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

Stem definition	Drug id	CAS RN
antibiotics, 6-aminopenicillanic acid derivatives	866	3116-76-5

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
2	g	O
2	g	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	67.50 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
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
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	2 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.88 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.11 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.03 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
April 22, 1968	FDA	WYETH AYERST

FDA Adverse Event Reporting System (Female)

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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
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

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FDA Adverse Event Reporting System (Male)

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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
Prothrombin time shortened	44.45	41.39	8	268	1456	34955199

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FDA Adverse Event Reporting System (Geriatric)

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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
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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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Disease	Relation	SNOMED_ID	DOID
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

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🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Pyoderma (pyogenic dermatitis) caused by penicillinase-producing staphylococci	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Dicloxin Capsules	Zoetis Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.76	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	5.96	WOMBAT-PK
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		IC50	5.66	WOMBAT-PK
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		IC50	5.60	WOMBAT-PK
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		IC50	4.80	WOMBAT-PK
Bile salt export pump	Transporter	O95342	ABCBB_HUMAN		IC50	4.16	CHEMBL
cGMP-dependent 3',5'-cyclic phosphodiesterase	Enzyme	O00408	PDE2A_HUMAN		IC50	4.42	WOMBAT-PK
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		IC50	4.11	WOMBAT-PK
Penicillin-binding protein	Enzyme		P72355_STAAU Q53707_STAAU Q53725_STAAU Q53729_STAAU Q9XDB3_STAAU	INHIBITOR			CHEMBL	CHEMBL
Penicillin-binding protein 1A	Enzyme		PBPA_CLOPE				WOMBAT-PK
Streptokinase A	Enzyme		STRP_STRP1		EC50	7.22	WOMBAT-PK

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External reference:

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ID	Source
002703	NDDF
002704	NDDF
1016	MMSL
12261	IUPHAR_LIGAND_ID
13412-64-1	SECONDARY_CAS_RN
18381	PUBCHEM_CID
1984	INN_ID
267257	RXNORM
372873001	SNOMEDCT_US
4017842	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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

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