dicloxacillin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, 6-aminopenicillanic acid derivatives 866 3116-76-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dicloxacillin
  • dicloxacycline
  • dicloxacillin sodium
  • dicloxacillin sodium hydrate
  • dicloxacillin sodium monohydrate
One of the PENICILLINS which is resistant to PENICILLINASE.
  • Molecular weight: 470.32
  • Formula: C19H17Cl2N3O5S
  • CLOGP: 3.02
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 112.74
  • ALOGS: -4.20
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 g O
2 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 35.51 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 67.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.11 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.88 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 22, 1968 FDA WYETH AYERST

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Tubulointerstitial nephritis 91.53 39.79 22 394 19881 63468725
Suspected transmission of an infectious agent via product 50.26 39.79 7 409 295 63488311
Drug hypersensitivity 40.39 39.79 25 391 310662 63177944

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Prothrombin time shortened 44.45 41.39 8 268 1456 34955199

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Tubulointerstitial nephritis 110.27 36.25 31 670 38204 79705483
Suspected transmission of an infectious agent via product 79.80 36.25 13 688 1173 79742514
Acute kidney injury 41.53 36.25 35 666 519369 79224318

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01CF01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
BETA-LACTAM ANTIBACTERIALS, PENICILLINS
Beta-lactamase resistant penicillins
FDA CS M0016152 Penicillins
FDA EPC N0000175497 Penicillin-class Antibacterial
CHEBI has role CHEBI:36047 antibacterial drugs
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Acute bacterial sinusitis indication 75498004
Infection due to Staphylococcus aureus indication 406602003
Staphylococcus Aureus Bronchitis indication
Continuation Therapy for Chronic Osteomyelitis indication
Continuation Therapy for Acute Osteomyelitis indication
Pyrexia of unknown origin off-label use 7520000
Diabetic Foot Infection Due to Gram-Positive Bacteria off-label use
Kidney disease contraindication 90708001 DOID:557
Infectious mononucleosis contraindication 271558008 DOID:8568
Pseudomembranous enterocolitis contraindication 397683000




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Pyoderma (pyogenic dermatitis) caused by penicillinase-producing staphylococci Indication

🐶 Veterinary products

ProductApplicantIngredients
Dicloxin Capsules Zoetis Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.76 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 250MG BASE DICLOXACILLIN SODIUM AUROBINDO PHARMA A216845 Sept. 23, 2022 RX CAPSULE ORAL March 29, 2023 COMPETITIVE GENERIC THERAPY
EQ 500MG BASE DICLOXACILLIN SODIUM AUROBINDO PHARMA A216845 Sept. 23, 2022 RX CAPSULE ORAL March 29, 2023 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR IC50 5.96 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR IC50 5.66 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR IC50 5.60 WOMBAT-PK
Histamine H2 receptor GPCR IC50 4.80 WOMBAT-PK
Bile salt export pump Transporter IC50 4.16 CHEMBL
cGMP-dependent 3',5'-cyclic phosphodiesterase Enzyme IC50 4.42 WOMBAT-PK
Sodium-dependent dopamine transporter Transporter IC50 4.11 WOMBAT-PK
Penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL
Penicillin-binding protein 1A Enzyme WOMBAT-PK
Streptokinase A Enzyme EC50 7.22 WOMBAT-PK

External reference:

IDSource
4019715 VUID
N0000147807 NUI
D02137 KEGG_DRUG
13412-64-1 SECONDARY_CAS_RN
267257 RXNORM
4017842 VANDF
4019715 VANDF
C0012093 UMLSCUI
CHEBI:4511 CHEBI
CHEMBL893 ChEMBL_ID
CHEMBL1200701 ChEMBL_ID
D004009 MESH_DESCRIPTOR_UI
DB00485 DRUGBANK_ID
12261 IUPHAR_LIGAND_ID
1984 INN_ID
COF19H7WBK UNII
18381 PUBCHEM_CID
1016 MMSL
4585 MMSL
d00153 MMSL
002703 NDDF
002704 NDDF
372873001 SNOMEDCT_US
70886000 SNOMEDCT_US
8416000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3123 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3123 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3123 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3125 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3125 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-3125 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0440-1380 CAPSULE 250 mg ORAL ANDA 21 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0440-7380 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-2248 CAPSULE 250 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-2258 CAPSULE 500 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 16590-076 CAPSULE 500 mg ORAL ANDA 12 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-124 CAPSULE 250 mg ORAL ANDA 21 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 33261-167 CAPSULE 250 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 43063-180 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 43063-180 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 43063-473 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 43063-473 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0116 CAPSULE 250 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0116 CAPSULE 250 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0116 CAPSULE 250 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0310 CAPSULE 500 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0310 CAPSULE 500 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-0310 CAPSULE 500 mg ORAL ANDA 20 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 52959-049 CAPSULE 500 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 54868-0937 CAPSULE 250 mg ORAL ANDA 21 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 54868-1380 CAPSULE 500 mg ORAL ANDA 21 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 55289-592 CAPSULE 250 mg ORAL ANDA 19 sections
Dicloxacillin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 55289-592 CAPSULE 250 mg ORAL ANDA 19 sections
DICLOXACILLIN SODIUM Human Prescription Drug Label 1 59651-565 CAPSULE 250 mg ORAL ANDA 20 sections
DICLOXACILLIN SODIUM Human Prescription Drug Label 1 59651-566 CAPSULE 500 mg ORAL ANDA 20 sections