| TAH Drug Code | IPROA |
|---|---|
| Indications | Treatment of overdosage or haemorrhage during heparin or Low Molecular Weight Heparin (LMWH) therapy. To counteract the anticoagulant effects of heparin or LMWH before emergency surgery. To reverse the anticoagulant effects of heparin in cardiopulmonary bypass procedures. |
| Dosing | Administered as a slow intravenous injection over 10 minutes or as a slow intravenous infusion. Bolus dose not to exceed 5 mL. Dose ideally guided by blood coagulation studies, such as APTT, ACT, anti-Xa, and protamine neutralization test. Coagulation tests performed 5-15 minutes after administration. Additional doses may be required due to rapid clearance from the blood. - For heparin neutralization: 1 mL of Protamine sulphate neutralizes approximately 1400 IU of heparin. - For LMWH neutralization: consult manufacturer guidelines; 1 mL per 1000 anti Xa IU is recommended. Repeat administrations may be necessary, especially for subcutaneously administered LMWH. - In cardiopulmonary bypass procedures: 0.1-0.2 mL for each 100 units of heparin given. Doses should be guided by blood coagulation studies. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Hypersensitivity to the active substance or to any of the excipients. |
| Adverse Effects | Common: Flushing, Nausea, Vomiting, Dyspnea Serious: Bradyarrhythmia, Hypotension, Anaphylaxis, Non-allergic anaphylaxis, Circulatory collapse, capillary leak, noncardiogenic pulmonary edema |
| Pregnancy | Compatible |
| Lactation | No (Limited) Human Data - Probably Compatible |
| More Info | UpToDate |