HEPARIN SODIUM 20000UNIT/500ML IN DEXT 5% INJ SOLUTION

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Active ingredient:
HEPARIN SODIUM
Available from:
HOSPIRA HEALTHCARE ULC
ATC code:
B01AB01
INN (International Name):
HEPARIN
Dosage:
40UNIT
Pharmaceutical form:
SOLUTION
Composition:
HEPARIN SODIUM 40UNIT
Administration route:
INTRAVENOUS
Units in package:
500ML
Prescription type:
Ethical
Therapeutic area:
HEPARINS
Product summary:
Active ingredient group (AIG) number: 0104596010; AHFS: 20:12.04.16
Authorization status:
APPROVED
Authorization number:
00894648
Authorization date:
2004-05-27

Documents in other languages

PRESCRIBING INFORMATION

HEPARIN SODIUM 20 000 UNITS/500 ML IN DEXTROSE 5% INJECTION

HEPARIN SODIUM 25 000 UNITS/500 ML IN 5% DEXTROSE INJECTION

Heparin Sodium in 5% Dextrose

20 000 or 25 000 USP Units in Flexible Plastic Container

Anticoagulant

Hospira Healthcare Corporation

17300 Trans-Canada Highway

Kirkland, Quebec

H9J 2M5

Date of Approval:

May 09, 2017

Submission Control No: 203541

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

HEPARIN SODIUM 20 000 UNITS/500 ML IN DEXTROSE 5% INJECTION

HEPARIN SODIUM 25 000 UNITS/500 ML IN 5% DEXTROSE INJECTION

20 000 or 25 000 USP Units in Flexible Plastic Container

THERAPEUTIC CLASSIFICATION

Anticoagulant

CLINICAL PHARMACOLOGY

Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both

in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small

amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit

thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to

thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further

coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin.

Heparin also prevents the formation of a stable fibrin clot in inhibiting the activation of the fibrin

stabilizing factor.

Bleeding time is usually unaffected by heparin. Clotting time is prolonged by full therapeutic

doses of heparin; in most cases, it is not measurably affected by low doses of heparin.

Peak plasma levels of heparin are achieved 2 to 4 hours following subcutaneous administration,

although there are considerable individual variations. Log linear plots of heparin plasma

concentrations, with time for a wide range of dose levels, are linear, which suggests the absence

of zero order processes. The liver and the reticuloendothelial system are the site of

biotransformation. The biphasic elimination curve, a rapidly declining alpha phase (t

=10’) and

after the age of 40 a slower beta phase, indicate uptake in organs. The absence of a relationship

between anticoagulant half-life and concentration half-life may reflect factors such as protein

binding of heparin.

Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

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.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total

body weight. Average normal adult daily requirements range 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.

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

INDICATIONS AND USAGE

Heparin sodium is indicated for: Atrial fibrillation with embolization; diagnosis and treatment

of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);

prevention of clotting in arterial and heart surgery; prophylaxis and treatment of peripheral

arterial embolism; as an anticoagulant in extracorporeal arterial circulation and dialysis

procedures.

CONTRAINDICATIONS

Heparin sodium should not be used in patients: With severe thrombocytopenia; in whom

suitable blood coagulation tests (e.g., the whole blood clotting time, partial thromboplastin time,

etc.) cannot be performed at appropriate intervals (this contraindication refers to full-dose

heparin; there is usually no need to monitor coagulation parameters in patients receiving low-

dose heparin).

With an uncontrollable active bleeding state (see WARNINGS), except when this is due to

disseminated intravascular coagulation. Dextrose injection without electrolytes should not be

administered simultaneously with blood through the same infusion set because of possible

rouleau formation.

WARNINGS

Heparin is not intended for intramuscular use.

Hypersensitivity: Patients with documented hypersensitivity to heparin should be given the drug

only in clearly life-threatening situations.

Hemorrhage: Hemorrhage can occur at virtually any site in patients receiving heparin. An

unexplained fall in hematocrit, fall in blood pressure, or any other unexplained symptom should

lead to serious consideration of a hemorrhagic event.

Heparin sodium should be used with extreme caution in disease states in which there is increased

danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists

are:

Cardiovascular – Subacute bacterial endocarditis. Severe hypertension.

Surgical – During and immediately following (a) spinal tap or spinal anesthesia or (b) major

surgery, especially involving the brain, spinal cord or eye.

Hematologic – Conditions associated with increased bleeding tendencies, such as

hemophilia, thrombocytopenia, and some vascular purpuras.

Gastrointestinal – Ulcerative lesions and continuous tube drainage of the stomach or small

intestine.

Other – Menstruation, liver disease with impaired hemostasis.

