RINGER LACTATE SOLUTION

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RINGER’S LACTATE SOLUTION

Composition:

Active substances: sodium chloride, potassium chloride, sodium lactate, calcium chloride dihydrate;

100 ml of solution contains: sodium chloride – 0.602 g; potassium chloride – 0.0373 g; sodium lactate – 0.3138 g; calcium chloride dihydrate – 0.0294 g;

Ionic composition per 1000 ml of solution: Na+ – 131 mmol, K+ – 5 mmol, Ca++ – 2 mmol,
Cl− – 112 mmol, lactate – 28 mmol;

Excipients: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity — 278 mOsmol/l; pH 5.5–7.5.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Solutions for correction of electrolyte balance disorders. Electrolytes. ATC code B05B B01.

Pharmacological properties.

Pharmacodynamics. "Ringer's lactate solution" is a balanced electrolyte solution. It replenishes the deficit of circulating blood volume. The lactate contained in the drug is metabolized into bicarbonate anions, which slightly shifts blood pH toward alkalinity. The solution also exerts a detoxifying effect by reducing the concentration of toxic substances in the blood and stimulating diuresis. The solution is nearly isotonic.

Pharmacokinetics. After intravenous administration, the drug causes a temporary increase in blood osmolarity. The drug penetrates into tissues approximately within half an hour. The components of the drug are excreted in urine.

Clinical characteristics.

Indications. Correction of water-electrolyte imbalances in isotonic and hypotonic dehydration due to fluid loss from vomiting, diarrhea, insufficient fluid intake, biliary and intestinal fistulas, as well as for restoration of water-electrolyte balance in patients prior to surgery and during the postoperative period. Metabolic acidosis.

Contraindications. Hypervolemia, hypernatremia (including due to corticosteroid use), hyperkalemia, hyperchloremia, hypertonic dehydration, alkalosis, lactic acidosis; severe arterial hypertension; severe cardiac and/or renal dysfunction, hepatic insufficiency (due to reduced bicarbonate formation from lactate), pulmonary edema, thrombophlebitis; conditions associated with increased blood coagulability, uncompensated heart defects.

Oliguria, anuria; acute renal failure; cerebral edema; hypercalcemia; extracellular hyperhydration.

Interaction with other medicinal products and other types of interactions. When potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, and potassium-containing preparations are used concomitantly, the risk of developing hyperkalemia is increased. When "Ringer's lactate solution" is administered simultaneously with cardiac glycosides, the toxic effect of the latter is enhanced due to the presence of Ca++ ions in the solution.

The preparation is incompatible with cefamandole, amphotericin, ethyl alcohol, thiopental, aminocaproic acid, metaraminol, ampicillin, vibramycin, and monocycline.

It is not recommended to use "Ringer's lactate solution" as a diluent for antibiotics administered by infusion, or for dilution of anti-inflammatory drugs.

Sodium retention in the body may increase when the following medicinal products are used concomitantly: nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators, or ganglion blockers.

Due to the presence of lactate in the composition of the medicinal product, which increases pH (alkalinizing effect), "Ringer's lactate solution" should be used with caution when administered simultaneously with drugs whose renal elimination depends on pH. Renal clearance of salicylates, barbiturates, and lithium may be reduced, while that of sympathomimetics and stimulants (such as dexamphetamine sulfate, phenfluramine hydrochloride) may be increased.

Special precautions for use

During infusion therapy with the medicinal product "Ringer's lactate solution", the patient's clinical condition should be assessed by monitoring electrolyte concentrations, water-electrolyte balance, pH and pCO₂, and lactate levels (during massive infusions).

Due to the presence of sodium ions, "Ringer's lactate solution" should be administered with caution to patients with arterial hypertension, renal or cardiovascular insufficiency, elderly patients, as well as patients with clinical conditions associated with sodium retention and edema, and in patients with hypoxia or hepatic insufficiency.

