Carbocid pechevsky

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CARBACID PECHAYEVSKIY (CARBACIDPECHAYEVSKIY)

Composition:

Active ingredients: calcium carbonate, heavy magnesium carbonate.

One tablet contains 680 mg of calcium carbonate and 80 mg of heavy magnesium carbonate;

Excipients: sorbitol (E 420), pregelatinized starch, potato starch, talc, magnesium stearate, light mineral oil, peppermint flavor, lemon flavor, sodium saccharin.

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: single-layer, round-shaped tablets with flat upper and lower surfaces, white or almost white in color. When viewed under a magnifying glass, the cross-section reveals a relatively homogeneous structure.

Pharmacotherapeutic group. Drugs for the treatment of acid-related disorders. Antacids, other combinations.

ATC Code A02AX.

Pharmacological Properties.

Pharmacodynamics.

Karbacid Pechajevsky is a combination of two antacids: calcium carbonate and magnesium carbonate, which act locally by neutralizing gastric acid independently of systemic absorption. Calcium carbonate has a prolonged and strong neutralizing activity. This effect is enhanced by magnesium carbonate, which also has potent neutralizing activity. The total acid-neutralizing capacity of the drug in vitro is 16 mEq H+ (titration to pH endpoint of 2.5).

In healthy volunteers, the onset of neutralization is rapid. Administration of 2 tablets on an empty stomach resulted in an increase of more than 1 pH unit within 5 minutes and a significant elevation of gastric content pH above the baseline pH, achieved within 2 minutes.

Pharmacokinetics.

In the stomach, calcium carbonate and magnesium carbonate react with gastric juice to form water and soluble mineral salts.

CaCO₃ + 2HCl → CaCl₂ + H₂O + CO₂

MgCO₃ + 2HCl → MgCl₂ + H₂O + CO₂

Calcium and magnesium may be absorbed in the form of their soluble salts. The extent of absorption of calcium and magnesium from these compounds depends on the dose of the drug. Maximum absorption levels are 10% for calcium and 15–20% for magnesium. In healthy volunteers, a small amount of absorbed calcium and magnesium is excreted by the kidneys. In case of impaired renal function, plasma concentrations of calcium and magnesium may increase. In the intestine, insoluble compounds are formed from the soluble salts and excreted in feces.

Clinical characteristics.

Indications.

For adults and children aged 15 years and older, to relieve symptoms associated with increased gastric acidity (e.g., heartburn, gastroesophageal reflux) leading to digestive disturbances and dyspepsia.

Contraindications.

• Hypersensitivity to the components of the drug;
• Hypercalcemia and/or conditions leading to hypercalcemia;
• Nephrolithiasis caused by calcium-containing stone deposition;
• Severe renal insufficiency (creatinine clearance below 30 ml/min);
• Hypophosphatemia.

Interaction with other medicinal products and other forms of interaction.

Other medicinal products should be administered 1–2 hours before or after taking the drug.

Antacids containing calcium and magnesium may form complexes with certain substances. Therefore, when Carbacid Pechayevsky is used concomitantly with antibiotics (tetracyclines, quinolones) and cardiac glycosides (digoxin), phosphates, fluoride compounds, iron-containing products, levothyroxine, and eltrombopag, the absorption of the latter is reduced.

Thiazide diuretics reduce urinary excretion of calcium and increase its serum levels. Due to the increased risk of hypercalcemia when used concomitantly with thiazide diuretics, serum calcium levels should be monitored regularly.

Calcium salts reduce the absorption of fluorides and iron-containing agents. Also, calcium and magnesium salts may interfere with the absorption of phosphates.

A 2-hour interval should also be maintained between administration of Carbacid Pechayevsky and the following drugs: H2-antihistamines, atenolol, metoprolol or propranolol, chloroquine, diflunisal, digoxin, bisphosphonates, fexofenadine, glucocorticoids (prednisolone and dexamethasone, except hydrocortisone in replacement therapy), indomethacin, ketoconazole, phenothiazine neuroleptics, penicillamine, thyroxine, ethambutol, isoniazid, lansoprazole, lincosamides.

It should be noted that concomitant use leads to enhanced renal excretion of salicylates due to urine alkalinization.

Sodium sulfonate – a cation-exchange resin: the resin's ability to bind potassium is reduced, increasing the risk of metabolic alkalosis in renal insufficiency.

Special precautions for use

If symptoms do not disappear, are partially maintained, or worsen after 10 days of treatment, a medical examination is necessary to determine their cause and to reassess the treatment regimen. The treatment course with Karbatsid Pechayevsky should not exceed 10 days.

