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

Stem definition	Drug id	CAS RN
histamine-H2-receptor antagonists, cimetidine derivatives	1955	76963-41-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nizatidine naxidine nizaxid	A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers. Molecular weight: 331.45 Formula: C12H21N5O2S2 CLOGP: -0.16 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 83.33 ALOGS: -3.93 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nizatidine
naxidine
nizaxid

A histamine H2 receptor antagonist with low toxicity that inhibits gastric acid secretion. The drug is used for the treatment of duodenal ulcers.

Molecular weight: 331.45
Formula: C12H21N5O2S2
CLOGP: -0.16
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 83.33
ALOGS: -3.93
ROTB: 10

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
CL (Clearance)	9.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	61 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	21.40 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	15.08 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	1.50 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.65 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
April 12, 1988	FDA

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
Chronic kidney disease	33.63	21.62	18	1509	45380	63442115

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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
Tonsillar ulcer	52.46	25.27	8	855	162	34955906
Catheter site cellulitis	31.62	25.27	5	858	129	34955939
Intestinal metaplasia	29.34	25.27	4	859	35	34956033
Aortic valve disease mixed	25.49	25.27	4	859	98	34955970

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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
Tonsillar ulcer	44.03	20.23	8	2217	423	79741740
Platelet count decreased	28.58	20.23	31	2194	194633	79547530
Intestinal metaplasia	28.10	20.23	4	2221	43	79742120
Catheter site cellulitis	24.60	20.23	5	2220	478	79741685
Aortic valve disease mixed	23.43	20.23	4	2221	147	79742016
Hepatic function abnormal	23.29	20.23	18	2207	73089	79669074
Chronic kidney disease	22.64	20.23	17	2208	66137	79676026

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	A02BA04	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) H2-receptor antagonists
CHEBI has role	CHEBI:37961	H2 receptor antagonists
CHEBI has role	CHEBI:38323	cholinergic drugs
CHEBI has role	CHEBI:49201	anti-ulcer drugs
FDA EPC	N0000175784	Histamine-2 Receptor Antagonist
FDA MoA	N0000000151	Histamine H2 Receptor Antagonists
MeSH PA	D000897	Anti-Ulcer Agents
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D018494	Histamine Agents
MeSH PA	D006633	Histamine Antagonists

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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
Peptic ulcer	indication	13200003	DOID:750
Heartburn	indication	16331000
Erosive esophagitis	indication	40719004
Duodenal ulcer disease	indication	51868009	DOID:1724
Peptic reflux disease	indication	57643001
Indigestion	indication	162031009
Gastroesophageal reflux disease	indication	235595009	DOID:8534
Gastric ulcer	indication	397825006	DOID:10808
Maintenance of Healing Duodenal Ulcer	indication
Upper gastrointestinal hemorrhage	off-label use	37372002

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.68	Basic
pKa2	6.01	Basic
pKa3	1.26	Basic
pKa4	0.34	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN	ANTAGONIST	Kd	6.92		WOMBAT-PK	CHEMBL
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		IC50	5.25		DRUG MATRIX

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External reference:

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ID	Source
003418	NDDF
108664005	SNOMEDCT_US
3033637	PUBCHEM_CID
386887009	SNOMEDCT_US
4019342	VUID
4019342	VANDF
42319	RXNORM
44069	MMSL
5184	MMSL
5194	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3137	CAPSULE	150 mg	ORAL	ANDA	10 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3138	CAPSULE	300 mg	ORAL	ANDA	10 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	16590-741	CAPSULE	150 mg	ORAL	ANDA	9 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-043	CAPSULE	300 mg	ORAL	ANDA	10 sections
nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	21695-375	CAPSULE	150 mg	ORAL	ANDA	10 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	42254-093	CAPSULE	150 mg	ORAL	ANDA	10 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	45865-374	CAPSULE	150 mg	ORAL	ANDA	21 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	52959-824	CAPSULE	150 mg	ORAL	ANDA	10 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	55111-310	CAPSULE	150 mg	ORAL	ANDA	23 sections
Nizatidine	HUMAN PRESCRIPTION DRUG LABEL	1	55111-311	CAPSULE	300 mg	ORAL	ANDA	23 sections

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