Dextran 40 (Solution) Instructions for Use
ATC Code
B05AA05 (Dextran)
Active Substance
Dextran 40 (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Plasma substitute
Pharmacotherapeutic Group
Blood substitutes and perfusion solutions; blood products and related agents; blood substitutes and plasma protein fractions
Pharmacological Action
A plasma-substituting agent that increases the suspension stability of blood, reduces its viscosity, restores blood flow in small capillaries, normalizes arterial and venous circulation, prevents and reduces the aggregation of blood formed elements, and has a detoxifying effect.
It has an average molecular mass (40 thousand Da). With rapid administration, the plasma volume can increase by 2 times compared to the volume of the administered drug, because each gram of the dextrose polymer with a molecular mass of 30-40 thousand Da promotes the redistribution of 20-25 ml of fluid from the tissues into the bloodstream. It is apyrogenic and non-toxic.
Through an osmotic mechanism, it stimulates diuresis (it filters in the glomeruli, creates high oncotic pressure in the primary urine and prevents water reabsorption in the tubules), thereby promoting (and accelerating) the elimination of poisons, toxins, and metabolic degradation products. The pronounced volumetric effect has a positive effect on hemodynamics and is simultaneously accompanied by the washing out of metabolic products from the tissues, which, together with the increase in diuresis, provides accelerated detoxification of the body.
It causes a rapid and short-term increase in the circulating blood volume (CBV), resulting in an increased return of venous blood to the heart.
In vascular insufficiency, it increases blood pressure, cardiac output, and central venous pressure.
It prevents or reduces the aggregation of erythrocytes, which improves microcirculation. It reduces platelet adhesiveness, prevents thrombus formation after surgeries and injuries, and increases their solubility (due to a change in fibrin structure). When used in doses up to 15 ml/kg, it does not cause a noticeable change in bleeding time.
The mechanism of the antithrombotic effect is explained, among other things, by the “coating” effect. Studies have shown that dextrans form a monomolecular film on the vascular intima, as well as on the surface of platelets, which prevents both platelet aggregation and their adhesion to the vessel wall. It has also been shown that dextrans increase the amount of circulating tissue plasminogen activator by blocking the action of plasminogen activator inhibitor.
Pharmacokinetics
T1/2 – 6 h. Excretion – by the kidneys, 60% is excreted in 6 h, and 70% in 24 h. 30% enters the reticuloendothelial system (RES), liver, where it is broken down by the enzyme acid α-glucosidase into glucose, but it is not a source of carbohydrate nutrition.
Indications
Prevention and treatment of traumatic, surgical, and burn shock, replenishment of circulating blood volume; impaired arterial and venous circulation, treatment and prevention of thrombosis and thrombophlebitis, endarteritis and other circulatory disorders; for addition to the perfusion fluid during heart surgeries performed using a heart-lung machine; to improve local circulation in vascular and plastic surgery; for detoxification in burns, peritonitis, pancreatitis and other conditions requiring detoxification.
ICD codes
| ICD-10 code | Indication |
| A48.3 | Toxic shock syndrome |
| E86 | Volume depletion (including dehydration, hypovolemia) |
| I73.8 | Other specified peripheral vascular diseases |
| I74 | Embolism and thrombosis of arteries |
| I82 | Embolism and thrombosis of other veins |
| K65 | Peritonitis |
| K85 | Acute pancreatitis |
| R57.1 | Hypovolemic shock |
| R57.2 | Septic shock |
| R57.8 | Other types of shock |
| T30 | Burns and corrosions of unspecified body region |
| T79.4 | Traumatic shock |
| T81.1 | Shock during or following a procedure, not elsewhere classified |
| T88.2 | Shock due to anaesthesia |
| ICD-11 code | Indication |
| 1C45.Z | Toxic shock syndrome without specification of infectious agent |
| 1G41 | Sepsis with septic shock |
| 5C70.Z | Decrease of volume of fluid [hypovolemia], unspecified |
| BD5Z | Diseases of arteries or arterioles, unspecified |
| BD70.2 | Migratory thrombophlebitis |
| BD7Z | Diseases of veins, unspecified |
| DB98.5 | Budd-Chiari syndrome |
| DC31.Z | Acute pancreatitis, unspecified |
| DC50.Z | Peritonitis, unspecified |
| EG00 | Dilation of skin vessels of the extremities |
| MB40.7 | Acroparesthesia |
| MG40.1 | Hypovolemic shock |
| MG40.Z | Shock, unspecified |
| NE11 | Burn of unspecified body region |
| NF0A.4 | Traumatic shock, not elsewhere classified |
| BD72 | Venous thromboembolism |
| XA60H0 | Vena cava |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
Intravenously as a bolus, bolus-drip, and drip, as well as by electrophoresis (in ophthalmology). The dosage regimen is set individually, depending on the indications and clinical situation.
Solutions of high molecular weight dextran are administered intravenously at a rate of 60-80 drops/min in an amount of up to 2-2.5 liters (with significant blood loss – with additional blood transfusion).
Solutions of low molecular weight dextran, when used as a blood substitute, are usually administered in the same doses. In other cases, the daily dose should not exceed 20 ml/kg. The rate of intravenous infusion is determined by the indications and the severity of the patient’s condition.
Dextran with a molecular mass of 1000 is administered intravenously as a bolus to adults at a dose of 3 g (20 ml), to children – at a dose of 45 mg/kg (0.3 ml/kg) – over 1-2 minutes before the intravenous infusion of the dextran solution. The interval between the administration of dextran with a molecular mass of 1000 and the infusion of the dextran solution should not exceed 15 minutes. If more than 15 minutes have passed, then Dextran with a molecular mass of 1000 should be administered again. It can be administered before each infusion of the dextran solution, especially if more than 48 hours have passed since the previous infusion.
