No

Low Molecular Weight Heparin

Prevention of deep vein thrombosis which may lead to pulmonary embolism, in patients requiring abdominal surgery who are at risk for thromboembolism complications (ie, patients >40 years of age, obese, patients with malignancy, history of deep vein thrombosis or pulmonary embolism, and surgical procedures requiring general anesthesia and lasting longer than 30 minutes); prevention of DVT in patients undergoing hip surgery; acute treatment of unstable angina or non-Q-wave myocardial infarction

B

Hypersensitivity to the drug, or thrombocytopenia associated with a positive in vitro test for antiplatelet antibodies in the presence of dalteparin; hypersensitivity to pork products; patient with active major bleeding; not for I.M. or I.V. use

Patients with recent or anticipated neuraxial anesthesia (epidural or spinal anesthesia) are at risk of spinal or epidural hematoma and subsequent paralysis. Consider risk versus benefit prior to neuraxial anesthesia; Risk is increased by concomitant agents which may alter hemostasis, as well as traumatic or repeated epidural or spinal puncture. Patient should be observed closely for bleeding if dalteparin is administered during or immediately following diagnostic lumbar puncture, epidural anesthesia, or spinal anesthesia.

Not to be used interchangeably (unit for unit) with heparin or any other low molecular weight heparins. Cautious use with known hypersensitivity to methylparaben or propylparaben. Cautious use in patient with history of heparin-induced thrombocytopenia. Monitor patient closely for signs or symptoms of bleeding. Certain patients are at increased risk of bleeding. Risk factors include bacterial endocarditis; congenital or acquired bleeding disorders; active ulcerative or angiodysplastic GI diseases; severe uncontrolled hypertension; hemorrhagic stroke; or use shortly after brain, spinal, or ophthalmology surgery; in patient treated concomitantly with platelet inhibitors; recent GI bleeding; thrombocytopenia or platelet defects; severe liver disease; hypertensive or diabetic retinopathy; or in patients undergoing invasive procedures. Cautious use in patients with severe renal failure (has not been studied). Safety and efficacy in pediatric patients have not been established. Rare cases of thrombocytopenia with thrombosis have occurred. Multidose vials contain benzyl alcohol and should not be used in pregnant women. Heparin can cause hyperkalemia by affecting aldosterone. Similar reactions could occur with LMWHs. Monitor for hyperkalemia. Discontinue therapy if platelets are <100,000/mm³.

1% to 10%

Hematologic: Bleeding (2.7% to 4.6%), wound hematoma (0.1% to 3.4%)

Local: Pain at injection site (up to 12%), injection site hematoma (0.2% to 7.1%)

<1% (Limited to important or life-threatening symptoms): Thrombocytopenia (including heparin-induced thrombocytopenia), allergic reaction (fever, pruritus, rash, injections site reaction, bullous eruption), anaphylactoid reaction, injection site hematoma, operative site bleeding, gastrointestinal bleeding, skin necrosis. Spinal or epidural hematomas can occur following neuraxial anesthesia or spinal puncture, resulting in paralysis. Risk is increased in patients with indwelling epidural catheters or concomitant use of other drugs affecting hemostasis, osteoporosis (3-6 month use).

Drugs which affect platelet function (eg, aspirin, NSAIDs, dipyridamole, ticlopidine, clopidogrel) may potentiate the risk of hemorrhage.

Thrombolytic agents increase the risk of hemorrhage.

Warfarin: Risk of bleeding may be increased during concurrent therapy. Dalteparin is commonly continued during the initiation of warfarin therapy to assure anticoagulation and to protect against possible transient hypercoagulability.

Store at temperatures less than or equal to 25°C

Low molecular weight heparin analog with a molecular weight of 4000-6000 daltons; the commercial product contains 3% to 15% heparin with a molecular weight <3000 daltons, 65% to 78% with a molecular weight of 3000-8000 daltons and 14% to 26% with a molecular weight >8000 daltons; while dalteparin has been shown to inhibit both factor Xa and factor IIa (thrombin), the antithrombotic effect of dalteparin is characterized by a higher ratio of antifactor Xa to antifactor IIa activity (ratio = 4)

Onset of action: 1-2 hours

Duration: >12 hours

Peak serum concentrations: 4 hours

Half-life, elimination: 2-5 hours (route dependent)

Adults: S.C.:

High-risk patients undergoing abdominal surgery: 5000 units 1-2 hours prior to surgery and then once daily for 5-10 days postoperatively

Patients undergoing total hip surgery: 2500 units 1-2 hours prior to surgery, then 2500 units 6 hours after surgery (evening of the day of surgery), followed by 5000 units once daily for 7-10 days

Patients with unstable angina or non-Q-wave myocardial infarction: 120 IU/kg body weight (maximum dose: 10,000 IU) every 12 hours for 5-8 days with concurrent aspirin therapy. Discontinue dalteparin once patient is clinically stable.

Periodic CBC including platelet count; stool occult blood tests; monitoring of PT and PTT is not necessary

LMWHs compare favorably to unfractionated heparin in the prevention and treatment of venous thromboembolism. LMWHs are associated with less thrombocytopenia, compared to heparin, and do not require routine therapeutic monitoring. There is no consensus for adjusting/correcting the weight-based dosage of LMWH for patients who are morbidly obese or very lean. Monitoring of antifactor Xa concentration may be warranted in patients who weigh <50 kg or >90 kg and in those patients with renal insufficiency.

None reported

None reported

No information available to require special precautions

No effects or complications reported

This drug can only be administered by injection. You may have a tendency to bleed easily while taking this drug; brush teeth with soft brush, floss with waxed floss, use electric razor, avoid scissors or sharp knives and potentially harmful activities. Report unusual fever; unusual bleeding or bruising (bleeding gums, nosebleed, blood in urine, dark stool); pain in joints or back; severe head pain; skin rash; or redness, swelling, or pain at injection site. Breast-feeding precautions: Consult prescriber if breast-feeding.

Injection:

Multidose vial: 95,000 international units

Harenberg J, "Pharmacology of Low Molecular Weight Heparins," Semin Thromb Hemost, 1990, 16(Suppl):12-8.

Simoneau G, Bergmann JF, Kher A, et al, "Pharmacokinetics of a Low Molecular Weight Heparin (Fragmin®) in Young and Elderly Subjects," Thromb Res, 1992, 66(5):603-7.

Thomas DP, "Bleeding After Low-Molecular Weight Heparin," Lancet, 1992, 339(8801):1119.

Verstraete M, "Pharmacotherapeutic Aspects of Unfractionated and Low Molecular Weight Heparins," Drugs, 1990, 40(4):498-530.