TROYNOXA Injection

TROYNOXA Injection is used for: Myocardial infarction, Unstable angina, Venous thromboembolism, Deep vein thrombosis

Deep Vein Thrombosis (Prophylaxis) Prevent the occurrence of pulmonary embolism in patients at risk for thromboembolic complications who are undergoing abdominal surgery or hip or knee replacement surgery, as well as in medical patients with severely restricted mobility during acute illness Abdominal surgery 40 mg SC qDay; initiate 2 hr preoperatively Knee or hip replacement surgery 30 mg SC q12hr; initiate therapy 12-24 hr postoperatively and continued for 10 days or up to 35 days postoperatively or until risk of DVT has been significantly reduced or patient is on anticoagulant therapy For hip replacement surgery, may consider administering 40 mg SC qDay, initiated 9-15 hr preoperatively and continued for 10 days or up to 35 days postoperatively or until risk of DVT has been significantly reduced or patient is on anticoagulant therapy Medical patients with restricted mobility 40 mg SC qDay; continue until risk of DVT has been significantly (6-11 days) reduced or patient is on anticoagulant therapy Dosing considerations Abdominal surgery: Duration of administration is 7-10 days; up to 12 days has been administered in clinical trials or until risk of DVT has diminished Knee or hip replacement surgery: Duration of administration is 7-10 days; up to 14 days has been administered in clinical trials or until risk of DVT has diminished Medical patients with restricted mobility: Duration of administration is 6-11 days; up to 14 days has been administered in clinical trials Deep Vein Thrombosis (Treatment) Inpatient treatment Acute DVT with or without PE, when administered in conjunction with warfarin sodium 1 mg/kg SC q12hr, OR 1.5 mg/kg SC qDay (administer at same time each day) Outpatient treatment Acute DVT without PE, when administered in conjunction with warfarin sodium 1 mg/kg SC q12hr Dosing considerations In inpatient and outpatient treatments, initiate warfarin therapy within 72 hours of starting enoxaparin Continue enoxaparin for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (INR 2.0-3.0) Average duration of administration is 7 days; up to 17 days has been administered in clinical trials Unstable Angina & Non-Q-Wave MI Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg SC q12hr Regimen includes aspirin (100-325 mg/day PO) Dosing considerations Administer for at least 2 days and then continue until clinical stabilization Usual duration of treatment is 2-8 days; up to 12.5 days has been administered in clinical trials Acute STEMI Reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI) All patients should receive aspirin as soon as they are identified as having STEMI and should be maintained with 75-325 mg PO qDay unless contraindicated <75 years Loading dose: 30 mg IV bolus once plus 1 mg/kg SC once; not to exceed 100 mg cumulative loading dose Maintenance: 1 mg/kg SC q12hr >75 years No IV bolus 0.75 mg/kg SC q12hr Not to exceed 75 mg/dose for first 2 doses only, followed by 0.75 mg/kg for remaining doses With PCI If last enoxaparin was given <8 hr before balloon inflation, no additional dosing is needed If last enoxaparin was given 8-12 hr before balloon inflation, an IV bolus of 0.3 mg/kg should be administered If PCI occurs >12 hr after last SC dose; use established anticoagulation therapy (full-dose unfractionated heparin or LMWH Patient that has not received prior anticoagulant therapy: 0.5-0.75 mg/kg bolus dose Dosing considerations Administered concurrently with aspirin In conjunction with thrombolytic: Administer enoxaparin between 15 minutes before and 30 minutes after initiating fibrinolytic therapy; optimal treatment duration of enoxaparin is 8 days or until hospital discharge (whichever comes first)

Renal impairment Severe (CrCl <30 mL/min): Dosage reductions required Prophylaxis in abdominal surgery: 30 mg SC qDay Prophylaxis in hip or knee replacement surgery: 30 mg SC qDay Prophylaxis in medical patients with restricted mobility: 30 mg SC qDay DVT treatment (inpatient or outpatient) coadministered with warfarin: 1 mg/kg SC qDay Non-Q-wave myocardial infarction: 1 mg/kg SC qDay Treatment of acute STEMI (<75 years): 30 mg IV single bolus plus 1 mg/kg SC, THEN 1 mg/kg SC qDay Treatment of acute STEMI (>75 years): No initial bolus; maintenance of 1 mg/kg SC qDay

Low body weight (<45 kg for women or <57 kg for men): Increased exposure has been observed with prophylactic (non-weight adjusted) dosage; carefully monitor for sign/symptoms of bleeding Administer deep SC alternating right and left anterior and posterior abdominal walls into skin fold held between thumb and forefinger Use of tuberculin syringe (or equivalent) is recommended to assure appropriate measurement of dose For IV administration, may administer in IV line with 0.9% NaCl or D5W

Hypersensitivity, acute bacterial endocarditis; major bleeding disorder, haemorrhagic stroke, drug-induced thrombocytopenia.

Renal or hepatic impairment, history of GI ulceration, uncontrolled hypertension, spinal or epidural anaesthesia; lactation and pregnancy; elderly. Periodic blood counts, platelet count and stool occult blood test recommended. Lactation: Excretion in milk unknown; not recommended

Increased risk of bleeding w/ anticoagulants, platelet aggregation inhibitors (e.g. dipyridamole, salicylates, NSAIDs, sulfinpyrazone). May increase bleeding w/ vit E.

Side effects of Enoxaparin Sodium : 1-10% Hemorrhage (1-4%),Elevation of serum aminotransferases (6%),Fever (5-8%),Local site reactions (2-5%),Thrombocytopenia (3%),Nausea (3%),Anemia (2%),Ecchymosis (3%) <1% Atrial fibrillation,Heart failure,Pulmonary edema,Pneumonia Potentially Fatal: Haemorrhagic complications.

Enoxaparin is a low molecular weight heparin w/ anticoagulant properties. It acts by enhancing the inhibition rate of activated clotting factors including thrombin and factor Xa through its action on antithrombin III.

TROYNOXA 60MG Injection manufactured by Troikaa Pharmaceuticals Ltd.. Its generic name is Enoxaparin Sodium. TROYNOXA is availble in Nepal. Farmaco Nepal drug index information on TROYNOXA Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.