Cardinex 60mg/0.6ml Injection

✔️ Mechanism of Action:

• Enoxaparin enhances the activity of antithrombin III, which inhibits clotting factors such as thrombin (factor IIa) and activated factor Xa (factor Xa).
• This results in an anticoagulant effect, reducing the risk of thrombus formation.

✔️ Administration

Subcutaneous (SC) Injection:

• Administer deep SC injections into the right or left anterior and posterior abdominal walls. Alternate injection sites between sides.
• Pinch a fold of skin between the thumb and forefinger to form a skin fold for injection.
• Do not rub the site after injection to avoid bruising.

Low body weight considerations:

• Women: <45 kg.
• Men: <57 kg.
• These patients may experience increased exposure to the medication with non-weight-adjusted prophylactic doses. Careful monitoring for signs or symptoms of bleeding is necessary.

For IV Administration:

• May administered in an IV line using 0.9% sodium chloride (NaCl) or 5% dextrose (D5W) as the carrier solution.

Measurement of dose:

• Use a tuberculin syringe (or equivalent) to ensure precise dose measurement if adjustments are required.

✔️ Adult Dosing for Enoxaparin Sodium (Cardinex)

1. Deep Vein Thrombosis (DVT) Prophylaxis

• To prevent pulmonary embolism (PE) and thromboembolic complications in patients undergoing surgery or with restricted mobility.

Abdominal Surgery

• Dose: 40 mg SC once daily.
• Timing: Initiate 2 hours preoperatively.
• Duration: Administer for 7-10 days, or up to 12 days, until the DVT risk is diminished.

Knee or Hip Replacement Surgery

Option 1:

• Dose: 30 mg SC every 12 hours.
• Timing: Start 12–24 hours postoperatively.
• Duration: Continue for 10 days to 35 days or until the DVT risk is reduced.

Option 2 (for hip replacement):

• Dose: 40 mg SC once daily.
• Timing: Initiate 9–15 hours preoperatively.
• Duration: Continue for 10 days to 35 days.

Medical Patients with Restricted Mobility

• Dose: 40 mg SC once daily.
• Duration: Administer for 6–11 days, or up to 14 days, until DVT risk diminishes.

2. Deep Vein Thrombosis (DVT) Treatment

Inpatient (With or Without Pulmonary Embolism)

• Dose Options:

• 1 mg/kg SC every 12 hours, OR
• 1.5 mg/kg SC once daily.

Outpatient (Without Pulmonary Embolism)

• Dose: 1 mg/kg SC every 12 hours.

Considerations:

• Initiate warfarin therapy within 72 hours of starting enoxaparin.
• Continue enoxaparin for at least 5 days and until the INR is between 2.0–3.0.
• Typical duration is 7 days, but up to 17 days has been used in trials.

3. Unstable Angina & Non-Q-Wave Myocardial Infarction (MI)

• Dose: 1 mg/kg SC every 12 hours.
• Concomitant Therapy: Administer with aspirin (100–325 mg/day PO).
• Duration: Treat for 2–8 days; up to 12.5 days in trials.

4. Acute STEMI (ST-Elevation Myocardial Infarction)

Patients <75 Years Old

• Loading Dose: 30 mg IV bolus plus 1 mg/kg SC once (max 100 mg cumulative loading dose).
• Maintenance Dose: 1 mg/kg SC every 12 hours.

Patients ≥75 Years Old

• No IV bolus.

• Dose: 0.75 mg/kg SC every 12 hours (max 75 mg/dose for the first two doses).

PCI (Percutaneous Coronary Intervention)

• If Last Dose <8 Hours Ago: No additional dosing.
• If Last Dose 8–12 Hours Ago: 0.3 mg/kg IV bolus.
• If Last Dose >12 Hours Ago: Use alternative anticoagulation (e.g., unfractionated heparin or full-dose LMWH).

Concomitant Therapy

• Administer with aspirin (75–325 mg/day) and a thrombolytic agent, if appropriate.

Duration

• The optimal duration is 8 days or until hospital discharge, whichever comes first.

✔️ Dosing Considerations: Enoxaparin Sodium

• Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min:
  • Prophylaxis: 20 mg SC once daily.
  • Treatment: 1 mg/kg SC once daily.
• Elderly: No adjustments unless kidney function is impaired.
• Hepatic Impairment: Use caution due to increased bleeding risk.

✔️ Renal Dosing Adjustments for Enoxaparin Sodium (Cardinex)

Severe Renal Impairment (CrCl <30 mL/min)

Prophylaxis:

• Abdominal Surgery: 30 mg SC once daily.
• Hip or Knee Replacement Surgery: 30 mg SC once daily.
• Medical Patients with Restricted Mobility: 30 mg SC once daily.

Deep Vein Thrombosis (DVT) Treatment:

• Inpatient or Outpatient (with warfarin): 1 mg/kg SC once daily.

Non-Q-Wave Myocardial Infarction (MI):

• 1 mg/kg SC once daily.

Acute STEMI:

• For Patients <75 Years:
  • Loading Dose: 30 mg IV single bolus + 1 mg/kg SC.
  • Maintenance Dose: 1 mg/kg SC once daily.
• For Patients ≥75 Years:
  • No initial IV bolus.
  • Maintenance Dose: 1 mg/kg SC once daily.

