazide-like diuretics are effective only in patients with normal or mildly impaired renal function.

Patients with liver failure (see sections "Contraindications" and "Specialinstructions")

Ravel SR is contraindicated in patients with severe liver failure.

Elderly patients (see section "Special instructions")

In elderly patients, plasma creatinine concentrations should be monitored based on age, body weight and gender.

Ravel® SR at a dose of 1.5 mg/day (1 tablet) can be prescribed to elderly patients with normal or mildly impaired renal function (see section “Contraindications”).

Children and teenagers under 18 years of age

There are currently no data on the safety and effectiveness of indapamide in children and adolescents.

Side effect

The most common adverse reactions reported were: hypersensitivity, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions, as well as maculopapular rash.

In clinical studies, hypokalemia (plasma potassium less than 3.4 mmol/L) was observed in 10% of patients, and potassium levels less than 3.2 mmol/L were observed in 4% of patients 4-6 weeks after the start of therapy. After 12 weeks of therapy, the average decrease in plasma potassium was 0.23 mmol/L.

Majority adverse reactions(laboratory and clinical indicators) are dose-dependent.

Frequency adverse reactions that were noted during indapamide therapy are given in the following gradation: very often (>1/10), often (from >1/100 to<1/10), нечасто (от >1/1000 to<1/100), редко (от >1/10000 to<1/1000), очень редко (<1/10000), частота неизвестна (частота не может быть определена на основании имеющихся данных).

Blood and lymphatic system disorders:

very rare: agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, thrombocytopenia.

Metabolic and nutritional disorders:

very rarely: hypercalcemia; frequency unknown: decrease in potassium levels and the development of hypokalemia, especially significant for patients at risk (see section “Special Instructions”), hyponatremia (see section “Special Instructions”).

Nervous system disorders:

rarely: vertigo, fatigue, headache, paresthesia; frequency unknown: fainting.

Visual disorders:

frequency unknown: myopia, blurred vision, visual impairment.

Cardiac disorders:

very rarely: arrhythmia; frequency unknown: tachycardia of the "pirouette" type (potentially fatal) (see section "Special instructions" and "Interaction with other drugs").

Vascular disorders:

very rarely: decreased blood pressure (BP).

Digestive system disorders:

uncommon: vomiting; rarely: nausea, constipation, dry mouth; very rare: pancreatitis.

Disorders of the liver and biliary tract:

very rarely: liver dysfunction; frequency unknown: possible development of hepatic encephalopathy in case of liver failure (see sections “Contraindications” and “Special instructions”), hepatitis.

Skin and subcutaneous tissue disorders:

often: hypersensitivity reactions, maculopapular rash; uncommon: purpura; very rare: angioedema, urticaria, toxic endidermal necrolysis. Stevens-Johnson syndrome; frequency unknown: possible exacerbation of existing acute systemic lupus erythematosus, photosensitivity (see section “Special instructions”).

Renal and urinary tract disorders:

very rare: renal failure.

Laboratory and instrumental data:

frequency unknown: prolongation of the QT interval on the ECG (see sections "Interaction with other drugs" and "Special instructions"), increased concentration of glucose in the blood (see section "Special instructions"), increased concentration of uric acid (see section " Special instructions"), increased activity of “liver” enzymes in the blood plasma.

Overdose

Indapamide, even in very high doses (up to 40 mg, i.e. 27 times the therapeutic dose), does not have a toxic effect.

Signs of acute drug poisoning are primarily associated with water and electrolyte imbalance (hyponatremia, hypokalemia).

Symptoms: decreased blood pressure, nausea, vomiting, convulsions, vertigo, drowsiness, confusion, polyuria or oliguria up to anuria (due to hypovolemia).

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

When used simultaneously with lithium preparations it is possible to increase the content of lithium ions in the blood plasma due to a decrease in its excretion from the body by the kidneys, accompanied by the appearance of signs of overdose (nephrotoxic effect), as well as with compliance salt-free diet(decreased excretion of lithium ions by the kidneys). If necessary, diuretics can be used in combination with lithium preparations, and the lithium content in the blood plasma should be carefully monitored and the dose of Ravel SR should be adjusted accordingly.

