CLEXANE 20/MG/0.2/ML 2/PREF.SYR

Indications

Approved Uses

Prevention of venous thromboembolic disease in surgical patients, prevention of VTE in medical patients with restricted mobility, treatment of deep vein thrombosis (DVT) with or without pulmonary embolism, treatment of unstable angina and non-ST-elevation myocardial infarction (NSTEMI), treatment of ST-elevation myocardial infarction (STEMI) in patients managed medically or with percutaneous coronary intervention (PCI), prevention of thrombus formation in extracorporeal circulation during hemodialysis

Off-Label Uses

Antiphospholipid syndrome thromboprophylaxis, cancer-associated thrombosis, thromboprophylaxis during pregnancy in high-risk patients, heparin-induced thrombocytopenia bridging (with caution)

Dosage & Administration

Dosing by Condition

DVT prophylaxis (abdominal surgery): 40mg SC once daily; DVT prophylaxis (hip/knee replacement): 30mg SC every 12 hours; DVT prophylaxis (medical patients): 40mg SC once daily; DVT treatment: 1mg/kg SC every 12 hours or 1.5mg/kg SC once daily; Unstable angina/NSTEMI: 1mg/kg SC every 12 hou...

Initial Dose

30mg SC once daily (prophylaxis in abdominal surgery); 30mg SC once daily (prophylaxis in hip/knee replacement); 40mg SC once daily (prophylaxis in medical patients during acute illness); dosing varies by indication

Maintenance Dose

20-40mg SC once daily (prophylaxis); 1mg/kg SC every 12 hours (treatment)

Maximum Dose

Prophylaxis: 40mg SC once daily (abdominal surgery) or 30mg SC once daily (hip/knee replacement, medical patients); Treatment: 1mg/kg SC every 12 hours or 1.5mg/kg SC once daily; for acute STEMI in patients ≥75 years: maximum 75mg for first two doses only, followed by 0.75mg/kg dosing

Children's Dosage

Not approved for routine use in children; neonatal and pediatric dosing used off-label under specialist supervision: 1.5mg/kg SC every 12 hours (neonates), 1mg/kg SC every 12 hours (infants/children) with anti-Xa monitoring

Dose Adjustment Notes

Reduce to 20mg SC once daily (prophylaxis) or 1mg/kg SC once daily (treatment) in severe renal impairment (CrCl <30ml/min); no dose adjustment for mild-moderate renal impairment; no hepatic dose adjustment established; monitor anti-Xa levels in obese patients (>100kg) and underweight patients (<45kg)

How to Take

Administer by deep subcutaneous injection into the anterolateral or posterolateral abdominal wall, alternating sides; patient should be lying down; do not expel the air bubble from the prefilled syringe before injection; do not rub the injection site after administration; do not administer intramuscularly; IV bolus permitted only for STEMI indication

How to Prepare

N/A - ready-to-use prefilled syringe; inspect visually for particulate matter and discoloration before use

Side Effects

Side Effect Frequency

Very common (>10%): injection site hematoma, elevated hepatic enzymes (ALT/AST). Common (1-10%): bleeding events (minor), thrombocytopenia (mild), injection site pain, ecchymosis at injection site. Uncommon (<1%): major hemorrhage, HIT, spinal/epidural hematoma, hyperkalemia, anaphylactic reactions, osteoporosis (prolonged use), skin necrosis at injection site

Safety & Warnings

Contraindications

Active major bleeding, history of heparin-induced thrombocytopenia (HIT) with positive in vitro platelet aggregation test, hypersensitivity to enoxaparin sodium or heparin or pork products, hypersensitivity to benzyl alcohol (in multidose formulations), acute bacterial endocarditis, major clotting disorders, thrombocytopenia with positive anti-platelet antibody test in presence of enoxaparin

Warnings & Precautions

Risk of spinal/epidural hematoma with neuraxial anesthesia - do not use within 12 hours before or 4 hours after spinal/epidural procedures; monitor for signs of neurological impairment; use with caution in patients with renal impairment, low body weight, elderly patients, recent surgery, peptic ulcer disease, or hemorrhagic stroke; monitor platelet counts - discontinue if HIT suspected; contains benzyl alcohol in multidose vials (avoid in neonates); not interchangeable unit-for-unit with other LMWHs or unfractionated heparin

Driving Warning

Safe

Drug Interactions

Drug Interactions

NSAIDs (increased bleeding risk), antiplatelet agents (aspirin, clopidogrel, ticagrelor - increased bleeding risk), thrombolytics (increased hemorrhage risk), oral anticoagulants (warfarin, DOACs - additive anticoagulant effect), systemic corticosteroids (increased bleeding risk), dextran (potentiates anticoagulant effect), ketorolac (contraindicated combination due to severe bleeding risk)

Food Interaction

No restriction

Special Populations

Pregnancy

Category B

Children

Not approved for routine use in children; neonatal and pediatric dosing used off-label under specialist supervision: 1.5mg/kg SC every 12 hours (neonates), 1mg/kg SC every 12 hours (infants/children) with anti-Xa monitoring

Elderly

Patients ≥75 years with STEMI: omit initial IV bolus, use 0.75mg/kg SC every 12 hours (max 75mg for first two doses); increased risk of bleeding in elderly - monitor renal function and signs of hemorrhage; standard prophylactic dosing otherwise

Kidney Impairment

CrCl <30mL/min: prophylaxis 30mg SC once daily; treatment 1mg/kg SC once daily

Storage & Patient Advice

Storage Conditions

Store below 25°C. Do not freeze. Keep in original packaging. No special post-use storage applicable (single-dose prefilled syringe - discard after use)

Preparation Instructions

N/A - ready-to-use prefilled syringe; inspect visually for particulate matter and discoloration before use

Overdose

Symptoms: hemorrhagic complications. Treatment: slow IV injection of protamine sulfate (1mg protamine neutralizes approximately 1mg enoxaparin); if enoxaparin was given within 8 hours, 1mg protamine per 1mg enoxaparin; if more than 8 hours have elapsed, 0.5mg protamine per 1mg enoxaparin; anti-Xa activity may not be fully neutralized (maximum ~60%); seek immediate medical attention

Monitoring Requirements

Platelet count before and during therapy; anti-Xa levels in special populations (renal impairment, obesity, pregnancy, extremes of weight); serum potassium in at-risk patients; signs and symptoms of bleeding; renal function (serum creatinine/CrCl) before and during therapy

Pharmacology

Mechanism of Action

Binds to and potentiates antithrombin III, selectively inhibiting Factor Xa and, to a lesser extent, thrombin (Factor IIa), thereby preventing fibrin clot formation and thrombus propagation

Onset of Action

Anti-Xa activity peaks within 3-5 hours after subcutaneous injection

Half-Life

4.5-7 hours after subcutaneous injection

Excretion

Primarily renal; active and inactive fragments excreted in urine

Product Information

Available Dosage Forms

Solution for injection in prefilled syringe, solution for injection in multidose vial

Composition per Dose

Each 0.2ml prefilled syringe: 20mg enoxaparin sodium (equivalent to 2,000 IU anti-Xa activity)

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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