Instructions for use BLEMAREN tab. fizzy

Pharmacodynamics and pharmacokinetics

The use of this drug allows you to dissolve and prevent the formation of uric acid stones by alkalizing urine to optimal pH values ​​of 6.6-6.8. As is known, at a urine pH of 6.6-6.8, there is a significant increase in the dissolution of salts in uric acid. Calcium excretion is also reduced , the solubility of calcium oxalate in urine is improved, and the formation of crystals is inhibited, which prevents the appearance of calcium oxalate stones.

The bioavailability of this drug is almost 100%. Removal of substances from the body occurs through the kidneys.

Pharmacological properties of the drug Blemaren

A drug used to dissolve urinary stones. As a result of establishing the optimal urine pH value when taking the drug, favorable conditions are created to stop the growth and dissolution of uric acid and mixed stones. Reduces the secretion of calcium ions by stimulating the excretion of endogenous citrate, eliminating the conditions for the formation of stones containing calcium and making up the majority of all stones in urolithiasis. As a result of the metabolism of citrate (a salt of a strong alkali and a weak acid), alkalization (neutralization) of urine occurs. In this case, the citrate residue is oxidized to form CO2 or bicarbonate. Excess alkali, which is formed as a result of the hydrolysis of citrates, is excreted by the kidneys and causes an increase in urine pH. With oral administration of alkaline citrates (Blemaren citrate complex), dose-dependent neutralization or alkalinization of urine can be achieved. As a result, the degree of dissociation increases, and at the same time, the dissolution of uric acid or cystine. Litholysis of uric acid stones is confirmed by x-ray. Serum bicarbonate concentration is a regulating factor for citrate secretion by renal tubular cells. With an excess of alkalis and an increase in intracellular pH in the cells of the renal tubules, the tubular metabolism of citrates slows down, reverse resorption decreases and citrate excretion increases. Changes in renal calcium transport as a result of alkalization lead to a significant decrease in urinary calcium excretion. Alkalinization of urine, increased excretion of citrate and decreased excretion of calcium cause a decrease in the amount of calcium oxalate in the urine, since citrate forms a chemical compound with calcium in a weak alkaline environment. In addition, the citrate ion should be considered as the most important physiological inhibitor of the crystallization of calcium oxalate (as well as calcium phosphate) and the aggregation of these crystals. Regarding the solubility of cytostatic agents that are excreted by the kidneys, there are similar patterns. It can be assumed that there is a correlation between the aggressiveness of metabolites (for example, cytotoxic drugs such as cyclophosphamide) and the concentration of hydrogen ions in the urine, as well as the pH-dependent solubility of the cytostatic drug or its metabolites in urine (for example, methotrexate). When taking potassium sodium hydrogen citrate as an adjuvant agent as part of cytostatic therapy, the urine pH should be at least 7.0 in order to sufficiently reduce urotoxicity or nephrotoxic reactions that are caused by chemotherapy. In skin porphyria tarda there is a deficiency of uroporphyrinogen decarboxylase, which promotes the conversion of uroporphyrinogen to coproporphyrinogen. By means of metabolic alkalization, it is necessary to prevent the reverse diffusion of coproporphyrin in the renal tubules to increase the clearance of coproporphyrin. Due to increased excretion of coproporphyrin, there is an increase in the synthesis of coproporphyrinogen from uroporphyrinogen, and along with this, a decrease in the level of uroporphyrin. The bioavailability of the drug components is close to 100%. Citrate is metabolized almost completely, only 1.5–2% is excreted unchanged in the urine. When taking 4 effervescent tablets of Blemaren, 38 mmol of citrate enters the body, which corresponds to 2% of the amount of citrate that is metabolized daily in the body. After a one-day use of the drug Blemaren, the administered amount of sodium and potassium is excreted from the body by the kidneys over 24–48 hours. With prolonged use of the drug, the daily excretion of potassium and sodium corresponds to the daily intake. When using the drug, there are no changes in the gas composition or electrolyte balance of the blood.

Indications for use of the drug

Treatment with Blemaren is prescribed when necessary:

• dissolve uric acid and calcium oxalate stones and prevent their formation;
• dissolve mixed uric acid-oxalate stones , with an oxalate content of up to 25%;
• perform urine alkalinization in patients who receive cytostatics and agents that can increase the excretion of uric acid;
• carry out symptomatic treatment of skin porphyria.

