DARROW SOLUTION

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DARROW'S SOLUTION

Composition:

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

100 ml of solution contains: sodium chloride – 0.4 g; potassium chloride – 0.267 g; sodium lactate – 0.594 g;

Ionic composition per 1000 ml of solution: Na+ – 121 mmol, K+ – 36 mmol, Cl- – 104 mmol, lactate – 53 mmol;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physicochemical properties: clear, colorless liquid; theoretical osmolarity – 314 mosmol/l; pH 5.5–7.5.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Solutions used for correction of electrolyte balance disorders. Electrolytes.

ATC code B05B B01.

Pharmacological properties.

Pharmacodynamics.

An iso-osmotic electrolyte solution with increased potassium and lactate content. Lactate is transformed in the liver into bicarbonate, imparting alkaline properties to the solution. In the absence of impaired liver function and with adequate cellular oxygen supply, lactate acts as an energy source.

Pharmacokinetics.

After intravenous administration, the components of the medicinal product are rapidly excreted by the kidneys. Lactate is metabolized in the liver.

Clinical characteristics.

Indications.

Correction of water-electrolyte imbalances in dehydration associated with hypokalemia and acidosis; during prolonged administration of oral diuretics accompanied by potassium loss; for restoration of water-electrolyte balance in preparation of patients for surgery, as well as in intra- and postoperative periods.

Contraindications.

Hypervolemia, hypernatremia (including due to corticosteroid use), hyperkalemia, hyperchloremia, acute and hypertonic dehydration, pulmonary edema, decompensated heart failure, eclampsia, severe cardiac and/or renal dysfunction, hepatic insufficiency (due to reduced bicarbonate formation from lactate), thrombophlebitis, conditions with increased blood coagulation, decompensated heart defects.

Alkalosis, lactic acidosis, severe arterial hypertension, oliguria, anuria, cerebral edema, hypersensitivity to components of the medicinal product.

Special precautions.

When large volumes are administered and serum potassium concentration reaches high levels (6.5–8 mmol/L), hyperkalemia with cardiac rhythm disturbances may occur.

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.

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

It is not recommended to use the preparation as a diluent for antibiotics administered by infusion, or for dilution of anti-inflammatory agents.

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, which increases pH (alkalinizing effect), the preparation should be used with caution when co-administered with drugs 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.

Blood electrolyte levels, pH and pCO2 values, and fluid balance should be monitored.

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

"Darrow solution," which contains sodium, should be used cautiously in patients receiving corticosteroids or corticotropin.

The potassium content requires caution when administering the solution to patients with heart disease and clinical conditions associated with potassium retention.

When administering potassium-containing drugs, cardiac function should be monitored via ECG, especially in patients receiving cardiac glycosides.

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

"Darrow solution" is not used as a solvent for blood products.

During infusion therapy with this drug, laboratory parameters must be determined and clinical assessment of the patient's condition should be based on monitoring of electrolyte concentrations, water-electrolyte balance, pH and pCO2, and lactate levels (during massive infusions).

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

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

Since the drug contains sodium lactate, it should be used with particular caution in patients predisposed to hypernatremia (e.g., those with adrenocortical insufficiency, diabetes insipidus, or extensive tissue damage), or in patients with heart disease.

Use during pregnancy or breastfeeding.

The medicinal product should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to affect reaction rate when driving or operating machinery.

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

Method of Administration and Dosage

Administer intravenously by drip infusion at a daily dose ranging from 100 mL to 2 L. The dose is determined by the physician according to the patient's condition, course of the disease, and indicators of water-electrolyte balance.

Maximum infusion rate – 20–30 drops per minute.

The duration of treatment depends on the patient's condition and is determined individually by the physician.

Children.

Do not use in pediatrics due to lack of clinical trials.

Overdose.

Administration of a large volume of solution or too rapid infusion may lead to cardiorespiratory decompensation, disturbances in water-electrolyte balance (hypervolemia, hypernatremia, hyperkalemia, hyperchloremia), and/or acid-base equilibrium (alkalosis). In such cases, administration of the medicinal product should be immediately discontinued. Symptomatic therapy should be administered.

Side effects.

Electrolyte imbalance: changes in serum electrolyte levels (hyperkalemia, hypernatremia, hyperchloremia); metabolic alkalosis; chloride acidosis.

General systemic reactions: hypervolemia; hyperhydration; allergic or anaphylactic reactions (elevated body temperature, pruritus, cough, sneezing, dyspnea, localized or generalized urticaria, angioneurotic edema); panic attack; paresthesia; cardiac arrhythmia, increased frequency of extrasystoles.

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

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

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

Shelf life. 5 years.

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

Incompatibility. The solution should not be mixed with other drugs.

Packaging. 200 ml or 400 ml in bottles.

Prescription category. Prescription only.

Manufacturer. Private Joint-Stock Company "Infuziya".

Manufacturer's address and location of operations.

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