dalteparin sodium

Fragmin

FDA Box Warning

Epidural or spinal hematomas may occur in patients who are anticoagulated with low-molecular-weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Risk increases with use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis (such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, or other anticoagulants), traumatic or repeated epidural or spinal puncture, or history of spinal deformity or spinal surgery.

Monitor patient frequently for signs and symptoms of neurologic impairment. If these occur, provide urgent treatment.

Consider benefits and risks before neuraxial intervention in patients anti-coagulated or to be anticoagulated for thromboprophylaxis.

Action

Inhibits thrombus and clot formation by blocking factor Xa and thrombin

Availability

Solution for injection (prefilled syringes): 12,500 units/0.5 ml, 15,000 units/0.6 ml, 18,000 units/0.72 ml, 5,000 units/0.2 ml, 7,500 units/0.3 ml, 10,000 units/0.4 ml

Solution for injection (multidose vials): 95,000 units/3.8 ml, 95,000 units/9.5 ml

Solution for injection (single-dose graduated syringe): 10,000 units/1 ml

Indications and dosages

➣ Extended treatment of symptomatic venous thromboembolism (VTE), including proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) to reduce recurrence of VTE in patients with cancer

Adults: Recommended dosing: for first 30 days of treatment, give 200 international units/kg total body weight subcutaneously once daily. Give at dose of approximately 150 international units/kg subcutaneously once daily during months 2 through 6. Safety and efficacy beyond 6 months not established. Total daily dose shouldn't exceed 18,000 international units.

➣ To prevent DVT, which can lead to PE in patients undergoing hip and abdominal surgery who are at risk for thromboembolic complications

Adults: Abdominal surgery-2,500 international units subcutaneously 1 to 2 hours before surgery; then once daily for 5 to 10 days. For high-risk patients, 5,000 international units subcutaneously on evening before surgery; then once daily for 5 to 10 days. For cancer patients, 2,500 international units subcutaneously 1 to 2 hours before surgery; repeat dose 12 hours later, then give 5,000 international units subcutaneously every day for 5 to 10 days.

Hip replacement surgery-5,000 international units subcutaneously 10 to 14 hours before surgery; repeat dose 4 to 8 hours after surgery, then give 5,000 international units daily for 5 to 10 days. Or, 2,500 international units subcutaneously within 2 hours before surgery, followed by 2,500 international units subcutaneously 4 to 8 hours after surgery (allowing at least 6 hours between doses), followed by 5,000 international units subcutaneously daily for 5 to 10 days. Or, 2,500 international units subcutaneously 4 to 8 hours after surgery, followed by 5,000 international units subcutaneously daily for 5 to 10 days.

➣ Patients with severely restricted mobility during acute illness

Adults: 5,000 international units subcutaneously daily for 12 to 14 days

➣ Extended treatment of symptomatic venous thromboembolism in patients with cancer

Adults: For first 30 days of treatment, 200 international units/kg subcutaneously daily. Total daily dosage shouldn't exceed 18,000 international units. Give approximately 150 international units/kg subcutaneously daily during months 2 through 6. Total daily dosage shouldn't exceed 18,000 international units.

➣ To prevent ischemic complications in patients with unstable angina and non-Q-wave myocardial infarction

Adults: 120 international units/kg (not to exceed 10,000 international units) subcutaneously q 12 hours (concurrently with aspirin P.O.) for 5 to 8 days

Dosage adjustment

• Renal insufficiency

• Thrombocytopenia

Off-label uses

• Systemic anticoagulation

Contraindications

• Hypersensitivity to drug, heparin, pork products, sulfites, or benzyl alcohol

• Active major bleeding

• Thrombocytopenia

• Patients with unstable angina or non-Q-wave myocardial infarction who are undergoing regional anesthesia; cancer patients with symptomatic VTE who are undergoing regional anesthesia

Precautions

Use cautiously in:

• bacterial endocarditis, bleeding disorders, hemorrhagic stroke, severe uncontrolled hypertension, GI ulcer, severe renal or hepatic insufficiency, hypertensive or diabetic retinopathy

• history of thrombocytopenia from heparin use

• history of congenital or acquired bleeding disorder

• recent CNS or ophthalmologic surgery

• recent GI disease

• spinal or epidural anesthesia

• pregnant or breastfeeding patients

• children (safety not established).