Adverse Reactions
Allergic reactions frequency unknown – anaphylactic shock, anaphylactoid reactions, skin hyperemia, skin rash.
From the urinary system frequency unknown – oliguria, acute renal failure.
From the respiratory system frequency unknown – cough, bradypnea, bronchospasm, pulmonary edema.
From the cardiovascular system frequency unknown – arterial hypotension, arterial hypertension, tachycardia, bradycardia, acute heart failure, cardiac arrest.
From the hemostasis system frequency unknown – thrombocytopenia.
From water-electrolyte metabolism frequency unknown – acidosis.
Other frequency unknown – infusion reactions, facial flushing, dizziness, weakness, nausea, fever, chest pain, back pain.
Contraindications
Hypersensitivity to the components of the combination; decompensated cardiovascular failure; pulmonary edema; traumatic brain injuries with increased intracranial pressure; hemorrhagic stroke; ongoing internal bleeding; hypocoagulation; thrombocytopenia; severe renal impairment accompanied by oligo- and anuria; hypervolemia, hyperhydration and other situations in which the administration of large volumes of fluids is contraindicated.
With caution
In case of blood coagulation system disorders, degradation, in patients with diabetes mellitus with severe hyperglycemia and hyperosmolarity, in case of water-electrolyte balance disorders.
Use in Pregnancy and Lactation
During pregnancy, the drug is used if the expected benefit to the mother outweighs the potential risk to the fetus. Breastfeeding should be avoided due to the lack of clinical safety data in this category of patients.
Use in Hepatic Impairment
Can be used according to indications.
Use in Renal Impairment
Can be used according to indications.
Pediatric Use
Can be used according to indications.
Geriatric Use
Can be used according to indications.
Special Precautions
It is advisable to administer crystalloid solutions (0.9% sodium chloride solution, 5% dextrose solution) together with dextran 40 in such an amount as to replenish and maintain fluid and electrolyte balance. This is especially important when treating dehydrated patients and after major surgeries.
It causes an increase in diuresis (if a decrease in diuresis with the release of viscous, syrup-like urine is observed, this may indicate dehydration). In this case, it is necessary to administer intravenous colloid solutions to replenish and maintain water-electrolyte balance. In case of oliguria, saline solutions and furosemide should be administered.
In patients with reduced renal filtration capacity, the administration of sodium chloride should be limited.
Dextrans are capable of coating the surface of erythrocytes, interfering with blood group determination, therefore washed erythrocytes should be used.
When administered into peripheral veins, a burning sensation and pain in the limb along the vein may occur. Special caution should be exercised when there is a risk of circulatory overload, especially in the case of latent or clinically overt heart failure.
Dextran reduces plasma levels of coagulation factor VIII and von Willebrand platelet factor, mainly due to dilution, which can cause bleeding, especially in patients with a deficiency of these factors when using dextran in daily doses exceeding 1.5 g/kg of body weight (approximately 15 ml/kg of body weight).
Drug Interactions
It is necessary to preliminarily check for compatibility with medicinal products that are planned to be added to the infusion solution.
When used concomitantly with anticoagulants and antiplatelet agents, a reduction in their dose is necessary.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for infusion 10%: bottle 100, 200, 250, 400 or 500 ml
Marketing Authorization Holder
IST-Pharm, LLC (Russia)
Dosage Form
 |
Dextran 40 | Solution for infusion 10%: bottle 100, 200, 250, 400 or 500 ml |
Dosage Form, Packaging, and Composition
Solution for infusion in the form of a transparent, colorless or slightly yellowish liquid.
| 1 L | |
| Dextran 40 (avg. mol. mass 35000-45000) | 100 g |
Excipients : sodium chloride – 9 g, water for injections up to 1 L.
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard boxes (for hospitals).
100 ml – bottles (10) – cardboard boxes (for hospitals).
100 ml – bottles (20) – cardboard boxes (for hospitals).
100 ml – bottles (24) – cardboard boxes (for hospitals).
200 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard boxes (for hospitals).
200 ml – bottles (10) – cardboard boxes (for hospitals).
200 ml – bottles (20) – cardboard boxes (for hospitals).
200 ml – bottles (24) – cardboard boxes (for hospitals).
250 ml – bottles (1) – cardboard packs.
250 ml – bottles (1) – cardboard boxes (for hospitals).
250 ml – bottles (10) – cardboard boxes (for hospitals).
250 ml – bottles (20) – cardboard boxes (for hospitals).
250 ml – bottles (24) – cardboard boxes (for hospitals).
400 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard boxes (for hospitals).
400 ml – bottles (10) – cardboard boxes (for hospitals).
400 ml – bottles (20) – cardboard boxes (for hospitals).
400 ml – bottles (24) – cardboard boxes (for hospitals).
500 ml – bottles (1) – cardboard packs.
500 ml – bottles (1) – cardboard boxes (for hospitals).
500 ml – bottles (10) – cardboard boxes (for hospitals).
500 ml – bottles (20) – cardboard boxes (for hospitals).
500 ml – bottles (24) – cardboard boxes (for hospitals).
Infusion solution 10%: bottles 200 ml or 400 ml
Marketing Authorization Holder
Kursk Biofactory – Firm “BIOK”, FSUE (Russia)
Dosage Form
|
Dextran 40 | Infusion solution 10%: bottles 200 ml or 400 ml |
Dosage Form, Packaging, and Composition
| Solution for infusion 10% | 100 ml |
| Dextran with a molecular mass from 35,000 to 45,000 | 10 g |
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.
![Dextran 40 [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Dextran 40 [Solution] 2")