SODA-BUFFER®

INSTRUCTIONS for medical use of the medicinal product SODA-BUFER® (SODA-BUFER)

Composition:

Active substance: sodium hydrogencarbonate;

1 ml of solution contains 42 mg of sodium hydrogencarbonate;

Excipients: disodium edetate, carbon dioxide, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Ion composition per 1 liter of product: sodium ion – 0.5 mol; hydrogencarbonate ion – 0.5 mol. Theoretical osmolarity – 1000 mOsm/L. pH 7.0–8.5.

Pharmacotherapeutic group. Solutions for intravenous administration. Sodium bicarbonate. ATC code B05X A02.

Pharmacological Properties

Pharmacodynamics

A drug for the restoration of blood acid-base balance and correction of metabolic acidosis. Upon dissociation, sodium bicarbonate releases the bicarbonate anion, which binds hydrogen ions to form carbonic acid. Carbonic acid then decomposes into water and carbon dioxide, which is eliminated through respiration. The solution adjusted to a pH of 7.3–7.8 prevents abrupt alkalization and ensures smooth correction of acidosis, simultaneously increasing blood alkaline reserves. The drug also enhances excretion of sodium and chloride ions from the body, increases osmotic diuresis, alkalinizes urine, and prevents precipitation of uric acid in the urinary tract. The bicarbonate anion does not penetrate into cells.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

Uncompensated metabolic acidosis in intoxications of various etiologies, severe postoperative period, extensive and/or deep burns, shock, diabetic coma, prolonged diarrhea, intractable vomiting, acute massive blood loss, severe liver and kidney damage, prolonged febrile conditions, severe hypoxia in newborns. An absolute indication is a blood pH reduction below 7.2.

Contraindications.

Metabolic or respiratory alkalosis, hypokalemia, hypernatremia.

Interaction with other medicinal products and other types of interactions.

May enhance the antihypertensive effect of reserpine.

Special precautions for use.

It is necessary to monitor pH and acid-base balance of blood. In patients with concomitant heart or kidney diseases, heart failure and edema may develop. In case of too rapid correction of acidosis, especially in the presence of impaired lung ventilation, rapid release of CO₂ may exacerbate cerebral acidosis. Small amounts of SODA-BUFFER® administered together with other infusion solutions having an acidic pH act as neutralizing agents and help prevent post-infusion phlebitis (e.g. glucose solutions of various concentrations, Ringer's solution, sodium chloride solution, ciprofloxacin and some other fluoroquinolones).

Use during pregnancy or breastfeeding.

It is not known whether sodium bicarbonate causes harmful effects on the fetus when administered to pregnant women or whether it may affect reproductive function. Therefore, the drug should be administered during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

Use of the drug during breastfeeding is possible only under life-threatening conditions.

Ability to influence reaction rate when driving or operating machinery.

Data are lacking due to the exclusive use of the drug under hospital conditions.

Dosage and Administration

Administer intravenously by drip infusion to adults and children at a rate of 1.5 mmol/kg per hour (3 ml of 4.2% Sода-Bufer®/kg per hour).

For newborns, administer intravenously at a dose of 1–2 ml per 1 kg of body weight as a single dose under monitoring of acid-base and water-electrolyte balance parameters.

In correction of metabolic acidosis, dosage should be determined according to the degree of acid-base imbalance. The dose should be calculated based on blood gas parameters using the following formula:

Volume of 0.5-molar buffered sodium bicarbonate 4.2% in ml =

deficit of base (-BE) × patient's body weight in kg × 0.3 × 2

(the factor 0.3 corresponds to the fraction of extracellular fluid relative to total body fluid).

Maximum daily dose of the drug is 300 ml for adults (400 ml in patients with increased body weight) and 100–200 ml for children depending on body weight.

Children. Can be used in children from birth.

Overdose.

Due to the buffering properties of the drug, the likelihood of developing alkalosis in overdose is significantly reduced. However, overdose may lead to development of alkalosis, hypernatremia, hyperosmia, and tetanic seizures. If clinical signs of alkalosis occur (seizures, including tetany, excitability, decreased levels of potassium and calcium, increased sodium levels in blood, elevated pH), discontinue administration of the drug. If necessary, administer isotonic sodium chloride solution or 5% glucose solution. In case of risk of tetany development, administer 1–3 g of calcium gluconate intravenously to adults.

Adverse reactions.

Nausea, vomiting, anorexia, stomach pain, headache, restlessness. Arterial hypertension.

Shelf life. 2 years.

Storage conditions. Store in a place inaccessible to children, at a temperature not exceeding 25 °C. Do not freeze.

Incompatibility. Acidic substances (ascorbic acid, nicotinic acid, and other acids), alkaloids (atropine, apomorphine, caffeine, theobromine, papaverine), cardiac glycosides, calcium, magnesium, and heavy metal salts (iron, copper, zinc) must not be dissolved in Sода-bufer® solution, as precipitation or hydrolysis of organic compounds may occur. Do not mix with phosphate-containing solutions.

Packaging. 20 ml, 100 ml, and 200 ml in glass bottles.

Prescription status. Prescription only.

Manufacturer/Applicant.

Yuria-Pharm LLC

Manufacturer's address and place of business.

108, Kozbirska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.