Administration

Know that dalteparin sodium is a high-alert drug.

Administer by subcutaneous route only. Don't give by I.M. or I.V. route.

• To minimize bruising at injection site, massage site with ice before giving injection.

• To give subcutaneous injection, have patient either sit up or lie down. Inject in U-shaped area around navel, upper outer side of thigh, or upper outer quadrangle of buttock. Rotate injection sites daily.

• Don't use interchangeably with heparin or other low-molecular-weight heparins.

Adverse reactions

Hematologic: anemia, ecchymosis, bleeding, thrombocytopenia, hemorrhage

Skin: rash, urticaria

Other: pain, irritation, and hematoma at injection site; fever; edema

Interactions

Drug-drug. Antiplatelet drugs (aspirin, clopidogrel, dipyridamole, ticlopidine), thrombolytics, warfarin: increased risk of bleeding

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels

Platelets: decreased count

Drug-herbs. Anise, arnica, chamomile, clove, feverfew, garlic, ginger, ginkgo, ginseng: increased risk of bleeding

Patient monitoring

Monitor patient for increased risk of bleeding if he's receiving concomitant drugs that affect platelet function.

• Monitor CBC and platelet count.

• Monitor stools for occult blood.

Patient teaching

• Teach patient proper injection technique if self-administering at home.

• Tell patient that drug may cause him to bleed easily. To avoid injury, advise him to brush teeth with soft toothbrush, use electric razor, and avoid scissors and sharp knives.

Advise patient to immediately report bleeding, bruising, dizziness, light-headedness, itching, rash, fever, swelling, or difficulty breathing.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

dalteparin sodium

A low molecular weight HEPARIN used to treat acute deep vein thrombosis. The drug is given by subcutaneous injection to adults only in a single daily dose calculated on the basis of body weight. A brand name is Fragmin.

