Dosing & Uses
Product discontinued in the United States
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Pain, local (16%)
Irritation, local (16%)
Increased LFT's, asymptomatic (9-13%)
Urinary tract infection (4%)
Pulmonary embolism (2%)
Chest pain (2%)
Back pain (1.5%)
General pain (1.5%)
Granulocytopenic disorder (rare)
Hematoma, spinal/epidural (rare)
Black Box Warnings
Epidural or spinal hematomas may occur in patients anticoagulated with LMWH or heparinoids who receive neuraxial (epidural/spinal) anesthesia or spinal puncture
These hematomas may result in long-term or permanent paralysis
Patients should be frequently monitored for signs and symptoms of neurologic impairment
If neurological compromise is noted, urgent treatment is necessary
Physicians should consider the benefits versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
Factors increasing risk of epidural or spinal hematomas
- Indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
- History of traumatic or repeated epidural or spinal punctures
- History of spinal deformity or spinal surgery
Active major bleeding, heparin-induced thrombocytopenia
Hypersensitivity to heparin, sulfites, benzyl alcohol, pork products
May increase risk for death compared to UHF when used to treat elderly patients with renal insufficiency
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known if excreted in breast milk
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Half-life: 3-4 hr
Peak plasma time: 4-5 hr
Peak plasma concentration: 0.87 IU/mL
Vd: 3.1-5.0 L
Clearance: 1.7 L/hr
Mechanism of Action
LMW heparin, anti-Factor Xa & IIa