Contraindications for use

The main contraindications to taking Blemaren are:

• hypersensitivity;
• metabolic alkalosis;
• acute and chronic forms of renal failure ;
• urinary tract infections , caused by microorganisms that break down urea ;
• adherence to a strict salt-free diet, for example, with severe arterial hypertension;
• urine pH level is more than 7;
• The age of patients is less than 12 years, since clinical experience for this age group has not been studied.

Blemaren, instructions for use (Method and dosage)

The tablets are intended to be taken orally after eating. To do this, the medicine is dissolved in 200 ml of any liquid - tea, fruit juice or water.

According to the instructions for use of Blemaren, the daily dosage can be 2-6 tablets , the intake of which should be evenly distributed throughout the day. Correctly selected dosage allows you to maintain the pH throughout the day within 6.2-7 - if you need to dissolve uric acid stones, 7.5-8.5 when dissolving cystine stones, at least 7 - therapy with cytostatics , 7.2-7.5 – treatment of porphyria. When the urine pH value is less than specified, the dosage is increased, and when the pH value is high, it is reduced. The average duration of treatment can be 4-6 months.

During therapy, it is necessary to monitor the effectiveness, that is, determine the urine pH at least 3 times a day, before taking each dose, using indicator paper. The results on paper need to be compared with the scale and the indicator entered into the control calendar.

Use of the drug Blemaren

The average daily dose is determined individually and can be 6–18 g of active substance (2–6 effervescent tablets per day). Effervescent tablets are taken after dissolving in water or fruit juice. The daily dose is divided into 3 equal parts, which are taken throughout the day (for example, at 8.00, 14.00, 21.00). Monitoring the effectiveness of the drug is carried out by determining the pH of fresh urine 3 times a day before the next dose of the drug. To do this, use standard indicator strips included in each package. The indicator zone of the test strip should be briefly immersed in urine, then removed and after 2 minutes, compare the resulting color of the test strip with the color scale applied to the set of indicator strips, and record the determined pH values ​​in the control calendar. The dose of the drug is considered correctly selected if the pH values ​​determined 3 times a day are within the recommended limits for each pathology. To dissolve urate stones, urine pH should be between 6.2–6.8. If the daily profile of pH values ​​is below 6.2, the dose should be increased, and if it is above 6.8, the dose should be reduced. To dissolve urate-oxalate stones and prevent the re-formation of calcium-oxalate stones, urine pH must be maintained for a certain time at a level of 6.8 to 7.4. Blemaren is used before external nephrolithotripsy for mixed (X-ray heterogeneous) stones to enhance its effectiveness, reduce the structural density of the stone and reduce the frequency of repeated sessions. The duration of therapy to prepare for extracorporeal lithotripsy should be at least 3 weeks. To alkalinize the urine in patients with cystine stones, the urine pH should be between 7.5 and 8.5. This requires the use of the drug at a higher dose. When carrying out cytostatic therapy, urine pH should not be lower than 7.0, and when treating late porphyria of the skin - 7.2–7.5. With uricosuric therapy, as with litholysis of urate stones, the pH should be 6.2–6.8. pH values ​​that can be determined using standard test strips are in the range of 5.4–7.4. If it is necessary to control urine pH in patients with cystine stones or with late porphyria of the skin, special indicator strips are used to determine pH in the range of 7.2–9.7 (prescribed additionally by a doctor). For litholysis of stones (depending on their size and composition), the duration of treatment usually ranges from 4 weeks to 6 months. To prevent relapses of nephrolithiasis, the drug is prescribed in courses, the duration and number of which are determined individually for each patient.

Interaction

The combination of Blemaren and products that contain citrates and aluminum sometimes causes increased absorption of aluminum. In this case, it is necessary to maintain an interval between doses of about 2 hours.

cardiac glycosides may be weakened , since Blemaren contains a substance such as potassium.

Concomitant use of drugs that lower blood pressure, such as aldosterone antagonists, potassium-sparing diuretics, ACE blockers or NSAIDs and analgesics , can reduce potassium excretion.

