Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1941
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Hep-Lock U/P (Injection)
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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. Preservative-Free
Heparin Lock Flush Solution in the 100 unit/mL concentration is not
recommended for use in neonates and infants (see WARNINGS, Use In
Neonates and Infants).<br/>Maintenance Of
Patency Of Intravenous Devices: To prevent
clot formation in a heparin lock set or central venous catheter
following its proper insertion, Heparin Lock Flush Solution, USP
is injected via the injection hub in a quantity sufficient to
fill the entire device. This solution should be replaced each
time the device is used. Aspirate before administering any
solution via the device in order to confirm patency and location
of needle or catheter tip. If the drug to be administered is
incompatible with heparin, the entire device should be flushed
with normal saline before and after the medication is
administered; following the second saline flush, Heparin Lock
Flush Solution, USP may be reinstilled into the device. The
device manufacturer's instructions should be consulted for
specifics concerning its use. Usually this dilute heparin
solution will maintain anticoagulation within the device for up
to 4 hours. NOTE: Since
repeated injections of small doses of heparin can alter tests
for activated partial thromboplastin time (APTT), a baseline
value for APTT should be obtained prior to insertion of an
intravenous device.<br/>Withdrawal Of Blood
Samples: Preservative-Free Heparin Lock Flush Solution, USP may also be
used after each withdrawal of blood for laboratory tests. When
heparin would interfere with or alter the results of blood
tests, the heparin solution should be cleared from the device by
aspirating and discarding it before withdrawing the blood
sample.
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dailymed-instance:descripti... |
Heparin is a
heterogeneous 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. Structural formula
of Heparin Sodium (representative sub-units): HEP-LOCK U/P
(Preservative-Free Heparin Lock Flush Solution, USP) is a sterile
solution for intravenous flush only. It is not to be used for
anticoagulant therapy. HEP-LOCK U/P is specially formulated for use in
situations where the use of preservatives is not advisable. Each mL
contains heparin sodium 10 or 100 USP units, derived from porcine
intestines and standardized for use as an anticoagulant, sodium chloride
8 mg, monobasic sodium phosphate monohydrate 2.3 mg, and dibasic sodium
phosphate anhydrous 0.5 mg in Water for Injection. pH 5.0-7.5. The
potency is determined by biological assay using a USP reference standard
based on units of heparin activity per milligram.
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dailymed-instance:clinicalP... |
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. 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
reticulo-endothelial system are the sites of biotransformation. The
biphasic elimination curve, a rapidly declining alpha phase
(t= 10 min), 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. 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.
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Heparin sodium
should NOT be used in patients with the following conditions: severe
thrombocytopenia; an uncontrollable active bleeding state , except when this is due to disseminated
intravascular coagulation.
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dailymed-instance:supply |
HEP-LOCK U/P (Preservative-Free Heparin Lock Flush Solution, USP) 10 USP units/mL 1 mL DOSETTE vials
packaged in 25s (NDC 0641-0272-25) 100 USP units/mL 1 mL DOSETTE vials
packaged in 25s (NDC 0641-0273-25)<br/>Storage: Store at 20��-25��C (68��-77��F) [see USP
Controlled Room Temperature].
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dailymed-instance:precautio... |
General: Precautions
must be exercised when drugs that are incompatible with heparin
are administered through an indwelling intravenous catheter
containing Preservative-Free Heparin Lock Flush Solution. (SeeDOSAGE AND
ADMINISTRATION, Maintenance of Patency of Intravenous
Devices.) The concentration of phosphorus in the
heparin solution is 0.63 mg/mL.<br/>Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT)
and Heparin-induced Thrombocytopenia and Thrombosis (HITT): SeeWARNINGS<br/>Increased
Risk to Older Patients, Especially Women: A
higher incidence of bleeding has been reported in
patients, particularly women, over 60 years of
age.<br/>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/>Drug Interactions:<br/>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.<br/>Other
Interactions: Digitalis, tetracyclines, nicotine or antihistamines
may partially counteract the anticoagulant action of
heparin sodium.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility: No
long-term studies in animals have been performed to evaluate
carcinogenic potential of heparin sodium. Also, no reproduction
studies in animals have been performed concerning mutagenesis or
impairment of fertility.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>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 in pediatric patients have not been established
(see WARNINGS,
Use in Neonates and Infants).<br/>Geriatric Use: A higher
incidence of bleeding has been reported in patients over 60
years of age, especially women (see CLINICAL
PHARMACOLOGY and PRECAUTIONS, General).
