Reodar
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT REODAR® (REODAR)
Composition:
Active substances: 1 ml of solution contains sorbitol 60.0 mg, sodium (S)-lactate solution (calculated as 100 % substance) 19.0 mg, sodium chloride 6.0 mg, calcium chloride dihydrate (calculated as calcium chloride) 0.1 mg, potassium chloride 0.3 mg, magnesium chloride hexahydrate (calculated as magnesium chloride) 0.2 mg;
Excipient: water for injections.
Pharmaceutical form. Infusion solution.
Main physicochemical properties: clear, colorless liquid.
Theoretical osmolarity: 891 mOsmol/l; pH 6.0−7.6;
Ion composition: 1 l of the preparation contains Na+ – 272.20 mmol, K+ – 4.02 mmol, Ca++ – 0.90 mmol, Mg++ – 2.10 mmol, Cl− – 112.69 mmol, Lac− – 169.55 mmol.
Pharmacotherapeutic group. Solutions affecting electrolyte balance. Electrolytes in combination with other agents. ATC code B05B B04.
Pharmacological Properties
Pharmacodynamics
The medicinal product Reodar**®** has rheological, anti-shock, detoxifying, alkalizing, and intestinal peristalsis-stimulating effects. The main pharmacologically active ingredients of the medicinal product are sorbitol and sodium lactate. In the liver, sorbitol is initially converted into fructose, which is then transformed into glucose and subsequently into glycogen. Part of the sorbitol is used to meet immediate energy requirements, while the remainder is stored as glycogen. An isotonic sorbitol solution has a disaggregating effect, thereby improving microcirculation and tissue perfusion.
Unlike bicarbonate solution, correction of metabolic acidosis with sodium lactate occurs more gradually as it is incorporated into metabolism, avoiding abrupt pH fluctuations. The effect of sodium lactate becomes apparent 20–30 minutes after administration.
Sodium chloride exerts a rehydrating effect and replenishes sodium and chloride ion deficits occurring in various pathological conditions.
Calcium chloride compensates for calcium ion deficiency. Calcium ions are essential for nerve impulse transmission, skeletal and smooth muscle contraction, myocardial function, bone formation, and blood coagulation. They reduce cellular and vascular wall permeability, prevent inflammatory reactions, and enhance organism resistance to infections.
Potassium chloride restores water-electrolyte balance. It exerts negative chronotropic and bathmotropic effects; at high doses, it also has negative inotropic and dromotropic effects, as well as a moderate diuretic effect. It participates in nerve impulse conduction, increases acetylcholine levels, and stimulates the sympathetic division of the autonomic nervous system. It improves skeletal muscle contraction in muscular dystrophy and myasthenia.
Magnesium is the second most abundant cation in intracellular fluid. Magnesium chloride is a necessary cation for metabolism, participating in energy-dependent enzymatic processes, protein molecule synthesis, oxidative phosphorylation, muscle contraction, and nerve impulse transmission. It exhibits antispasmodic properties and promotes cholesterol elimination from the body.
Pharmacokinetics
Sorbitol is rapidly incorporated into general metabolism. 80–90% is utilized in the liver and stored as glycogen; 5% accumulates in brain tissue, cardiac muscle, and skeletal muscles; 6–12% is excreted in urine. When administered intravascularly, sodium lactate releases sodium, CO₂, and H₂O, which form sodium bicarbonate, thereby increasing the blood alkaline reserve.
Distribution and elimination of sodium (Na⁺) and chloride (Cl⁻) are largely controlled by the kidneys, which maintain balance between intake and excretion.
Sodium chloride is rapidly eliminated from the vascular system, only temporarily increasing circulating blood volume. It enhances diuresis.
Plasma calcium concentration is regulated by parathyroid hormone, calcitonin, and vitamin D. Approximately 47% of plasma calcium exists in the ionized, physiologically active form; about 6% forms complexes with anions such as phosphate or citrate; the remainder is bound to proteins, primarily albumin. Changes in plasma albumin concentration—either increased (e.g., in dehydration) or decreased (e.g., in malignant neoplasms)—affect the proportion of ionized calcium. Thus, total plasma calcium concentration is generally regulated by plasma albumin levels. Excess calcium is primarily excreted by the kidneys. Unabsorbed calcium is eliminated in feces, particularly via bile and pancreatic secretions. A small amount is excreted in sweat, skin, hair, and nails. Calcium crosses the placenta and is excreted in breast milk.
Factors affecting potassium distribution between intracellular and extracellular fluids, such as acid-base imbalances, may alter the relationship between plasma potassium concentration and total body potassium stores. Normally, potassium is excreted by the kidneys in urine (it is secreted in the distal tubules in exchange for sodium or hydrogen ions); the remainder is excreted in feces and in small amounts in sweat. The kidneys have a poor ability to retain potassium, and minimal potassium excretion in urine continues even during severe body depletion.
50–60% of magnesium is distributed in bones and 1–2% in extracellular fluid. 30% of magnesium is bound to albumin. Magnesium is not metabolized. It is excreted by the kidneys, although excretion rate may vary. It crosses the placenta and is excreted in breast milk.
Clinical characteristics.
Indications.