Interactions of the drug Blemaren

Simultaneous use of drugs containing citrate and aluminum may cause an increase in aluminum resorption, so it is recommended to maintain a 2-hour pause between doses of such drugs. The drug enhances the therapeutic effect of allopurinol. Aldosterone antagonists, potassium-sparing diuretics, ACE inhibitors, as well as non-narcotic analgesics and NSAIDs may reduce potassium excretion, which should be taken into account when prescribing Blemaren simultaneously. With long-term use of Blemaren, accumulation of quinidine in the body is possible if it is taken simultaneously, as well as a decrease in the effectiveness of nitrofurantoin, salicylates and lithium preparations.

special instructions

The average daily dosage is 4 tablets and contains almost 0.9 g of sodium and 1.5 mg of potassium, so this must be taken into account when treating patients whose salt intake is limited.

Taking Blemaren is allowed in case of chronic renal failure, unless potassium ion retention is established.

During the dissolution of uric acid stones, it is necessary to strictly adhere to the daily dose, since an increase in pH above 7 leads to the precipitation of phosphates on uric acid crystals, preventing their subsequent dissolution.

It is also recommended to limit the consumption of foods rich in proteins or purine bases, ensuring adequate fluid intake - about 1.5-2 liters.

Treatment does not have a particular effect on the ability to drive vehicles or operate machinery that require increased attention.

Instructions for use BLEMAREN tab. fizzy

Serum electrolytes and renal function may need to be checked prior to use. If renal tubular acidosis is suspected, the acid-base balance should also be checked.

In the presence of diseases that can contribute to the formation of uric acid stones (for example, parathyroid adenoma, malignant neoplasms accompanied by the formation of uric acid stones), etiotropic therapy must first be carried out.

Caution should be exercised when prescribing Blemaren effervescent tablets to patients who have been prescribed a salt-free diet, especially to patients with severe arterial hypertension. It is important to note that 1 effervescent tablet contains 220 mg of sodium ions / 9.7 mmol of sodium (corresponding to 0.57 g of table salt).

During treatment, urine and blood parameters should be regularly monitored. Particular attention should be paid to the acid-base balance.

To maintain and maintain the effect of the drug, patients should be advised to reduce salt intake during treatment.

A daily intake of 2-3 liters of fluid in the form of tea, juice or alkaline mineral water is necessary to form a sufficient amount of urine, which in turn reduces the risk of stone formation.

Patients with severe functional liver failure should be prescribed Blemaren with extreme caution.

One effervescent tablet contains 9.7 mmol (380 mg) of potassium, which must be taken into account when treating patients with renal failure and those on a potassium-controlled diet.

One effervescent tablet contains 9.7 mmol (220 mg) sodium, which must be taken into account when treating patients on a sodium-controlled (salt-free) diet.

Blemaren is safe when prescribed to patients with diabetes (0.02 carbohydrates/per tablet).

The drug contains lactose monohydrate. In this regard, the drug is not recommended for patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Influence on reaction speed when driving vehicles and working with other mechanisms

Blemaren does not affect the reaction rate when driving vehicles or operating other mechanisms.

Preclinical safety data

Acute toxicity

Acute toxicity studies in rats and mice following oral administration showed an LD50 value of 5000 mg/kg body weight.

Chronic toxicity

Chronic toxicity studies in rats and dogs showed no evidence of specific toxic reactions at doses up to max. 3000 mg/kg when taken orally.

Oncogenic and mutagenic potential

No oncogenic or mutagenic effects were detected at therapeutic doses.

Reproductive toxicity

In a reproductive toxicity study in rats and rabbits, no embryotoxic potential was observed up to the maximum tested dose of 2000 mg/kg PO.

Fertility studies in the pre- and postpartum period have not been conducted.

No special studies have been conducted in pregnant and lactating women. However, existing experience with the use of this class of substances indicates that there are no possible risks during use.

Preclinical safety data based on standard acute toxicity, repeated dose toxicity, genotoxicity and carcinogenic potential studies do not indicate any risk to human health.

Analogs

Level 4 ATC code matches:
Phytolit

Cyston

Uronephron

Rowatinex

The main analogues of Blemaren are K-Na hydrogen citrate and Soluran .

There are also drugs with a similar effect, for example: Urolesan, Cystenal, Phytolysin, Uronephron and others.