Coagulation Testing: When heparin sodium is administered in therapeutic amounts, its dosage

should be regulated by frequent blood coagulation tests. If the coagulation test is unduly

prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly (see

OVERDOSAGE).

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Thrombocytopenia: Thrombocytopenia has been reported to occur in patients receiving

heparin, with a reported incidence of 0 to 30%. Mild thrombocytopenia (count greater than

100 000/mm

) may remain stable or reverse even if heparin is continued. However,

thrombocytopenia of any degree should be monitored closely. If the count falls below

100 000/mm

or if recurrent thrombosis develops (see PRECAUTIONS, White Clot

Syndrome), the heparin product should be discontinued. If continued heparin therapy is

essential, administration of heparin from a different organ source can be reinstituted with

caution.

The intravenous administration of these solutions 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.

Excessive administration of potassium-free solutions may result in significant hypokalemia.

Heparin sodium contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain

susceptible people. The overall prevalence of sulfite sensitivity in the general population is

unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in

nonasthmatic people.

As the dosage of solutions of heparin sodium must be titrated to individual patient response,

additive medications should not be delivered via this solution.

PRECAUTIONS

General

a.

White Clot Syndrome

It has been reported that patients on heparin may develop new thrombus formation in

association with thrombocytopenia resulting from irreversible aggregation of platelets

induced by heparin, the so-called “white clot syndrome”. The process may lead to severe

thromboembolic complications like skin necrosis, gangrene of the extremities that may

lead to amputation, myocardial infarction, pulmonary embolism, stroke, and possibly

death. Therefore, heparin administration should be promptly discontinued if a patient

develops new thrombosis in association with thrombocytopenia.

b.

Heparin Resistance

Increased resistance to heparin is frequently encountered in fever, thrombosis,

thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer

and in postsurgical patients.

c.

Increased Risk in Older Women

A higher incidence of bleeding has been reported in women over 60 years of age.

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Laboratory Tests: Periodic platelet counts, hematocrits and tests for occult blood in stool are

recommended during the entire course of heparin therapy, regardless of the route of

administration (see DOSAGE AND ADMINISTRATION).

Drug Interactions

Oral Anticoagulants: Heparin sodium may prolong the one-stage prothrombin time. Therefore,

when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours

after the last intravenous dose should elapse before blood is drawn if a valid PROTHROMBIN

time is to be obtained. Heparin may be used to prevent blood clotting during blood transfusions

and in blood sampling for laboratory purposes. However, heparinized blood should not be used

for isoagglutinin, complement, or for an erythrocyte fragility test, or for platelet counts. In

addition, leukocyte counts should be performed within 2 hours after heparin is added to the blood

sample.

Platelet Inhibitors: Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen,

indomethacin, dipyridamole, hydroxychloroquine and others that interfere with platelet-

aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding

and should be used with caution in patients receiving heparin sodium.

Other Interactions: Digitalis, quinine, tetracyclines, nicotine, antihistamines, or intravenous

(i.v.) nitroglycerin may partially counteract the anticoagulant action of heparin sodium.

Drugs such as codeine phosphate, pethidine hydrochloride, streptomycin, erythromycin,

kanamycin, neomycin, novobiocin, ampicillin, penicillins, glucocorticoids, polymyxin B,

vancomycin, hydrocortisone sodium succinate, pentobarbitone, promazine hydrochloride,

vitamin B complex and vitamin C may complex with heparin. This complex may be reversible

(heparin rebound) and may result in excess bleeding at the surgical site. Extra protamine sulfate

may then be indicated. Intravenously administered ethacrynic acid can cause gastrointestinal

(G.I.) bleeding. However, a significantly higher incidence of G.I. bleeding has been attributed to

the concurrent use of i.v. ethacrynic acid and heparin.

Drug/Laboratory Test Interactions

Hyperaminotransferasemia: Significant elevations of amino transferase (SGOT [S-AST] and

SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who

have received heparin. Since aminotransferase determinations are important in the differential

diagnosis of myocardial infarction, liver disease, and pulmonary emboli, rises that might be

caused by drugs (like heparin) should be interpreted with caution.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals have

been performed to evaluate the carcinogenic potential of heparin. Also, no reproduction studies

in animals have been performed concerning mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects: Animal reproduction studies have not been conducted with heparin sodium

or dextrose. It is also not known whether heparin sodium or dextrose can cause fetal harm when

administered to a pregnant woman or can affect reproduction capacity. Heparin sodium or

dextrose should be given to a pregnant woman only if clearly needed.

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Nonteratogenic Effects: Heparin does not cross the placental barrier.

