DRUGS & SUPPLEMENTS
Dextran 40 uses
SPL UNCLASSIFIED SECTION
10% LMD in 0.9% Sodium Chloride Injection
Low Molecular Weight Dextran for Intravenous Administration
Flexible Plastic Container
LMD (dextran 40) is a sterile, nonpyrogenic preparation of low molecular weight dextran (average mol. wt. 40,000) in 5% Dextrose Injection or 0.9% Sodium Chloride Injection. It is administered by intravenous infusion.
Also described as low viscous or low viscosity dextran, Dextran 40 is prepared by acid hydrolysis and differential fractionation of a crude macromolecular polysaccharide produced from the fermentation of sucrose by the bacterium, Leuconostoc mesenteroides (strain B-512). The crude material is composed of linked glucose units. In the fraction represented by Dextran 40, 80% of the molecules have a molecular weight ranging from 10,000 to 90,000 (average approximately 40,000) when measured by a light scattering method. More than 90% of the linkages are of the 1,6 alpha glucosidic, straight chain type.
Each 100 mL of 10% LMD (dextran 40) in 5% Dextrose Injection contains 10 g Dextran 40 and 5 g dextrose hydrous in water for injection. Total osmolar concentration is 255 mOsmol/liter (calc.); pH is 4.4 (3.0 to 7.0).
Each 100 mL of 10% LMD (dextran 40) in 0.9% Sodium Chloride Injection contains 10 g Dextran 40 and 0.9 g sodium chloride in water for injection. Total osmolar concentration is 310 mOsmol/liter (calc.); pH is 4.9 (3.5 to 7.0) (may contain sodium hydroxide and/or hydrochloric acid for pH adjustment). Electrolyte concentration per liter: Na+ 154 mEq; Cl- 154 mEq (not including ions for pH adjustment).
The solutions contain no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and are intended only for single-dose injection. When smaller doses are required the unused portion should be discarded.
10% LMD (dextran 40) is an artificial colloid pharmacologically classified as a plasma volume expander; 5% Dextrose Injection is a fluid and nutrient replenisher; 0.9% Sodium Chloride Injection is a fluid and electrolyte replenisher.
Dextran 40 is a linear glucose polymer (polysaccharide) chemically designated (C6 H10 O5)n.
The structural formula for dextran (repeating unit) is:
Dextrose, USP is chemically designated D-glucose monohydrate (C6 H12 O6 - H2O), a hexose sugar freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of the chemical components of the plastic in very small amounts before the expiration period is attained. However, safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
structural formula dextrose
The fundamental action of LMD is the enhancement of blood flow, particularly in the microcirculation. This enhancement is due to:
It should be emphasized that the above effects are not exerted separately, but conjointly they result in the enhancement of blood flow.
LMD, used in the treatment of shock, produces significant increases in blood volume, central venous pressure, cardiac output, stroke volume, blood pressure and urinary output. It reduces blood viscosity, peripheral resistance and improves peripheral blood flow with the release of sequestered blood cells, thereby increasing venous return to the heart.
When used as part of the pump prime for extracorporeal procedures, LMD, as compared to whole blood, albumin 5%, or whole blood plus 5% dextrose and water, leads to less destruction of red blood cells and platelets, reduces intravascular hemagglutination and maintains erythrocyte electronegativity.
The infusion of LMD (dextran 40) during and after surgical trauma reduces the incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients subject to surgical procedures with a high incidence of thromboembolic complication. Unlike antithrombogenic agents of the anticoagulant type, LMD does not achieve its effect so much by blocking fibrinogen-fibrin conversion but acts by simultaneously inhibiting other mechanisms essential to thrombus formation such as vascular stasis and platelet adhesiveness and by altering the structure and thereby the lysability of fibrin clots.
Histopathological studies have shown that the development of a mural platelet thrombus is the first stage of thrombus formation not only in the arterial, but also in the venous system. A number of studies have further shown that many patients who develop thromboembolic complications show an abnormally high platelet adhesiveness. Infusion of LMD has been shown to reduce platelet adhesiveness as measured by various in vitro tests on blood samples obtained from humans and to inhibit the growth of a mural platelet thrombus at the site of experimental (laser beam) injury in the rabbit’s ear chamber.
