dalteparin


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dalteparin

 [dal-tep´ah-rin]
an agent used as the sodium salt for prevention of pulmonary thromboembolism and deep venous thrombosis in at-risk abdominal surgery patients.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

dalteparin

(dal-te-pa-rin) ,

Fragmin

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: antithrombotics
Pregnancy Category: B

Indications

Prevention of venous thromboembolism (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) in surgical or medical patients.Extended treatment of symptomatic DVT and/or PE in patients with cancer.Prevention of ischemic complications (with aspirin) in patients with:
  • unstable angina,
  • non–Q-wave MI.

Action

Potentiates the inhibitory effect of antithrombin on Factor Xa and thrombin.

Therapeutic effects

Prevention of thrombus formation.
Decreased incidence of death or recurrent MI.

Pharmacokinetics

Absorption: Well absorbed (87%) after administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 2.1–2.3 hr.

Time/action profile (antithrombotic effect)

ROUTEONSETPEAKDURATION
Subcutrapid4 hrup to 24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to dalteparin, heparin, or pork products; Active major bleeding; Thrombocytopenia related to previous dalteparin therapy.
Use Cautiously in: Patients with severe renal or hepatic impairment; Retinopathy (hypertensive or diabetic); Spinal or epidural anesthesia; Geriatric: Risk of bleeding may be ↑, consider age-related ↓ in renal function and body weight; Obstetric / Lactation / Pediatric: Safety not established; products containing benzyl alcohol should not be used in neonates.
Exercise Extreme Caution in: Spinal/epidural anesthesia or spinal puncture (↑ risk of spinal/epidural hematoma that may lead to long-term or permanent paralysis); Severe uncontrolled hypertension; Bacterial endocarditis, bleeding disorders; GI bleeding/ulceration/pathology; Hemorrhagic stroke; Recent CNS or ophthalmologic surgery; Active GI bleeding/ulceration; History of thrombocytopenia related to heparin.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Gastrointestinal

  • reversible ↑ in liver enzymes

Hematologic

  • bleeding
  • thrombocytopenia

Interactions

Drug-Drug interaction

Risk of bleeding ↑ by concurrent use of thrombolytics, anticoagulants, or agents that affect platelet function including NSAIDS, ticlopidine, clopidogrel, tirofiban, or eptifibatide.

Route/Dosage

DVT Prophylaxis

Subcutaneous (Adults) Abdominal surgery—2500 IU 1–2 hr before surgery, then once daily for 5–10 days; High-risk patients undergoing abdominal surgery—5000 IU evening before surgery, then once daily for 5–10 days or 2500 IU 1–2 hr before surgery, another 2500 IU 12 hour later, then 5000 IU daily for 5–10 days; Hip replacement surgery—2500 IU within 2 hr before surgery, another 2500 IU evening of the day of surgery ≥6 hr after first dose, then 5000 IU daily for 5–10 days (if surgery is in the evening omit second dose day of surgery) or 5000 IU evening before surgery, then 5000 IU daily for 5–10 days.Medical patients with severely restricted mobility: 5000 IU for 12 to 14 days.

Extended Treatment of Symptomatic VTE in Patients with Cancer

Subcutaneous (Adults) 200 IU/kg once daily (not to exceed 18,000 IU/day) for first 30 days, then 150 IU/kg once daily (not to exceed 18,000 IU/day) for months 2–6.

Angina/Non–Q-wave MI

Subcutaneous (Adults) 120 IU/kg (not to exceed 10,000 IU) q 12 hr with concurrent aspirin.

Renal Impairment

Subcutaneous (Adults) Cancer patients receiving extended treatment of symptomatic VTE with CCr <30 mL/min—Monitor anti-Xa levels (target 0.5–1.5 IU/mL).

Availability

Solution for injection (prefilled syringes): 2500 IU/0.2 mL, 5000 IU/0.2 mL, 7500 IU/0.3 mL, 10,000 IU/mL, 12,500 IU/0.5 mL, 15,000 IU/0.6 mL, 18,000 IU/0.72 mL
Solution for injection (multidose vials): 25,000 IU/mL in 3.8–mL vials

Nursing implications

Nursing assessment

  • Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stool; hematuria; fall in hematocrit or BP; guaiac-positive stools). Notify health care professional if these occur.
  • Subcutaneous: Observe injection sites for hematoma, ecchymosis, or inflammation.
  • Lab Test Considerations: Monitor CBC, platelet count, and stools for occult blood periodically during therapy. If thrombocytopenia occurs, monitor closely. If hematocrit ↓ unexpectedly, assess patient for potential bleeding sites.
    • Special monitoring of clotting times (aPTT) is not necessary.
    • May cause asymptomatic ↑ in transaminase levels (AST, ALT).