Adverse reactions have been observed when used concomitantly with thiazide diuretics (see section "Interaction with other medicinal products and other forms of interaction"). Prolonged use of the drug in high doses may lead to adverse reactions such as hypercalcemia, hypermagnesemia, and milk-alkali syndrome, especially in patients with renal insufficiency.

The drug should not be taken simultaneously with large amounts of milk or dairy products. Prolonged use of Karbatsid Pechayevsky may increase the risk of kidney stone formation. When using 4 to 5 tablets per day, the treatment course should be short, and therapy should be discontinued immediately after symptoms resolve.

Patients should consult a physician if they experience: weight loss, difficulty swallowing, or persistent discomfort in the stomach, signs of digestive disorders—especially if they are new or have changed in nature—or if they have renal insufficiency (calcium and magnesium levels should be monitored).

Calcium carbonate and magnesium carbonate should not be used in cases of hypercalciuria. This medicinal product should be used with caution in patients with impaired renal function. If calcium carbonate and magnesium carbonate must be administered to such patients, plasma levels of calcium, phosphate, and magnesium should be monitored regularly.

The preparation contains sorbitol, which may be harmful to patients with sorbitol intolerance.

Diabetic patients: 1 tablet contains approximately 300 mg of sorbitol and sodium saccharin; therefore, the medicinal product can be used in patients with diabetes.

Use during pregnancy or breastfeeding

There are no reliable data regarding teratogenesis in animals. Bone formation disorders have been reported with high-dose and prolonged use of calcium carbonate.

To date, administration of calcium carbonate and magnesium carbonate during pregnancy has not been associated with an increased risk of fetal malformations. However, monitoring of pregnancies exposed to this combination is insufficient to exclude any risk.

Karbatsid Pechayevsky may be prescribed during pregnancy and breastfeeding if used according to the instructions, but prolonged use of high doses should be avoided. It should also be noted that magnesium salts may cause diarrhea, while prolonged intake of high calcium doses increases the risk of hypercalcemia with calcinosis of various organs, including the kidneys.

It should be considered that during pregnancy and breastfeeding, calcium carbonate and magnesium carbonate provide a significant amount of calcium in addition to dietary intake. Therefore, pregnant women should limit the use of the drug to 1 week and avoid continuous consumption of milk (1 liter contains up to 1.2 g of elemental calcium) and dairy products to prevent calcium excess, which may lead to the so-called milk-alkali syndrome (Burnett's syndrome)—a rare but serious condition requiring medical intervention.

Ability to influence reaction rate while driving or operating machinery

No effect.

Method of Administration and Dosage

The drug is intended for oral use in adults and children aged 15 years and older. The usual daily dose is 1–2 chewable tablets during episodes of pain or heartburn; in case of pain, the dose may be temporarily increased to up to 5 tablets per day. The duration of treatment should not exceed 10 days.

Children.

Do not use in children under 15 years of age.

Overdose.

Prolonged use of high doses of calcium carbonate and magnesium carbonate, especially in patients with impaired kidney function, may lead to renal failure, hypermagnesemia, hypercalcemia, and alkalosis, manifested by gastrointestinal symptoms (nausea, vomiting, constipation) and muscle weakness. In such cases, the drug should be discontinued and adequate fluid intake ensured. In case of severe overdose (e.g., Burnett's syndrome), consult a physician, as additional rehydration (e.g., infusions) may be required. Diarrhea may also occur in case of overdose.

Side effects.

Immune system disorders.

Very rarely, hypersensitivity reactions have been reported, manifesting as rashes, urticaria, angioneurotic edema, and anaphylaxis.

Metabolism and nutrition disorders.

In patients, especially those with impaired renal function, prolonged use of high doses may lead to hypermagnesemia (when using magnesium-containing antacids) or hypercalcemia and alkalosis, which may present with gastrointestinal symptoms and muscle weakness. There is also a risk of kidney stone formation and development of renal failure.

Gastrointestinal disorders.

Possible nausea, vomiting, gastric discomfort, and diarrhea.

Musculoskeletal and connective tissue disorders.

Possible muscle weakness.

Adverse effects observed only in milk-alkali syndrome (Burnett's syndrome):

• Gastrointestinal disorders (ageusia);
• General disorders (calcinosis and asthenia);
• Nervous system disorders (headache);
• Renal and urinary disorders (azotemia).

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Packaging.

10 tablets in a blister. 2 blisters in a cardboard box.

10 tablets in a polymer container. 2 containers in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and location of business activity.

8 Stara Prorizna Street, City of Uman, Cherkasy Region, 20300, Ukraine.