Hartman’s solution (Solution) Instructions for Use

ATC Code

B05BB01 (Electrolytes)

Active Substance

Compound solution of sodium lactate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Electrolyte balance restoring agent

Pharmacological Action

Rehydration agent. It has a detoxifying effect. It normalizes the acid-base status, replenishes the circulating blood volume deficit, and stabilizes the water-electrolyte composition of the blood. The solution is close to isotonic. The main effect of the agent is to compensate for the extracellular exchange of interstitial and intravascular fluid.

An increase in central venous pressure leads to an increase in the production of natriuretic peptide. The agent causes a decrease in blood osmolality and an increase in pH.

Pharmacokinetics

After intravenous administration, the solution passes into the tissues within no more than 30 minutes.

It is primarily excreted in the urine.

Sodium chloride, after administration, quickly spreads throughout the body, is not significantly metabolized, and is primarily excreted in the urine, to a lesser extent in sweat, tears, and saliva.

The potassium ion is excreted mainly in the urine, in small amounts in feces, and also in saliva, bile, and pancreatic juice.

Most of the calcium is excreted in the urine, and the non-absorbable part of calcium is excreted in the feces; some amount is excreted via bile and with pancreatic juice. A small amount of calcium is excreted in sweat and breast milk.

The lactate ion is distributed throughout the body and is metabolized in the liver to sodium bicarbonate, contributing to the alkalinization of plasma.

Indications

Hypovolemia, isotonic dehydration, metabolic acidosis.

ICD codes

Dosage Regimen

Administer intravenously by drip infusion only.

Determine the dose, infusion rate, and duration individually for each patient.

Base the regimen on the indication, severity of hypovolemia, and degree of metabolic acidosis.

Consider the patient’s age, body weight, and clinical condition.

Adjust administration based on acid-base balance and electrolyte status.

Continuously monitor clinical and laboratory response to therapy.

Assess for signs of volume overload during infusion, especially in patients with cardiac or renal impairment.

For adults, a typical initial volume ranges from 500 mL to 1000 mL.

Infusion rates for adults commonly range from 5 mL/kg/hour to 10 mL/kg/hour for moderate dehydration.

Do not exceed a rate that may cause circulatory overload.

For pediatric patients, calculate the dose based on body weight (mL/kg).

Administer to children with extreme caution, monitoring for fluid and electrolyte shifts.

Frequently monitor serum electrolytes, plasma pH, and fluid balance throughout treatment.

Discontinue or adjust the infusion rate if adverse reactions occur.

Use only for temporary plasma volume maintenance in emergency settings.

Adverse Reactions

Immune system disorders: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.

Metabolism and nutrition disorders: hyperkalemia.

Local reactions: reactions at the infusion site.

Contraindications

Hypersensitivity to the agent; extracellular hyperhydration or hypervolemia, severe renal failure (with oliguria/anuria), decompensated heart failure, hyperkalemia, hypercalcemia, metabolic alkalosis, ascites in cirrhosis, severe metabolic acidosis, conditions associated with increased lactate levels (hyperlactatemia), including lactic acidosis, or with impaired lactate utilization, for example, severe hepatic failure, concomitant therapy with cardiac glycosides, simultaneous use with ceftriaxone in neonates (under 28 days of age).

With caution: hypernatremia, including in diabetes insipidus, extensive tissue damage, chronic heart failure; hyperchloremia, including in renal tubular necrosis, diabetes insipidus, with urinary diversion, with concomitant use of diuretics – carbonic anhydrase inhibitors, steroid hormones; in severe dehydration; conditions predisposing to the development of hyperkalemia, including renal failure, adrenocortical insufficiency, acute dehydration, extensive tissue damage, including due to burns; conditions predisposing to the development of hypercalcemia: renal failure, granulomatoses associated with increased synthesis of calcitriol (e.g., sarcoidosis), current or history of calcium kidney stones; impaired renal function; hypervolemia or hyperhydration (primary and secondary aldosteronism (caused by, for example, arterial hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis) or preeclampsia); children under 6 months of age; simultaneous use with ceftriaxone in patients older than 28 days (including adults) through the same infusion system.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Contraindicated in severe hepatic failure. Use with caution in liver diseases.

Use in Renal Impairment

Contraindicated in severe renal failure (with oliguria/anuria). Use with caution in patients with kidney diseases.

Pediatric Use

Simultaneous use of this agent with ceftriaxone is contraindicated in neonates (under 28 days of age), even when using separate infusion systems; in children over 28 days of age, this combination should be used with extreme caution. Use with caution in children under 6 months of age.

Special Precautions

It is used only for temporary maintenance of plasma volume within physiological limits, in emergency conditions. It should not be used for severe deficiency of Na⁺, K⁺, Ca²⁺.

This agent should be used in patients with hypernatremia only after careful investigation of the underlying cause and consideration of alternative agents for intravenous administration. During use, it is recommended to monitor plasma sodium levels and the degree of body hydration.

