右旋糖酐 Dextran 40

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10% LMD in 5% Dextrose Injection(Dextran 40 in Dextrose Injection, USP)10% LMD in 0.9% Sodium Chloride Injection(Dextran 40 in Sodium Chloride Injection, USP)Low Molecular Weight Dextran forIntravenous AdministrationFlexible Plastic ContainerRx onlyDESCRIPTIONLMD (dextran 40) is a sterile, nonpyrogenic preparation of low molecular weightdextran (average mol.wt. 40,000) in 5% Dextrose Injection or 0.9%SodiumChlorideInjection. It is administered byintravenous infusion.Also described as low viscous or low viscosity dextran, dextran 40 is prepared by acid hydrolysis anddifferential fractionation of a crudemacromolecular polysaccharide produced from the fermentation ofsucrose by the bacterium, Leuconostoc mesenteroides(strain B-512). The crude material is composed oflinked glucose units. In the fraction represented bydextran 40, 80% of the molecules have a molecularweight ranging from 10,000 to 90,000 (average approximay 40,000) when measured by a lightscattering 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 gdextrose 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 dextran40 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 bufers (except for pH adjustment)and are intended only for single-dose injection. When smaller doses are required the unused portionshould be discarded.10% LMD (dextran 40) is an artificial colloid pharmacologically classified as a plasma volumeexpander; 5% Dextrose Injection isa fluid and nutrient replenisher; 0.9% Sodium Chloride Injection is aluid and electrolyte replenisher.Dextran 40 is a linear glucose polymer (polysaccharide) chemically designated
The structural formula for dextran (repeating unit) is:Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6• H2O), a hexose sugarfreely soluble in water.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble inwater.Water for Injection, USP is chemically designated H

2O.The flexible plastic container is fabricated from a specially formulatedpolyvinylchloride. Water canpermeate from inside the container into the overwrap but not in amounts sufficient to affect the solutionsignificantly. Solutions inside the plastic container also can leach out certain of the chemical componentsof the plastic in very small amounts before the expiration period is attained. However, safety of the plastichas been confirmed by tests in animals according to USP biological standards for plastic containers.

CLINICAL PHARMACOLOGY

The fundamental action of LMD (dextran 40) is the

enhancement of blood flow, particularly in themicrocirculation. This enhancement is due to:

1. Its primary effect of volume expansion with resultant hemodilution;

2. Maintenance of the electronegativity of red blood cells;

3. Coating of red blood cells and plaets;

4. Increase in the suspension stability of blood;

5. Decrease in the viscosity of blood.

It should be emphasized that the above

effects are not exerted separay,but conjointly they result in theenhancement of blood flow.LMD, used in the treatment of shock, produces significant increases in blood volume, central venouspressure, cardiac output, stroke volume, blood pressure and urinary output. It reduces blood viscosity,

peripheral resistance and improves peripheral blood flowwith 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 wholeblood, albumin 5%, or whole blood plus 5% dextroseand water, leads to lessdestruction of red bloodcells and plaets, reduces intravascular hemagglutination and maintains erythrocyte electronegativity.

The infusion of LMD (dextran 40) during and after surgical trauma reduces the incidence of deepvenous thrombosis (DVT) and pulmonary embolism (PE) inpatients subject to surgical procedures with ahigh incidence of thromboembolic complication. Unlike antithrombogenic agents of the anticoagulanttype, LMD does not achieve its effect so much byblocking fibrinogen-fibrin conversion but acts bysimultaneously inhibiting other mechanisms essential to thrombus formation such as vascular stasis andplaet adhesiveness and by altering the structure and thereby the lysability of fibrin clots.Histopathological studies have shown that the development of a mural plaet thrombus is the firststage of thrombus formation not only in the arterial, but also in the venous system. A number of studieshave further shown that many patients who develop thromboembolic complicationsshowan abnormallyhigh plaet adhesiveness. Infusion of LMD has been shown to reduceplaet adhesiveness as measuredby variousin vitrotests on blood samples obtained from humansand to inhibit thegrowth of a muralplaet 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. Aconsistent and characteristic alteration in fibrin structure has been observed when fibrin is formed in thepresence of dextran, and further experiments demonstrated such fibrinto be more susceptible to plasmindigestion. Other studies have shown that dextran infused into patients during surgery increases thelysability ofex vivothrombi. Controlled clinical trials have shown that thrombi in patients treated withdextran 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 shiftstoward higher molecular weights as the smaller molecules are excreted by the kidney. In normovolemicsubjects, approximay 50% is excreted within 3hours, 60% is excreted within 6 hours and about 75%within 24 hours. Reabsorption of dextran by the renaltubules is negligible. The unexcreted molecules ofdextran diffuse into the extravascular compartment and are temporarily taken up by thereticuloendothelial 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 gluc

