Thenox

Thenox

enoxaparin

Manufacturer:

Siam Bioscience

Distributor:

Zuellig Pharma

Marketer:

Apexcela
Concise Prescribing Info
Contents
Enoxaparin Na
Indications/Uses
Acute DVT &/or pulmonary embolism (PE) in conjunction w/ warfarin; acute ST-segment elevation MI (STEMI) in patients receiving thrombolysis & managed medically or w/ percutaneous coronary intervention (PCI). Prevention of thrombus formation in extracorporeal circulation during hemodialysis. Prophylaxis & treatment of ischemic complications of unstable angina & non-ST elevation MI (NSTEMI) coadministered w/ aspirin &/or other therapy. Prophylaxis of post-op DVT &/or PE; DVT w/ acute illness.
Dosage/Direction for Use
IV/SC Adult Treatment of acute DVT w/ or w/o PE 1 mg/kg 12 hr or 1.5 mg/kg every 24 hr SC at the same time every day for inpatient; w/ PE 1 mg/kg SC every 12 hr for outpatient. Ave duration of therapy: 7 days. Up to 17 days. Initiate warfarin when appropriate usually w/in 72 hr of treatment. Treatment of acute STEMI 30 mg single IV bolus + 1 mg/kg SC followed by 1 mg/kg followed by 1 mg/kg SC every 12 hr. Initiate treatment between 15 min before or 30 min after start of thrombolytic (fibrin-/non-fibrin- specific) therapy. Max dose: 100 mg for 1st 2 doses, only followed by 1 mg/kg for the remaining dose. Duration of therapy: May continue up to 8 days or until revascularization. Treatment of ischemic complications of unstable angina & NSTEMI 100 anti-Xa IU/kg by SC inj bid at 12-hr interval, in combination w/ aspirin (recommended doses: 75-325 mg PO, following a min loading dose of 160 mg). Recommended duration of treatment: 2-8 days, until the patient is clinically stable. Prevention of thrombus formation (clotting) in the extracorporeal circulation during hemodialysis 1 mg/kg (100 u/kg) into arterial line of circuit at the beginning of dialysis. May give further dose of 0.5-1 mg/kg (50-100 u/kg) if required. PCI 0.3 mg/kg IV bolus if last SC administration was given >8 hr before balloon inflation. Prophylaxis of post-op DVT &/or PE in abdominal surgery 40 mg once daily SC inj w/ initial dose given 2 hr prior surgery. Duration of therapy: 7-10 days up to 12 days; hip or knee replacement surgery 30 mg SC every 12 hr initially given 12-24 hr prior surgery provided that hemostasis has been established. Alternative dose for hip replacement surgery: 40 mg every 24 hr initially given 12 (±3) hr prior surgery. Following initial phase of thromboprophylaxis in hip replacement surgery, continued prophylaxis w/ 40 mg SC once daily for 3 wk. Duration of therapy: 7-10 days up to 14 days. Prophylaxis of DVT in patients w/ acute illness 40 mg once daily. Duration of therapy: 6-11 days, up to 14 days. Prophylaxis of ischemic complications of unstable angina & NSTEMI 1 mg/kg SC every 12 hr. Duration of therapy: 2-8 days. Concomitant therapy: 100-325 mg aspirin PO once daily. Elderly ≥75 yr Acute STEMI Initially 0.75 mg/kg SC every 12 hr. Max dose: 75 mg for 1st 2 doses only, followed by 0.75 mg/kg for remaining doses. Severe renal impairment (CrCl <30 mL/min) Acute DVT w/ or w/o PE (inpatient) & w/o PE (outpatient) in conjunction w/ aspirin 1 mg/kg SC once daily. Acute STEMI in conjunction w/ aspirin Patients ≥75 yr 1 mg/kg SC once daily; <75 yr 30 mg single IV bolus + 1 mg/kg SC, followed by 1 mg/kg SC once daily. Prophylaxis of DVT in abdominal surgery/hip or knee replacement surgery; during acute illness 30 mg SC once daily; ischemic complications of unstable angina/NSTEMI when co-administered w/ aspirin 1 mg/kg SC once daily.
Contraindications
Hypersensitivity to enoxaparin, heparin, pork products. Active major bleeding & high risk hemorrhage eg, major blood clotting disorders, active gastric or duodenal ulcer, hemorrhagic CVA (except systemic emboli), injuries to & operation on brain, spinal cord, eyes & ears. Current heparin induced thrombocytopenia (HIT) or HIT w/ thrombosis.
Special Precautions
Hypersensitivity including anaphylactoid reactions, pruritus, urticaria, vesiculobullous & rare cases of hypersensitivity cutaneous vesiculitis. Not to be administered by IM inj. Not to be used interchangeably w/ heparin or any other LMWH. Discontinue use if platelet count fall <100,000/mm3. Patients w/ increased risk of hemorrhage (eg, congenital or acquired bleeding disorders; active ulceration & angiodysplastic GI disease; hemorrhagic stroke; recent brain, spinal or ophth surgery; uncontrolled arterial HTN; history of recent GI ulceration; diabetic retinopathy); mechanical prosthetic heart valves. Avoid in patients w/ history of HIT, especially if administered w/in 100 days of HIT episode. History of traumatic or repeated epidural/spinal punctures & spinal deformity or surgery. Patients w/ low body wt (<45 kg in women or <57 kg in men). Obese patients (BMI >30 kg/m2). Carefully consider benefit & risk before neuraxial intervention; timing of spinal catheter placement & removal in relation to anticoagulant use; monitoring of signs & symptoms of neurological impairment. Periodic CBC, including platelet counts & stool occult blood tests during treatment. Concomitant use of other drugs affecting hemostasis eg, NSAIDs, platelet inhibitors & anticoagulants. Renal & hepatic impairment. Pregnancy; frequently monitor peak & trough anti-factor Xa conc in pregnant women w/ mechanical heart valves receiving enoxaparin for thromboembolism prevention. Lactation. Childn <18 yr. Elderly.
Adverse Reactions
Confusion, pain; nausea, diarrhea; major hemorrhage, thrombocytopenia, anemia, bruise; increased serum ALT & AST; inj site hematoma, irritation, bruising, erythema & pain; hematuria; fever.
Drug Interactions
Increased risk of bleeding w/ anticoagulants, platelet aggregation inhibitors eg, salicylates or other NSAIDs, dipyridamole, sulfinpyrazone. Drugs affecting hemostasis.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Form
Thenox soln for inj 40 mg/0.4 mL
Packing/Price
((pre-filled syringe)) 2's
Form
Thenox soln for inj 60 mg/0.6 mL
Packing/Price
((pre-filled syringe)) 2's
Form
Thenox soln for inj 80 mg/0.8 mL
Packing/Price
((pre-filled syringe)) 2's
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