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

Stem definition	Drug id	CAS RN
antiprotozoals and radiosensitizers, metronidazole derivatives	2671	19387-91-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tindamax tinidazole tinidazol trimonase	A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections. Molecular weight: 247.27 Formula: C8H13N3O4S CLOGP: -0.32 LIPINSKI: 0 HAC: 7 HDO: 0 TPSA: 97.78 ALOGS: -1.91 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tindamax
tinidazole
tinidazol
trimonase

A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.

Molecular weight: 247.27
Formula: C8H13N3O4S
CLOGP: -0.32
LIPINSKI: 0
HAC: 7
HDO: 0
TPSA: 97.78
ALOGS: -1.91
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	g	V
1.50	g	P
2	g	O
2	g	R

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	98 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	22.50 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	20 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	134.67 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	13 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.80 %	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.59 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
May 17, 2004	FDA	MISSION PHARMA

FDA Adverse Event Reporting System (Female)

None

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
Drug effective for unapproved indication	58.75	54.36	10	134	2592	34954195

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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
Drug effective for unapproved indication	52.46	42.46	10	253	5991	79738134

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A02BD09	ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori
ATC	G01AF21	GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Imidazole derivatives
ATC	J01RA11	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
ATC	J01RA13	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
ATC	J01XD02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER ANTIBACTERIALS Imidazole derivatives
ATC	P01AB02	ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPROTOZOALS AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES Nitroimidazole derivatives
FDA CS	M0014907	Nitroimidazoles
FDA EPC	N0000175435	Nitroimidazole Antimicrobial
MeSH PA	D000477	Alkylating Agents
MeSH PA	D000900	Anti-Bacterial 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
Acute amebiasis	indication	39224005
Infection by Trichomonas	indication	56335008	DOID:1947
Giardiasis	indication	58265007	DOID:10718
Amebic liver abscess	indication	75119003
Bacterial vaginosis	indication	419760006	DOID:3385
Epilepsy	contraindication	84757009	DOID:1826
Peripheral nerve disease	contraindication	302226006
Neutropenic disorder	contraindication	303011007	DOID:1227
Breastfeeding (mother)	contraindication	413712001

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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	1.96	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

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ID	Source
004057	NDDF
033KF7V46H	UNII
10612	RXNORM
12341	IUPHAR_LIGAND_ID
17775	MMSL
2653	INN_ID
324550004	SNOMEDCT_US
395907001	SNOMEDCT_US
4021467	VANDF
54062	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tindamax	HUMAN PRESCRIPTION DRUG LABEL	1	0178-8250	TABLET, FILM COATED	250 mg	ORAL	NDA	29 sections
Tindamax	HUMAN PRESCRIPTION DRUG LABEL	1	0178-8500	TABLET, FILM COATED	500 mg	ORAL	NDA	29 sections
Tindamax	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6155	TABLET, FILM COATED	500 mg	ORAL	NDA	28 sections
Tindazole	HUMAN PRESCRIPTION DRUG LABEL	1	16571-214	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Tindazole	HUMAN PRESCRIPTION DRUG LABEL	1	16571-215	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Tindazole	Human Prescription Drug Label	1	64980-426	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Tindazole	Human Prescription Drug Label	1	64980-426	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Tindazole	Human Prescription Drug Label	1	64980-426	TABLET, FILM COATED	250 mg	ORAL	ANDA	28 sections
Tindazole	Human Prescription Drug Label	1	64980-427	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections
Tindazole	Human Prescription Drug Label	1	64980-427	TABLET, FILM COATED	500 mg	ORAL	ANDA	28 sections

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