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Risk for injury (Side Effects)

Implementation

  • First dose is administered 1–2 hr before surgery.
    • Dalteparin cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
  • Subcutaneous: Administer deep subcut while patient is sitting or lying down. Dalteparin may be injected into the abdominal wall inferior and lateral to the umbilicus, the upper outer side of the thigh, or the upper outer quadrant of the buttock. Rotate injection sites daily. Inject entire length of needle at a 45° or 90° angle while lifting and holding skin between thumb and forefinger.
    • Do not administer IM.
  • Syringe Incompatibility: Do not mix with other injections or infusions.

Patient/Family Teaching

  • Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care professional immediately.
  • Instruct patient not to take aspirin or NSAIDs without consulting health care professional while on dalteparin therapy.

Evaluation/Desired Outcomes

  • Prevention of deep vein thrombosis and pulmonary embolism.
  • Prevention of ischemic complications (with aspirin) in patients with unstable angina or non-Q-wave MI.
  • Reduction of recurrence of VTE in patients with cancer.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
The Global Low Molecular Weight Heparin Market, by Drug (Enoxaparin, Dalteparin, Nadroparin, Bemiparin, Tinzaparin, and Others), by Packaging (Multi-vials and Prefilled Syringes), by Application (Deep Vein Thrombosis, Acute Coronary Syndrome (ACS), Pulmonary Embolism and Atrial Fibrillation), by End Use (Hospitals (Private and Public), Clinics, and Home) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) was valued US$ 3,050.4 million in 2018, and is projected to exhibit a CAGR of 6.7% during the forecast period (2018 - 2026) as highlighted in a new report published by Coherent Market Insights.
-- The Food and Drug Administration last month approved Pfizer Inc.'s Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.
The United States Food and Drug Administration (FDA) has granted approval to United States-based Pfizer for the subcutaneous use of Fragmin (dalteparin sodium) injection intended for the treatment of potentially life-threatening blood clots in paediatric patients, it was reported on Friday.
In a large, randomized, placebo-controlled trial of acutely ill medical patients, the LMWH dalteparin (5000 IU subcutaneously once daily) halved the rate of VTE, with a low risk of bleeding [35].
(2001) stated that serum pH and bicarbonate were elevated, but both were less significant than those in the dalteparin arm.
MONDAY, May 21, 2018 (HealthDay News) -- For patients with active cancer and venous thromboembolism (VTE), rivaroxaban is associated with lower VTE recurrence compared with dalteparin, but with elevated clinically relevant non-major bleeding (CRNMB), according to a study published online May 10 in the Journal of Clinical Oncology.
Therefore, current expert consensus supports the combination of aspirin and prophylactic doses of subcutaneous UFH (5000-10000 U every 12 h) or LMWH (i.e., enoxaparin 1 mg/kg or 40-80 mg, dalteparin 5000 U, or nadroparin 3800 U daily) throughout pregnancy for patients with APS associated RPL.
dalteparin 5 000 units daily or nadroparin 2 850 units daily or enoxaparin 40 mg daily are recommended.
Patients in the trial received either dalteparin at a therapeutic dose of 100 IU/kg or a matching placebo administered subcutaneously bid from 3 days before the procedure until 24 hours before the procedure, and then for 5 to 10 days after the procedure.
Gent, "Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery," British Journal of Surgery, vol.
Patient Postoperative Adverse event drug use (1) None Acute pulmonary embolism (2) Carbazochrome Acute splenic 80 mg infarction Vitamin K110 mg Somatostatin 6 mg (3) Carbazochrome Acute cerebral 80 mg infarction Somatostatin 3 mg Hemocoagulase 2 U (4) Hemocoagulase 1IU Acute superior Somatostatin 6 mg mesenteric infarction (5) Hemocoagulase 1 IU Acute cerebral Somatostatin 6 mg infarction Patient Treatment Hospital stay (1) BCLS 1 day (2) Dalteparin 5000 IU 64 days Antibiotics (meropenem + vancomycin) (3) Dalteparin 5000 IU 13 days Edaravone Mannitol Dexamethasone (4) LMWH 4000 IU 9 days Simethicone p.o.