Reviews about Blemarin

This drug is actively used in clinical practice. At the same time, patient reviews of Blemaren report that its effectiveness is manifested in cases where they strictly adhered to the therapeutic regimen prescribed by a specialist.

Many patients report that they were prescribed this drug to treat kidney stones due to a shift in pH towards acidity. It was course therapy with this medicine that helped completely eliminate this disease.

There are also reviews of Blemaren for gout, when patients tried to get rid of the problem on their own. However, they were subsequently forced to see a doctor and after treatment with this drug they experienced significant relief.

More than one forum is dedicated to reviews of Blemaren, where you can find a detailed description of therapeutic regimens using this drug and mineral water. This treatment helps restore the pH level of urine and normalize health.

The effectiveness of using the citrate mixture "Blemaren" for uric acid nephrolithiasis

I.A. Aboyan, V.A. Sknar, S.V. Pavlov Municipal budgetary healthcare institution “Clinical Diagnostic, Rostov-on-Don”, Russia

Urolithiasis (UCD) has a high medical and social significance, which is due to a fairly high incidence, reaching 10% in the world, its annual growth in many countries and the defeat of the most able-bodied part of the population [1].

In the Russian Federation in 2012, the incidence of urolithiasis was 550.5 people per 100 thousand population, and its increase over the period from 2002 to 2012 exceeded 25% [2]. The prevalence of uric acid stones worldwide varies from 5 to 40% and varies geographically, so in North America it ranges from 5 to 10%, and in Israel it is 40% [3-5].

In the structure of the incidence of urolithiasis, there is an increase in the frequency of uric acid nephrolithiasis to 20-30%, which may be due to an increase in people's life expectancy, physical inactivity leading to impaired purine metabolism, and increased consumption of protein foods and alcohol.

The ratio of uric acid stones according to the results of a study of the composition of uroliths in recent years was 11.9-30.5% [7-10].

Numerous studies indicate the high efficiency of litholysis of uric acid stones using citrate mixtures (Blémaren and others) [11-17].

According to the recommendations of the European Association of Urology, the method of choice for non-invasive surgical treatment of stones up to 2 cm can be external shock wave lithotripsy (ESW) [11,18].

Most authors indicate that the effectiveness of this procedure depends on the size and density of the stone [6,14,17,19], along with some negative assessments of such a correlation [21].

In recent years, increasing attention has been paid to the effect of citrate drugs on stone density and the results of a subsequent course of extracorporeal lithotripsy (ESLT). Most studies have noted an increase in efficiency and a reduction in the duration of a course of DLT as a result of the use of citrates [14,16,19, 21].

The purpose of the study is to study the effectiveness of litholysis and the dynamics of the density of uric acid and mixed stones during therapy using citrate mixtures.

MATERIALS AND METHODS

We conducted a study of a group of 30 patients (14 women and 16 men aged 27-64 years) with uric acid nephrolithiasis. The size of the stones ranged from 8 mm to 22 mm, there were no signs of obstructive uropathy. Multislice computed tomography (MSCT) of the kidneys was performed on Siemens Somatom Difinition AS 64 and AS 40 devices in all patients before the start of therapy, after 3 months and after the end of the 6-month course of treatment (if a stone was present after 3 months according to MSCT).

The diagnosis of uric acid (urate) nephrolithiasis was established if the patient had a low stone density (138-600 NU) on MSCT of the kidneys; X-ray negative stones on plain urography or when performing a topographic image before MSCT of the kidneys, the results of X-ray phase analysis (XRF) of urinary stones that had passed earlier or were obtained as a result of lithotripsy, lithoextraction or surgical treatment before the current course of treatment, the presence of hyperuricemia and/or hyperuricuria. All patients received the Blemaren citrate mixture 3 times a day, in an individual pH-dependent dose from 0.5 tablets to 1.5 - 2 tablets 3 times a day during the course of litholysis (3-6 months).

In the presence of hyperuricemia and/or hyperuricuria, allopurinol 100–200 mg per day was also prescribed during the course of litholysis, usually in one dose. Some patients were recommended to take allopurinol twice a day if they had complaints of discomfort in the stomach with a single dose of the drug. In this case, the daily dose of allopurinol depended on the degree of hyperuricemia and/or hyperuricuria and was the minimum necessary to normalize the level of uric acid in the blood and/or urine.

