Enoxaparin STADA Overdosage

Signs and Symptoms: Accidental overdosage with enoxaparin sodium after intravenous, extracorporeal or subcutaneous administration may lead to hemorrhagic complications. Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.
Management: Antidote and treatment: In case of hemorrhage, certain patients can be treated with protamine sulfate, taking the following factors into account: its efficacy is far lower than that reported in overdoses with unfractionated heparin; due to its undesirable effects (particularly anaphylactic shock), the benefit/risk ratio of protamine sulfate should be carefully weighed beforehand.
Neutralization is performed by slow intravenous injection of protamine (sulfate or hydrochloride). The protamine dose required depends on: the heparin dose injected (100 anti-heparin units of protamine neutralizes the activity of 1 mg (100 anti-Xa IU) of low molecular-weight heparin), if enoxaparin sodium was administered within the last 8 hours; the time since the heparin injection; an infusion of 50 anti-heparin units of protamine per 1 mg (100 anti-Xa IU) of enoxaparin sodium may be administered if enoxaparin sodium was given more than 8 hours previously, or if a second dose of protamine seems necessary; if the injection of enoxaparin sodium was given more than 12 hours previously, it is not necessary to administer protamine.
These recommendations concern patients with normal renal function receiving repeated doses.
Nevertheless, the anti-Xa activity cannot be completely neutralized (maximum about 60%). Furthermore, the neutralization may be transient due to the absorption pharmacokinetics of low-molecular-weight heparin, which may require dividing the total calculated dose of protamine into several injections (2 to 4) given over 24 hours.
In principle, no serious consequences are likely after ingestion of low-molecular weight heparin, even in massive quantities (no cases reported), due to the very low gastric and intestinal absorption of the drug.