Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3213
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Heparin Sodium in Dextrose (Injection)
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Heparin Sodium in
5% Dextrose Injection is for intravenous administration only. Parenteral
drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. 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. Physicians should refer to medical
literature. 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.<br/>Converting to 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. This is about 5 hours after the last I.V. bolus and 24
hours after the last subcutaneous dose. If continuous I.V.
heparin infusion is used, prothrombin time can usually be
measured at any time. In
converting from heparin to 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 thetherapeutic range. Heparin
therapy may then be discontinued without tapering.<br/>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
may be used as a guideline for continuous intravenous infusion
(based on 150 lb [68 kg] patient):<br/>Pediatric Use: Follow
recommendations of appropriate pediatric reference texts. In
general, the following dosage schedule may be used as a
guideline:<br/>Geriatric Use: Patients
over 60 years of age may require lower doses of
heparin.<br/>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. All
injections in Viaflex' Plus plastic containers are intended for
intravenous administration using sterile equipment. Because
dosages of this drug are titrated to response, no additives
should be made to Heparin Sodium in 5% Dextrose
Injection.
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Heparin Sodium in
5% Dextrose Injection is a buffered, sterile, nonpyrogenic solution of
Heparin Sodium, USP, derived from porcine intestinal mucosa,
standardized for anticoagulant activity, and dextrose in water for
injection. Heparin Sodium, USP, is a heterogenous group of
straight-chain anionic mucopolysaccharides, called glycosaminoglycans
having anticoagulant properties. Although others may be present, the
main sugars occurring in heparin are: (1)��-L-iduronic acid 2-sulfate,
(2) 2-deoxy-2-sulfamino-��-D-glucose 6-sulfate, (3)��-D-glucuronic acid,
(4) 2-acetamido-2-deoxy-��-D-glucose, and (5)��-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 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 of the
heparin is determined by biological assay using USP reference standard
based upon units of heparin activity per milligram.<br/>Structure of
Heparin Sodium (representative subunits):: Dextrose
Hydrous, USP, is chemically designated D-gluco pyranose
monohydrate, a hexose sugar freely soluble in water. It has the
following structural formula: The
solution is intended for intravenous use only. It contains no
antimicrobial agents or bacteriostatic agents. Each 100 mL
contains 4,000 or 5,000 or 10,000 USP Heparin Units Heparin
Sodium, USP with 5 g Dextrose Hydrous, USP, 103 mg Dibasic
Sodium Phosphate Dried, USP (Na2HPO4) and 51 mg Citric Acid
Anhydrous, USP (C6H8O7) added as buffers. 20 mg sodium bisulfite
is added as a stabilizer. pH 5.5 (5.0 - 6.0). pH may have been
adjusted with citric acid and/or sodium hydroxide. Osmolarity
298 mOsmol/L (Actual). This Viaflex' Plus plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146' Plastic). Viaflex' Plus
on the container indicates the presence of a drug additive in a
drug vehicle. The Viaflex' Plus plastic container system
utilizes the same container as the Viaflex' plastic container
system. The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the
solution significantly. Solutions in contact with the plastic
container can leach out certain of its chemical components in
very small amounts within the expiration period, e.g.,
di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million.
However, the safety of the plastic has been confirmed in tests
in animals according to USP biological tests for plastic
containers as well as by tissue culture toxicity
studies.
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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 by 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. Patients over 60
years of age, following similar doses of heparin, may have higher plasma
levels of heparin and longer activated partial thromboplastin times
(APTTs) compared with patients under 60 years of age. Heparin does not
have fibrinolytic activity; therefore, it will not lyse existing clots. Peak plasma levels
of heparin are achieved 2-4 hours following subcutaneous administration,
although there are considerable individual variations. Loglinear 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
reticulo-endothelial system are the sites of biotransformation of
heparin. The biphasic elimination curve, a rapidly declining alpha phase
(t1/2 = 10 minutes), and after the age of 40 a slower beta phase,
indicates 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.