ose levels and provide

calories. Carbohydrate in the form of dextrose may ai

d in minimizing liver glycogen depletion and exerts

a protein sparing action. Dextrose

injected parenterally undergoes ox

idation to carbon dioxide and water.

Sodium chloride in water disso

ciates 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 di

stribution and excretion of sodium (Na) and chloride (Cl ? ) are

largely under the control of the kidney, which

maintains a balance betw

een intake and output.

Water is an essential constituent

of all body tissues and accounts for

approximay 70% of total body

weight. Average normal adult daily re

quirement ranges from two to three lite

rs (1.0 to 1.5 liters each for

insensible water loss by pers

piration 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 adjunc

tive treatment of shock or

impending shock due to

hemorrhage, burns, surgery or other trauma. It is no

t indicated as a replacem

ent for whole blood or blood

components if they are available. It

should not replace other forms of th

erapy 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.

CONTRAINDICATIONS

LMD (dextran 40) is contraindicated in patients with

known hypersensitivity to dextran, in those with

marked hemostatic defects of all types (thrombo

cytopenia, hypofibrinogenem

ia, etc.) including those

caused by drugs (heparin, warfarin, etc.), marked cardi

ac decompensation and in renal disease with severe

oliguria or anuria.

WARNINGS

Although infrequent, severe and fa

tal anaphylactoid reactions consisting of marked hypotension or

cardiac and respiratory arrest have been reported, mo

st 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 de

xtran be observed closely dur

ing the first minutes of

the infusion period.

Anaphylactoid Reactions

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 infu

sion of Dextran 40 or Dextra

n 70 consistent with the

dextran 1 package insert.

1-5

See

DOSAGE AND ADMINISTRATION

. Investigators have reported a 35-

fold decrease (from 1:2000 to 1:70,000) in the incide

nce of DIAR following prophylactic use of dextran

1.6

However, serious and life-threatening reactions may still occur following initiation of an infusion of

any clinical dextran (see

ADVERSE REACTIONS).

Because of the seriousness of anaphylactoid r

eactions, it is recommended that the infusion of

intravenous dextran be stopped at th

e first sign of an allergic reac

tion provided that other means of

sustaining the circulation are availa

ble. 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 patie

nt’s state of hydration

be assessed by determinati

on of urine or serum osmolarity. If sign

s of dehydration are present, additional

fluid should be administered. An osmotic diuretic su

ch 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 nephr

osis) 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 concentra

tion of the drug, its exact clinical

significance is presently unknown.

Occasional abnormal renal and hepatic

function values have been repo

rted following administration of

LMD. However, the specific effect of LMD on re

nal and hepatic function c

ould 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 ope

n-heart surgery has shown similar

elevations of serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase and serum

glutamic pyruvic transaminase

(SGPT), alanine am

inotransferase values in both groups.

Caution should be employed when LMD is administ

ered 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 s

hould be avoided, since a dose-

related increase in the incidence of wound hemato

ma, 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 plaet

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 1000 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 concen

trations, overhydration, congested

states or pulmonary edema. The

risk of dilutional states is inve

rsely 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, admini

stration of solutions containing sodium ions may

result in sodium retention.

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, dext

ran should be used with caution.