单词	dalteparin sodium
释义	dalteparin sodium dalteparin sodium Fragmin FDA Box Warning Epidural or spinal hematomas may occur in patients who are anticoagulated with low-molecular-weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Risk increases with use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis (such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, or other anticoagulants), traumatic or repeated epidural or spinal puncture, or history of spinal deformity or spinal surgery. Monitor patient frequently for signs and symptoms of neurologic impairment. If these occur, provide urgent treatment. Consider benefits and risks before neuraxial intervention in patients anti-coagulated or to be anticoagulated for thromboprophylaxis. Action Inhibits thrombus and clot formation by blocking factor Xa and thrombin Availability Solution for injection (prefilled syringes): 12,500 units/0.5 ml, 15,000 units/0.6 ml, 18,000 units/0.72 ml, 5,000 units/0.2 ml, 7,500 units/0.3 ml, 10,000 units/0.4 ml Solution for injection (multidose vials): 95,000 units/3.8 ml, 95,000 units/9.5 ml Solution for injection (single-dose graduated syringe): 10,000 units/1 ml Indications and dosages ➣ Extended treatment of symptomatic venous thromboembolism (VTE), including proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) to reduce recurrence of VTE in patients with cancer Adults: Recommended dosing: for first 30 days of treatment, give 200 international units/kg total body weight subcutaneously once daily. Give at dose of approximately 150 international units/kg subcutaneously once daily during months 2 through 6. Safety and efficacy beyond 6 months not established. Total daily dose shouldn't exceed 18,000 international units. ➣ To prevent DVT, which can lead to PE in patients undergoing hip and abdominal surgery who are at risk for thromboembolic complications Adults: Abdominal surgery-2,500 international units subcutaneously 1 to 2 hours before surgery; then once daily for 5 to 10 days. For high-risk patients, 5,000 international units subcutaneously on evening before surgery; then once daily for 5 to 10 days. For cancer patients, 2,500 international units subcutaneously 1 to 2 hours before surgery; repeat dose 12 hours later, then give 5,000 international units subcutaneously every day for 5 to 10 days. Hip replacement surgery-5,000 international units subcutaneously 10 to 14 hours before surgery; repeat dose 4 to 8 hours after surgery, then give 5,000 international units daily for 5 to 10 days. Or, 2,500 international units subcutaneously within 2 hours before surgery, followed by 2,500 international units subcutaneously 4 to 8 hours after surgery (allowing at least 6 hours between doses), followed by 5,000 international units subcutaneously daily for 5 to 10 days. Or, 2,500 international units subcutaneously 4 to 8 hours after surgery, followed by 5,000 international units subcutaneously daily for 5 to 10 days. ➣ Patients with severely restricted mobility during acute illness Adults: 5,000 international units subcutaneously daily for 12 to 14 days ➣ Extended treatment of symptomatic venous thromboembolism in patients with cancer Adults: For first 30 days of treatment, 200 international units/kg subcutaneously daily. Total daily dosage shouldn't exceed 18,000 international units. Give approximately 150 international units/kg subcutaneously daily during months 2 through 6. Total daily dosage shouldn't exceed 18,000 international units. ➣ To prevent ischemic complications in patients with unstable angina and non-Q-wave myocardial infarction Adults: 120 international units/kg (not to exceed 10,000 international units) subcutaneously q 12 hours (concurrently with aspirin P.O.) for 5 to 8 days Dosage adjustment • Renal insufficiency • Thrombocytopenia Off-label uses • Systemic anticoagulation Contraindications • Hypersensitivity to drug, heparin, pork products, sulfites, or benzyl alcohol • Active major bleeding • Thrombocytopenia • Patients with unstable angina or non-Q-wave myocardial infarction who are undergoing regional anesthesia; cancer patients with symptomatic VTE who are undergoing regional anesthesia Precautions Use cautiously in: • bacterial endocarditis, bleeding disorders, hemorrhagic stroke, severe uncontrolled hypertension, GI ulcer, severe renal or hepatic insufficiency, hypertensive or diabetic retinopathy • history of thrombocytopenia from heparin use • history of congenital or acquired bleeding disorder • recent CNS or ophthalmologic surgery • recent GI disease • spinal or epidural anesthesia • pregnant or breastfeeding patients • children (safety not established). Administration Know that dalteparin sodium is a high-alert drug. Administer by subcutaneous route only. Don't give by I.M. or I.V. route. • To minimize bruising at injection site, massage site with ice before giving injection. • To give subcutaneous injection, have patient either sit up or lie down. Inject in U-shaped area around navel, upper outer side of thigh, or upper outer quadrangle of buttock. Rotate injection sites daily. • Don't use interchangeably with heparin or other low-molecular-weight heparins. Adverse reactions Hematologic: anemia, ecchymosis, bleeding, thrombocytopenia, hemorrhage Skin: rash, urticaria Other: pain, irritation, and hematoma at injection site; fever; edema Interactions Drug-drug. Antiplatelet drugs (aspirin, clopidogrel, dipyridamole, ticlopidine), thrombolytics, warfarin: increased risk of bleeding Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels Platelets: decreased count Drug-herbs. Anise, arnica, chamomile, clove, feverfew, garlic, ginger, ginkgo, ginseng: increased risk of bleeding Patient monitoring Monitor patient for increased risk of bleeding if he's receiving concomitant drugs that affect platelet function. • Monitor CBC and platelet count. • Monitor stools for occult blood. Patient teaching • Teach patient proper injection technique if self-administering at home. • Tell patient that drug may cause him to bleed easily. To avoid injury, advise him to brush teeth with soft toothbrush, use electric razor, and avoid scissors and sharp knives. Advise patient to immediately report bleeding, bruising, dizziness, light-headedness, itching, rash, fever, swelling, or difficulty breathing. • As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above. dalteparin sodium A low molecular weight HEPARIN used to treat acute deep vein thrombosis. The drug is given by subcutaneous injection to adults only in a single daily dose calculated on the basis of body weight. A brand name is Fragmin.
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