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

Stem definition	Drug id	CAS RN
	1497	54-85-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: isoniazid 4-Pyridinecarboxylic hydrazide armazid isoniazide isonicotinohydrazide	Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis. Molecular weight: 137.14 Formula: C6H7N3O CLOGP: -0.67 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 68.01 ALOGS: -0.59 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

isoniazid
4-Pyridinecarboxylic hydrazide
armazid
isoniazide
isonicotinohydrazide

Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.

Molecular weight: 137.14
Formula: C6H7N3O
CLOGP: -0.67
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 68.01
ALOGS: -0.59
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.30	g	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	72.92 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
CL (Clearance)	7.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	7 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	140 mg/mL	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	1 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.82 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Sept. 29, 1952	FDA	SANDOZ

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
Drug reaction with eosinophilia and systemic symptoms	641.63	13.88	285	21411	33551	63433775
Drug-induced liver injury	498.99	13.88	253	21443	39969	63427357
Paradoxical drug reaction	463.63	13.88	131	21565	4021	63463305
Acute hepatic failure	342.72	13.88	153	21543	18174	63449152
Drug resistance	277.63	13.88	142	21554	22791	63444535
Hepatitis	255.99	13.88	163	21533	39625	63427701
Hepatotoxicity	238.92	13.88	152	21544	36889	63430437
Tuberculoma of central nervous system	222.41	13.88	45	21651	302	63467024
Tuberculosis	217.26	13.88	96	21600	11115	63456211
Jaundice	211.26	13.88	129	21567	29122	63438204

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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
Paradoxical drug reaction	865.35	14.66	229	20136	3122	34933444
Drug-induced liver injury	503.82	14.66	272	20093	28560	34908006
Immune reconstitution inflammatory syndrome	456.54	14.66	177	20188	8582	34927984
Drug reaction with eosinophilia and systemic symptoms	391.29	14.66	242	20123	32770	34903796
Hepatotoxicity	356.55	14.66	196	20169	21289	34915277
Jaundice	294.70	14.66	200	20165	31682	34904884
Drug resistance	286.79	14.66	182	20183	25745	34910821
Immune reconstitution inflammatory syndrome associated tuberculosis	254.48	14.66	58	20307	400	34936166
Tuberculosis	229.18	14.66	108	20257	8469	34928097
Tuberculoma of central nervous system	188.21	14.66	41	20324	223	34936343

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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
Paradoxical drug reaction	1263.69	12.59	348	37824	6837	79699379
Drug reaction with eosinophilia and systemic symptoms	981.55	12.59	519	37653	63725	79642491
Drug-induced liver injury	950.70	12.59	513	37659	65604	79640612
Immune reconstitution inflammatory syndrome	625.28	12.59	239	37933	13602	79692614
Hepatotoxicity	524.39	12.59	319	37853	51033	79655183
Jaundice	510.63	12.59	318	37854	53031	79653185
Drug resistance	493.03	12.59	286	37886	41927	79664289
Immune reconstitution inflammatory syndrome associated tuberculosis	436.11	12.59	97	38075	739	79705477
Acute hepatic failure	411.02	12.59	226	37946	29887	79676329
Tuberculosis	386.02	12.59	174	37998	15024	79691192

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J04AC01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Hydrazides
ATC	J04AC51	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Hydrazides
ATC	J04AM01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM04	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM05	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM06	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis
ATC	J04AM08	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Combinations of drugs for treatment of tuberculosis

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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
Inactive tuberculosis	indication	11999007
Acute tuberculosis	indication	25629007
Pulmonary tuberculosis	indication	154283005	DOID:2957
Tuberculosis of meninges	off-label use	58437007
Atypical mycobacterial infection	off-label use	111812000
Nutritional disorder	contraindication	2492009	DOID:374
Alcoholism	contraindication	7200002
Jaundice	contraindication	18165001
Acute hepatitis	contraindication	37871000
Acute nephropathy	contraindication	58574008

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.98	acidic
pKa2	3.79	Basic
pKa3	1.94	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Cytochrome P450 3A5	Enzyme	P20815	CP3A5_HUMAN		IC50	4.96	WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		IC50	5.31	WOMBAT-PK
Myeloperoxidase	Enzyme	P05164	PERM_HUMAN		IC50	5.33	CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH]	Enzyme		INHA_MYCTU	INHIBITOR	IC50	5.08	CHEMBL	CHEMBL
Catalase-peroxidase	Enzyme		KATG_MYCTO				WOMBAT-PK
Dihydrofolate reductase	Enzyme		DYR_MYCTU		Ki	9	CHEMBL

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External reference:

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ID	Source
ISZ	PDB_CHEM_ID
002844	NDDF
12761	IUPHAR_LIGAND_ID
2955	MMSL
3767	PUBCHEM_CID
387472004	SNOMEDCT_US
4017505	VUID
4017505	VANDF
4188	INN_ID
4929	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0440-1655	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0440-7655	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1109	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0066	TABLET	100 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0071	TABLET	300 mg	ORAL	ANDA	24 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3056	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	ANDA	25 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3056	INJECTION, SOLUTION	100 mg	INTRAMUSCULAR	ANDA	25 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10135-584	TABLET	300 mg	ORAL	ANDA	22 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10544-087	TABLET	300 mg	ORAL	ANDA	23 sections
Isoniazid	HUMAN PRESCRIPTION DRUG LABEL	1	10544-121	TABLET	300 mg	ORAL	ANDA	23 sections

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