| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4355 | 57644-54-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
contains tripotassium di-citratobismuthate used in gastric & duodenal ulcer therapy; do not confuse with colloidal bismuth subnitrate
|
| Dose | Unit | Route |
|---|---|---|
| 0.48 | g | O |
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 28, 2006 | FDA |
None
None
| 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 |
|---|---|---|---|---|---|---|
| Drug eruption | 67.92 | 56.65 | 16 | 146 | 43919 | 79700307 |
None
| Source | Code | Description |
|---|---|---|
| ATC | A02BD08 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori |
| ATC | A02BX05 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) |
| MeSH PA | D000863 | Antacids |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000897 | Anti-Ulcer Agents |
| MeSH PA | D005765 | Gastrointestinal Agents |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Duodenal Ulcer due to H. Pylori | indication | ||
| Alcoholism | contraindication | 7200002 | |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Alcohol intoxication | contraindication | 25702006 | |
| Hepatic failure | contraindication | 59927004 | |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Disorder of brain | contraindication | 81308009 | DOID:936 |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Seizure disorder | contraindication | 128613002 | |
| Non-infective meningitis | contraindication | 230155003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pregnancy, function | contraindication | 289908002 | |
| Peripheral nerve disease | contraindication | 302226006 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Pseudomembranous enterocolitis | contraindication | 397683000 | |
| Breastfeeding (mother) | contraindication | 413712001 |
None
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 140MG;125MG;125MG | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | RICONPHARMA LLC | A217511 | July 3, 2023 | RX | CAPSULE | ORAL | Dec. 29, 2023 | COMPETITIVE GENERIC THERAPY |
None
| ID | Source |
|---|---|
| 4026166 | VUID |
| N0000179322 | NUI |
| D09739 | KEGG_DRUG |
| 4026166 | VANDF |
| C0106556 | UMLSCUI |
| CHEMBL1201186 | ChEMBL_ID |
| CHEMBL1744033 | ChEMBL_ID |
| C002791 | MESH_SUPPLEMENTAL_RECORD_UI |
| HS813P8QPX | UNII |
| 10101269 | PUBCHEM_CID |
| DB09275 | DRUGBANK_ID |
| 1294617 | RXNORM |
| 23879 | MMSL |
| d04952 | MMSL |
| 003773 | NDDF |
| 396007005 | SNOMEDCT_US |
| 420020009 | SNOMEDCT_US |
| 735064002 | SNOMEDCT_US |
| 737682001 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 3 | 49884-151 | CAPSULE | 140 mg | ORAL | ANDA | 27 sections |
| Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 3 | 50742-283 | CAPSULE | 140 mg | ORAL | ANDA | 20 sections |
| Pylera | HUMAN PRESCRIPTION DRUG LABEL | 3 | 54868-6151 | CAPSULE | 140 mg | ORAL | NDA | 27 sections |
| Pylera | HUMAN PRESCRIPTION DRUG LABEL | 3 | 58914-601 | CAPSULE | 140 mg | ORAL | NDA | 32 sections |
| Pylera | HUMAN PRESCRIPTION DRUG LABEL | 3 | 58914-601 | CAPSULE | 140 mg | ORAL | NDA | 32 sections |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 61269-385 | CAPSULE | 140 mg | ORAL | NDA | 32 sections |