Enoma
Enoxaparin Sodium BP 

Composition

• Enoma 40 Injection: Each Pre-filled syringe contains Enoxaparin Sodium BP 4000 anti-Xa IU/0.4 ml.
• Enoma 60 Injection: Each Pre-filled syringe contains Enoxaparin Sodium BP 6000 anti-Xa IU/0.6 ml.

Description
Enoxaparin Sodium is a low molecular weight heparin with high anti-Xa activity (100 IU/mg) and low anti-IIa or anti-thrombin activity (28 IU/mg). At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. After subcutaneous injection of 20 to 80 mg and 1 or 2 mg/kg, Enoxaparin Sodium is rapidly and completely absorbed. The absolute bioavailability of Enoxaparin Sodium after subcutaneous injection, based on anti-Xa activity, is close to 100%. The mean maximum plasma anti-Xa activity is observed 3 to 5 hours after subcutaneous injection and achieved approximately 0.2, 0.4, 1.0, and 1.3 anti-Xa IU/ml following single-subcutaneous administration of 20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg doses respectively. Elimination appears monophasic with a half-life of about 4 hours after a single-subcutaneous dose to about 7 hours after repeated dosing. Enoxaparin Sodium is primarily metabolized in the liver.
Indications
Enoma is indicated for
 Prophylaxis of venous thromboembolic disease, in particular, those which may be associated with orthopedic, general, major colorectal, or cancer surgery
 Prophylaxis of venous thromboembolism in general medical patients bedridden due to acute illnesses including acute heart failure, respiratory failure, severe infections, rheumatic disease
 Treatment of venous thromboembolic disease
 Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with Aspirin
 Prevention of thrombus formation in the extracorporeal circulation during hemodialysis
Dosage and Administration
Method of Administration:
Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravenous route during
hemodialysis. DO NOT ADMINISTER BY THE INTRAMUSCULAR ROUTE.
The pre-filled syringes are ready-to-use. The air bubble from the syringe should not be expelled before the injection. The subcutaneous injection should preferably be made when the patient is lying down. Enoxaparin Sodium is administered in the subcutaneous tissue of the anterolateral or posterolateral abdominal wall, alternately on the left and the right side. The injection itself consists in introducing the needle perpendicularly and not tangentially, throughout its entire length into a fold of skin held between the thumb and index finger. The skin fold should be held throughout the injection.
Adult dosage:
Prophylaxis of venous thrombosis in surgical patients: Prophylaxis against thromboembolism should be tailored according to the patient's risk. Risk factors include age over 40 years, history of deep vein thrombosis or pulmonary embolism, surgery and other trauma, prolonged immobilization, cardiac disease, obesity, malignancy, varicose veins, hypercoagulable states, pregnancy and the puerperium, oral contraceptives, severe infection, inflammatory bowel disease. a) High Risk Patients: In patients with high risk of thromboembolism, a Enoma dosage of 40 mg should be administered
subcutaneously once daily. In high risk patients undergoing surgery, the initial dose should be given approximately 12 hours preoperatively. b) Moderate Risk Patients: In patients with a moderate risk of thromboembolism, the recommended Enoma dosage is 20 mg subcutaneously once daily. In moderate risk patients undergoing surgery, the initial dose should be given approximately 2 hours preoperatively. Note: The timing of the first dose may need to be modified if spinal/epidural anaesthesia is to be performed. Prophylaxis should be continued for 7 to 10 days or until the risk of thromboembolism has diminished. c) Prolonged Thromboprophylaxis: Therapy with 40 mg once daily for 30 post-operative days has been proven to be beneficial in total hip replacement surgery. Prophylaxis of venous thromboembolism in medical patients: The recommended dose of Enoma is 40 mg once daily by subcutaneous injection. Treatment with Enoma is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days. Treatment of venous thromboembolic disease: Enoma can be administered subcutaneously either as a single injection of 1.5 mg/kg or as twice daily injections of 1 mg/kg. In high risk patients, e.g., the obese or patients with baseline iliac vein thrombosis or cancer, a dose of 1 mg/kg body weight administered twice daily may be more beneficial. Enoma treatment is usually prescribed for an average period of 10 days.

