Clexane 60Mg Inj 6Ml
Each pre-filled syringe also contains water for injection as excipient.
Enoxaparin sodium is a low molecular weight heparin (LMWH) with a mean molecular weight of approximately 4,500 daltons.
Indications / Uses :
Prophylaxis of venous thromboembolic disease, in particular those which may be associated with orthopedic or general surgery.
Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illnesses, including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases.
Treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE).
Prevention of thrombus formation in extra-corporeal circulation during hemodialysis.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Hypersensitivity to either enoxaparin sodium, heparin or its derivatives including other LMWH. Active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.
Special Precautions :
Do not administer by IM route.
Hemorrhage: As with other anticoagulants, bleeding may occur at any site (see Adverse Reactions).
If bleeding occurs, the origin of the hemorrhage should be investigated and appropriate treatment instituted.
Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding eg, impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis (see Interactions).
Mechanical Prosthetic Heart Valves: The use of Clexane injection has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves. Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin for thromboprophylaxis. Confounding factors, including underlying disease and insufficient clinical data, limit the evaluation of these cases. Some of these cases were pregnant women in whom thrombosis led to maternal and fetal death. Pregnant women with prosthetic heart valves may be at higher risk for thromboembolism (see Warnings).
Hemorrhage in the Elderly: No increased bleeding tendency is observed in the elderly with the prophylactic dosage ranges. Elderly patients (especially patients =80 years) may be at an increased risk for bleeding complications with the therapeutic dosage ranges. Careful clinical monitoring is advised (see Pharmacology: Pharmacokinetics under Actions and Dosage & Administration).
Renal Impairment: In patients with renal impairment, there is an increase in exposure of enoxaparin sodium which increases the risk of bleeding. Since exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (CrCl <30 mL/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. Although no dose adjustment is recommended in patients with moderate (CrCl 30-50 mL/min) and mild (CrCl 50-80 mL/min) renal impairment, careful clinical monitoring is advised (see Pharmacology: Pharmacokinetics under Actions and Dosage & Administration).
Low Weight: An increase in exposure of enoxaparin sodium with prophylactic dosages (nonweight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg), which may lead to a higher risk of bleeding. Therefore, careful clinical monitoring is advised in these patients (see Pharmacology: Pharmacokinetics under Actions).
Obese Patients: Obese patients are at higher risk for thromboembolism. The safety and efficacy of prophylactic doses in obese patients (BMI >30 kg/m2) has not been fully determined and there is no consensus for dose adjustment. These patients should be observed carefully for signs and symptoms of thromboembolism.
Monitoring of Platelet Counts: The risk of antibody-mediated heparin-induced thrombocytopenia also exists with LMWH. Should thrombocytopenia occur, it usually appears between the 5th and the 21st day following the beginning of enoxaparin sodium treatment. Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment. In practice, if a confirmed significant decrease of the platelet count is observed (30-50% of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another therapy.
Effects on the Ability to Drive or Operate Machinery: Enoxaparin sodium has no effect on the ability to drive and operate machines.
Use in pregnancy: Animal studies have not shown any evidence of fetotoxicity or teratogenicity. In the pregnant rat, the transfer of 35S-enoxaparin sodium across the maternal placenta to the fetus is minimal.
In humans, there is no evidence that enoxaparin sodium crosses the placental barrier during the 2nd trimester of pregnancy. There is no information available concerning the 1st and the 3rd trimesters.
As there are no adequate and well-controlled studies in pregnant women and, because animal studies are not always predictive of human response, Clexane should be used during pregnancy only if the physician has established a clear need.
Use in lactation: In lactating rats, the concentration of 35S-enoxaparin sodium or its labeled metabolites in milk is very low.
It is not known whether unchanged enoxaparin sodium is excreted in human breast milk. The oral absorption of enoxaparin sodium is unlikely. However, as a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breastfeeding.
Use in children: The safety and efficacy of enoxaparin sodium in children have not been established.