2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Unless really needed, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Enoxaparin therapy.
These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDS (including ketorolac, tromethamine), dipyridamole, or sulfinpyrazone. If coadministration, conduct close clinical and laboratory monitoring.
Heparin-induced thrombocytopenia: Enoxaparin should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.
Hemorrhage: Enoxaparin, like other anticoagulants, should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors. Cases of epidural or spinal hematomas have been reported with the associated use of Enoxaparin and spinal/epidural anesthesia or spinal puncture resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative in-dwelling epidural catheters or by the concomitant use of additional drugs affecting homeostasis such as NSAIDs.
Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.
Bleeding can occur at any site during therapy with Enoxaparin. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.
Low-weight patients: An increase in exposure of Enoxaparin with sodium with prophylactic dosage (Non-weight adjusted) has been observed in low-weight (<45 kg) and low-weight men (<57 kg), which may lead to a higher risk of bleeding. Therefore, careful clinical monitoring is advised. All such patients should be observed carefully for signs and symptoms of bleeding.
Use in Pregnancy: Enoxaparin is not predicated to increase the risk of development and abnormalities.
Enoxaparin does not cross the placenta based on human and animal studies and shows no evidence of teratogenic effects of fetotoxicity. Since there are no adequate and well-controlled studies in pregnant women, Enoxaparin should be used during pregnancy only if clearly needed. Pregnant women should be apprised of the potential hazard to the fetus and the mother if Enoxaparin is administered during pregnancy.
4000 IU/0.4 mL soln for inj: Concomitant use not recommended: Medicinal products affecting hemostasis: It is recommended that some agents which affect hemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDS including ketorolac.
Other thrombolytics (e.g., alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants.
Concomitant use with caution: The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: Other medicinal products affecting hemostasis such as: Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardio protection), clopidogrel, ticlopidine, and glycoprotein IIb/Illa antagonists indicated in acute coronary syndrome due to the risk of bleeding.
Dextran 40.
Systemic glucocorticoids.
Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring.
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