Combinations requiring special attention

Drugs that can cause pirouette-type cardiac arrhythmias Class 1A antiarrhythmics(quinidine, hydroquinidine, disopyramide), antiarrhythmic drugsIII class(amiodarone, dofetilide, ibutilide, bretylium tosylate), sotalol, some antipsychotics: phenothiazines(chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides(amisulpride, sulpiride, sultopride, tiapride), butyrophenones(droperidol, haloperidol), other(bepridil, cisapride, difemanil. erythromycin (iv), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine (iv), astemizole.

Concomitant use with any of these drugs, especially against the background of hypokalemia. increases the risk of ventricular arrhythmias such as “pirouette”. Before starting combination therapy with Ravel SR and the above drugs, the potassium content in the blood plasma should be monitored and, if necessary, adjusted. Recommended: monitoring the patient’s clinical condition, as well as the content of electrolytes in the blood plasma and ECG. In patients with hypokalemia, it is necessary to use drugs that do not provoke the development of pirouette-type arrhythmias.

Nonsteroidal anti-inflammatory drugs (NSAIDs) (for systemic use), including selective cyclooxygenase-2 (COX-2) inhibitors, high doses of acetylsalicylic acid (3 g/day or more)

It is possible to reduce the antihypertensive effect of indapamide and develop acute renal failure in dehydrated patients (due to a decrease in glomerular filtration rate). At the beginning of indapamide therapy, it is necessary to restore water and electrolyte balance and monitor renal function.

Angiotensin-converting enzyme (ACE) inhibitors

In patients with hyponatremia (especially in patients with renal artery stenosis), the administration of ACE inhibitors increases the risk of developing arterial hypotension and/or acute renal failure. Patients with arterial hypertension and possibly hyponatremia due to diuretics should:

Stop taking the drug 3 days before starting therapy with ACE inhibitors and switch to therapy with potassium-sparing diuretics

Or start ACE inhibitor therapy with low doses, followed by a gradual increase in dose if necessary. During the first week of therapy with ACE inhibitors, it is recommended to monitor plasma creatinine concentrations.

In chronic heart failure, treatment with ACE inhibitors should begin with the lowest doses, with a possible preliminary reduction in the doses of diuretics.

In all cases, in the first weeks of taking ACE inhibitors in patients, it is necessary to monitor renal function (plasma creatinine concentration).

Other drugs that can cause hypokalemia

Amphotericin B (iv), gluco- and mineralocorticosteroids(for systemic administration) (see also information in the section “Drug combinations requiring attention”), tetracosactide(see also information in the section “Combinations of drugs that require attention”), laxatives that stimulate intestinal motility.

When taken simultaneously with indapamide, the above drugs increase the risk of developing hypokalemia (additive effect). If necessary, the content of potassium ions in the blood plasma should be monitored and adjusted.

Baclofep

Simultaneous therapy with baclofen enhances the antihypertensive effect of indapamide. Patients need to compensate for fluid loss and carefully monitor renal function at the beginning of treatment.

Cardiac glycosides

Hypokalemia increases the toxic effect of cardiac glycosides (glycoside intoxication). With the simultaneous use of indapamide and cardiac glycosides, the content of potassium ions in the blood plasma, ECG parameters should be monitored, and, if necessary, therapy should be adjusted.

Combinations of drugs requiring attention

Potassium-sparingdiuretics (amiloride, spironolactone, triamterene)

Combination with this group of drugs is advisable in some patients, but the possibility of developing hypokalemia or hyperkalemia cannot be excluded (especially in patients with renal failure or in patients with diabetes mellitus).

It is necessary to monitor the content of potassium ions in the blood plasma, ECG indicators, and, if necessary, adjust therapy.

Metformin

Increases the risk of developing lactic acidosis, since renal failure may develop while taking diuretics, especially loop diuretics. Metformin should not be taken if the plasma creatinine concentration is more than 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women.

The use of iodine-containing contrast agents against the background of hypovolemia and diuretics increases the risk of developing acute renal failure, especially when using high doses of contrast agents. It is recommended to restore the water and electrolyte balance of the blood before using the drugs.

Tricyclicantidepressants (imipramine-like) and antipsychotics

They increase the antihypertensive effect and the risk of developing orthostatic hypotension (additive effect).

Preparations containing calcium salts

Increase the risk of developing hypercalcemia due to decreased excretion of calcium ions by the kidneys.