Administration of intravenous solutions may lead to fluid overload, hyperhydration, congestion, and pulmonary edema. The risk of developing dilutional effects is inversely proportional to the electrolyte concentration. The risk of developing volume overload causing congestive phenomena with peripheral edema and pulmonary edema is directly proportional to the electrolyte concentration.

If any signs of hypersensitivity reactions occur, infusion of the solution must be stopped immediately and appropriate treatment initiated.

Since the preparation contains sodium lactate, it should be used with particular caution in patients predisposed to hypernatremia (e.g., those with adrenocortical insufficiency, non-diabetic diabetes, or massive tissue injury) and in patients with heart disease. Due to the presence of sodium ions, the solution should be used cautiously in patients with renal or cardiovascular insufficiency, congestive heart failure—especially in the postoperative period—and in patients with clinical conditions associated with sodium retention and edema.

Solutions containing sodium should be administered with caution to patients receiving corticosteroids or corticotropin.

Due to the potassium content, caution is required when administering the solution to patients with heart disease and clinical conditions associated with potassium retention in the body.

When calcium is administered, cardiac function should be monitored by electrocardiography (ECG), especially in patients receiving digitalis. Serum calcium levels do not always reflect tissue calcium levels.

In patients with impaired renal excretory function, administration of the solution may lead to sodium or potassium retention.

Due to the presence of calcium ions in the solution, caution is required when co-administering blood products, as coagulation may occur.

When parenteral calcium is administered, special attention is required in patients receiving cardiac glycosides.

Lactate is a substrate for gluconeogenesis; therefore, blood glucose levels should be carefully monitored in patients with type 2 diabetes mellitus.

Use during pregnancy or breastfeeding. The medicinal product may be used only if clearly needed, when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to affect the speed of reactions when driving or operating machinery. Data are unavailable due to the exclusive use of the medicinal product in a hospital setting.

Method of Administration and Dosage.

Administer intravenously by drip infusion. The dose is determined by the physician according to the patient's condition. The maximum daily dose for adults is 40 ml/kg/day (on average, 2500 ml at a rate of 60 drops/min). The duration of treatment depends on the patient's condition.

Children. Not used in pediatrics due to lack of clinical trials.

Overdose. Overdose or too rapid administration of the solution may lead to disturbances in water-electrolyte balance, manifestations of alkalosis, and cardiorespiratory decompensation. In such cases, administration of the drug should be immediately discontinued. Symptomatic therapy should be initiated.

Excessive lactate administration may result in metabolic alkalosis, which in turn may be accompanied by hypokalemia. Symptoms include: mood changes, fatigue, shortness of breath, muscle weakness, polydipsia, polyuria, impaired cognition, and arrhythmia. Increased muscle tone, twitching, and tetanic seizures may develop in patients with hypocalcemia.

Side effects.

Electrolyte imbalance: changes in serum electrolyte levels (potassium, calcium, sodium, chloride); metabolic alkalosis; chloride acidosis.

General reactions: hypervolemia; allergic or anaphylactic reactions (fever, pruritus, cough, sneezing, dyspnea, localized or generalized urticaria, angioneurotic edema).

Local infusion site reactions: inflammation, swelling, rash, pruritus, erythema, pain, burning, numbness at the infusion site, thrombophlebitis.

Psychiatric disorders: panic attack.

Rapid administration may lead to acute circulatory failure and pulmonary edema.

If adverse reactions occur, infusion should be stopped immediately, the patient's condition assessed, and appropriate medical management initiated.

Shelf life. 5 years.

Storage conditions. Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility. The drug must not be mixed with phosphate- or carbonate-containing solutions.

Packaging. 200 ml, 250 ml, 400 ml, or 500 ml in bottles.

Prescription status. Prescription only.

Manufacturer. Private Joint Stock Company "Infuziya".

Manufacturer's address and location of operations.

84A Nemirovskе Highway, Vinnytski Khutory village, Vinnytsia district, Vinnytsia region, 23219, Ukraine.