ENDOSA 4000 IU ENOXAPARIN PRE‑FILLED SYRINGESX2

Indications

Approved Uses

Prevention of venous thromboembolism (DVT/PE) in surgical patients (including orthopedic surgery) and in acutely ill medical patients with restricted mobility; treatment of acute DVT with or without pulmonary embolism; prevention of ischemic complications in unstable angina and non-Q-wave MI (NSTEMI); treatment of acute ST-elevation myocardial infarction (STEMI).

Off-Label Uses

Common off-label uses include anticoagulation in pregnancy for VTE treatment/prophylaxis (including antiphospholipid syndrome-related thromboprophylaxis), peri-procedural bridging anticoagulation, and anticoagulation for extracorporeal circuits in some settings (institution-dependent).

Dosage & Administration

Dosing by Condition

VTE prophylaxis (general surgery/medical immobilization): 40 mg SC once daily (typical). Orthopedic prophylaxis: either 30 mg SC every 12 hours (common in knee/hip protocols) or 40 mg SC once daily (used in some hip/general prophylaxis protocols) per local labeling/guidelines. DVT/PE treatment: 1 mg/kg SC every 12 hours OR 1.5 mg/kg SC once daily. Unstable angina/NSTEMI: 1 mg/kg SC every 12 hours with antiplatelet therapy. STEMI: 30 mg IV bolus then 1 mg/kg SC every 12 hours (with age/renal adjustments per protocol).

Initial Dose

40 mg (4000 IU) subcutaneously once daily (prophylaxis; e.g., abdominal surgery/medical prophylaxis), using one 0.4 mL pre-filled syringe.

Maintenance Dose

4000 IU (40mg) SC once daily (prophylaxis); 1mg/kg SC every 12 hours (treatment)

Maximum Dose

40 mg (4000 IU) per 0.4 mL syringe: inject the full contents subcutaneously once daily for prophylaxis when this strength is prescribed; treatment dosing is weight-based and must be determined by the prescriber.

Dose Adjustment Notes

Dose adjustment is required in severe renal impairment (CrCl <30 mL/min), typically by reducing frequency to once daily for treatment regimens and using reduced prophylaxis doses per labeling; use caution in elderly and extremes of body weight, and consider anti-Xa monitoring in special populations (e.g., pregnancy, severe renal impairment, extreme body weight).

How to Take

Subcutaneous injection only (do NOT administer IM). Inject into the anterolateral or posterolateral abdominal wall; alternate left/right sites. Do not expel the air bubble from the pre-filled syringe. Insert the needle fully into a skin fold (typically 90°; 45° may be used in very thin patients). Do not rub the injection site after injection.

How to Prepare

Ready-to-use pre‑filled syringe for subcutaneous use; do not expel the air bubble (if present) unless specifically instructed; inspect solution for discoloration/particulates and do not use if abnormal.

Side Effects

Common Side Effects

Bleeding (including injection-site bleeding/hematoma/ecchymosis), injection-site pain/bruising, anemia, thrombocytopenia (including risk of HIT), and transient elevations in liver enzymes (AST/ALT).

Safety & Warnings

Contraindications

Contraindicated in: active major bleeding; hypersensitivity to enoxaparin/heparin/heparinoids (including pork-derived products) or formulation components; history of immune-mediated HIT (HIT within ~100 days or with circulating antibodies) or thrombocytopenia with positive in-vitro platelet aggregation test in presence of enoxaparin.

Warnings & Precautions

Key warnings/precautions: bleeding risk; boxed warning for spinal/epidural hematoma with neuraxial anesthesia/spinal puncture (monitor neurologic signs); monitor platelets for HIT; adjust/monitor in renal impairment and in elderly/low body weight; caution with hepatic impairment and uncontrolled hypertension; avoid interchangeability (not unit-for-unit with other LMWH/UFH); avoid/limit concomitant drugs affecting hemostasis; monitor for hyperkalemia in at-risk patients.

Drug Interactions

Drug Interactions

Clinically significant interactions: other anticoagulants (warfarin, DOACs, UFH), antiplatelets (aspirin, clopidogrel), NSAIDs, thrombolytics; additional bleeding-risk enhancers include SSRIs/SNRIs and dextran (and other agents affecting hemostasis).

Interaction Severity

MAJOR: Concomitant anticoagulants (e.g., warfarin, DOACs, heparins) and thrombolytics (e.g., alteplase) due to markedly increased bleeding risk. MODERATE: Antiplatelets (aspirin, clopidogrel, ticagrelor) and NSAIDs; SSRIs/SNRIs may also increase bleeding risk. MINOR/variable: Other agents affecting hemostasis depending on patient risk.

Special Populations

Elderly

Use standard dosing with caution; increased risk of bleeding due to age-related decline in renal function; monitor renal function and anti-Xa levels; patients ≥75 years with STEMI - omit IV bolus, use 0.75mg/kg SC every 12 hours

Kidney Impairment

CrCl ≥30 mL/min: 40 mg (4000 IU) subcutaneously once daily (prophylaxis). CrCl <30 mL/min: 30 mg subcutaneously once daily (prophylaxis) with close bleeding monitoring.

Storage & Patient Advice

Preparation Instructions

Ready-to-use pre‑filled syringe for subcutaneous use; do not expel the air bubble (if present) unless specifically instructed; inspect solution for discoloration/particulates and do not use if abnormal.

Missed Dose

Take/administer the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule. Do not double doses.

Stopping the Medicine

Do not stop without prescriber direction; if discontinuation is clinically indicated, ensure appropriate alternative anticoagulation/transition to avoid thrombosis.

Patient Counseling

Use exactly as prescribed; inject subcutaneously in the abdomen and rotate sites; do not expel the air bubble; do not rub after injection; never inject IM. Seek urgent care for signs of bleeding (e.g., black stools, blood in urine, prolonged bleeding), severe bruising, or neurologic symptoms suggestive of spinal/epidural hematoma (back pain, numbness/weakness). Tell all healthcare providers/dentists you are using enoxaparin before procedures and avoid new NSAIDs/antiplatelets unless directed. Store below 30°C and do not freeze (per SFDA).

Monitoring Requirements

Routine anti-Xa monitoring is not required for most patients, but monitor CBC (hemoglobin/hematocrit) and platelets (baseline and periodically) for bleeding/HIT, and monitor renal function (SCr/CrCl). Consider anti-Xa levels in selected patients (e.g., pregnancy, severe renal impairment, extremes of body weight, pediatrics) and monitor potassium in at-risk patients for hyperkalemia.

Pharmacology

Mechanism of Action

Enoxaparin potentiates antithrombin (ATIII), leading to preferential inhibition of factor Xa and lesser inhibition of thrombin (factor IIa), reducing fibrin clot formation and thrombus propagation.

Duration of Effect

Anti-factor Xa activity persists for approximately 12 hours after a subcutaneous dose (supporting q12h treatment dosing; prophylaxis may be once daily depending on regimen).

Bioavailability

Approximately 90% (commonly cited ~90-92%) bioavailability after subcutaneous administration based on anti-Xa activity.

Excretion

Primarily renal elimination; enoxaparin (anti‑Xa activity) and its metabolites are excreted mainly in urine.

Protein Binding

Lower, less nonspecific plasma protein binding than unfractionated heparin; binds to antithrombin to exert activity (anti‑Xa).

Product Information

Available Dosage Forms

Solution for injection in a pre-filled syringe, Solution for injection in a multiple-dose vial.

Composition per Dose

Each pre-filled syringe (0.4 ml): Enoxaparin sodium 40mg (4000 IU anti-Xa activity)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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