Nursing Mothers: Heparin is not excreted in human milk.

Pediatric Use: See DOSAGE AND ADMINISTRATION.

Solutions containing dextrose should be used with caution in patients with known subclinical or

overt diabetes mellitus.

Do not administer unless the solution is clear and container is undamaged. Discard unused

portion.

ADVERSE REACTIONS

Hemorrhage: Hemorrhage is the chief complication that may result from heparin therapy (see

WARNINGS). An overly prolonged clotting time or minor bleeding during therapy can usually

be controlled by withdrawing the drug (see OVERDOSAGE). It should be appreciated that

gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the

presence of an underlying occult lesion. Bleeding can occur at any site but certain specific

hemorrhagic complications may be difficult to detect:

Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during

anticoagulant therapy. Therefore, such treatment should be discontinued in patients who

develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of

corrective therapy should not depend on laboratory confirmation of the diagnosis, since

any delay in an acute situation may result in the patient’s death.

Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive

age receiving short- or long-term anticoagulant therapy. This complication, if

unrecognized, may be fatal.

Retroperitoneal hemorrhage.

Local Irritation: Local irritation, erythema, mild pain, hematoma or ulceration may follow deep

subcutaneous (intrafat) injection of heparin sodium. These complications are much more

common after intramuscular use, and such use is not recommended.

Hypersensitivity: Generalized hypersensitivity reactions have been reported, with chills, fever

and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache,

nausea and vomiting and anaphylactoid reactions, including shock, occurring more rarely.

Itching and burning, especially on the plantar site of the feet, may occur.

Thrombocytopenia has been reported to occur in patients receiving heparin, with a reported

incidence of 0 to 30%. While often mild and of no obvious clinical significance, such

thrombocytopenia can be accompanied by severe thromboembolic complications such as skin

necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction,

pulmonary embolism, stroke, and possibly death (see WARNINGS and PRECAUTIONS).

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Certain episodes of painful, ischemic and cyanosed limbs have, in the past, been attributed to

allergic vasospastic reactions. Whether these are, in fact, identical to the thrombocytopenia-

associated complications remains to be determined.

Miscellaneous: Osteoporosis following long-term administration of high doses of heparin,

cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed

transient alopecia, priapism and rebound hyperlipemia on discontinuation of heparin sodium

have also been reported.

Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have

occurred in a high percentage of patients (and healthy subjects) who have received heparin.

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.

OVERDOSAGE

Symptoms: Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry

stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may

precede frank bleeding.

Treatment: Neutralization of heparin effect.

When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1%

solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be

administered, very slowly, in any 10 minute period. Each mg of protamine sulfate neutralizes

approximately 100 USP heparin units. The amount of protamine required decreases over time as

heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose

of choosing a protamine dose, be assumed to have a half-life of about ½ hour after intravenous

injection.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.

Because fatal reactions often resembling anaphylaxis have been reported, the drug should be

given only when resuscitation techniques and treatment of anaphylactoid shock are readily

available.

For additional information, the labelling of Protamine Sulfate Injection USP products should be

consulted.

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate

corrective measures (see WARNINGS and PRECAUTIONS).

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

DOSAGE AND ADMINISTRATION

Heparin sodium is not effective by oral administration and these premixed formulations should

be given by intermittent intravenous injection or intravenous infusion.

The dosage of heparin sodium should be adjusted according to the patient’s coagulation test

results. When heparin is given by continuous intravenous infusion, the coagulation time should

be determined approximately every 4 hours in the early stages of treatment. When the drug is

administered intermittently by intravenous injection, coagulation tests should be performed

before each injection during the early stages of treatment and at appropriate intervals thereafter.

Dosage is considered adequate when the activated partial thromboplastin time (APTT) is 1.5 to 2

times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the

control value.

Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during

the entire course of heparin therapy, regardless of the route of administration.

Converting to an Oral Anticoagulant: When an oral anticoagulant of the coumarin or similar

type is to be begun in patients already receiving heparin sodium, baseline and subsequent tests of

prothrombin activity must be determined at a time when heparin activity is too low to affect the

prothrombin time. If continuous intravenous (i.v.) heparin infusion is used, prothrombin time can

usually be measured at any time.

In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be

the usual initial amount and thereafter prothrombin time should be determined at the usual

intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy

for several days after the prothrombin time has reached the therapeutic range. Heparin therapy

may then be discontinued without tapering.