Cyclosporine, tacrolimus

With simultaneous use, there is a risk of increasing the concentration of creatinine in the blood plasma without changing the concentration of circulating cyclosporine, even with normal fluid and sodium ion levels.

Glucocorticosteroid drugs, tetracosactide (for systemic use)

Reduce the antihypertensive effect (retention of sodium ions and fluid).

Special instructions

Liver dysfunction

Photosensitivity

When using thiazide-like diuretics, cases of photosensitivity reactions have been reported. If they develop, the drug should be discontinued. During indapamide therapy, it is necessary to protect exposed areas of the body from exposure to sunlight and artificial ultraviolet radiation.

Vodno- electrolyte tower

All diuretic drugs can cause hyponatremia, sometimes leading to extremely serious consequences. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in chlorine ions can lead to secondary compensatory alkalosis; the frequency and severity of this effect are insignificant.

The content of sodium ions in the blood plasma should be measured before starting treatment with Ravel® CP. and then regularly during the treatment period. Determination of the content of sodium ions in the blood plasma must be carried out before starting therapy with Ravel® SR, as well as during the period of therapy. It is important to regularly monitor the content of sodium ions in the blood plasma, since hyponatremia may initially be asymptomatic.

The most careful monitoring of the content of sodium ions in the blood plasma is indicated for elderly patients and patients with liver cirrhosis.

The greatest risk during treatment with thiazide-like diuretics is hypokalemia. Particular attention should be paid to the prevention of hypokalemia (less than 3.4 mmol/l) in the following cases: debilitated patients and/or those receiving other therapy (antiarrhythmic drugs and drugs that can prolong the QT interval on the ECG), elderly patients, patients with liver cirrhosis, peripheral edema and ascites; with coronary heart disease and chronic heart failure. Hypokalemia in such patients increases the toxic effect of cardiac glycosides and increases the risk of developing arrhythmia.

Patients with a prolonged QT interval on the ECG, either congenital or drug-induced, are also at increased risk.

Hypokalemia. as well as bradycardia. is a predisposing factor in the occurrence of severe arrhythmias, and especially pirouette-type arrhythmias, which can be fatal.

In all the described cases, it is necessary to regularly monitor the potassium content in the blood plasma. The first determination of potassium in the blood plasma should be carried out during the first week of therapy with Ravel SR. If hypokalemia is detected, appropriate therapy should be administered.

Thiazide-like and thiazide diuretics may reduce the excretion of calcium ions by the kidneys, leading to mild and/or temporary hypercalcemia. Severe hypercalcemia while taking Ravel SR may be a consequence of previously undiagnosed hyperparathyroidism. Diuretics should be discontinued before testing parathyroid function.

Plasma glucose concentration

In patients with diabetes mellitus, especially in the presence of hypokalemia, monitoring of plasma glucose concentration is necessary.

Uric acid

In patients with hyperuricemia, it may increase the frequency of attacks or exacerbation of gout.

Kidney function and diuretics

Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly reduced renal function (plasma creatinine concentration in adults less than 25 mg/l or 220 µmol/l). Severe hypovolemia. which in turn is caused by the loss of fluid and sodium ions while taking diuretics, can lead to the development of acute renal failure (decreased glomerular filtration rate), which may be accompanied by an increase in the concentration of urea and creatinine in the blood plasma. With normal renal function, transient functional renal failure usually resolves without consequences. With existing renal failure, the patient's condition may worsen.

Elderly patients

Regular monitoring of creatinine concentration and potassium content in blood plasma is recommended, taking into account the patient's age, body weight and gender. The drug Ravel® SR can be prescribed to elderly patients with preserved or slightly impaired renal function (creatinine clearance above 30 ml/min).

Athletes

Indapamide may give a positive result during a doping test.

Impact on the ability to drive vehicles and machinery

The use of indapamide does not lead to impairment of psychomotor reactions. However, some patients may develop different individual reactions 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 SR, it is not recommended to drive vehicles or other complex mechanisms that require increased attention.

Release form

Extended-release film-coated tablets, 1.5 mg.

10 tablets in a blister pack made of a combined material (polyvinyl chloride film / polyvinylidene chloride) and aluminum foil. 2, 3 or 6 blister packs along with instructions for use are placed in a cardboard pack.