Instructions for use Blemaren effervescent tablets No. 80
Composition
active ingredients: citric acid anhydrous, trisodium citrate anhydrous, potassium bicarbonate;
1 tablet contains citric acid anhydrous 1197 mg; trisodium citrate anhydrous 835.5 mg; potassium bicarbonate 967.5 mg;
excipients: lactose monohydrate, mannitol (E 421), lemon flavor, sodium saccharin, adipic acid, polyethylene glycol.
Dosage form
Effervescent tablets.
Main physicochemical properties: white, round tablets with a bevel, with a lemon odor.
Pharmacotherapeutic group
Means used to dissolve urinary calculi. ATX code G04B C.
Pharmacological properties
Pharmacodynamics
When Blemaren® effervescent tablets are dissolved in water, potassium-sodium hydrocitrate is formed and carbon dioxide is released.
This creates residual alkaline ions that are excreted by the kidneys. This increases the pH of the urine (depending on the dosage, it is neutralized or alkalized).
This increases the degree of dissociation and at the same time the degree of dissolution of uric acid/cystine. Confirmation of litholysis of uric acid stones is performed radiographically.
When taking the drug, the excretion of citrate increases and the excretion of calcium in the urine decreases. Alkalinization of urine, increased excretion of citrate and decreased excretion of calcium lead to a decrease in the amount of calcium oxalate in the urine, since in a weak alkaline environment citrate forms stable complex compounds with calcium. In addition, the citrate ion should be considered as the most effective physiological inhibitor of crystal formation and accumulation of oxalate and calcium phosphate.
Pharmacokinetics
After one day of taking Blemaren® effervescent tablets, the administered amount of sodium and potassium is excreted from the body by the kidneys within 24-48 hours. With prolonged use of the drug, the daily excretion of potassium and sodium corresponds to their daily intake. No significant changes in blood gases or electrolytes are observed in the blood or blood serum. This means that due to renal regulation of alkalization, the acid-base balance in the body is maintained, and the accumulation of sodium and potassium does not occur with normal kidney function.
Indication
Blemaren® is used to treat urolithiasis for the following purposes:
alkalinization of urine in patients with urate stones, with or without concomitant calcium stones; metaphylaxis of calcium stones (prevention of re-formation of new stones and/or enlargement of residual fragments).
Contraindication
Hypersensitivity to the components of the drug. Renal failure. Urinary tract infections caused by bacteria that decompose urea (risk of struvite stone formation). Metabolic alkalosis. Episodic hereditary adynamia.
Interaction with other medicinal products and other types of interactions
Interaction studies have only been performed in adults. The simultaneous administration of substances containing citrate and aluminum may cause increased aluminum absorption, therefore it is recommended to observe a two-hour interval between taking such drugs and Blemaren®.
The drug enhances the therapeutic effect of allopurinol.
Some drugs intended to lower blood pressure (aldosterone antagonists and other low-potassium diuretics such as triamterenes, spironolactones and amilorides), ACE inhibitors, sartans, as well as analgesic and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs and peripheral analgesics) may reduce potassium excretion, which should be taken into account when prescribing them simultaneously with Blemaren® (the risk of hyperkalemia increases). An increase in the extracellular potassium concentration reduces the effectiveness of cardiac glycosides, while its decrease increases the effect of arrhythmogenic cardiac glycosides.
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 (alkaline reaction of the environment), salicylates and lithium preparations (accelerated elimination).
Application features
For conditions that contribute to the formation of urinary stones (e.g., parathyroid adenoma, uric acid stones associated with malignancy), etiotropic therapy measures should be taken.
When dissolving uric acid stones, excessive alkalization of urine (pH above 7.8) for several days should not be allowed due to the possible appearance of phosphate salt deposits on the surface of the uric acid stone, which may prevent its further dissolution. In addition, a long-term and pronounced alkaline state of metabolism is undesirable.
Before use, serum electrolyte levels and renal function should be determined. If renal tubular acidosis is suspected, additional acid-base balance monitoring is necessary.
Patients with heart failure should consider the effect of potassium on myocardial excitability: 1 tablet of Blemaren® contains 380 mg of potassium ions, or 9.7 mmol of potassium, which may affect the effect of cardiac glycosides (an increase in the extracellular potassium concentration reduces the effectiveness of glycosides, and its decrease enhances the arrhythmogenic effect).
For patients with impaired uric acid metabolism, it is recommended to combine the drug with allopurinol.
Individuals following a diet that restricts sodium intake, in particular, those with hypertension, should take into account the increased sodium content of this medicinal product (1 tablet contains 220 mg of sodium ions, or 9.7 mmol of sodium, which corresponds to 0.57 g of salt).
One effervescent tablet contains 9.7 mmol (380 mg) of potassium. This should be taken into account when treating patients with hepatic insufficiency or those on a potassium-restricted diet.