Treatment of unstable angina and non-Q-wave myocardial infarction: The recommended dose of Enoma is 1 mg/kg every 12 hours by subcutaneous injection, administered concurrently with oral Aspirin (100 to 325 mg once daily). Treatment with Enoma in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days. Prevention of extracorporeal thrombus during hemodialysis: The recommended dose of Enoma is 1 mg/kg. For patients with a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg for double vascular access or 0.75 mg/kg for singular vascular access. During hemodialysis, Enoma should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4 hour session however, if fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1 mg/kg may be given.
Elderly: No dose reduction is necessary in the elderly, unless kidney function is impaired.
Children: The safety and efficacy of Enoma in children has not been established.
Renal Impairment:
Severe Renal Impairment: A dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 ml/min). The recommended dosage ranges for therapeutic use is 1 mg/kg once daily and for prophylactic use is 20 mg once daily. The recommended dosage adjustments do not apply to the hemodialysis indication. Moderate & Mild Renal Impairment: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 ml/min) and mild (creatinine clearance 50-80 ml/min) renal impairment, careful clinical monitoring is advised.
Adverse Effects
Haemorrhage (bleeding), Thrombocytopenia, Local reactions (pain, haematoma and mild local irritation) may follow the subcutaneous injection of Enoxaparin. There have been reports of neuraxial hematomas with the concurrent use of Enoxaparin Sodium and spinal/epidural anesthesia or spinal puncture resulting in varying degrees of neurologic injuries.
Contraindication

• Hypersensitivity to Enoxaparin Sodium, heparin or its derivatives including other LMWH's. Active major bleeding and conditions with a high risk of uncontrolled haemorrhage including recent haemorrhagic stroke.

Drug Interactions

• It is recommended that agents that affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as  systemic Salicylates, Acetylsalicylic acid, and NSAIDs including Ketorolac  Dextran 40, Ticlopidine, and Clopidogrel  systemic Glucocorticoids  Thrombolytics and Anticoagulants  other anti platelet agents including Glycoprotein IIb/IIIa antagonists

Precautions
Enoxaparin injection should not be administered by the intramuscular route. Enoxaparin Sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischaemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery. It is recommended that the platelet counts be measured before the initiation of therapy with Enoxaparin Sodium and then regularly thereafter during the treatment.
Pregnancy and Lactation
Pregnancy: Pregnancy category C. As there are no adequate and well-controlled studies in pregnant women and because animal studies are not always predictive of human response, Enoxaparin Sodium should be used during pregnancy only if the physician has established a clear need.
Lactation: It is not known whether unchanged Enoxaparin Sodium is excreted in human breast milk. However, as a precaution, lactating mothers receiving Enoxaparin Sodium should be advised to avoid breastfeeding.
Overdosage
Accidental overdosage after extracorporeal or subcutaneous administration of massive doses of Enoxaparin Sodium may lead to bleeding complications. Neutralization can be obtained by slow intravenous injection of protamine (1 mg protamine can be used to neutralize the anticoagulant effect of about 1 mg Enoxaparin Sodium). However, the anti-Xa activity of Enoxaparin Sodium is never completely neutralized (maximum about 60%).
Pharmaceutical Precautions

• Store at below 25oC in a dry place, protected from light. Keep out of reach of children. Do not freeze pre-filled syringes.

Commercial Packs

• Enoma 40 Injection: Each box contains 1 Pre-filled syringe containing
• Enoxaparin Sodium BP 4000 anti-Xa IU/0.4 ml in a blister pack.
• Enoma 60 Injection: Each box contains 1 Pre-filled syringe containing
• Enoxaparin Sodium BP 6000 anti-Xa IU/0.6 ml in a blister pack.