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All about: Dalteparin Sodium

Big Image Pronouncation: (dal-TE-pa-rin SO-dee-um)
Class: Low molecular weight heparin (LMWH)

Trade Names:
Fragmin
- Injection 2,500 units (16 mg per 0.2 mL)
- Injection 5,000 units (32 mg per 0.2 mL)
- Injection 7,500 units (48 mg per 0.3 mL)
- Injection 10,000 units (64 mg per mL)
- Injection 12,500 units (80 mg per 0.5 mL)
- Injection 15,000 units (96 mg per 0.6 mL)
- Injection 18,000 units (115.2 mg per 0.72 mL) in prefilled syringes
- Injection 95,000 units per 3.8 mL (160 mg per mL)
- Injection 95,000 units per 9.5 mL (64 mg per mL) in multiple-dose vials

Mechanism of Action

Pharmacology

Inhibits reactions that lead to clotting.

Pharmacokinetics

Absorption

Bioavailability is approximately 87%.

T max is approximately 4 h.

Distribution

Vd is 40 to 60 mL/kg.

Elimination

Subcutaneous

The t ½ is 3 to 5 h.

Indications and Usage

Prophylaxis of ischemic complications in unstable angina and non–Q-wave MI in patients on aspirin therapy; prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients undergoing hip replacement surgery, in patients undergoing abdominal surgery who are at risk for thromboembolic complications, or in patients who are at risk of thromboembolic complications due to severely restricted mobility during acute illness; extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE) to reduce recurrence of VTE in patients with cancer.

Contraindications

Active major bleeding; thrombocytopenia associated with positive in vitro tests for antiplatelet antibody; patients undergoing regional anesthesia for unstable angina or non–Q-wave MI; hypersensitivity to heparin or pork products or to any component of the product. Patients with cancer undergoing anesthesia should not receive dalteparin for extended treatment of symptomatic VTE.

Dosage and Administration

Unstable Angina/Non–Q-Wave MI
Adults

Subcutaneous 120 units/kg of body weight (max, 10,000 units) every 12 h with aspirin (75 to 165 mg/day, unless contraindicated) therapy. Continue treatment until patient is clinically stabilized, usually 5 to 8 days.

DVT Prophylaxis (Hip Replacement Surgery)
Adults

Subcutaneous If started postoperatively, 2,500 units within 4 to 8 h after surgery, followed by 5,000 units/day for 5 to 10 days; if started preoperatively on day of surgery, 2,500 units within 2 h before surgery, followed by 2,500 units 4 to 8 h after surgery and continued at 5,000 units/day for 5 to 10 days; if started preoperatively on the evening before surgery, 5,000 units 10 to 14 h before surgery, followed by 5,000 units 4 to 8 h after surgery and continued at 5,000 units/day for 5 to 10 days.

DVT Prophylaxis (Abdominal Surgery)
Adults

Subcutaneous 2,500 units starting 1 to 2 h before surgery and continuing every day for 5 to 10 days.

Medical Patients With Severely Restricted Mobility During Acute Illness
Adults

Subcutaneous 5,000 units/day for 12 to 14 days.

Extended Treatment of Symptomatic Venous Thromboembolism in Cancer Patients
Adults

Subcutaneous For the first 30 days of treatment, give 200 units/kg once daily (max, 18,000 units/day). Months 2 to 6: Administer 150 units/kg once daily (max, 18,000 units/day).

In patients with platelet counts between 50,000 and 100,000/mm 3 , reduce dose to 2,500 units once daily until platelet count recovers to at least 100,000 units/mm 3 . In patients who experience platelet counts below 50,000 units/mm 3 , discontinue dalteparin until platelet count recovers to 50,000 units/mm 3 .

In patients with severe renal function impairment (CrCl less than 30 mL/min), monitor for anti-Xa levels to determine dalteparin dose. Target anti-Xa range is 0.5 to 1.5 units/mL. Sampling should be performed 4 to 6 h after dosing and only after 3 to 4 doses have been given.

General Advice

  • Do not administer by IM injection.
  • Vary injection site daily.
  • Do not mix with other injections or infusions until compatibility is determined.
  • Inspect all preparations for particulate matter prior to administration.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Anticoagulants, platelet inhibitors, and thrombolytic agents

Increased risk of bleeding.

Laboratory Test Interactions

Aminotransferase (AST and ALT)

Dalteparin caused increased concentrations.

Adverse Reactions

Cardiovascular

Thrombocytopenia.

Dermatologic

Alopecia, skin necrosis (postmarketing).

Genitourinary

Hematuria (3%).

Hematologic-Lymphatic

Any bleeding event (19%); major bleeding events (6%).

Local

Injection-site hematoma (5%); wound hematoma (3%); injection-site pain (at least 2%).

Miscellaneous

Allergic reactions, including pruritus, rash, fever, injection-site reaction, or bullous eruption; anaphylactoid reactions.

Precautions

Warnings

Spinal/Epidural hematomas

Risk of spinal/epidural hematoma, which can result in long-term or permanent paralysis, is increased in patients receiving neuraxial anesthesia or spinal puncture who are anticoagulated with LMWHs or heparinoids. Other risk factors include indwelling epidural catheters, repeated/traumatic epidural/spinal puncture, or use of other drugs affecting hemostasis (eg, NSAIDs, platelet inhibitors, anticoagulants). Frequently monitor for signs or symptoms of neurological impairment.


Monitor

Periodic routine CBC, including platelet count, blood chemistry, and stool occult blood tests, is recommended; anticoagulant effect can be monitored by using anti-factor Xa in patients with severe renal function impairment or if abnormal coagulation parameters or bleeding occur.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Thrombocytopenia

Use very cautiously in patients with history of heparin-induced thrombocytopenia.

Interchangeability with heparin

Cannot be exchanged on a unit-per-unit basis with other types of heparin.

Bleeding risk

Avoid use in patients at risk for bleeding (eg, severe hypertension, severe liver or kidney disease, platelet defects, recent GI bleeding) or shortly after brain, spinal, or ophthalmological surgery.

Benzyl alcohol

The multiple-dose vial of dalteparin contains benzyl alcohol as a preservative, which has been associated with fatal “gasping syndrome” in premature infants.

Overdosage

Symptoms

Hemorrhagic complications.

Patient Information

  • Instruct patient to immediately report any signs of bleeding.

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