- To improve capillary blood flow for prevention and treatment of traumatic, surgical, hemolytic, toxic, and burn shock, in acute blood loss, and in burn disease;
- in infectious diseases accompanied by intoxication, particularly as part of complex therapy in patients with community-acquired pneumonia, purulent peritonitis, exacerbation of chronic hepatitis; in sepsis;
- for preoperative preparation and in the postoperative period;
- to improve arterial and venous circulation for prevention of thrombosis, thrombophlebitis, endarteritis, and Raynaud's disease.
Contraindications.
Individual hypersensitivity to the components of the drug. Reodar**®** must not be used in alkalosis, as well as in conditions where infusion of large fluid volumes is contraindicated (cerebral hemorrhage, thromboembolism, cardiovascular decompensation, grade III arterial hypertension, decompensated heart defects, terminal renal failure), dehydration, oliguria.
Interaction with other medicinal products and other forms of interactions.
Do not use as a solvent/carrier for other medicinal products.
Special precautions for use.
When using the medicinal product, it is necessary to monitor blood acid-base balance and electrolyte levels, liver function, and arterial pressure. Administer with caution to patients with calculous cholecystitis.
Important information about excipients.
The medicinal product contains sorbitol, therefore it should not be used in patients with rare hereditary fructose intolerance.
Use during pregnancy or breastfeeding.
There are no data regarding contraindications during pregnancy or breastfeeding.
Ability to influence reaction rate when driving or operating machinery.
Since the medicinal product is administered under hospital conditions, data on such effects are not available.
Method of Administration and Dosage
Reodar**®** should be administered intravenously by drip infusion to adults at a rate of 40–60 drops per minute. If necessary, bolus administration of the drug is permitted after performing a test drip infusion at a rate of 30 drops/min. After administering 15 drops, the drug should be discontinued; if no reaction occurs within 3 minutes, Reodar**®** may then be administered by bolus injection.
In traumatic, burn, postoperative, and hemolytic shock, administer to adults a single dose of 600–1000 mL (10–15 mL/kg of patient's body weight), followed by repeated doses of 600–1000 mL (10–15 mL/kg of patient's body weight), initially by bolus injection, then by drip infusion.
In purulent peritonitis, administer to adults 400–1200 mL intravenously by drip infusion.
In community-acquired pneumonia and exacerbation of chronic hepatitis, administer to adults 400 mL (6–7 mL/kg of body weight) by drip infusion.
In acute blood loss, administer to adults 1500–1800 mL (up to 25 mL/kg of body weight). In such cases, Reodar**®** infusions are recommended to be administered at the pre-hospital stage using a specialized emergency medical vehicle.
In the preoperative period and following various surgical procedures – administer 400 mL (6–7 mL/kg of body weight) by drip infusion for 3–5 days.
In thromboobliterative diseases of blood vessels – administer at a dose of 8–10 mL/kg of body weight by drip infusion, repeated every other day, up to 10 infusions per treatment course.
Method of Administration
Do not insert the needle(s) into areas of the polymer bottle not intended for this purpose; use only sterile ports!
To perform infusion therapy, follow this procedure:
- Remove the protective plastic cap with tamper-evident seal (if present).
- Tear off protective valve(s) № 1 as shown in Fig. 1 and Fig. 2 (the manufacturer may use different types and materials for protective valves).
- Remove the cap from the needle and insert it into any of the special ports № 2 of the infusion bottle (see Fig. 1 and Fig. 2).
- The other sterile port may be used to introduce other medicinal agents into the infusion bottle (№ 4, see Fig. 3), or, if necessary, to improve flow rate, for a venting needle (№ 4, see Fig. 3).
- Hang the bottle with solution using the special ring № 3 located at the bottom of the bottle (see Fig. 3).
Children
There is insufficient data on experience of use in children.
Overdose.
Symptoms of alkalosis may occur, which resolve spontaneously upon immediate discontinuation of the drug. Occasionally, collapse and dehydration (due to enhanced diuresis) may occur. If the infusion rate exceeds recommended levels, tachycardia, increased arterial pressure, dyspnea, headache, chest pain, and abdominal pain may develop. These symptoms resolve rapidly after stopping or significantly reducing the infusion rate.
Side effects.
Gastrointestinal disorders: nausea, vomiting.
Central and peripheral nervous system disorders: tremor, headache, dizziness, general weakness.
Cardiovascular system disorders: increased or decreased blood pressure, tachycardia, dyspnea, acrocyanosis.
Immune system disorders: anaphylactoid reactions, angioneurotic edema, hyperthermia.
Skin and subcutaneous tissue disorders: skin rashes, urticaria, itching sensation.
General disorders and administration site reactions: changes at the injection site, including pain and burning sensation.
Reporting of suspected side effects.
Reporting of suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.
Shelf life. 3 years.
Storage conditions.
Store at a temperature not exceeding 25 °C. Do not freeze.
Keep out of reach and sight of children.
Incompatibility.
The medicinal product Reodar**®** must not be mixed with phosphate- and carbonate-containing solutions.
Packaging.
200 ml in a bottle.
Prescription status. Prescription only.
Manufacturer. JSC "Pharmaceutical Company "Darnitsya".
Manufacturer's address and place of business.
13, Borispilska Street, Kyiv, 02093, Ukraine.