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Drugs reference index «Enoxaparin Sodium»

Enoxaparin Sodium
Enoxaparin Sodium


Enoxaparin Sodium

Pronunciation: (ee-nox-AP-a-rin SO-dee-um)Class: Low molecular weight heparin (LMWH)

Trade Names:Lovenox- Injection 30 mg per 0.3 mL- Injection 40 mg per 0.4 mL- Injection 60 mg per 0.6 mL- Injection 80 mg per 0.8 mL- Injection 100 mg/mL- Injection 120 mg per 0.8 mL- Injection 150 mg/mL- Injection 300 mg per 3 mL

Lovenox HP (Canada)

Pharmacology

Causes higher anti-factor Xa to antithrombin activities (anti-factor IIa) ratio than heparin, which may prevent thrombosis.

Pharmacokinetics

Absorption

Bioavailability is 92%.

Distribution

Vd is approximately 6 L (for anti-factor Xa activity).

Metabolism

Metabolized in the liver by desulfation and/or depolymerization to low molecular weight species.

Elimination

Cl is approximately 15 mL/min. The t ½ is 4.5 h (based on anti-factor Xa activity).

Peak

3 to 5 h.

Special Populations

Renal Function Impairment

Cl is approximately 30% lower in those with severe renal function impairment (CrCl less than 30 mL/min).

Gender

Apparent clearance and maximum observed activity derived from anti-Factor Xa values following subcutaneous dosing were slightly higher in males than in females.

Weight

Mean AUC of anti-Factor Xa activity is marginally higher at steady state in obese healthy patients.

Indications and Usage

Prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery or abdominal surgery; in conjunction with warfarin for inpatient treatment of acute DVT with or without PE, or outpatient treatment of acute DVT without PE; prevention of ischemic complications of unstable and non–Q-wave MI when coadministered with aspirin. In medical patients who are at risk for thromboembolic complications because of severely restricted mobility during acute illness.

Treatment of acute ST-segment elevation MI (STEMI).

Contraindications

Hypersensitivity to enoxaparin, heparin, benzyl alcohol, or pork products; active major bleeding; thrombocytopenia associated with positive in vitro test for antiplatelet antibody in presence of enoxaparin.

Dosage and Administration

Hip or Knee Replacement SurgeryAdults

Subcutaneous 30 mg twice daily, with initial dose given within 12 to 24 h postoperatively, provided hemostasis has been established. Average duration of administration is 7 to 10 days, up to 14 days. For hip replacement surgery, 40 mg every day, given initially 9 to 15 h prior to surgery may be considered; continue prophylaxis for 3 wk.

Abdominal SurgeryAdults

Subcutaneous 40 mg/day with the initial dose given 2 h prior to surgery. Usual duration of administration is 7 to 10 days, up to 12 days.

Acute IllnessAdults

Subcutaneous 40 mg every day for 6 to 11 days, up to 14 days, in patients at risk for thromboembolic complications caused by severely restricted mobility during acute illness.

DVT/PE TreatmentAdults, Outpatient

Subcutaneous 1 mg/kg every 12 h.

Adults, Inpatient

Subcutaneous 1 mg/kg every 12 h or 1.5 mg/kg every day (same time each day).

Adults, Outpatient and Inpatient

Initiate warfarin therapy when appropriate (usually within 72 h of enoxaparin). Continue enoxaparin for a minimum of 5 days and until a therapeutic anticoagulant effect has been achieved. The average duration is 7 days; up to 17 days has been well tolerated.

Unstable Angina/Non–Q-Wave MIAdults

Subcutaneous 1 mg/kg every 12 h in conjunction with oral aspirin therapy (100 to 325 mg every day); usual duration of treatment is 2 to 8 days, up to 12.5 days.

Acute STEMIAdults

IV/Subcutaneous Single IV bolus of 30 mg plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg every 12 hr (max, 100 mg for first 2 doses only, followed by 1 mg/kg dosing for the remaining doses).

Renal Function ImpairmentAdults

Subcutaneous No dosage adjustment is recommended for mild (CrCl 50 to 80 mL/min) or moderate (CrCl 30 to 50 mL/min) impairment. Severe renal function impairment (Crcl less than 30 mL/min):

Prophylaxis in abdominal surgery or hip or knee replacement surgery; prophylaxis in medical patients during acute illness

30 mg subcutaneous once daily.

