Instructions for Arstifen effervescent tablets No. 80
Composition
active ingredients: citric acid anhydrous, sodium citrate anhydrous, potassium bicarbonate;
1 tablet contains: citric acid anhydrous 1197 mg, sodium citrate anhydrous 835.5 mg, potassium bicarbonate 967.5 mg;
excipients: lactose monohydrate, mannitol (E 421), sodium saccharin, "Powdarome Lemon Premium" flavoring, adipic acid, polyethylene glycol.
Dosage form
Effervescent tablets.
Main physicochemical properties: round, flat tablets with a bevel, white to almost white in color, with a smooth surface on both sides.
Pharmacotherapeutic group
Means used to dissolve urinary calculi. ATX code G04B C.
Pharmacological properties
Pharmacodynamics.
When Arstifen® 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 Arstifen® 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
Arstifen® 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.
Kidney failure.
Urinary tract infections caused by bacteria that break down urea (risk of struvite stone formation).
Metabolic alkalosis.
Episodic hereditary adynamia.
Interaction with other medicinal products and other types of interactions
Interaction studies have been performed only in adults. The simultaneous administration of substances containing citrate and aluminum may cause increased aluminum resorption, therefore it is recommended to observe a two-hour interval between taking such drugs and Arstifen®.
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 Arstifen® (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 the drug Arstifen®, accumulation of quinidine in the body is possible in the event of its simultaneous administration, 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 cause urinary calculi (e.g., parathyroid adenoma, uric acid calculi 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 take into account the effect of potassium on myocardial excitability: 1 tablet of Arstifen® 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, particularly those with hypertension, should take into account the high 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).
1 effervescent tablet contains 9.7 mmol (380 mg) of potassium. This should be taken into account when treating patients with impaired renal function 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, so it can be used to treat patients with diabetes.
Patients with severe hepatic impairment should take Arstifen® only under close supervision.
This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Use during pregnancy or breastfeeding
When using the drug according to the instructions, no negative effects were observed during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The optimal daily dose of Arstifen® is determined individually by determining the urine pH.
For alkalizing urine in patients with uric acid (urate) stones.
To prevent recurrence, the pH of fresh urine should be in the range of 6.2 to 6.8. The required daily dose of Arstifen® is individual for different patients. Usually the daily dose is 3 effervescent tablets. The daily dose is divided into three equal single doses taken during the day. If the pH of urine is below 6.2, the dose should be increased. Such correction should be made by increasing the evening dose to 2, and in exceptional cases - to 3 effervescent tablets. If the pH value exceeds 6.8, the dose should be reduced. It is advisable to adjust the dosage at the expense of the evening dose.
To dissolve (hemolitholysis) uric acid (urate) stones, the pH value of urine should be between 7.0 and 7.2.
For metaphylaxis of calcium stones and alkalinization of urine in patients with uric acid stones, in the presence of concomitant calcium stones.
The pH of fresh urine should be adjusted to 6.8 - 7.4. The dose should be determined in each individual case to achieve this pH range. Usually this is 3 effervescent tablets. If necessary, the dose can be increased, but in most cases 5 effervescent tablets are sufficient to achieve results in the specified pH range.
The daily dose of 3 effervescent tablets can be taken as a single evening dose or divided into three individual doses taken throughout the day. For higher doses, it is advisable to take 1 effervescent tablet in the morning, 1 at lunchtime and 2-3 tablets in the evening.
Arstifen® is contraindicated in children under 18 years of age (see the “Children” section).
Method of application
Effervescent tablets of the drug Arstifen® should be dissolved in a glass of water, stirred and drunk immediately.
The liquid may be slightly cloudy and have some undissolved particles on the surface.
The effectiveness is usually monitored 3 times a day by measuring the pH of the urine. This is done using standard indicator strips included in each package. The indicator area of the test strip should be briefly immersed in the urine. The colour of the test strip is then compared to the colour scale for 2 minutes, the pH value is read and recorded in the control calendar.
Children
The efficacy and safety of the drug in children have not been sufficiently studied, therefore it is not recommended to prescribe Arstifen® 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.
Side effects
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of this medicinal product. Healthcare professionals should report all suspected adverse reactions to the State Expert Center of the Ministry of Health of Ukraine and to the applicant via the feedback form on the website: https://kusum.ua/pharmacovigilance/.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 effervescent tablets in a tube, 4 tubes in a cardboard box with indicator paper and a control calendar.
Vacation category
Without a prescription.
Producer
Kusum Healthcare Pvt Ltd.
Address
Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India.