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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. With an
uncontrollable active bleeding state (see Warnings), except when this is due to disseminated
intravascular coagulation. Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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Heparin Sodium in
5% Dextrose Injection in Viaflex' Plus plastic containers is available
as follows: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.<br/>Direction for Use
of Viaflex' Plus Plastic Container: Do not use
plastic containers in series connections. Such use could result
in air embolism due to residual air being drawn from the primary
container before administration of the fluid from the secondary container is completed.<br/>To Open: Tear
overwrap down side at slit 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 the solution quality or safety. The opacity will
diminish gradually. Check for minute leaks by squeezing chamber.
If external leaks are found, discard solution as sterility or
stability may be impaired. Do not add supplementary
medication.<br/>Preparation of
Administration: Baxter Healthcare
Corporation Deerfield,
IL 60015 USA Printed in
USA
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1. General:<br/>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.<br/>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.<br/>c.
Increased Risk in Older Patients, Especially Women:: A
higher incidence of bleeding has been reported in
patients, particularly women, over 60 years of
age.<br/>d.
Solutions Containing Dextrose:: These solutions should be used with caution in patients
with overt or subclinical diabetes mellitis.<br/>e. Use of an electronic flow control device is recommended.: If
administration is controlled by a pumping device, care
must be taken to discontinue pumping action before the
container runs dry or air embolism may
result.<br/>2. 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 (seeDosage and
Administration).<br/>3. 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 or 24 hours after the last
subcutaneous dose should elapse before blood is drawn if a valid
prothrombin time is to be obtained. 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, tetracyclines, nicotine,
antihistamines, or intravenous nitroglycerin may partially
counteract the anticoagulant action of heparin
sodium.<br/>4. Drug/Laboratory
Tests Interactions: Hyperaminotransferasemia: Significant
elevations of aminotransferase (SGOT [AST] and SGPT [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.<br/>5. Carcinogenesis,
Mutagenesis, Impairment of Fertility: No
long-term studies in animals have been performed to evaluate
carcinogenic potential of heparin. Also, no reproduction studies
in animals have been performed concerning mutagenesis or
impairment of fertility.<br/>6. Pregnancy:<br/>Teratogenic
Effects:<br/>Nonteratogenic Effects: Heparin does not cross the placental
barrier.<br/>7. Nursing Mothers: Heparin is
not excreted in human milk.<br/>8. Pediatric Use: SeeDosage and
Administration.<br/>9. Geriatric Use: A higher
incidence of bleeding has been reported in patients over 60
years of age, especially women (see Precautions, General). Clinical studies indicate
that lower doses of heparin may be indicated in these patients
(see Clinical
Pharmacology and Dosage and
Administration). Do not
administer unless solution is clear and seal is
intact.
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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.<br/>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 1/2 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 labeling of Protamine Sulfate
Injection, USP products should be consulted.
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Heparin Sodium and Dextrose monohydrate
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Heparin Sodium in Dextrose (Injection)
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1. 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: a. 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. b. 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. c.
Retroperitoneal hemorrhage.<br/>2. 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.<br/>3. Hypersensitivity: General
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 0-30%. 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, Precautions.) 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.<br/>4. 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 [AST] and SGPT [ALT])
levels have occurred in a high percentage of patients (and
healthy subjects) who have received heparin. Other
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.
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Hypersensitivity:: Patients
with documented hypersensitivity to heparin should be given the
drug only in clearly life-threatening situations.<br/>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 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.<br/>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).<br/>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/mm3) 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/mm3 or if recurrent thrombosis
develops (see White Clot Syndrome, Precautions), 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. Dextrose
solutions with low electrolyte concentrations should not be
administered simultaneously with blood through the same
administration set because of the possibility of
pseudoagglutination or hemolysis. The bag container label for
these solutions bears the statement: Do not administer
simultaneously with blood. The
intravenous administration of 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 the injections. The risk of
solute overload causing congested states with peripheral and
pulmonary edema is directly proportional to the electrolyte
concentrations of the injections. Heparin
Sodium in 5% Dextrose Injection contains sodium bisulfite, 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. Excessive
administration of potassium-free solutions may result in
significant hypokalemia.
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Heparin Sodium is
indicated for: Anticoagulant
therapy in prophylaxis and treatment of venous and arterial thrombosis
and its extension; Prophylaxis and
treatment of pulmonary embolism; 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.
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Heparin Sodium in Dextrose
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