balsalazide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| phenylazosalicylic acid derivatives antibacterial | 284 | 80573-04-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a mesalamine 5-aminosalicylate prodrug; 99% of ingested drug remains intact through the stomach and is delivered to and activated in the colon; used for inflammatory bowel disease, ulcerative colitis and radiation-induced proctosigmoiditis but avoided in patients with known hypersensitivity reaction to salicylates or mesalamine
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 6.75 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 269.86 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 1 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 18, 2000 | FDA | SALIX PHARMS |
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 |
|---|---|---|---|---|---|---|
| Colitis ulcerative | 83.07 | 31.75 | 25 | 872 | 17707 | 46667458 |
| Effusion | 42.82 | 31.75 | 9 | 888 | 1482 | 46683683 |
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 |
|---|---|---|---|---|---|---|
| Colitis ulcerative | 57.07 | 31.10 | 18 | 577 | 14416 | 29937467 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A07EC04 | ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Aminosalicylic acid and similar agents |
| FDA CS | M0000971 | Aminosalicylic Acids |
| FDA EPC | N0000175781 | Aminosalicylate |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
| CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory drugs |
| CHEBI has role | CHEBI:49201 | anti-ulcer agents |
| CHEBI has role | CHEBI:55324 | gastrointestinal agents |
| CHEBI has role | CHEBI:50266 | prodrugs |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Ulcerative colitis | indication | 64766004 | DOID:8577 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Pyloric obstruction | contraindication | 244815007 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.28 | acidic |
| pKa2 | 4.08 | acidic |
| pKa3 | 11.45 | acidic |
| pKa4 | 12.18 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Prostaglandin G/H synthase 1 | Enzyme | INHIBITOR | WOMBAT-PK | CHEMBL | |||||
| Prostaglandin G/H synthase 2 | Enzyme | INHIBITOR | WOMBAT-PK | CHEMBL | |||||
| Arachidonate 5-lipoxygenase | Enzyme | INHIBITOR | CHEMBL | CHEMBL | |||||
| Peroxisome proliferator-activated receptor gamma | Nuclear hormone receptor | AGONIST | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| P80AL8J7ZP | UNII |
| 4021231 | VUID |
| N0000148675 | NUI |
| D02715 | KEGG_DRUG |
| 150399-21-6 | SECONDARY_CAS_RN |
| 4021231 | VANDF |
| 4021232 | VANDF |
| C0052940 | UMLSCUI |
| CHEBI:267413 | CHEBI |
| BLQ | PDB_CHEM_ID |
| CHEMBL1201346 | ChEMBL_ID |
| CHEMBL1200760 | ChEMBL_ID |
| DB01014 | DRUGBANK_ID |
| 54585 | PUBCHEM_CID |
| 5221 | INN_ID |
| C038637 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11569 | IUPHAR_LIGAND_ID |
| 153718 | RXNORM |
| 130137 | MMSL |
| 15641 | MMSL |
| d04700 | MMSL |
| 007156 | NDDF |
| 007157 | NDDF |
| 391811002 | SNOMEDCT_US |
| 420306005 | SNOMEDCT_US |
| 420557005 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0079 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-157 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-102 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-102 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6137 | CAPSULE | 750 mg | ORAL | ANDA | 25 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-952 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-2575 | CAPSULE | 750 mg | ORAL | ANDA | 25 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8301 | CAPSULE | 750 mg | ORAL | ANDA | 23 sections |
| Colazal | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65649-101 | CAPSULE | 750 mg | ORAL | NDA authorized generic | 21 sections |
| Balsalazide Disodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72789-149 | CAPSULE | 750 mg | ORAL | ANDA | 24 sections |