RESULTS AND DISCUSSION

Complete dissolution of stones occurred in 22 patients (73.3%). In 6 cases (20%) there was a decrease in the size of the stone (Table 1). Of these, in three patients the stones decreased in size and passed naturally. The three remaining patients with a decrease in stone size underwent EBRT of stones. We noted greater efficiency in dissolving calculi when their size is less than 1 cm.

Table 1. Results of litholysis of uric acid stones using Blemaren

As for two cases of lack of effect from the course of litholysis, in one case DLT was successfully performed. The density of this stone after the course of litholysis decreased slightly (by 6 HU units). Analysis of stone fragments showed a combination of uric acid dihydrate and apatite in a ratio of 70% and 30%. The second patient underwent laser nephrolithotripsy. XRF of this calculus revealed the presence of uricite and insoluble sodium urate in a ratio of 60%:40%. The density of the stone in this case also decreased slightly - by 3 units. HU.

In the study group, we studied the relationship between the effectiveness of treatment, stone density before and after treatment and the degree of reduction in stone density depending on the composition of stones according to X-ray phase analysis. The density and composition of stones from patients who had complete stone dissolution after 3 months are presented in Table 2.

Table 2. Initial density and composition of stones in patients who had complete stone dissolution after 3 months.

The initial composition of stones and the degree of reduction in the density of stones in patients who had complete stone dissolution after 6 months are presented in Table 3.

Table 3. Composition of stones and the degree of reduction in the density of stones in patients who had complete stone dissolution after 6 months.

The density, the degree of its reduction and the composition of the stones of patients in whom partial dissolution of the stones was noted are presented in Table 4.

Table 4. Density, degree of density reduction and composition of stones from patients with partial dissolution of stones

The density, the degree of its reduction and the composition of the stones of patients in whom stone dissolution was not noted are presented in Table 5. These patients are characterized by a relatively high density of stones and a low degree of reduction in the density of stones.

Table 5. Density, degree of density reduction and composition of stones from patients in whom stone dissolution was not noted

As can be seen from tables 2-5, the best results were observed with litholysis of monophasic uric acid stones. As the density of stones increases, the proportion of patients with successful litholysis decreases and the duration of the dissolution process lengthens.

Table 6 shows the dynamics of stone density during litholysis in patients receiving the Blemaren citrate mixture for 6 months (complete dissolution, partial dissolution and no dissolution).

Table 6. Dynamics of stone density during litholysis in patients receiving the citrate drug Blemaren for 6 months (complete dissolution, partial dissolution and no dissolution)

As can be seen from the table, during the treatment the density of stones decreased significantly, by an average of 89 units. НU (31.6%).

During the study, we noted a decrease in the level of stone density during therapy with the citrate drug Blemaren in all patients, while the stone density according to MSCT in all patients with successful litholysis was less than 500 NU.

Figure 1 shows the relationship between the average density of stones and the results of litholysis (the degree and timing of stone dissolution).

Rice. 1. Relationship between the average density of stones and the results of litholysis

Our study also revealed a directly proportional relationship between the average degree of reduction in stone density during treatment and the results of litholysis, that is, the degree and timing of stone dissolution (Fig. 2).

Rice. 2. Average degree of reduction in the density of calculi during litholysis

CONCLUSIONS

Litholysis of uric acid stones using a citrate mixture (Blemaren) is a highly effective non-traumatic method of treating patients.

During treatment, a significant decrease in the density of uric acid and mixed stones was noted

The noted decrease in density turned out to be more pronounced when performing litholysis of monophasic (single-component) uric acid stones.

In addition, we noted that this type of treatment turned out to be highly effective when the stone density according to MSCT data is less than P 500 NU.