Therapeutic Anticoagulant Effect with Full-Dose Heparin

Although dosage must be adjusted for the individual patient according to the results of suitable

laboratory tests, the following dosage schedules may be used as guidelines:

Method of

Administration

Frequency

Recommended Dose*

Intermittent

Intravenous

Injection

Initial Dose

Every 4 to 6 hours

10 000 Units, either

undiluted or in 50 – 100 mL of

5% Dextrose Injection

5 000 – 10 000 Units,

either undiluted or in 50 – 100

mL of 5% Dextrose Injection

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Method of

Administration

Frequency

Recommended Dose*

Continuous

Intravenous

Infusion

Initial Dose

Continuous

5 000 Units by I.V. Injection

20 000 – 40 000

Units/24 hours in 1 000 mL of

5% Dextrose Injection

*Based on 150 lb. (68 kg) patient.

Pediatric Use: Follow recommendations of appropriate pediatric reference texts. In general, the

following dosage schedule may be used as a guideline.

Initial Dose

Maintenance Dose

50 Units/kg (I.V. drip)

100 Units/kg (l.V. drip) every

4 hours, or

20 000 Units/M

continuously for 24 hours

Surgery of the Heart and Blood Vessels: Patients undergoing total body perfusion for open-

heart surgery should receive an initial dose of not less than 150 units of heparin sodium per

kilogram of body weight. Frequently, a dose of 300 units per kilogram is used for procedures

estimated to last less than 60 minutes or 400 units per kilogram for those estimated to last longer

than 60 minutes.

Extracorporeal Dialysis: Follow equipment manufacturers’ operating directions carefully.

Parenteral drug products should be inspected visually for particulate matter and discolouration

prior to administration, whenever solution and container permit. Slight discolouration does not

alter potency (see PRECAUTIONS).

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove container. Some opacity of the plastic due to moisture

absorption during the sterilization process may be observed. This is normal and does not affect

the solution quality or safety. The opacity will diminish gradually.

Preparation for Administration (use aseptic technique)

Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

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.

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

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

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

venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED

Intravenous solutions with heparin sodium are supplied in single-dose flexible plastic containers,

in various sizes and concentrations, as shown in the accompanying Table.

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

Contents and Characteristics

List

No.

Product

Heparin

Sodium

(Units/mL)

Per 100 mL

Tonicity

Osmolarity

mOsmol/

liter (calc)

pH

Solution

Volume

Heparin

Sodium

(Units)

Dextrose

(anhy-

drous)

07760

Heparin

Sodium

20 000 USP

Units in 5%

Dextrose

Injection

4 000

Isotonic

5.4 (5.2

to 6.0)

500 mL

07761

Heparin

Sodium

25 000 USP

Units in 5%

Dextrose

Injection

5 000

Isotonic

5.4 (5.2

to 6.0)

500 mL

Exposure of pharmaceutical products to heat should be minimized. Protect from freezing. It is recommended that

the product be stored between 20 to 25°C (see “Controlled Room Temperature” in USP), however, brief exposure

to 40°C does not adversely affect the product.

DESCRIPTION

Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile,

nonpyrogenic fluids for intravenous administration. Each 100 mL contains: Heparin sodium

4 000 or 5 000 USP Heparin Units; dextrose anhydrous 5 g; citric acid anhydrous 51 mg and

dibasic sodium phosphate anhydrous 103 mg added as buffers; sodium metabisulfite 20 mg,

added as an antioxidant. Each liter contains the following electrolytes: sodium 17 mEq;

phosphate 15 mEq and citrate 8 mEq. May contain citric acid for pH adjustment. See Table for

summary of contents and characteristics of these solutions.

Heparin Sodium USP is a heterogenous group of straight-chain anionic muco-polysaccharides,

called glycosaminoglycans, having anticoagulant properties. Although others may be present, the

main sugars occurring in heparin are:

(1) α-L-iduronic acid 2-sulfate,

(2) 2-deoxy-2-sulfamino- α -D-glucose 6-sulfate,

(3) β-D-glucuronic acid,

(4) 2-acetamido-2-deoxy- α -D-glucose,

(5) α-L-iduronic acid.

These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5), and are

joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic

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Heparin Sodium in 20 000 Units/500 mL in Dextrose 5% Injection

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Heparin Sodium in 25 000 Units/500 mL in 5% Dextrose Injection

because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium,

the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is

determined by a biological assay, using a USP reference standard based on units of heparin

activity per milligram.

Structure of Heparin Sodium (representative subunits):

Dextrose USP is chemically designated D-glucose, monohydrate (C

H

O), a hexose

sugar freely soluble in water. It has the following structural formula:

Water for Injection USP is chemically designated H

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 can also leach out certain of its

chemical components in very small amounts before the expiration period is attained. However,

the safety of the plastic has been confirmed by tests in animals according to USP biological

standards for plastic containers.

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