Dalteparin

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Fragmin; Belgium: Fragmin; Bulgaria: Fragmin; Cyprus: Fragmin; Czech Republic: Fragmin; Denmark: Fragmin; Estonia: Fragmin; Finland: Fragmin; France: Fragmine; Germany: Fragmin; Greece: Fragmin; Hungary: Fragmin; Ireland: Fragmin; Italy: Fragmin; Latvia: Fragmin; Lithuania: Fragmin; Luxembourg: Fragmin; Netherlands: Fragmin; Poland: Fragmin; Portugal: Fragmin; Romania: Fragmin; Slovakia: Fragmin; Slovenia: Fragmin; Spain: Fragmin; Sweden: Fragmin; UK: Fragmin.

North America

Canada: Fragmin; USA: Fragmin.

Latin America

Argentina: Ligofragmin.

Asia

Japan: Daltepan, Dalteparin, Fluzepamin, Fragmin, Fresubaru, Hepachron, Hepagumin, Resolmin.

Drug combinations

Chemistry

Dalteparin Sodium: Mw: 5000 (average), 90% ranges 2000-9000. Sodium salt of depolymerized heparin obtained by nitrous acid degradation of heparin from pork intestinal mucosa. The majority of the components have a 2-O-sulfo-α-L-idopyranosuronic acid structure at the non-reducing end and a 6-O-sulfo-2,5-anhydro-D-mannitol structure at the reducing end of their chain. The degree of sulfation is 2 to 2.5 per disaccharide unit. CAS-9041-08-1 (1993).

Pharmacologic Category

Antithrombotic Agents; Anticoagulants; Heparins. Low Molecular Weight Heparin. (ATC-Code: B01AB04).

Mechanism of action

Inhibits both factor Xa and factor IIa (thrombin). The antithrombotic effect is characterized by a higher ratio of antifactor Xa to antifactor IIa activity.

Therapeutic use

Thrombosis in abdominal surgery. Prevention of deep vein thrombosis in hip-replacement surgery. Immobile patients during acute illness. Acute treatment of unstable angina or non-Q-wave MI. Prevention of ischemic complications in aspirin therapy, cancer, and venous thromboembolism.

Pregnancy and lactiation implications

Multiple-dose vials contain benzyl alcohol (avoid use in pregnant women). Adverse effects not observed in animal studies. Use during pregnancy only if clearly needed. Caution during lactation.

Unlabeled use

Active treatment of deep vein thrombosis (noncancer patients).

Contraindications

Hypersensitivity to dalteparin or any component of the formulation. Thrombocytopenia associated with a positive in vitro test for antiplatelet antibodies. Hypersensitivity to heparin or pork products. Patients with active major bleeding. Patients with unstable angina, non-Q-wave MI, or acute venous thromboembolism undergoing regional anesthesia. Not for I.M. or I.V. use.

Warnings and precautions

Risk of bleeding (risk factors include bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative or angiodysplastic gastrointestinal diseases, severe uncontrolled hypertension, hemorrhagic stroke, or use shortly after brain, spinal, or ophthalmologic surgery). Can cause hyperkalemia by affecting aldosterone. Caution in hypersensitivity to methylparaben or propylparaben. Rare cases of thrombocytopenia (use with extreme caution in history of heparin-induced thrombocytopenia) or thrombocytopenia with thrombosis (use caution in congenital or drug-induced thrombocytopenia or platelet defects) have occurred. Cancer patients with thrombocytopenia may require dose adjustments for treatment of acute venous thromboembolism. Caution in severe renal failure (not studied). Multidose vials may contain benzyl alcohol and should not be used in pregnant women. In neonates, large amounts of benzyl alcohol (>100 mg/kg/day) have been associated with fatal toxicity («gasping syndrome»). Not interchangeable with heparin or any other low molecular weight heparins. Patients with recent neuraxial anesthesia are at risk of spinal or epidural hematoma and subsequent paralysis (risk is increased by concomitant agents which may alter hemostasis, as well as traumatic or repeated epidural or spinal puncture).

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