Lactulose
Acilac, Cephulac, Cholac, Chronulac, Constilac, Constulose, Duphalac, Enulose, Evalose, Generlac, Heptalac, Laxilose, Portalac (lactulose) is a small molecule pharmaceutical. Lactulose was first approved as Cephulac on 1982-01-01. It is used to treat constipation and hepatic encephalopathy in the USA.
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Trade Name
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| constulose | ANDA | 2022-06-01 |
| enulose | ANDA | 2023-03-15 |
| generlac | ANDA | 2019-01-08 |
| lactulose | ANDA | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
| hepatic encephalopathy | — | D006501 | K72.91 |
Agency Specific
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HCPCS
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Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic encephalopathy | D006501 | K72.91 | 3 | 7 | 5 | 11 | 9 | 33 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 3 | 1 | 5 | 8 | 16 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | 2 | 2 | 4 | 2 | 9 |
| Acute-on-chronic liver failure | D065290 | 2 | — | — | 1 | 1 | 4 | ||
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | 2 | — | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | 2 | 1 | 3 |
| Fissure in ano | D005401 | HP_0012390 | K60.2 | — | 1 | 1 | 1 | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Pathologic processes | D010335 | — | — | — | 1 | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | 2 | 3 | ||
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | — | 1 |
| Burns | D002056 | T30.0 | 1 | — | — | — | — | 1 | |
| Persian gulf syndrome | D018923 | EFO_0007430 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic diseases | D003108 | — | — | — | — | 1 | 1 | ||
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | — | — | — | — | 1 | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 1 | 1 |
| Parkinsonian disorders | D020734 | HP_0001300 | — | — | — | — | 1 | 1 | |
| Hirschsprung disease | D006627 | Q43.1 | — | — | — | — | 1 | 1 | |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | — | — | 1 | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | — | 1 | 1 |
| Abdominal pain | D015746 | R10.9 | — | — | — | — | 1 | 1 | |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LACTULOSE |
| INN | lactulose |
| Description | Lactulose is a synthetic galactosylfructose disaccharide used in the treatment of constipation and hepatic encephalopathy. It has a role as a laxative and a gastrointestinal drug. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 4618-18-2 |
| RxCUI | 6218 |
| ChEMBL ID | CHEMBL296306 |
| ChEBI ID | 6359 |
| PubChem CID | 11333 |
| DrugBank | DB00581 |
| UNII ID | 9U7D5QH5AE (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Trends
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Safety
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Adverse Events
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44 adverse events reported
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