Inpatient DVT with or without PE in conjunction with warfarin; outpatient treatment of DVT without PE in conjunction with warfarin; prophylaxis of ischemic complications of unstable angina and non–Q-wave MI in conjunction with aspirin; acute STEMI in patients 75 yr of age or older (no initial bolus)

1 mg/kg subcutaneous once daily.

Acute STEMI in patients younger than 75 yr of age

30 mg IV bolus plus 1 mg/kg subcutaneously followed by 1 mg/kg subcutaneously once daily.

ElderlyAdults

For treatment of acute STEMI in elderly patients at least 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg subcutaneous every 12 h (max 75 mg for the first 2 doses only, followed by 0.75 mg/kg dosing for the remaining doses).

General Advice

  • Enoxaparin is a clear, colorless to pale yellow solution and should be inspected visually for particulate matter and discoloration prior to administration.
  • Do not administer by IM injection.
  • With patient lying down, administer drug by subcutaneous injection. Alternate administration between left and right anterolateral and posterolateral abdominal wall. Introduce whole length of needle into skinfold held between thumb and forefinger; hold skinfold throughout injection.
  • Do not aspirate into syringe; do not rub site after injection. These activities may cause tissue damage and subcutaneous bleeding.

Storage/Stability

Store at room temperature (59° to 86°F). Do not freeze.

Drug Interactions

Anticoagulants, NSAIDs, platelet inhibitors

Use enoxaparin with caution because of increased risk of hemorrhagic reactions.

Incompatibility

Do not mix enoxaparin with other injections or infusions.

Laboratory Test Interactions

Transaminase determinations

Drug causes asymptomatic elevations in AST and ALT.

Adverse Reactions

CNS

Confusion (2%).

Dermatologic

Cutaneous vasculitis, purpura, vesiculobullous rash (postmarketing).

GI

Nausea (3%); diarrhea (2%).

Genitourinary

Hematuria (2%).

Hematologic-Lymphatic

Anemia (16%); hemorrhage (13%); major bleeding (4%); thrombocytopenia (3%); thrombocytopenia with thrombosis, thrombocytosis (postmarketing).

Lab Tests

Increased AST and ALT greater than 3 times ULN (6%); hyperlipidemia, hypertriglyceridemia (postmarketing).

Local

Injection-site hemorrhage (5%); ecchymosis (3%); injection-site pain (2%); erythema, hematoma, mild local irritation, pain, injection-site reactions, including anaphylactoid reactions, pruritus, urticaria (postmarketing).

Miscellaneous

Fever (8%); peripheral edema (6%); dyspnea epidural (3%); spinal hematoma (postmarketing).

Precautions

Warnings

Spinal/Epidural hematomas

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

Monitor

Periodic CBCs, including platelet count, and stool occult blood tests are recommended

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Delayed elimination of drug possible. Use with caution.

Renal Function

Delayed elimination of drug may occur. Use with caution.

Hepatic Function

Dosage adjustments are recommended in severe hepatic function impairment.

Special Risk Patients

Use drug with caution in patients with diabetic retinopathy, bleeding diathesis, uncontrolled arterial hypertension, or history of recent GI ulceration and hemorrhage.

Benzyl alcohol

Multiple-dose vials contain benzyl alcohol as a preservative; has been associated with a fatal “gasping syndrome” in premature neonates.

Hemorrhage

Use drug with extreme caution in patients with conditions associated with increased risk of hemorrhage.

Interchangeability with heparin

Cannot be used interchangeably (unit for unit) with heparin or other LMWHs.

Percutaneous coronary revascularization procedures

To minimize the risk of bleeding, adhere precisely to the recommended dosing intervals.

Prosthetic heart valves

Use is not recommended for thromboprophylaxis in patients with prosthetic heart valves.

Teratogenesis

There have been reports of congenital anomalies in infants born to women who received enoxaparin during pregnancy, including cerebral anomalies, limb anomalies, hypospadias, peripheral vascular malformation, fibrotic dysplasia, and cardiac defects. A cause-and-effect relationship has not been established.

Thrombocytopenia

Use with extreme caution in patients who have a history of heparin-induced thrombocytopenia. Closely monitor any degree of thrombocytopenia.

Overdosage

Symptoms

Hemorrhage.

Patient Information

  • Instruct patient to report any signs of bleeding or bruising, or black, bloody, or tarry stools immediately.
  • If patient has home therapy, teach patient or family member proper subcutaneous injection technique.
  • Caution patient to take safety precautions to prevent cuts and bruising (eg, use electric razor, soft toothbrush, handrails).

Copyright © 2009 Wolters Kluwer Health.

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