Studies have shown an increase in the lysability of thrombi formed in the presence of dextran. A consistent and characteristic alteration in fibrin structure has been observed when fibrin is formed in the presence of dextran, and further experiments demonstrated such fibrin to be more susceptible to plasmin digestion. Other studies have shown that dextran infused into patients during surgery increases the lysability of ex vivo thrombi. Controlled clinical trials have shown that thrombi in patients treated with dextran have a more pronounced tendency to undergo lysis as determined by phlebography.
LMD is evenly distributed in the vascular system. Its distribution according to molecular weight shifts toward higher molecular weights as the smaller molecules are excreted by the kidney. In normovolemic subjects, approximately 50% is excreted within 3 hours, 60% is excreted within 6 hours and about 75% within 24 hours. Reabsorption of dextran by the renal tubules is negligible. The unexcreted molecules of dextran diffuse into the extravascular compartment and are temporarily taken up by the reticuloendothelial system. Some of these molecules are returned to the intravascular compartment via the lymphatics. Dextran is slowly degraded by the enzyme dextranase to glucose.
Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.
Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidney, which maintains a balance between intake and output.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
INDICATIONS AND USAGE
LMD (dextran 40) is indicated for use in the adjunctive treatment of shock or impending shock due to hemorrhage, burns, surgery or other trauma. It is not indicated as a replacement for whole blood or blood components if they are available. It should not replace other forms of therapy known to be of value in the treatment of shock.
LMD is also indicated for use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation.
LMD is also indicated for use in prophylaxis of venous thrombosis and pulmonary embolism in patients undergoing procedures known to be associated with a high incidence of thromboembolic complications, such as hip surgery.
LMD is contraindicated in patients with known hypersensitivity to dextran, in those with marked hemostatic defects of all types (thrombocytopenia, hypofibrinogenemia, etc.) including those caused by drugs (heparin, warfarin, etc.), marked cardiac decompensation and in renal disease with severe oliguria or anuria.
Although infrequent, severe and fatal anaphylactoid reactions consisting of marked hypotension or cardiac and respiratory arrest have been reported, most of these reactions have occurred in patients not previously exposed to intravenous dextran and early in the infusion period. It is strongly recommended, therefore, that patients not previously exposed to dextran be observed closely during the first minutes of the infusion period.
There have been rare reports of serious and life-threatening dextran-induced anaphylactoid reactions (DIAR) associated with Dextran 40 and Dextran 70 administration. To reduce the likelihood of DIAR, 20 mL dextran 1 should be administered prior to infusion of Dextran 40 or Dextran 70 consistent with the dextran 1 package insert.1-5 See
Because of the seriousness of anaphylactoid reactions, it is recommended that the infusion of intravenous dextran be stopped at the first sign of an allergic reaction provided that other means of sustaining the circulation are available. Resuscitative measures should be readily available for emergency administration in the event such a reaction occurs. In circulatory collapse due to anaphylaxis, rapid volume substitutions with an agent other than dextran should be instituted.
Because LMD (dextran 40) is a hypertonic colloid solution, it attracts water from the extravascular space. This shift of fluid should be considered if the drug is used for poorly hydrated patients where additional fluid therapy will be needed. If LMD is given in excess, vascular overload could occur. The latter possibility can be avoided with careful clinical monitoring preferably by central venous pressure.
Renal excretion of LMD causes elevations of the specific gravity of the urine. In the presence of adequate urine flow only minor elevation will occur, whereas in patients with reduced urine output, urine viscosity and specific gravity can be increased markedly. Since urine osmolarity is only slightly increased by the presence of dextran molecules, it is recommended that, when desired, a patient’s state of hydration be assessed by determination of urine or serum osmolarity. If signs of dehydration are present, additional fluid should be administered. An osmotic diuretic such as mannitol also can be used to maintain an adequate urine flow.
Although numerous studies attest to the “nephrotonic” effect of LMD, renal failure has been reported to occur after the use of LMD.
Evidence of tubular vacuolization (osmotic nephrosis) has been found following LMD administration in animals and man. While this appears to be reversible experimentally in animals and to be a consequence of high urine concentration of the drug, its exact clinical significance is presently unknown.
Occasional abnormal renal and hepatic function values have been reported following administration of LMD. However, the specific effect of LMD on renal and hepatic function could not be determined because most of the patients also had undergone surgery or cardiac catheterization. A comparative study of Dextran 40 and 5% dextrose in water as pump-priming fluids in open-heart surgery has shown similar elevations of serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase and serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase values in both groups.
Caution should be employed when LMD is administered to patients with active hemorrhage as the resulting increase in perfusion pressure and improved microcirculatory flow may result in additional blood loss.