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dailymed-instance:overdosag... |
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 consult the labeling of Protamine Sulfate
Injection, USP products.
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dailymed-instance:genericMe... |
heparin sodium
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dailymed-instance:fullName |
Hep-Lock U/P (Injection)
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dailymed-instance:adverseRe... |
Hemorrhage: Hemorrhage
is the chief complication that may result from heparin use (seeWARNINGS,
Hemorrhage). An overly prolonged clotting time or
minor bleeding during therapy can usually be controlled by
withdrawing the drug .<br/>Thrombocytopenia,
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and
HITT: SeeWARNINGS.<br/>Local Irritation: Local
irritation and erythema have been reported with the use of
Heparin Lock Flush Solution.<br/>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 side of
the feet, may occur. Thrombocytopenia has been reported to occur in patients
receiving heparin with a reported incidence of up 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. 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.
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Heparin is not
intended for intramuscular use.<br/>Hypersensitivity: Patients
with documented hypersensitivity to heparin should be given the
drug only in clearly life-threatening situations. (See ADVERSE
REACTIONS, Hypersensitivity.)<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 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:<br/>Cardiovascular: Subacute bacterial endocarditis, severe
hypertension.<br/>Surgical: During and immediately following (a) spinal tap or
spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.<br/>Hematologic: Conditions associated with increased bleeding
tendencies, such as hemophilia, thrombocytopenia and
some vascular purpuras.<br/>Gastrointestinal: Ulcerative lesions and continuous tube drainage of the
stomach or small intestine.<br/>Other: Menstruation, liver disease with impaired
hemostasis.<br/>Thrombocytopenia: Thrombocytopenia has been reported to occur in patients
receiving heparin with a reported incidence of up to 30%.
Platelet counts should be obtained at baseline and periodically
during heparin administration. 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 Heparin-induced Thrombocytopenia and Heparin-induced
Thrombocytopenia and Thrombosis), the heparin
product should be discontinued and, if necessary, an alternative
anticoagulant administered.<br/>Heparin-induced
Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and
Thrombosis (HITT): Heparin-induced Thrombocytopenia (HIT) is a serious
antibody-mediated reaction resulting from irreversible
aggregation of platelets. HIT may progress to the development of
venous and arterial thromboses, a condition referred to as
Heparin-induced Thrombocytopenia and Thrombosis (HITT).
Thrombotic events may also be the initial presentation for HITT.
These serious thromboembolic events include deep vein
thrombosis, pulmonary embolism, cerebral vein thrombosis, limb
ischemia, stroke, myocardial infarction, mesenteric thrombosis,
renal arterial thrombosis, skin necrosis, gangrene of the
extremities that may lead to amputation, and possibly death.
Thrombocytopenia of any degree should be monitored closely. If
the platelet count falls below 100,000/mmor if
recurrent thrombosis develops, the heparin product should be
promptly discontinued and alternative anticoagulants considered
if patients require continued anticoagulation.<br/>Delayed Onset of
HIT and HITT: Heparin-induced Thrombocytopenia and Heparin-induced
Thrombocytopenia and Thrombosis can occur up to several weeks
after the discontinuation of heparin therapy. Patients
presenting with thrombocytopenia or thrombosis after
discontinuation of heparin should be evaluated for HIT and
HITT.<br/>Use in Neonates and
Infants: The 100
unit/mL concentration should not be used in neonates or in
infants who weigh less than 10 kg because of the risk of
systemic anticoagulation. Caution is necessary when using the 10
unit/mL concentration in premature infants who weigh less than 1
kg who are receiving frequent flushes since a therapeutic
heparin dose may be given to the infant in a 24-hour
period.
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dailymed-instance:indicatio... |
HEP-LOCK U/P
(Preservative-Free Heparin Lock Flush Solution, USP) is intended to
maintain patency of an indwelling venipuncture device designed for
intermittent injection or infusion therapy or blood sampling. Heparin
Lock Flush Solution 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 tests. (See DOSAGE AND
ADMINISTRATION, Maintenance Of Patency Of Intravenous
Devices for directions for use.) HEP-LOCK U/P is not to be used for
anticoagulant therapy.
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Hep-Lock U/P
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