lactitol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1534 | 585-86-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 667 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 12, 2020 | FDA | BRAINTREE LABS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic encephalopathy | 42.00 | 40.44 | 11 | 499 | 11271 | 63477241 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic encephalopathy | 43.53 | 40.83 | 12 | 276 | 14673 | 34941970 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hepatic encephalopathy | 80.80 | 33.49 | 23 | 830 | 24143 | 79719392 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A06AD12 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives |
| FDA PE | N0000009875 | Stimulation Small Intestine Fluid/Electrolyte Secretion |
| FDA MoA | N0000010288 | Osmotic Activity |
| MeSH PA | D002400 | Cathartics |
| MeSH PA | D005421 | Flavoring Agents |
| MeSH PA | D005503 | Food Additives |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D013549 | Sweetening Agents |
| FDA EPC | N0000175811 | Osmotic Laxative |
| CHEBI has role | CHEBI:50503 | laxante |
| CHEBI has role | CHEBI:75324 | excipient |
| CHEBI has role | CHEBI:75325 | cathartics |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic idiopathic constipation | indication | 82934008 | |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Galactosemia | contraindication | 190745006 | DOID:9870 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.27 | acidic |
| pKa2 | 13.48 | acidic |
| pKa3 | 13.97 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10GM | PIZENSY | BRAINTREE LABS | N211281 | Feb. 12, 2020 | DISCN | FOR SOLUTION | ORAL | 10806743 | May 12, 2037 | METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS. |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10GM | PIZENSY | BRAINTREE LABS | N211281 | Feb. 12, 2020 | DISCN | FOR SOLUTION | ORAL | Feb. 12, 2025 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D08266 | KEGG_DRUG |
| C0064585 | UMLSCUI |
| CHEBI:75323 | CHEBI |
| CHEMBL1661 | ChEMBL_ID |
| DB12942 | DRUGBANK_ID |
| C014635 | MESH_SUPPLEMENTAL_RECORD_UI |
| 157355 | PUBCHEM_CID |
| 6414 | INN_ID |
| L2B0WJF7ZY | UNII |
| 2284606 | RXNORM |
| 23072 | MMSL |
| d06357 | MMSL |
| 003987 | NDDF |
| 317599009 | SNOMEDCT_US |
| 418929008 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PIZENSY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52268-600 | POWDER, FOR SOLUTION | 1 g | ORAL | NDA | 15 sections |