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nisoldipine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| calcium channel blockers, nifedipine derivatives | 1942 | 63675-72-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 20 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.25 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Hosey CM, Chan R, Benet LZ |
| BA (Bioavailability) | 5 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 5.50 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 15 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 11 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 0.01 mg/mL | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.089 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.117 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 38.459 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 148.594 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 1.250 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 1.820 | % | High | 1 |
| herg | hERG pIC50 | 4.753 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 114.551 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 265.461 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 1.680 | % | High | 1 |
| kinase-safety-class | ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,NTRK2,PDK1,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,TEK,TTK,ZAP70 | 40 | |||
| kinase-selectivity-class | AXL,BRAF,GRK2,PDK4,PIK3CD,STK33 | 6 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 0.650 | High | 0.80 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.094 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 124.738 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 1.060 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 2.979 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 1.780 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.148 | % | High | 0.80 |
| rh-clint | Rat hepatocyte intrinsic clearance | 284.446 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 10.910 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 1.350 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 10.914 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 2, 1995 | FDA | SHIONOGI INC |
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 |
|---|---|---|---|---|---|---|
| Intestinal angioedema | 34.43 | 29.63 | 6 | 758 | 842 | 90626841 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Intestinal angioedema | 32.52 | 27.28 | 6 | 984 | 1091 | 110587218 |
| Anhedonia | 28.77 | 27.28 | 9 | 981 | 15419 | 110572890 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C08CA07 | CARDIOVASCULAR SYSTEM CALCIUM CHANNEL BLOCKERS SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS Dihydropyridine derivatives |
| FDA CS | M0006414 | Dihydropyridines |
| FDA MoA | N0000000069 | Calcium Channel Antagonists |
| FDA EPC | N0000175421 | Dihydropyridine Calcium Channel Blocker |
| MeSH PA | D000077264 | Calcium-Regulating Hormones and Agents |
| MeSH PA | D000959 | Antihypertensive Agents |
| MeSH PA | D002121 | Calcium Channel Blockers |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D014665 | Vasodilator Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| FDA PE | N0000178477 | Decreased Blood Pressure |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:38215 | calcium channel blocker |
| CHEBI has role | CHEBI:50427 | platelet aggregation inhibitor |
Related Drugs by ATC class:
C08CA Dihydropyridine derivatives 17 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypertensive disorder | indication | 38341003 | DOID:10763 |
| Low blood pressure | contraindication | 45007003 | |
| Chronic heart failure | contraindication | 48447003 | |
| Coronary arteriosclerosis | contraindication | 53741008 | DOID:3393 |
| Hepatic failure | contraindication | 59927004 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.37 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Voltage-dependent L-type calcium channel subunit alpha-1D | Ion channel | BLOCKER | UNKNOWN | CHEMBL | |||||
| Voltage-dependent L-type calcium channel subunit alpha-1C | Ion channel | GATING INHIBITOR | IC50 | 7.10 | IUPHAR | CHEMBL | |||
| Voltage-dependent P/Q-type calcium channel subunit alpha-1A | Ion channel | WOMBAT-PK | |||||||
| Adenosine receptor A3 | GPCR | Ki | 5.40 | DRUG MATRIX | |||||
| Voltage-dependent T-type calcium channel subunit alpha-1H | Ion channel | Ki | 5.34 | WOMBAT-PK | |||||
| Cytochrome P450 1A2 | Enzyme | IC50 | 6 | DRUG MATRIX | |||||
| Sodium channel alpha subunits; brain (Types I, II, III) | Ion channel | IC50 | 4.59 | CHEMBL | |||||
| Adenosine receptor A2a | GPCR | Ki | 5.64 | DRUG MATRIX | |||||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 4.64 | WOMBAT-PK | |||||
| Voltage-dependent L-type calcium channel subunit alpha-1C | Ion channel | GATING INHIBITOR | IC50 | 8 | IUPHAR | ||||
| Voltage-dependent L-type calcium channel subunit alpha-1D | Ion channel | GATING INHIBITOR | IC50 | 7 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 4020942 | VUID |
| N0000148422 | NUI |
| D00618 | KEGG_DRUG |
| 4020942 | VANDF |
| C0028116 | UMLSCUI |
| CHEBI:7577 | CHEBI |
| CHEMBL1726 | ChEMBL_ID |
| DB00401 | DRUGBANK_ID |
| D015737 | MESH_DESCRIPTOR_UI |
| 4499 | PUBCHEM_CID |
| 2524 | IUPHAR_LIGAND_ID |
| 4753 | INN_ID |
| 4I8HAB65SZ | UNII |
| 7435 | RXNORM |
| 147682 | MMSL |
| 5178 | MMSL |
| d03825 | MMSL |
| 004175 | NDDF |
| 108524004 | SNOMEDCT_US |
| 386861009 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0677-1978 | TABLET, FILM COATED, EXTENDED RELEASE | 8.50 mg | ORAL | NDA authorized generic | 27 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0677-1979 | TABLET, FILM COATED, EXTENDED RELEASE | 17 mg | ORAL | NDA authorized generic | 27 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0677-1980 | TABLET, FILM COATED, EXTENDED RELEASE | 25.50 mg | ORAL | NDA authorized generic | 27 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0677-1981 | TABLET, FILM COATED, EXTENDED RELEASE | 34 mg | ORAL | NDA authorized generic | 27 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5931 | TABLET, FILM COATED, EXTENDED RELEASE | 40 mg | ORAL | ANDA | 26 sections |
| SULAR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5993 | TABLET, FILM COATED, EXTENDED RELEASE | 25.50 mg | ORAL | NDA | 26 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-472 | TABLET, FILM COATED, EXTENDED RELEASE | 8.50 mg | ORAL | NDA authorized generic | 25 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-472 | TABLET, FILM COATED, EXTENDED RELEASE | 8.50 mg | ORAL | NDA authorized generic | 25 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-473 | TABLET, FILM COATED, EXTENDED RELEASE | 17 mg | ORAL | NDA authorized generic | 25 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-473 | TABLET, FILM COATED, EXTENDED RELEASE | 17 mg | ORAL | NDA authorized generic | 25 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-475 | TABLET, FILM COATED, EXTENDED RELEASE | 34 mg | ORAL | NDA authorized generic | 25 sections |
| Nisoldipine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66993-475 | TABLET, FILM COATED, EXTENDED RELEASE | 34 mg | ORAL | NDA authorized generic | 25 sections |
| Sular | Human Prescription Drug Label | 1 | 70515-500 | TABLET, FILM COATED, EXTENDED RELEASE | 8.50 mg | ORAL | NDA | 25 sections |
| Sular | Human Prescription Drug Label | 1 | 70515-501 | TABLET, FILM COATED, EXTENDED RELEASE | 17 mg | ORAL | NDA | 25 sections |
| Sular | Human Prescription Drug Label | 1 | 70515-503 | TABLET, FILM COATED, EXTENDED RELEASE | 34 mg | ORAL | NDA | 25 sections |