Plasmafuzole (Solution) Instructions for Use

Marketing Authorization Holder

IST-Pharm, LLC (Russia)

ATC Code

B05BB01 (Electrolytes)

Dosage Form

Plasmafuzole

Solution for infusion: bot. 250 ml or 500 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

Excipients : Sodium chloride – 0.2 g, water for injection – up to 1000 ml.

250 ml – bottles – cardboard packs.
250 ml – bottles (10) – cardboard boxes (for hospitals).
250 ml – bottles (20) – cardboard boxes (for hospitals).
250 ml – bottles (24) – cardboard boxes (for hospitals).
500 ml – bottles – cardboard packs.
500 ml – bottles (10) – cardboard boxes (for hospitals).
500 ml – bottles (20) – cardboard boxes (for hospitals).
500 ml – bottles (24) – cardboard boxes (for hospitals).

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Rehydrating agent

Pharmacological Action

An isotonic solution of electrolytes with an electrolyte concentration adapted to the concentration of electrolytes in blood plasma. It is used to correct the loss of extracellular fluid (i.e., loss of water and electrolytes in proportionate amounts). The administration of the solution is aimed at restoring and maintaining the osmotic status in the extracellular and intracellular space. The anionic composition is represented by a balanced combination of chlorides, acetates, and malates, which is close in molar concentration to the composition of blood plasma, which contributes to the correction of metabolic acidosis.

Pharmacokinetics

It is administered intravenously, the bioavailability of all its components is 100%.

Sodium and chlorides are mainly distributed in the extracellular space, while potassium, magnesium, and calcium are located inside the cells. Sodium, potassium, magnesium, and chlorides are excreted mainly by the kidneys, as well as in small amounts through the skin and gastrointestinal tract. Calcium is excreted in approximately equal amounts in the urine and through endogenous intestinal secretion.

During the infusion of acetates and malates, their concentration in the blood plasma increases to a constant value. Then, after the infusion is stopped, their concentration drops sharply. The excretion of acetates and malates in the urine increases during the infusion. However, the metabolism of these substances in the body’s tissues is so rapid that only a small amount of them enters the urine. Acetates are metabolized in the liver, heart, and other tissues under the influence of acetyl-CoA synthetase. The resulting acetyl-CoA is metabolized in the Krebs cycle under the influence of malate dehydrogenase, which catalyzes the conversion of malate to oxaloacetate.

Indications

Replacement of extracellular fluid losses in isotonic dehydration in patients with acidosis or the threat of its development.

ICD codes

Dosage Regimen

It is administered by drip into peripheral and central veins. The dose depends on the age, body weight, clinical and biological condition of the patient, and concomitant therapy.

For elderly patients, adults, and children from 11 years old – from 500 ml to 3 L/day, which corresponds to 1-6 mmol sodium/kg/day and 0.03-0.17 mmol potassium/kg body weight/day; for children under 11 years old – from 20 ml to 100 ml/kg/day, which corresponds to 3-14 mmol sodium/kg/day and 0.08-0.04 potassium/kg/day.

The maximum rate of administration is determined by the patient’s needs for fluid and electrolytes, body weight, clinical condition, and biological status.

This agent can be administered for as long as required to restore the water-electrolyte balance.

Adverse Reactions

Allergic reactions urticaria is possible after intravenous administration of magnesium salts.

From the digestive system there are reports of isolated cases of paralytic intestinal obstruction after intravenous administration of magnesium sulfate.

Local reactions febrile reactions, infection, pain and other reactions at the puncture site, irritation, thrombosis or phlebitis at the site of puncture or extravascular penetration of the solution.

Contraindications

Hypervolemia, chronic heart failure III-IV FC, renal failure with oliguria or anuria, severe generalized edema, hyperkalemia, hypercalcemia, metabolic alkalosis, severe arterial hypertension.

With caution

Solutions containing Sodium chloride should be used with caution in patients with: mild or moderate heart failure, peripheral edema or pulmonary edema, or extracellular hyperhydration, hypernatremia, hyperchloremia, hypertensive dehydration, mild to moderate arterial hypertension, impaired renal function, eclampsia or threat of its occurrence, aldosteronism and other conditions and treatments (e.g., corticosteroids) associated with sodium retention.

Solutions containing potassium salts should be used with caution in patients with heart disease or a predisposition to hyperkalemia, in renal failure or adrenal cortex insufficiency, acute dehydration, or extensive tissue destruction observed in severe burns.

The solution containing calcium salts should be administered with caution to patients with impaired renal function or diseases accompanied by an increase in vitamin D concentration, such as sarcoidosis.

Solutions containing metabolizable anions should be used with caution in patients with respiratory impairment.

Use with caution in toxicosis of pregnancy.

Use in Pregnancy and Lactation

Data on use during pregnancy and breastfeeding are limited. With constant monitoring of the infusion volume, electrolyte concentrations, and acid-base balance, complications when using the drug according to indications do not arise.

Use in Renal Impairment

Contraindication: renal failure with oliguria or anuria.

Pediatric Use

Used in children according to indications.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

During the infusion, constant monitoring of the water-electrolyte balance and acid-base status is required.

Infusions of a large volume in patients with cardiac or pulmonary insufficiency should be carried out under constant supervision.

When administering solutions containing calcium salts, it is necessary to exclude the possibility of extravasal penetration of the solution during intravenous infusion.

After blood transfusion, the solution should not be administered using the same infusion system.

Drug Interactions

To avoid the formation of a precipitate, this solution should not be mixed with preparations containing carbonates, phosphates, sulfates, or tartrates.

Interaction with sodium: corticosteroids and carbenoxolone have the ability to retain sodium and water (with the occurrence of edema and arterial hypertension).

Interaction with potassium: suxamethonium, potassium-sparing diuretics (amiloride, spironolactone, triamterene), tacrolimus, cyclosporine may increase the concentration of potassium in the blood plasma, leading to potentially dangerous hyperkalemia, especially in renal failure.

Interaction with calcium: in hypercalcemia, the effect of cardiac glycosides may be enhanced, which can lead to severe cardiac arrhythmia with a possible fatal outcome. Vitamin D can cause hypercalcemia.

Storage Conditions

Store at 2°C (36°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.