Lomoh-40/Lomoh-60

Lomoh-40/Lomoh-60

enoxaparin sodium

Manufacturer:

Emcure Pharma

Distributor:

Macropharma Corp
Full Prescribing Info
Contents
Enoxaparin sodium.
Description
Lomoh injection is a sterile aqueous solution containing enoxaparin sodium, a low-molecular weight heparin. The average molecular weight is about 4500 daltons. One mg of Enoxaparin sodium has approximate anti-factor Xa activity of 100 IU. Lomoh-40 is equivalent to anti-Factor Xa activity of 4000 IU and Lomoh-60 is equivalent to anti-Factor Xa activity of 6000 IU.
Action
Pharmacology: Mechanism of Action: Enoxaparin is a low-molecular weight heparin are fragments or fractions of conventional (unfractionated) heparin that produce anticoagulation when administered SC.
In humans, Enoxaparin given SC is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity compared to the ratios observed for heparin. Increases of up to 1.8 times the control values are seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT).
Pharmacokinetics: Enoxaparin pharmacokinetics appear to be linear over the recommended dosage ranges. Bioavailability of enoxaparin is 100% and time to peak concentration is 3-5 hrs after SC injection. The volume of distribution of anti-Factor Xa activity in normal volunteers is about 4.3 L. Animal studies suggest preferential accumulation of enoxaparin in the kidney, liver and spleen. The primary route of elimination of enoxaparin is thought to be renal, largely through glomerular filtration. Anti-Factor Xa exposure, at steady-state is marginally increased in mild (creatinine clearance 50-80 mL/min) and moderate (creatinine clearance 30-50 mL/min) renal dysfunction after repeated SC dosages. In patients with severe renal impairment (creatinine clearance <30 mL/min) the exposure, at steady-state is increased by an average of 65% after multiple doses given once daily SC. Enoxaparin is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency. Elimination t½ of enoxaparin is 4.5 hrs after single SC dose (range 3-6 hrs) and 7 hrs after repeated dosing.
Indications/Uses
For the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism: In patients undergoing abdominal surgery who are at risk for thromboembolic complication; in patients undergoing hip replacement surgery, during and following hospitalizations; in patients undergoing knee replacement surgery; in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
It is also indicated for the prophylaxis of ischemic complications of unstable angina and non-Q wave myocardial infarction, when concurrently administered with aspirin.
It is also indicated for the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium; the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium; prevention of thrombus formation in extracorporeal circulation during hemodialysis.
Dosage/Direction for Use
All patients should be evaluated for a bleeding disorder before administration of Lomoh injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Lomoh injection activity, routine monitoring of coagulation parameters is not required.
Adult: Abdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Lomoh injection is 40 mg once a day administered by SC injection with the initial dose given 2 hrs prior to surgery. The usual duration of administration is 7-10 days, administration up to 12 days has been well tolerated.
Hip or Knee Replacement Surgery: The recommended dose of Lomoh injection is 30 mg every 12 hrs administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12-24 hrs after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hrs prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, continued prophylaxis with Lomoh-40 once a day administered by SC injection for 3 weeks is recommended. The usual duration of administration is 7-10 days, administration up to 14 days has been well tolerated.
Medical Patients during Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Lomoh injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6-11 days; administration up to 14 days has been well tolerated.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable or non-Q-wave myocardial infarction, the recommended dose of Lomoh injection is 1 mg/kg administered SC every 12 hrs in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Lomoh injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2-8 days, administration up to 12.5 days has been well tolerated.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Lomoh injection is 1 mg/kg every 12 hrs administered SC. In inpatient hospital treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Lomoh injection is 1 mg/kg every 12 hrs administered SC or 1.5 mg/kg once a day administered SC at the same time everyday. In both outpatient and inpatient treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hrs of Lomoh injection). Lomoh injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (international normalization ratio 2-3). The average duration of administration is 7 days; administration up to 17 days has been well tolerated.
Prevention of thrombus formation in extracorporeal circulation during hemodialysis: The recommended dose of enoxaparin sodium is 1 mg/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 0.5 mg/kg for double vascular access or 0.75 mg/kg for single vascular access. During hemodialysis, enoxaparin sodium 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-hr session. However, if fibrin rings are found, a further dose of 0.5-1 mg/kg may be given.
Renal Impairment: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. A dosage adjustment is required for patients with severe renal impairment (creatinine clearance <30 mL/min), since enoxaparin sodium exposure is increased significantly in this patient population. The following dosage adjustments are recommended: Prophylactic dose ranges: 20 mg once daily; therapeutic dose ranges: 1 mg/kg once daily.
Hepatic Impairment: Caution should be used in hepatically impaired patients.
Elderly: No dosage adjustment is necessary unless kidney function is impaired.
Children: Enoxaparin sodium is not recommended in children.
Administration: Lomoh injection is a clear, colorless to pale yellow sterile solution and as with other parental drug products, should be inspected visually for particulate matter and discoloration prior to administration. Lomoh injection is administered by SC injection in prophylactic and curative treatment and by intravascular route during hemodialysis. It must not be administered by IM injection. Lomoh injection is intended for use under the guidance of a physician. Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary. Proper training in SC injection technique should be provided.
SC Injection Technique: Patients should be lying down and Lomoh injection administered by deep SC injection. To avoid the loss of drug, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin-fold between the thumb and forefinger, the skin-fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
Overdosage
Accidental overdosage following administration of enoxaparin injection may lead to hemorrhagic complications. Injected Lomoh injection may be largely neutralized by slow IV injection of protamine sulfate (1%). The dose of protamine sulfate should be equal to the dose of Lomoh injected: Protamine sulfate 1 mg should be administered to neutralize Lomoh injection 1 mg, if enoxaparin sodium was administered in the previous 8 hrs. An infusion of protamine administration 0.5 mg, or if it has been determined that a 2nd dose of protamine is required. The 2nd infusion of protamine sulfate 0.5 mg/Lomoh injection 1 mg may be administered if the aPTT measured 2-4 hrs after the 1st infusion remains prolonged. After 12 hrs of the enoxaparin sodium injection, protamine administration may not be required. However, even with higher doses of protamine, the aPTT may remain more prolonged than under normal conditions found following administration of heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%). Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available. A single SC dose of enoxaparin 46.4 mg/kg was lethal to rats. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea, cyanosis and coma.
ATC Classification
B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Lomoh-40: Inj (pre-filled syringe) 40 mg/0.4 mL x 1's.
Lomoh-60: Inj (pre-filled syringe) 60 mg/0.6 mL x 1's.
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