LITERATURE

1. Yasui T, Ando R, Okada A. Et al. Epidemiology of urolithiasis for improving clinical practice. Hinyokika Kiyo. 2012. Vol. 58, (12):697-701.
2. Apolikhin O.I., Sivkov A.V., Moskaleva N.G., Solntseva T.V., Komarova V.A. Analysis of uronephrological morbidity and mortality in the Russian Federation for a ten-year period (2002-2012) according to official statistics. // Experimental and clinical urology. 2014; (2):2-12
3. Gutman AB, Yu TF. Uric acid nephrolithiasis. Am J Med 1968; 45:756.
4. Hesse A, Schneider HJ, Berg W, Hienzsch E. Uric acid dihydrate as urinary calculus component. Invest Urol 1975; 12:405.
5. Scholz D, Schwille PO, Ulbrich D. et al. Composition of renal stones and their frequency in a stone clinic: relationship to parameters of mineral metabolism in serum and urine. Urol Res 1979; 7:161.
6. Grenabo L, Hedelin H, Pettersson S. The severity of infection stones compared to other stones in the upper urinary tract. Scand J Urol Nephrol 1985; 19:285.
7. Konstantinova O.V., Shaderkina V.A. Epidemiological assessment of urolithiasis in outpatient urological practice. Experimental and clinical urology. 2015;(1): 11-14
8. Sknar V.A., Aboyan I.A., Shukaev I.L., Pavlov S.V., Zolotukhin D.A. Investigation of the composition of 2200 urinary stones using advanced X-ray diffraction analysis: our experience. Materials of the 1st scientific and practical conference of urologists of the North-Western Federal District of the Russian Federation “Current issues of urology”, St. Petersburg. 2015.s. 111
9. SpivacowFR, Del Valle EE, Lores E. et al. Kidney stones: Composition, frequency and relation to metabolic diagnosis., Medicina 2016;76(6):343-346
10. D'Alessandro M., Gennaro G., Tralongo P. et al. Fourier Transform Infrared Analysis of Urinary Calculi and Metabolic Studies in a Group of Sicilian Children, Iranian J Kid Dis. 2017;(3)209-216
11. Pytel Yu. A. Zolotarev I. I. Urate nephrolithiasis, Moscow, Medicine, 1995. 90 p.
12. S. H. Al-Shukri, M. N. Slesarevskaya, I. V. Kuzmin. Litholytic therapy of urate nephrolithiasis, Urology. 2016;(2): 23-27
13. Slesarevskaya M. N., I. V. Kuzmin, Al-Shukri S. Kh. Litholytic therapy of urolithiasis. Urological Journal 2015;(1):112-11319.
14. Rudenko V. I., Rapoport L. M., Kuzmicheva G. M. Modern aspects of citrate litholysis. Effective pharmacotherapy, 2017; 24, S. 10-12.
15. Alyaev Yu. G., Kuzmicheva G. M., Rapoport L. M., Rudenko V. I. Modern aspects of citrate therapy in patients with urolithiasis. Medical class, 2004;4. S.. 20-24.
16. Chistik T. Citrate therapy in outpatient practice of urolithiasis: focus on Blemaren®. Kidneys 2015; 4 (14): 71-74.
17. Glybochko P. V., Blumberg B. I., Osnovin O. V., Soldatenko M. V., Rossolovsky A. N., Maksimova A. V., The influence of stone density and size on the effectiveness of external lithotripsy using Dornier Compact Delta and Sonolit devices . Saratov Scientific and Medical Journal, 2011;7,(S2):208.
18. Neisius A, et al. Shock wave lithotripsy: the new phoenix? World J Urol 2015 Feb; 33 (2): 213-221.
19. Alyaev Yu. G., Rapoport L. M., Rudenko V. I. Citrate therapy to prepare for extracorporeal lithotripsy. Urology and Nephrology 2002;(4):20-23
20. Chekhonatskaya M. L., Rossolovsky A. N., Bobylev D. A. The relationship between the density and size of stones in patients with nephrolithiasis and the effectiveness of treatment using external shock wave lithotripsy, Saratov Journal of Medical Scientific Research, 2017;13(1):77 -81
21. Alyaev Yu. G., Rapoport L. M., Rudenko V. I. Citrate therapy to prepare for extracorporeal lithotripsy. - Urology 2002;(4):20-23

The article was published in the journal “Experimental and Clinical Urology” No. 2 2021, pp. 44-49

Topics and tags

Urolithiasis disease

Magazine

Journal "Experimental and Clinical Urology" Issue No. 2, 2018

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Blemarin price, where to buy

The drug can be bought in Moscow in pharmacies without a prescription at a cost of 635-990 rubles for 80 pieces.

The price of Blemarin in Ukraine varies between 288-350 UAH.

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