PRECAUTIONS

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 (dextran 40) 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:

1.

Blood sugar determinations that employ high concentrations of acid may result in hydrolysis of dextran, yielding falsely elevated glucose assay results. This has been observed both with sulfuric acid and with acetic acid.

2.

In other laboratory tests, the presence of dextran in the blood may result in the development of turbidity, which can interfere with the assay. This has been observed in bilirubin assays in which alcohol is employed and in total protein assays employing biuret reagent.

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. 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.