Lactulose
Generlac, Lactulose (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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Commercial
Trade Name
FDA
EMA
Generlac, Lactulose (discontinued: Acilac, Cephulac, Cholac, Chronulac, Constilac, Constulose, Duphalac, Enulose, Evalose, Heptalac, Lactulose, Laxilose, Portalac)
Drug Products
FDA
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 | 2024-12-18 |
| generlac | ANDA | 2024-07-16 |
| kristalose | ANDA | 2018-09-17 |
| lactulose | ANDA | 2025-11-13 |
| lactulose solution | ANDA | 2025-02-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | — | D003248 | K59.0 |
| hepatic encephalopathy | — | D006501 | K72.91 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
208 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | — | K59.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonoscopy | D003113 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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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 | — |
| ChEMBL ID | CHEMBL296306 |
| ChEBI ID | 6359 |
| PubChem CID | 11333 |
| DrugBank | DB00581 |
| UNII ID | 9U7D5QH5AE (ChemIDplus, GSRS) |
Target
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Financial
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Kristalose – Cumberland Pharmaceuticals
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Estimated US medical usage
Lactulose
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 13,985 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,056 adverse events reported
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