✔️ Side Effects of Enoxaparin Sodium (Cardinex)

Common Side Effects

• Bleeding (Hemorrhage): Increased risk of bleeding at various sites, including gastrointestinal or surgical wounds.
• Thrombocytopenia: Low platelet count, potentially leading to increased bleeding risk.
• Elevations of Serum Aminotransferase: Temporary increases in liver enzymes (ALT/AST), usually asymptomatic.

Localized Reactions

• Pain at Injection Sites: Mild to moderate discomfort or tenderness.
• Bruising (Bluish Marks): This may occur at injection sites due to small blood vessel trauma.
• Skin Rash: Allergic or localized reactions, including redness and irritation at the site of administration.

Serious Side Effects

• Neuraxial Hematomas:
  • Observed with concurrent use of enoxaparin and spinal/epidural anesthesia or during a spinal puncture.
  • May result in neurologic injuries of varying degrees, including paralysis.
  • Requires close monitoring for signs of spinal cord compression (e.g., back pain, weakness, sensory changes).

✔️ Contraindications for Enoxaparin Sodium

Hypersensitivity:

• Known hypersensitivity to Enoxaparin, heparin, or other low molecular weight heparins.

Active Bleeding Disorders:

• History of thrombocytopenia.
• Active gastrointestinal ulcers or organic lesions are likely to bleed.

Recent Hemorrhagic Stroke:

• Recent vascular cerebral hemorrhagic stroke.

Allergic Reactions:

• Rare but possible cutaneous or systemic allergic reactions.

✔️ Precautions and Warnings

• Do not administer intramuscularly (IM). Enoxaparin is designed for subcutaneous (SC) or intravenous (IV) use.

Exercise caution in patients with the following conditions:

• Impaired hemostasis.
• History of peptic ulcers (may increase the risk of gastrointestinal bleeding).
• Recent ischemic stroke (cerebral bleeding risk).
• Uncontrolled severe arterial hypertension.
• Diabetic retinopathy (increased bleeding risk in fragile vascular tissues).
• Recent neurosurgery or ophthalmologic surgery (higher risk of localized bleeding).
• Low body weight patients (higher exposure to the drug, increasing bleeding risk).

Platelet Monitoring:

• Platelet counts should be measured prior to treatment initiation and monitored regularly during therapy to detect potential thrombocytopenia.

Lactation:

• Unknown whether enoxaparin is excreted in breast milk.
• Not recommended during breastfeeding due to the potential for adverse effects on nursing infants.

✔️ Pregnancy and Lactation Considerations for Enoxaparin Sodium

Pregnancy

Category: Not formally classified under the FDA's previous categories, but data suggest minimal risk.

Human Data:

• A retrospective cohort study found no increased risk of major developmental abnormalities in pregnancies exposed to enoxaparin.
• Pregnancy itself increases the risk of thromboembolism, especially in women with:
  • Thromboembolic disease.
  • Mechanical prosthetic heart valves.
  • Inherited or acquired thrombophilias.

High-Risk Pregnancies:

• Women with these conditions are at a greater risk of maternal complications and fetal loss, regardless of the anticoagulant used.
• Pregnant women with mechanical prosthetic heart valves are particularly vulnerable to thrombosis and require heightened monitoring.

Bleeding Risks:

• All patients on anticoagulants, including pregnant women, are at risk for bleeding complications.
• Bleeding can occur at any site, potentially leading to maternal and/or fetal death.
• Close monitoring for bleeding or excessive anticoagulation is necessary during therapy.

Counseling:

• Pregnant women should be informed of the potential risks to both the mother and fetus if enoxaparin is used during pregnancy.

Lactation

Excretion in Human Milk:

• Unknown if enoxaparin or its metabolites are excreted in human breast milk.
• Studies in lactating rats show minimal passage of enoxaparin or its metabolites into milk.

Considerations:

• The benefits of breastfeeding for the infant should be weighed against:
  • The mother’s clinical need for enoxaparin.
  • The potential for adverse effects on the infant.

Recommendation:

• As a precaution, breastfeeding is not recommended during enoxaparin therapy due to the lack of data on potential adverse effects on the breastfed child or milk production.

✔️ Drug Interaction Information for Enoxaparin Sodium

Concurrent use with other anticoagulants (e.g., warfarin, and heparin) significantly increases the risk of bleeding.

Platelet Aggregation Inhibitors:

• Examples: Dipyridamole, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors.
• These agents impair platelet function, further increasing bleeding risk.

Salicylates and NSAIDs:

• Includes acetylsalicylic acid (aspirin) and other nonsteroidal anti-inflammatory drugs.
• Both classes can exacerbate gastrointestinal bleeding or inhibit platelet aggregation, heightening the risk.

Sulfinpyrazone:

• May potentiate bleeding tendencies when combined with enoxaparin.

Vitamin E

• Vitamin E may enhance bleeding risk due to its potential anticoagulant effects. Use with care when combined with enoxaparin, especially in high doses.

✔️ Storage:

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children