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;

Ion composition per 1000 ml of medicinal product: Na+ — 131 mmol, K+ — 5 mmol, Ca++ — 2 mmol, Cl− — 112 mmol, lactate — 28 mmol;

Excipients: water for injections.

Pharmaceutical form. Infusion solution.

Main physico-chemical 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 an electrolyte-balanced saline solution. It replenishes the deficit of circulating blood volume. The lactate contained in the medicinal product is metabolized into bicarbonate anions, which slightly shifts blood reaction toward alkaline. The solution also has a detoxifying effect due to reduction of concentration of toxic substances in blood and stimulation of diuresis. The solution is close to isotonic.

Pharmacokinetics

After intravenous administration of the medicinal product, blood osmolarity increases temporarily. Ringer's lactate solution penetrates into tissues within approximately half an hour. The components of the medicinal product 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 in 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 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, the risk of hyperkalemia increases. When "Ringer's lactate solution" is used concomitantly with cardiac glycosides, the toxicity of the latter is enhanced due to the presence of Ca++ ions in the solution.

The medicinal product 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 medicinal products.

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 medicinal product, which alkalinizes pH, "Ringer's lactate solution" should be used with caution when administered simultaneously with medicinal products whose renal elimination is pH-dependent. 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 based on monitoring of electrolyte concentrations, fluid and electrolyte balance, pH and pCO₂ levels, 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 to 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.

In case of any signs of hypersensitivity reactions, discontinue the infusion immediately and initiate appropriate treatment.

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

Sodium-containing solutions should be used cautiously in 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.

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 retention of sodium or potassium in the body.

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

Special attention is required when parenteral calcium is administered to 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 under life-threatening indications when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Ability to influence the speed of reaction when driving or operating machinery

Data are unavailable due to the exclusive use of the medicinal product under hospital conditions.

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 per minute). 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 medicinal product should be immediately discontinued. Symptomatic therapy should be administered.

Excessive administration of lactate may lead to the development of 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. Muscle hypertonia, 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 systemic reactions: hypervolemia; allergic or anaphylactic reactions (fever, pruritus, cough, sneezing, dyspnea, localized or generalized urticaria, angioneurotic edema).

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

Psychiatric disorders: panic attack.

Rapid administration of the drug may cause acute circulatory failure and pulmonary edema.

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

Reporting suspected adverse reactions

Reporting of adverse reactions following drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the drug. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Do not freeze.

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

Packaging. 200 ml or 400 ml in glass bottles (flasks).

Prescription status. Prescription only.

Manufacturer. JSC "Halychpharm".

Manufacturer's address and location of business operations

6/8 Opryshkovska St., Lviv, 79024, Ukraine.