During therapy with the drug, it is recommended to follow a low-protein diet, i.e. limit the consumption of foods rich in purines (e.g. meat, sausages, animal offal, sardines), and also limit salt intake.
Every day you need to drink 2 - 3 liters of liquid in the form of tea, fruit juice or alkaline mineral water.
The drug does not contain carbohydrates and can be used to treat patients with diabetes.
Patients with severe hepatic impairment should take Blemaren® only under close monitoring.
Do not use in patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
When using the drug according to the instructions, no negative effects were observed during pregnancy or breastfeeding.
Method of administration and doses
The average daily dose is determined individually; it is established by determining the pH of urine.
The effervescent tablets should be taken dissolved in a liquid (water or fruit juice). The liquid may be slightly cloudy and have some undissolved particles on the surface.
The daily dose can be taken as a single dose in the evening or divided into 3 equal doses to be taken throughout the day (e.g. at 8:00 a.m., 2:00 p.m., 9:00 p.m.). If the required daily dose is more than 3 tablets, it is recommended to take one tablet in the morning, one in the afternoon, and the rest at night.
The effectiveness of the drug is monitored by determining the pH of fresh urine 3 times a day before the next dose of the drug. For this, standard indicator strips included in each package are used. The indicator zone of the test strip should be briefly immersed in urine, then removed from the liquid and after 2 minutes, compare the resulting color of the test strip with the color scale printed on the set of indicator strips, and record the determined pH values in the control calendar. The dose of the drug is considered to be correctly set if the pH values determined 3 times a day are within the recommended limits for each pathology. The color change of unused indicator strips does not affect the results of pH determination.
To dissolve uric acid (urate) stones, the pH level of urine should be within 7.0–7.2.
If the daily pH profile is below 7.0, the dose should be increased, and if it is above 7.2, the dose should be reduced.
For maintenance treatment of patients with urolithiasis accompanied by calcium stones, the pH level should be kept within 6.2 - 6.8.
If the daily pH profile is below 6.2, the dose should be increased, and if it is above 6.8, the dose should be reduced.
To dissolve mixed urate-oxalate stones and prevent the formation of calcium-oxalate stones, urine pH must be maintained at 6.8 - 7.4 for a certain time.
The drug Blemaren® is used before conducting remote nephrolithotripsy for mixed (radiographically inhomogeneous) stones to enhance its effectiveness, reduce the structural density of the stone and reduce the number of repeated sessions. The duration of citrate therapy in preparation for remote lithotripsy should be at least 3 weeks.
To alkalinize the urine in patients with cystine stones, the urine pH should be in the range of 7.5 to 8.5. This requires a higher dose of the drug.
When conducting cytostatic therapy, the pH of urine should be at least 7.0, and when treating porphyria cutanea tarda, 7.2 - 7.5.
Uricosuric therapy, like the treatment of urate stones, should be performed at a urine pH of 7.0 to 7.2.
The pH values that can be determined using standard indicator strips are in the range of 5.4 - 7.4. If it is necessary to control the pH of urine in patients with cystine stones or in porphyria cutanea tarda, special indicator strips should be used to determine the pH in the range of 7.2 - 9.7.
To dissolve stones (depending on their size and composition), the duration of the treatment course is from 4 weeks to 6 months. To prevent recurrence of nephrolithiasis, the drug is prescribed in courses, the duration and frequency of which are set individually for each patient.
Children
The efficacy and safety of the drug in children have not been sufficiently studied, therefore it is not recommended to prescribe Blemaren® to children (under 18 years of age).
Overdose
With normal kidney function, the undesirable effect of the drug on changing the physiological parameters of metabolism is not observed either at the usual recommended dose or at a higher one, since the excretion of excess alkalis by the kidneys is a natural mechanism for regulating the acid-base balance in the body.
The upper limit of the urine pH range mentioned above should not be exceeded for several days, as there is a correspondingly increased risk of phosphate crystallization due to the increased pH (pH factor >7.8); moreover, a pronounced alkaline metabolic status is not a long-term problem.
Possible overdose can be corrected by reducing the dose of the drug. If necessary, measures can be taken to treat metabolic alkalosis.
Adverse reactions
In case of individual intolerance to any of the components of the drug, hypersensitivity reactions are possible. In some cases, taking the tablets may cause gastrointestinal disorders in susceptible patients. There have been reports of belching, heartburn, abdominal pain, flatulence, diarrhea, nausea, vomiting.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
20 effervescent tablets in a polypropylene container; 4 containers in a cardboard box together with indicator paper and a control calendar with labeling in Ukrainian.
Vacation category
Without a prescription.
Producer
Alfamed Farbil Artsneimittel GmbH, Germany.