This agent should be used with particular caution in patients with conditions that predispose to the development of hypernatremia (adrenocortical insufficiency, diabetes insipidus, or extensive tissue damage), and in patients with heart disease.

This agent should be used in patients with hyperchloremia only after careful investigation of the underlying cause and consideration of alternative agents for intravenous administration. During use, it is recommended to monitor plasma chloride levels and acid-base balance.

This agent should be used with particular caution in patients with conditions that predispose to the development of hyperchloremia (e.g., renal failure and renal tubular acidosis, diabetes insipidus), in patients with urinary diversion or patients taking certain diuretics (carbonic anhydrase inhibitors, e.g., acetazolamide) or steroids (androgenic agents, estrogenic corticosteroids), and in patients with severe dehydration.

In patients with hyperkalemia or conditions predisposing to its development (renal or adrenocortical insufficiency, acute dehydration, extensive tissue damage or burns), as well as in patients with heart disease, this agent should be used with extreme caution. In patients at risk of developing hyperkalemia, plasma potassium levels should be monitored with particular care.

Calcium chloride has an irritating effect, so when administering it intravenously, caution should be exercised and its leakage into surrounding tissues should be avoided, and intramuscular administration should be avoided. Solutions containing calcium salts should be prescribed with caution to patients with conditions predisposing to the development of hypercalcemia, for example, with renal failure and granulomatoses associated with increased synthesis of calcitriol (e.g., sarcoidosis), current or history of calcium kidney stones.

Depending on the volume and rate of infusion, the following conditions may develop during intravenous administration of this agent: excess fluid and/or dissolved substances, leading to hyperhydration and, for example, to congestion, including pulmonary congestion and pulmonary edema; clinically significant disturbances in electrolyte balance and acid-base balance.

In patients with cardiac or pulmonary insufficiency, large volume infusions should be performed under constant supervision.

This agent should be used with extreme caution in patients with hypervolemia or hyperhydration.

Due to the sodium chloride content, this agent should be used with extreme caution in conditions causing sodium retention, hypervolemia, and edema, such as primary and secondary aldosteronism (caused by, for example, arterial hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis) or preeclampsia.

This agent should be used with extreme caution in patients at risk of developing alkalosis. Since lactate is metabolized to bicarbonate, the use of the agent may cause or worsen metabolic alkalosis. Against the background of lactate-induced alkalosis, seizures may occur.

Due to the risk of blood clotting due to the calcium content, this agent must not be added to citrate-stabilized (preserved) blood or administered simultaneously with it through the same system.

Lactate is a substrate for gluconeogenesis, so in patients receiving this agent, blood glucose levels should be carefully monitored.

The use of other medicinal products or a violation of the administration technique may cause fever due to the possible entry of pyrogens into the body. In this case, the infusion should be stopped immediately.

During long-term parenteral treatment, the patient must be provided with adequate nutrient intake.

Drug Interactions

Interaction associated with the presence of sodium: steroid hormones and carbenoxolone, which are associated with sodium and water retention (accompanied by edema and hypertension).

Interaction associated with the presence of potassium: potassium-sparing diuretics (amiloride, spironolactone, triamterene, separately or in combination). ACE inhibitors and angiotensin II receptor antagonists. Tacrolimus, cyclosporine increase plasma sodium concentration and can lead to potentially fatal hyperkalemia, especially in the case of renal failure, which enhances the hyperkalemic effect.

Interaction associated with the presence of calcium: cardiac glycosides, whose effects are enhanced in the presence of calcium and can lead to serious fatal cardiac arrhythmia. Thiazide diuretics, vitamin D can lead to hypercalcemia when used concomitantly with calcium. Bisphosphonates, fluorides, some fluoroquinolones and tetracyclines, which are less absorbed (lower bioavailability) when used concomitantly with calcium.

Interaction associated with the presence of lactate (which is metabolized to bicarbonate): medicinal products with an acidic reaction, such as salicylates, barbiturates, and lithium, whose renal clearance increases due to the alkalinization of urine by bicarbonate formed during lactate metabolism.

Medicinal products with an alkaline reaction, in particular sympathomimetics (e.g., ephedrine, pseudoephedrine) and psychostimulants (e.g., dexamfetamine, fenfluramine), whose half-life is prolonged.

Drugs incompatible with this agent: aminocaproic acid, amphotericin B, metaraminol bitartrate, cefamandole, cortisone acetate, diethylstilbestrol, etamivan, ethyl alcohol, phosphate and carbonate solutions, oxytetracycline, sodium thiopental, sodium versenate.

Drugs partially incompatible with this agent: tetracycline – the solution is stable for 12 hours; sodium ampicillin – a solution with a concentration of 2-3% is stable for 4 hours, a concentration > 3% should be prescribed no later than 1 hour; minocycline – the solution is stable for 12 hours; doxycycline – the solution is stable for 6 hours.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.