Ringer solution

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Ringer's Solution (Solutio Ringeri)

Composition:

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

100 ml of solution contain sodium chloride – 0.86 g; potassium chloride – 0.03 g; calcium chloride dihydrate – 0.0322 g;

Excipient: water for injections.

Ion composition per 1000 ml of product: Na+ – 147.15 mmol; K+ – 4.016 mmol; Ca++ – 2.19 mmol;
Cl- – 155.60 mmol.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – 309 mosmol/L; pH 5.0–7.5.

Pharmacotherapeutic group. Solutions for intravenous administration. Solutions used for correction of electrolyte balance disorders. ATC code B05B B01.

Pharmacological Properties.

Pharmacodynamics.

Ringer's solution is a source of water and electrolytes. It may induce diuresis depending on the patient's condition.

Sodium, the principal cation of extracellular fluid, is primarily involved in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base balance of body fluids.

Potassium, the main intracellular cation, participates in carbohydrate utilization and protein synthesis, and is required for the regulation of nerve conduction and muscle contraction, especially in the heart.

Chloride, the major extracellular anion, is closely related to sodium metabolism, and changes in the body's acid-base balance are reflected in chloride concentration changes. Infusion of a large amount of chloride ions may cause loss of bicarbonate ions, leading to acidosis. For this reason, Ringer's solution is buffered with lactate or acetate.

Calcium, an essential cation, contributes to the formation of bones and teeth (in the form of calcium phosphate and calcium carbonate). In its ionized form, calcium is required for the functional mechanism of blood coagulation, normal cardiac function, and regulation of neuromuscular excitability.

Pharmacokinetics.

Sodium (Na+) and chloride (Cl-) ions administered with Ringer's solution undergo the same pharmacokinetics as those derived from food. They freely distribute throughout all organs, tissues, and interstitial spaces and are excreted via glomerular filtration in the kidneys. Substantial reabsorption of Na+ and Cl- ions occurs in the tubules, primarily in the loop of Henle and distal tubules, including mechanisms blocked by loop and thiazide diuretics, respectively.

Potassium ions (K+) are freely filtered in the glomeruli but almost completely reabsorbed in the proximal tubules, with only 10% of filtered K+ ions being excreted. Secretion in the distal tubules and collecting ducts can significantly increase K+ elimination. The kidneys have a limited capacity to retain K+ concentration. Therefore, when Na+ concentration in the distal tubules is high, K+ loss may be substantial and hypokalemia may develop. This justifies the inclusion of K+ in Ringer's solution.

Calcium ion (Ca++) homeostasis is well regulated by hormones and rarely requires clinical intervention with intravenous infusion of calcium-containing solutions.

Clinical characteristics.

Indications.

Used for hypovolemia and extracellular dehydration due to prolonged vomiting, diarrhea, extensive burns, frostbite, peritonitis, severe infectious diseases, shock conditions, collapse; during surgical intervention and in the postoperative period. Used for dilution of concentrated electrolyte solutions.

Contraindications.

• Hypernatremia;
• Hyperkalemia;
• Hypercalcemia;
• Hypervolemia;
• Metabolic alkalosis;
• Decompensated heart failure;
• Oliguria and anuria;
• Acute renal failure;
• Pulmonary edema;
• Cerebral edema;
• Hypercoagulation;
• Thrombophlebitis.

Interaction with other medicinal products and other types of interactions.

Possible increased sodium retention in the body when used concomitantly with the following medicinal products: nonsteroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators or ganglion blockers.

When used with potassium-sparing diuretics, ACE inhibitors, and potassium-containing preparations, the risk of developing hyperkalemia increases.

When used in combination with cardiac glycosides, the likelihood of their toxic effects increases.

Special precautions for use

During prolonged parenteral therapy, laboratory parameters and the patient's clinical condition should be monitored to assess electrolyte concentrations and fluid-electrolyte balance every 6 hours (depending on the infusion rate).

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

Due to its sodium ion content, this solution should be administered with caution to patients with renal or cardiovascular insufficiency, congestive heart failure—especially in the postoperative period—or elderly patients, as well as to patients with clinical conditions associated with sodium retention and edema.

Solutions containing sodium should be used cautiously in patients receiving corticosteroids or corticotropin.

The potassium content requires caution when administering the solution to patients with cardiac disease, hyperkalemia, severe renal insufficiency, and clinical conditions associated with potassium retention.

Calcium administration should be performed under ECG monitoring, 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 result in sodium or potassium retention.

The presence of calcium ions requires caution when co-administering with blood products due to the potential risk of coagulation.

Parenteral calcium administration requires particular attention in patients receiving cardiac glycosides.

This solution is intended for intravenous use with sterile equipment. It is recommended to replace the intravenous administration set at least every 24 hours.

The solution should be used only if it is clear and the container is intact and sealed.

The physician should also consider the potential for adverse reactions due to concomitant medications administered with Ringer's solution.

If an adverse reaction occurs, the infusion should be discontinued, the patient's condition assessed, and appropriate therapeutic measures initiated.

Use during pregnancy or breastfeeding

Studies on the use of Ringer's solution in pregnant women have not been conducted.

It is not known whether this preparation is excreted in human milk. Since most drugs are excreted in human milk, Ringer's solution should be administered to nursing women with caution.

Ability to influence reaction rate when driving or operating machinery

Data are unavailable due to the exclusive use of the drug under inpatient conditions.

Method of Administration and Dosage.

The solution is intended for intravenous use only.

The dosage is prescribed by a physician and depends on the patient's age, body weight, clinical condition, and laboratory parameters.

The usual adult dose is up to 1–2 liters per day; the maximum dose depends on the patient's fluid and electrolyte balance, cardiovascular status, and renal function.

The infusion rate for adults is 60–80 drops/minute or as a bolus injection.

The administration of the solution should be based on the calculated maintenance or replacement fluid requirements for each individual patient.

Before use, parenteral preparations should be visually inspected for the presence of particles and discoloration.

Children.

Studies on the use of Ringer's solution in children have not been conducted.

Overdose.

Administration of an excessive amount of the solution may lead to disturbances in fluid and electrolyte balance (hypervolemia, hypernatremia, hypercalcemia, hyperchloremia) and acid-base equilibrium. Treatment is symptomatic.

Side effects.

Electrolyte imbalances (potassium, calcium, sodium, chloride), chloride acidosis, and hyperhydration may occur.

If adverse reactions occur, administration of the solution should be discontinued, the patient's condition should be assessed, and appropriate medical assistance should be provided.

Shelf life. 3 years.

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

Incompatibility. To reduce the risk of possible incompatibility arising from mixing this solution with other additives, the final infusion solution should be examined for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Packaging. 200 ml and 400 ml in bottles.

Prescription status. Prescription only.

Manufacturer. Private Joint Stock Company "Infuziya".

Manufacturer's name and address of place of business.

84A Nemyrivske Highway, village Vinnitski Khotory, Vinnitsa district, Vinnitsa region, 23219, Ukraine.

Marketing Authorization Holder. Private Joint Stock Company "Infuziya".

Address of the Marketing Authorization Holder and/or its representative.

21-A Moskovskyi Avenue, Kyiv, 04073, Ukraine.