Administering infusions of LMD that exceed the recommended dose should be avoided, since a dose-related increase in the incidence of wound hematoma, wound seroma, wound bleeding, distant bleeding (hematuria and melena) and pulmonary edema has been observed. Recommended doses should never be exceeded in patients with advanced renal disease, since excessive doses may precipitate renal failure.
Dextran may interfere to some extent with platelet function and should be used with caution in cases with thrombocytopenia. Transient prolongation of bleeding time and/or slightly increased bleeding tendency may occur with the administration of doses greater than 1,000 mL. Care should be taken to prevent a depression of hematocrit below 30% by volume. When large volumes of dextran are administered, plasma protein levels will be decreased.
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The possibility of circulatory overload should be kept in mind. Special care should be exercised in patients with impaired renal clearance of dextran. When the risk of pulmonary edema and/or congestive heart failure may be increased, dextran should be used with caution.
In patients with normal hemostasis, dosage of LMD approximating 15 mL/kg of body weight may prolong bleeding time and depress platelet function. Dosages in this range also markedly decrease factor VIII, and decrease factors V and IX to a greater degree than would be expected to occur from hemodilution alone. Since these changes tend to be more pronounced following trauma or major surgery, patients should be observed for early signs of bleeding complications.
Since increased rouleaux formation may occur in the presence of dextran, it is recommended that blood samples be drawn for typing and cross-matching prior to the infusion of dextran and reserved for subsequent use if necessary. If blood is drawn after infusion of dextran, the saline agglutination and indirect antiglobulin methods may be used for typing and cross-matching. Difficulty may be encountered when proteolytic enzyme techniques are used to match blood.
Consideration should be given to withdrawal of blood for chemical laboratory tests prior to initiating therapy with dextran because of the following:
Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Drug Interactions. Additive medications should not be delivered via plasma volume expanders.
Pregnancy Category C. Animal reproduction studies have not been conducted with Dextran 40 in dextrose or sodium chloride. It is also not known whether Dextran 40 in dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% LMD (dextran 40) in dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.
Nursing Mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 10% LMD (dextran 40) in dextrose or sodium chloride is administered to a nursing woman.
Pediatric Use. The safety and effectiveness of Dextran 40 have not been established in neonates. Its limited use in neonates has been inadequate to fully define proper dosage and limitations for use.
Antigenicity of dextrans is directly related to their degree of branching. Since LMD (dextran 40) has a low degree of branching, it is relatively free of antigenic effect. However, a few individuals have experienced mild urticarial reactions. More severe reactions, consisting of severe anaphylactoid reaction, generalized urticaria, tightness of the chest, wheezing, hypotension, nausea and vomiting may occur in rare instances. Symptoms and signs of adverse systemic reaction may be relieved by parenteral administration of antihistamines, ephedrine or epinephrine, while other means of shock therapy are instituted. The route of administration and dosages of the therapeutic agent selected will depend upon the severity and rapidity of progression of the reaction.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary (see
Severe reactions have been observed with Dextran 40 and Dextran 70. Reported reactions include: generalized urticaria, nausea and vomiting, wheezing, hypotension, shock and cardiac arrest (dextran-induced anaphylactoid reactions, DIAR). FDA has received 94 reports of severe DIAR since 1964. Because these reactions are reported voluntarily and the treated population is of indeterminate size, the frequency of reactions cannot be estimated reliably.
DOSAGE AND ADMINISTRATION
LMD is administered by I.V. infusion only.
Dextran 1 should be administered prior to administration of clinical dextran solutions.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See
Note: When infusing concentrated LMD, the administration set should include a filter.
Instructions for use
Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect solution quality or safety. The opacity will diminish gradually.
Preparation for Administration
(Use aseptic technique)
WARNING: Do not use flexible container in series connections.
10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) is supplied as follows:
10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) is supplied as follows:
Hospira, Inc., Lake Forest, IL 60045 USA
Dextran 40 pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Dextran 40 available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Dextran 40 destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Dextran 40 Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Dextran 40 pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Dextran 40?
Depending on the reaction of the Dextran 40 after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dextran 40 not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Dextran 40 addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Dextran 40, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dextran 40 consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
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One visitor reported frequency of useHow often in a day do you take the medicine?
Are you taking the Dextran 40 drug as prescribed by the doctor?
Few medications can be taken 3 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Dextran 40 is mentioned below.
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
Visitor reported ageNo survey data has been collected yet
The information was verified by Dr. Arunabha Ray, MD Pharmacology