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Heparin

Generic Name
Heparin
Brand Names
Heparin Leo
Drug Type
Small Molecule
CAS Number
9005-49-6
Unique Ingredient Identifier
T2410KM04A

Overview

Unfractionated heparin (UH) is a heterogenous preparation of anionic, sulfated glycosaminoglycan polymers with weights ranging from 3000 to 30,000 Da. It is a naturally occurring anticoagulant released from mast cells. It binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. UH is different from low molecular weight heparin (LMWH) in the following ways: the average molecular weight of LMWH is about 4.5 kDa whereas it is 15 kDa for UH; UH requires continuous infusions; activated partial prothrombin time (aPTT) monitoring is required when using UH; and UH has a higher risk of bleeding and higher risk of osteoporosis in long term use. Unfractionated heparin is more specific than LMWH for thrombin. Furthermore, the effects of UH can typically be reversed by using protamine sulfate.

Background

Unfractionated heparin (UH) is a heterogenous preparation of anionic, sulfated glycosaminoglycan polymers with weights ranging from 3000 to 30,000 Da. It is a naturally occurring anticoagulant released from mast cells. It binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. UH is different from low molecular weight heparin (LMWH) in the following ways: the average molecular weight of LMWH is about 4.5 kDa whereas it is 15 kDa for UH; UH requires continuous infusions; activated partial prothrombin time (aPTT) monitoring is required when using UH; and UH has a higher risk of bleeding and higher risk of osteoporosis in long term use. Unfractionated heparin is more specific than LMWH for thrombin. Furthermore, the effects of UH can typically be reversed by using protamine sulfate.

Indication

Unfractionated heparin is indicated for prophylaxis and treatment of venous thrombosis and its extension, prevention of post-operative deep venous thrombosis and pulmonary embolism and prevention of clotting in arterial and cardiac surgery. In cardiology, it is used to prevent embolisms in patients with atrial fibrillation and as an adjunct antithrombin therapy in patients with unstable angina and/or non-Q wave myocardial infarctions (i.e. non-ST elevated acute coronary artery syndrome) who are on platelet glycoprotein (IIb/IIIa) receptor inhibitors. Additionally, it is used to prevent clotting during dialysis and surgical procedures, maintain the patency of intravenous injection devices and prevent in vitro coagulation of blood transfusions and in blood samples drawn for laboratory values.

Associated Conditions

  • Blunt Injury
  • Clotting
  • Coagulopathy, Consumption
  • Contusions
  • Deep vein thrombosis postoperative
  • Disseminated Intravascular Coagulation (DIC)
  • External Hemorrhoid
  • Inflammation
  • Inflammatory, non-infectious pruritic dermatosis
  • Interstitial Cystitis
  • Post procedural pulmonary embolism
  • Pulmonary Embolism
  • ST Segment Elevation Myocardial Infarction (STEMI)
  • Sprains
  • Thromboembolism
  • Unstable Angina Pectoris
  • Venous Thrombosis (Disorder)
  • Hematomas
  • Peripheral arterial embolism
  • Thromboembolic phenomena
  • Varicosities of the great saphenous vein

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2016/10/21
Phase 1
UNKNOWN
2016/09/22
Phase 1
Completed
2016/09/12
Phase 3
UNKNOWN
2016/08/09
Phase 4
Completed
2016/06/24
Phase 4
UNKNOWN
Azienda Ospedaliera di Lecco
2016/06/01
Phase 4
UNKNOWN
Chinese PLA General Hospital
2016/05/04
N/A
UNKNOWN
Azienda Sanitaria ULSS 13 Dolo, Mirano
2016/04/29
N/A
Terminated
2016/04/21
Phase 3
Completed
2016/03/14
Not Applicable
Withdrawn

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
HF Acquisition Co LLC, DBA HealthFirst
51662-1434
INTRAVENOUS, SUBCUTANEOUS
10000 [USP'U] in 1 mL
2/22/2020
Meitheal Pharmaceuticals Inc.
71288-423
INTRAVENOUS, SUBCUTANEOUS
5000 [USP'U] in 1 mL
11/22/2021
Mylan Institutional LLC
67457-373
INTRAVENOUS, SUBCUTANEOUS
20000 [USP'U] in 1 mL
2/11/2019
Cantrell Drug Company
52533-216
INTRAVENOUS
50 [USP'U] in 1 mL
12/24/2014
CorMedix Inc.
72990-105
INTRALUMINAL
5000 [USP'U] in 5 mL
12/21/2023
Cardinal Health 107, LLC
55154-2827
INTRAVENOUS, SUBCUTANEOUS
5000 [USP'U] in 1 mL
2/13/2020
Hikma Pharmaceuticals USA Inc.
0641-6199
INTRAVENOUS, SUBCUTANEOUS
5000 [USP'U] in 1 mL
12/12/2022
Pfizer Laboratories Div Pfizer Inc
0069-0137
INTRAVENOUS, SUBCUTANEOUS
1000 [USP'U] in 1 mL
5/27/2020
Fresenius Kabi USA, LLC
63323-262
INTRAVENOUS, SUBCUTANEOUS
5000 [USP'U] in 1 mL
2/18/2020
Sagent Pharmaceuticals
25021-403
INTRAVENOUS, SUBCUTANEOUS
10000 [USP'U] in 1 mL
6/30/2017

EMA Drug Approvals

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NMPA Drug Approvals

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TGA Drug Approvals

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