Cardinex 6000 Anti-Xa IU/0.6 ml

Description

Indications:
Cardinex is indicated for:

• Treatment of deep vein thrombosis (DVT), with or without pulmonary embolism.
• Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
• Prevention of thrombus formation during hemodialysis in extra-corporeal circulation.
• Prophylaxis of venous thromboembolic disease, especially in patients undergoing orthopedic or general surgery.
• Prophylaxis of venous thromboembolic disease in bedridden medical patients due to acute illness (e.g., cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases).
  Consult a registered medical professional before use.

Composition:

• Each 0.2 ml pre-filled syringe contains Enoxaparin Sodium BP 20 mg (equivalent to 2000 anti-Xa IU).
• Each 0.4 ml pre-filled syringe contains Enoxaparin Sodium BP 40 mg (equivalent to 4000 anti-Xa IU).
• Each 0.6 ml pre-filled syringe contains Enoxaparin Sodium BP 60 mg (equivalent to 6000 anti-Xa IU).
• Each 0.8 ml pre-filled syringe contains Enoxaparin Sodium BP 80 mg (equivalent to 8000 anti-Xa IU).

Pharmacology:

• Enoxaparin Sodium is a low molecular weight heparin with high anti-Xa activity and low anti-IIa activity.
• At therapeutic doses, it does not prolong bleeding time. At preventive doses, it does not significantly modify activated Partial Thromboplastin Time (aPTT).
• It does not affect platelet aggregation or fibrinogen binding to platelets.
• Enoxaparin Sodium is primarily metabolized in the liver.

Dosage:

• Deep vein thrombosis (DVT) with or without pulmonary embolism:

  • 100 anti-Xa IU/kg subcutaneously twice daily for 10 days
  • OR 150 anti-Xa IU/kg subcutaneously once daily for 10 days
  • Initiate oral anticoagulant therapy when appropriate and continue until a therapeutic anticoagulant effect is achieved.

• Unstable angina and non-Q-wave myocardial infarction (administered concurrently with aspirin):

  • 100 anti-Xa IU/kg subcutaneously twice daily for 2-8 days, in combination with oral aspirin (100 to 325 mg once daily).
  • Continue treatment for a minimum of 2 days and until clinical stabilization.

• Prevention of thrombus formation during hemodialysis:

  • 100 anti-Xa IU/kg is recommended for dialysis.
  • For patients at high hemorrhagic risk, reduce the dose to 50 anti-Xa IU/kg for double vascular access or 75 anti-Xa IU/kg for single vascular access.
  • Administer into the arterial line at the start of dialysis.

• Prophylaxis of venous thromboembolic disease in surgical patients:

  • General surgery (moderate risk): 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7-10 days.
  • Administer the first injection 2 hours before surgery.
  • Orthopedic surgery (high risk): 4000 anti-Xa IU (0.4 ml) once daily for 7-10 days, first injection 12 hours before surgery.
  • In some cases, longer treatment (e.g., 3 weeks) may be beneficial.

• Prevention of venous thromboembolic disease in medical patients:

  • 4000 anti-Xa IU (0.4 ml) once daily for 6-14 days.

Administration (Self-injection):

1. Choose an injection site on either side of the stomach, at least 5 cm away from the belly button.
2. Clean the area with an alcohol swab or soap and water.
3. Remove the needle cap and check the syringe to ensure it matches your prescribed dose. If needed, adjust by expelling excess medicine.
4. Pinch the skin to form a fold, and inject the medication at a 90° angle.
5. Press the plunger until all the medicine is injected.
6. Dispose of the syringe in a sharps container.
   Consult a registered medical professional for more details.

Interactions:

• Discontinue agents that affect hemostasis (e.g., acetylsalicylic acid, NSAIDs, clopidogrel, anticoagulants) before starting Cardinex, unless strictly indicated.
• If combinations are necessary, careful clinical and laboratory monitoring is required.

Contraindications:

• Hypersensitivity to Enoxaparin Sodium, heparin, or other low molecular weight heparins.
• Active major bleeding or conditions with a high risk of uncontrolled hemorrhage, including recent hemorrhagic stroke.

Side Effects:

• Hemorrhage (bleeding)
• Thrombocytopenia (low platelet count)
• Elevations in serum aminotransferase levels
• Pain, bruising, or skin rash at the injection site
• Neuraxial hematomas (with concurrent use of spinal/epidural anesthesia or spinal puncture) leading to neurological injuries.

Pregnancy & Lactation:

• Pregnancy Category B: Enoxaparin does not cross the placental barrier in humans. It should only be used in pregnancy if clearly needed.
• Breastfeeding: It is unknown whether Enoxaparin is excreted in human milk. A decision should be made whether to continue nursing or discontinue the drug, depending on the importance of Enoxaparin to the mother and benefits of breastfeeding.

Precautions & Warnings:

• Cardinex should be subcutaneously injected in prophylactic and curative treatments, and intravascularly during hemodialysis.
• Avoid intramuscular injection.
• Caution in conditions with increased bleeding potential, such as impaired hemostasis, recent ischemic stroke, uncontrolled hypertension, and history of peptic ulcers.
• Platelet count should be monitored before treatment and regularly during therapy.

Use in Special Populations:

• Elderly: No dosage adjustment needed unless kidney function is impaired.
• Renal Impairment:
  • Moderate renal impairment (creatinine clearance: 30-50 ml/min): No dose adjustment, but monitor closely for bleeding.
  • Severe renal impairment (creatinine clearance <30 ml/min): Adjust dose to 2000 anti-Xa IU once daily for prophylaxis and 100 anti-Xa IU/kg once daily for therapeutic dosing.
• Hepatic Impairment: Use with caution.

Overdose Effects:

• Hemorrhagic complications may result from overdose.
• Protamine sulfate (1% solution) can neutralize Cardinex: 1 mg of protamine sulfate neutralizes 1 mg of Cardinex.

Therapeutic Class:

• Parenteral Anti-coagulants

Storage Conditions:

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