In patients with normal hemostasis, dosage of LM

D (dextran 40) approximating 15 mL/kg of body

weight may prolong bleeding time a

nd depress plaet function. Dosage

s 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 a

nd cross-matching prior to the infu

sion of dextran and reserved for

subsequent use if necessary. If blood is drawn afte

r 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 w

ithdrawal of blood for chemical la

boratory tests prior to initiating

therapy with dextran because of the following:

1. Blood sugar determinations that employ high con

centrations of acid may result in hydrolysis of

dextran, yielding falsely elevated glucose assay re

sults. This has been observe

d both with sulfuric acid

and with acetic acid.

2. In other laboratory tests, the presence of dext

ran 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 prot

ein 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, esp

ecially 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 wh

ether 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 excr

eted in human milk. Because many drugs are

excreted in human milk, caution shoul

d 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 establis

hed in neonates. Its

limited use in neonates has been inadequate to fu

lly define proper dosage and limitations for use.

ADVERSE REACTIONS

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 r

eactions, 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 admini

stration 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

WARNINGS

for treatment of anaphylactic shock).

Post Marketing

Severe reactions have been observed with Dext

ran 40 and Dextran 70. Re

ported 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 populati

on is of indeterminate size, the

frequency of reactions cannot be estimated reliably.

DOSAGE AND ADMINISTRATION

LMD (dextran 40) is administer

ed by I.V. infusion only.

Dextran 1 should be administered prior to ad

ministration of clinical dextran solutions.

1.

In shock,

it is suggested that total dosage not exceed

20 mL/kg for adults and adolescents, during the

first 24 hours. The first 10 mL/kg may be infused as

rapidly as necessary to e

ffect improvement. It is

strongly recommended that central venous pressure be monitored frequently during the initial infusion

of the drug. Should therapy continue beyond

24 hours, subsequent dosage should not exceed

10 mL/kg per day and therapy should not continue beyond five days.

2.

In extracorporeal perfusion,

the dosage of LMD used will vary with the volume of the pump

oxygenator. LMD can serve as a sole primer or as an additive to other priming fluids. For adults and

adolescents, generally 10 to 20 mL of a 10% solution (1 to 2 g) of LMD per kilogram of body weight

are added to the perfusion circuit. Usually tota

l dosage should not exceed 2 g/kg of body weight.

3.

In prophylaxis of venous thrombosis and thromboembolism,

the dosage of LMD for adults and

adolescents, should be chosen according to the risk

of thromboembolic complications, e.g., type of

surgery and duration of immobilization. In general, treatment should be initiated during surgery;

500 to 1000 mL (approximay 10 mL/kg of body we

ight) should be administered on the day of

operation. Treatment should be continued at a dose of 500 mL daily for an additional two to three

days; then, according to the risk of complications

, 500 mL may be given every second or third day

during the period of risk, for up to two weeks.

4. Infants may be given 5 mL per kg body weight and children 10 mL per kg.

Parenteral drug products should be

inspected visually for particulate

matter and discoloration prior to

administration, whenever solu

tion and container permit. See

PRECAUTIONS

Note

: When infusing concentrated LMD, the

administration set should include a filter.

Instructions for use

To Open

Tear outer wrap at notch and rem

ove solution container. Some opacity

of the plastic due to moisture

absorption during the sterilization process may be obser

ved. This is normal and does not affect solution

quality or safety. The opacity will diminish gradually.

Preparation for Administration

(Use aseptic technique)

1. Close flow control clam

p of administration set.

2. Remove cover from outlet por

t at bottom of container.

3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.

Note:

See full directions on administration set carton.

4. Suspend container from hanger.

5. Squeeze and release drip chamber to esta

blish proper fluid level in drip chamber.

6. Open flow control clamp and clear air from set. Close clamp.

7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

8. Regulate rate of administra

tion with flow control clamp.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED

10% LMD in 5% Dextrose Injection (Dextran 40 in

Dextrose Injection, USP) is supplied in a 500 mL

single-dose flexible container

(NDC 0409-7418-03). 10% LMD in 0.9%

Sodium Chloride Injection

(Dextran 40 in Sodium Chloride Injection, USP) is

supplied in a 500 mL single-dose flexible container

(NDC 0409-7419-03).

Do not use if crystallization has occurred.

Store at 20 to 25°C (68 to 77°F). [See USP Contro

lled Room Temperature.] Protect from freezing.

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