Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/534
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Heparin (Injection, Solution)
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Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit. Slight discoloration does not alter potency (see PRECAUTIONS). Heparin
Lock Flush Solution, USP 100 USP Units/mL, is injected as a single dose into
an intravenous injection device using a volume of solution equivalent to that
of the indwelling venipuncture device (see catheter manufacturer's
labeling for specific catheter lumen volumes). A single
dose should be injected following venipuncture when the indwelling device
is not to be used immediately. After each use of the indwelling venipuncture
device for injection or infusion of medication, or withdrawal of blood samples,
another dose (using a volume of solution equivalent to that of the indwelling
venipuncture device) should be injected to restore the effectiveness of the
heparin lock. The amount of heparin solution in each single dose is sufficient
to prevent clotting within the lumen of indwelling venipuncture devices for
up to twenty-four hours. When the indwelling device
is used to administer a drug which is incompatible with heparin, the entire
heparin lock set should be flushed with 0.9% Sodium Chloride Injection, USP
before and after the medication is administered. Following the second flush,
another dose of heparin solution should be injected to restore the effectiveness
of the heparin lock. When the indwelling device is used
for repeated withdrawal of blood samples for laboratory analyses and the presence
of heparin or saline is likely to interfere with or alter results of the desired
blood tests, the in situ heparin flush
solution should be cleared from the device by aspirating and discarding a
volume of solution equivalent to that of the indwelling venipuncture device
before the desired blood sample is drawn. (See PRECAUTIONS.)
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Heparin Lock Flush Solution, USP is a sterile nonpyrogenic
preparation of Heparin Sodium Injection, USP with sufficient sodium chloride
to make it isotonic in water for injection. Each milliliter
(mL) contains: Heparin sodium, 100 USP units (derived from porcine intestinal
mucosa); edetate disodium, anhydrous 0.1 mg added as a stabilizer; and sodium
chloride, 4.5 mg to render the solution isotonic in water for injection. May
contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.1
(5.0 to 7.5). The solution contains no bacteriostat,
antimicrobial agent or added buffer. Each disposable syringe is intended only
for one-time use. Heparin Lock Flush Solution, USP is
intended for maintenance of patency of intravenous injection devices only
and is not to be used for anticoagulant therapy. 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 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): Sodium Chloride, USP is chemically designated NaCl, a white crystalline
compound freely soluble in water. The plastic syringe
is molded from a specially formulated polypropylene. Water permeates from
inside the container at an extremely slow rate which will have an insignificant
effect on solution concentration over the expected shelf life. Solutions in
contact with the plastic container may leach out certain chemical components
from the plastic in very small amounts; however, biological testing was supportive
of the safety of the syringe material.
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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 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. 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. Peak
plasma levels of heparin are achieved 2 to 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. 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, indicates uptake in organs. The
absence of a relationship between anticoagulant half-life and concentration
of half-life may reflect factors such as protein binding of heparin. Heparin
does not have fibrinolytic activity; therefore, it will not lyse existing
clots. Heparin Lock Flush Solution does not induce systemic
anticoagulant action at single doses of 100 USP units per mL when used for
maintenance of patency of intravenous injection devices. It may interfere
with laboratory tests on blood samples withdrawn from such devices, unless
the volume of in situ heparin-saline,
equal to that of the priming volumeof the catheter, is aspirated and discarded
before such samples are taken. Isotonic concentrations
of sodium chloride are suitable for parenteral replacement of chloride losses
that exceed or equal the sodium loss. Hypotonic concentrations of sodium chloride
are suited for parenteral maintenance of water requirements when only small
quantities of salt are desired. 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 the red blood cells. The distribution
and excretion of sodium (Na) are largely under the control of
the kidney which maintains a balance between intake and output.
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Heparin sodium should not be used in patients: With hypersensitivity to heparin; With an
uncontrollable active bleeding state (see WARNINGS), except when this is due
to disseminated intravascular coagulation; With inability
to perform suitable blood-coagulation tests, e.g., whole-blood clotting time,
partial thromboplastin time, etc., at required intervals. There is usually
no need to monitor effect of low-dose heparin in patients with normal coagulation
parameters.
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Heparin Lock Flush Solution is available as follows: Store at 20 to 25��C (68 to 77��F). [See USP Controlled
Room Temperature.] May be used with sharp needles. May
also be used with the LifeShield' Blunt Cannula. INSTRUCTIONS FOR USE For
access to a standard luer injection site: Remove luer cover from syringe.
