Sodium hydrogencarbonate

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SODIUM BICARBONATE (SODIUM HYDROCARBONATE)

Composition:

Active substance: sodium hydrocarbonate;

1 ml of solution contains 40 mg of sodium hydrocarbonate;

Excipients: disodium edetate, water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid.

Ion composition (mmol/l): sodium ion – 477, bicarbonate ion – 477.

Pharmacotherapeutic group. Plasma substitutes and solutions for intravenous use. Electrolyte solutions. ATC code B05X A02.

Pharmacological Properties.

Pharmacodynamics.

An agent for restoration of blood alkaline balance and correction of metabolic acidosis. Upon dissociation of sodium bicarbonate, bicarbonate anions are released; they bind hydrogen ions to form carbonic acid, which subsequently breaks down into water and carbon dioxide that is eliminated through respiration. As a result, blood pH shifts toward alkaline, and blood buffering capacity increases.

The drug also enhances excretion of sodium and chloride ions from the body, promotes osmotic diuresis, alkalinizes urine, and prevents deposition of uric acid in the urinary tract. The bicarbonate anion does not penetrate into cells.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Uncompensated metabolic acidosis, which may occur in intoxications of various etiologies, severe postoperative course, extensive burns, shock, diabetic coma, prolonged diarrhea, intractable vomiting, acute massive blood loss, severe liver and kidney damage, prolonged debilitating conditions, and severe neonatal hypoxia. An absolute indication is a decrease in blood pH below 7.2 (normal range: 7.37–7.42).

Contraindications.

Metabolic or respiratory alkalosis, hypokalemia, hypernatremia.

Interaction with other medicinal products and other forms of interactions.

May enhance the antihypertensive effect of reserpine.

Special precautions for use

It is necessary to monitor the acid-base balance of blood. In patients with concomitant heart or kidney diseases, heart failure and edema may develop.

Use during pregnancy or breastfeeding

There are no data on contraindications for administration during pregnancy or breastfeeding; however, in these cases the drug should be administered with caution and only for life-saving indications, with monitoring of acid-base balance.

Ability to affect reaction speed when driving or operating machinery

Information is lacking.

Method of Administration and Dosage.

The solution should be administered while monitoring the acid-base balance of the blood. Administer intravenously or rectally by drip infusion in adults; in children – intravenously by drip infusion. Depending on the severity of acidosis, the drug may be used undiluted or diluted with 5% glucose solution in a 1:1 ratio.

In adults, administer intravenously at a rate of approximately 60 drops per minute, up to 200 mL per day. The frequency of administration depends on acid-base balance parameters.

In newborns, administer intravenously at a dose of 4–5 mL per 1 kg of body weight; in children of other age groups – at a dose of 5–7 mL per 1 kg of body weight.

Subsequent administration is determined by acid-base balance parameters. The maximum dose in adults is up to 200 mL per day. The duration of treatment is determined by the physician according to acid-base balance parameters.

Children. The drug can be used in pediatric practice.

Overdose.

In case of overdose, hyperalkalosis and tetanic seizures may develop. If hyperalkalosis occurs, administration of the drug should be discontinued. In case of risk of tetany, administer 1–3 g of calcium gluconate intravenously to adults.

Adverse reactions.

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

Shelf life. 2 years.

Storage conditions.

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

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 sodium bicarbonate solution, as precipitation or hydrolysis of organic compounds may occur. Do not mix with phosphate-containing solutions.

Packaging.

100 ml and 200 ml in glass bottles.

Prescription status. Prescription only.

Manufacturer: LLC "Yuria-Farm".

Manufacturer's address and location of business activity:

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