Monograph Details
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Hematology
> Thromboembolic disorders
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FRAGMIN |
| Manufacturer |
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Eisai Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Low molecular weight heparin. |
| Generic Name |
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Dalteparin sodium 2500 IU/0.2 mL syringe, 5000 IU/0.2 mL syringe, 7500 IU/0.3 mL syringe, 10000 IU/0.4 mL syringe, 10000 IU/1 mL graduated syringe, 12500 IU/0.5 mL syringe, 15000 IU/0.6 mL syringe, 18000 IU/0.72 mL syringe for SC inj (preservative-free); 10000 IU/1 mL, 25000 IU/1 mL multidose vial, for SC inj (contains benzyl alcohol). |
| Indications |
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Prevention of ischemic complications in unstable angina and non-Q-wave MI with aspirin. Prevention of DVT in patients undergoing hip replacement or abdominal surgery or those with severely restricted mobility during acute illness at risk for thromboembolic complications. Extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or pulmonary embolism), to reduce the recurrence of VTE in cancer patients. |
| Children |
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Not recommended. |
| Adults |
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Give deep SC; rotate inj sites. Angina, MI: 120 IU/kg (max 10000 IU) every 12 hrs until stabilized (usually 5–8 days), with aspirin 75–165 mg once daily. Hip replacement, post-op start: 2500 IU 4–8 hrs after surgery, then 5000 IU once daily (at least 6 hrs after 1st dose); hip replacement, pre-op start day of surgery: 2500 IU within 2 hrs before surgery, then 2500 IU 4–8 hrs after surgery, then 5000 IU once daily (at least 6 hrs after previous dose); hip replacement pre-op evening before surgery: 5000 IU 10–14 hrs before surgery, then 5000 IU 4–8 hrs after surgery, then 5000 IU once daily (allow 24 hrs between doses); for all hip replacement regimens: usually treat for 5–10 days; max up to 14 days post-op. Abdominal surgery: 2500 IU once daily (usually for 5–10 days) starting 1–2 hrs pre-op; for high risk of thromboembolism (eg, malignancy): see literature. Severely restricted mobility: 5000 IU once daily (usually for 12–14 days). Extended treatment of symptomatic VTE in patients with cancer: 200 IU/kg once daily for the first 30 days, then 150 IU/kg once daily for months 2–6; max daily dose 18000 IU; dose reductions for thrombocytopenia or renal insufficiency: see literature. |
| Contraindications |
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Active major bleeding. Not for use in unstable angina, non-Q-wave MI, or cancer patients undergoing regional anesthesia. Thrombocytopenia associated with (+) in vitro tests for anti-platelet antibody in presence of dalteparin. Heparin or pork allergy. |
| Precautions |
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Not interchangeable (unit-for-unit) with heparin or other low molecular weight heparin products. Neuraxial anesthesia or spinal puncture (esp. with indwelling epidural catheters, drugs that affect hemostasis, traumatic or repeated epidural or spinal puncture) increase risk of epidural or spinal hematoma; monitor for neurological impairment. Hemorrhage risk. Bleeding diathesis. Thrombocytopenia (esp. heparin-induced). Platelet dysfunction or defects. Severe renal or hepatic insufficiency. Retinopathy. Recent GI bleeding. Pregnancy (Cat.B; do not use multidose vial). Nursing mothers. |
| Interactions |
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Caution with oral anticoagulants, platelet inhibitors, thrombolytics. |
| Adverse Reactions |
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Inj site pain, hematoma, hemorrhage; rare: anaphylaxis, rash, fever, thrombocytopenia. |
| How Supplied |
Prefilled syringes (w. needle)—10
10000 IU/mL (9.5mL multidose vial)—1 (95000 IU/vial)
25000 IU/mL (3.8mL multidose vial)—1 (95000 IU/vial) |
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