Hold plunger and push barrel forward to relieve any resistance that may bepresent. Pull the barrel down until air is expelled from the syringe. Attach
syringe to luer access device. Inject medication. (See DOSAGE AND ADMINISTRATION
section.) Discard unused portion after initial use. Discard syringe per health
care provider policy. For injection using a sharp needle
or blunt cannula: Remove luer cover from syringe. Attach desired compatible
sharp needle or blunt cannula to luer. Hold plunger and push barrel forward
to relieve any resistance that may be present. Pull the barrel down until
air is expelled from the syringe. Inject medication. (See DOSAGE AND ADMINISTRATION
section.) Discard unused portion after initial use. Discard syringe per health
care provider policy. Rev: October, 2004 HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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FOR IV FLUSH ONLY
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Do not use unless solution is clear and container is undamaged.
Not for multiple dosing. After single use, discard unused portion in the Ansyr unit
of use 5 mL plastic syringe (100 USP Units/mL). Since
heparin sodium in this product is derived from animal tissue, it should be
used with caution in patients with a history of allergy.<br/>Interference with Laboratory Tests:: Heparin interferes with competitive protein binding methods
for serum thyroxine determinations resulting in falsely elevated levels. Heparin
Lock Flush Solution may interfere with laboratory analyses or alter the results
of blood chemistry tests such as glucose, serum sodium and serum chloride,
blood coagulation studies, etc. (see CLINICAL PHARMACOLOGY). The
following information which pertains to the use of heparin sodium as a systemic
anticoagulant is included as a matter of interest only since it is not known
to apply to the use of the drug for heparin lock.<br/>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 Patients, Especially Women: A
higher incidence of bleeding has been reported in patients, particularly women,
over 60 years of age.<br/>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. 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,
anti-histamines or I.V. nitroglycerin may partially counteract the anticoagulant
action of heparin sodium.<br/>Drug/Laboratory Interactions:: Hyperaminotransferasemia: 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. 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/>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/>Pregnancy:: Teratogenic Effects:Pregnancy Category C. Animal reproduction studies
have not been conducted with heparin sodium or sodium chloride. It is also
not known whether heparin sodium or sodium chloride can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. Heparin
sodium or sodium chloride should be given to a pregnant woman only if clearly
needed. Nonteratogenic Effects: Heparin does not cross the placental barrier.<br/>Nursing Mothers:: Heparin is not excreted in human milk.<br/>Pediatric Use:: Safety and effectiveness of the 100 USP Units/mL Heparin
Lock Flush Solution, USP, in pediatric patients have not been established.<br/>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).
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Heparin Sodium
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Heparin (Injection, Solution)
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Heparin Lock Flush Solution is not known to cause adverse
local or systemic effects of any kind. Although a remote possibility of hypersensitivity
reaction exists with entry of extremely small subtherapeutic amounts of the
solution into the circulation, such an occurrence has not been reported.
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Heparin Lock Flush Solution, USP is not intended for intramuscular
use, systemic anticoagulation or injection by any parenteral route of administration.
Repeated flushing of a catheter device with the Heparin 100 USP Units/mL may
result in a systemic anticoagulant effect. 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: If the coagulation
test is unduly prolonged or if hemorrhage occurs, heparin sodium should be
discontinued promptly. Heparin solutions having a concentration of 100 USP
Heparin Units/mL will alter the results of blood coagulation tests. 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/mmor
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. 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.
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Heparin Lock Flush Solution, USP is indicated only to maintain
patency of an intravenous injection device. It may be used following initial
placement of the device in the vein, after each injection of a medication
or after withdrawal of blood for laboratory analysis. The
solution is not to be used for anticoagulation therapy. To
prevent clot formation in a central venous catheter or peripherally-inserted
central venous catheter following its proper insertion, Heparin Lock Flush
Solution, 100 Units/mL is injected into the catheter (or into each unused
lumen of a multiple-lumen catheter) in a quantity sufficient to fill the entire
catheter or lumen of a multiple-lumen catheterto the tip (see catheter manufacturer's
labeling for specific catheter lumen volumes). This solution should be replaced
each time the catheter (or catheter lumen in a multiple lumen catheter) is
used. Aspirate before administering any solution in order to confirm catheter
patency. If the drug to be administered is incompatible with heparin, the
entire catheter or catheter lumen should be flushed with sterile water or
normal saline before and after the medication is administered. Following the
second flush,Heparin Lock Flush Solution may be reinstilled into the set.
The catheter manufacturer's instructions should be consulted for specifics
concerning the catheter in use at a given time.
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Heparin
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