Heparin sodium
Calciparine, Defencath, Embolex, Heparin (heparin sodium) is an oligosaccharide pharmaceutical. Heparin sodium was first approved as Calciparine on 1982-01-01. It is used to treat cerebral infarction, coronary thrombosis, myocardial infarction, postoperative complications, and pulmonary embolism amongst others in the USA. The pharmaceutical is active against antithrombin-III.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Defencath (discontinued: Embolex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dihydroergotamine mesylate
+
Heparin sodium
+
Lidocaine hydrochloride
Heparin calcium
Heparin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019952 RX | 1992-07-20 | 1 products, RLD, RS |
| HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER | B. Braun Medical | N-019952 RX | 1992-07-20 | 2 products, RLD, RS |
| HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B. Braun Medical | N-019953 RX | 2023-12-15 | 1 products, RLD, RS |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B. Braun Medical | N-019953 RX | 1992-07-20 | 1 products, RLD, RS |
| HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter | N-018609 RX | 1982-04-28 | 1 products |
| HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Baxter | N-018609 RX | 1982-04-28 | 1 products |
| HEPARIN SODIUM | Fresenius Kabi | N-017029 RX | 2011-03-31 | 1 products, RLD, RS |
| HEPARIN SODIUM PRESERVATIVE FREE | Fresenius Kabi | N-017029 RX | 1986-04-28 | 2 products, RLD, RS |
| HEPARIN SODIUM IN PLASTIC CONTAINER | Fresenius Kabi | N-017029 RX | 1985-12-05 | 4 products, RLD, RS |
| HEPARIN SODIUM | Fresenius Kabi | N-017029 RX | 1982-01-01 | 3 products, RLD, RS |
Show 12 marketed
Show 58 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| defencath | New Drug Application | 2023-12-21 |
| heparin | unapproved drug other | 2012-08-09 |
| heparin sodium | unapproved drug other | 2014-12-24 |
| heparin sodium | New Drug Application | 2024-01-29 |
| heparin sodium and dextrose | New Drug Application | 2023-12-04 |
| heparin sodium and sodium chloride | New Drug Application | 2019-04-19 |
| heparin sodium in dextrose | New Drug Application | 2023-07-27 |
| heparin sodium in sodium chloride | New Drug Application | 2024-01-27 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
HEPARIN SODIUM / TAUROLIDINE, DEFENCATH, CORMEDIX | |||
| 2033-11-15 | GAIN | ||
| 2028-11-15 | NCE | ||
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AB: Heparin group antithrombotic drugs
— B01AB01: Heparin
— B01AB51: Heparin, combinations
— B01AC: Platelet aggregation inhibitors excl. heparin
— B01AC30: Platelet aggregation inhibitor combinations excl. heparin
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05B: Antivaricose therapy drugs
— C05BA: Heparins or heparinoids for topical use
— C05BA03: Heparin
— C05BA53: Heparin, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA14: Heparin
Clinical
Clinical Trials
501 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 2 | 3 | 10 | 10 | 13 | 37 |
| Covid-19 | D000086382 | — | U07.1 | 4 | 12 | 11 | 8 | 6 | 32 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | 2 | 4 | 11 | 5 | 9 | 30 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | 2 | 2 | 6 | 10 | 2 | 22 |
| Thrombosis | D013927 | — | — | 1 | 3 | 4 | 2 | 11 | 20 |
| Coronary artery disease | D003324 | — | I25.1 | — | 5 | 1 | 8 | 4 | 18 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | 6 | 1 | 6 | 16 |
| Catheter-related infections | D055499 | — | — | 1 | — | 2 | 3 | 6 | 12 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | 2 | 2 | 3 | 6 | 12 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | 3 | 6 | 2 | 1 | 11 |
Show 66 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | 1 | 1 | — | — | 10 |
| Septic shock | D012772 | — | A48.3 | — | 3 | 1 | — | 2 | 6 |
| Critical illness | D016638 | — | — | — | 2 | 2 | — | 1 | 5 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | — | 3 | 5 |
| Coronary artery bypass | D001026 | EFO_0003776 | — | — | — | 2 | — | 2 | 4 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | 3 | — | — | 3 |
| Proliferative vitreoretinopathy | D018630 | EFO_1001129 | — | — | — | 3 | — | — | 3 |
| Upper extremity deep vein thrombosis | D056824 | — | — | — | 2 | 1 | — | 1 | 3 |
| Burns | D002056 | — | T30.0 | — | 1 | 1 | — | 2 | 3 |
| Balloon angioplasty coronary | D015906 | EFO_0003951 | — | — | 1 | 2 | — | — | 3 |
Show 32 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 3 | — | — | 2 | 7 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | 6 | 7 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | 1 | — | — | 2 | 3 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | 2 | — | — | — | 2 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | 2 | — | — | — | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 1 | — | — | — | 1 |
| Embolic stroke | D000083262 | — | — | — | 1 | — | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | — | — | — | 1 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | 1 | — | — | — | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | 1 | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | 1 | — | — | — | 2 | 3 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
| Thrombophlebitis | D013924 | HP_0004418 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 3 | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 2 | 2 |
| Hyperlipoproteinemia type i | D008072 | Orphanet_411 | E78.3 | — | — | — | — | 2 | 2 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 2 | 2 |
| Optical coherence tomography | D041623 | — | — | — | — | — | — | 1 | 1 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | — | — | — | 1 | 1 |
| Undifferentiated connective tissue diseases | D000074079 | — | — | — | — | — | — | 1 | 1 |
| Urolithiasis | D052878 | — | N20-N23 | — | — | — | — | 1 | 1 |
| Carotid artery injuries | D020212 | — | S15.0 | — | — | — | — | 1 | 1 |
Show 45 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Heparin sodium |
| INN | heparin sodium |
| Description | Heparin, also known as unfractionated heparin (UFH), is a medication and naturally occurring glycosaminoglycan. Heparin is a blood anticoagulant that increases the activity of antithrombin. It is used in the treatment of heart attacks and unstable angina. It can be given intravenously or by injection under the skin. Its anticoagulant properties make it useful to prevent blood clotting in blood specimen test tubes and kidney dialysis machines.
|
| Classification | Oligosaccharide |
| Drug class | heparin derivatives and low molecular weight (or depolymerized) heparins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 9005-49-6 |
| RxCUI | 5224 |
| ChEMBL ID | CHEMBL1201657 |
| ChEBI ID | — |
| PubChem CID | 22833565 |
| DrugBank | DB01109 |
| UNII ID | ZZ45AB24CA (ChemIDplus, GSRS) |
Target
Agency Approved
SERPINC1
SERPINC1
Organism
Homo sapiens
Gene name
SERPINC1
Gene synonyms
AT3
NCBI Gene ID
Protein name
antithrombin-III
Protein synonyms
serine (or cysteine) proteinase inhibitor, clade C (antithrombin), member 1, Serpin C1, serpin peptidase inhibitor clade C member 1, serpin peptidase inhibitor, clade C (antithrombin), member 1
Uniprot ID
Mouse ortholog
Serpinc1 (11905)
antithrombin-III (P32261)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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30,050 adverse events reported
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